Repatha® (evolocumab) Side Effects & Safety Information

Do not use Repatha^® if you are allergic to evolocumab or to any of the ingredients in Repatha^®.

Before you start using Repatha^®, tell your healthcare provider about all your medical conditions, including if you are allergic to rubber or latex, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. The needle covers on the single-use prefilled syringes and the inside of the needle caps on the single-use prefilled SureClick^® autoinjectors contain dry natural rubber. The single-use Pushtronex^® system (on-body infusor with prefilled cartridge) is not made with natural rubber latex.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines, vitamins, or herbal supplements you take.

What are the possible side effects of Repatha^®?

Repatha^® can cause serious side effects including, serious allergic reactions. Stop taking Repatha^® and call your healthcare provider or seek emergency help right away if you have any of these symptoms: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.

The most common side effects of Repatha^® include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes), and redness, pain, or bruising at the injection site.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Repatha^®. Ask your healthcare provider or pharmacist for more information. Call your healthcare provider for medical advice about side effects.

Side effects, cost, dosage, generic, and more

Repatha is a brand-name prescription medication. It’s FDA-approved to:

• Decrease low-density lipoprotein (LDL) cholesterol in adults with primary hyperlipidemia (high cholesterol), including those with heterozygous familial hypercholesterolemia (HeFH). For this purpose, Repatha is used with a healthy diet and may be used with other LDL-lowering drugs or on its own.
• Treat high cholesterol caused by a genetic condition called homozygous familial hypercholesterolemia (HoFH) in adults and in children ages 13 to 17 years. For this purpose, Repatha is used along with a healthy diet and may be used with other LDL-lowering treatments.
• Reduce the risk of heart attack or stroke, and reduce the need for certain types of heart surgery, in adults with heart disease.

Repatha is approved to treat these conditions in certain situations. For more information about how the drug is used, see the “Repatha uses” section below.

Drug details

Repatha belongs to a class of medications called PCSK9 inhibitors. These drugs help your body remove LDL (“bad”) cholesterol more effectively than it could on its own. They work differently than other drugs used for high cholesterol, such as statins, and have different side effects as well. (For more information, see the “Repatha side effects” section below.)

Repatha comes as a liquid solution in three forms:

• Prefilled syringe.
• Prefilled SureClick autoinjector.
• Pushtronex system, which is a single-use, on-body infusor with prefilled cartridges. “On-body” means the infusor attaches to your body. It gives your Repatha injection over about 5 minutes.

Repatha is available in two strengths: 140 milligrams per milliliter (mg/mL) and 420 mg/3.5 mL. Your doctor will prescribe either a 140-mg dose of Repatha every 2 weeks or a 420-mg dose once every month.

Repatha is given by subcutaneous injection (an injection under the skin). You’ll use Repatha at home after your doctor trains you or your caregiver on how to give the injections.

Effectiveness

For information on the effectiveness of Repatha, see the “Repatha uses” section below.

Repatha is a biologic drug that’s available only as a brand-name medication. It doesn’t come in a biosimilar form.

A biologic drug is made from living cells, while other drugs are made from chemicals. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. Biologics, on the other hand, can’t be copied exactly. Therefore, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe.

Like generics, biosimilars are often less expensive compared with brand-name medications.

Repatha can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Repatha. These lists don’t include all possible side effects.

For more information on the possible side effects of Repatha, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Repatha, you can do so through MedWatch.

Mild side effects

Mild side effects of Repatha can include:*

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Repatha. To learn about other mild side effects, talk with your doctor or pharmacist, or view Repatha’s Patient Information.
† For more information on this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Repatha aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects, described below in “Side effect details,” can include:

How long do side effects of Repatha last?

It isn’t known exactly how long side effects from Repatha may last. This could vary from person to person. The drug can stay in your body for up to about 65 days. It’s possible you could experience side effects even after you stop taking the drug as your body continues to get rid of it.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on certain side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Repatha. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

It’s not known how often allergic reaction occurred in people taking Repatha in clinical trials.

Call your doctor right away if you have a severe allergic reaction to Repatha. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Diabetes

It’s possible that Repatha could raise blood sugar levels enough to lead to diabetes. In one large clinical study of Repatha, researchers looked at 27,525 people with heart disease. Some of the people didn’t have diabetes when the study began.

From the group that didn’t have diabetes at the start of the study:

• 8.1% of people who took Repatha developed diabetes
• 7.7% of people who took a placebo developed diabetes

Symptoms of diabetes can include fatigue (lack of energy), feeling thirstier than usual, dry mouth, and needing to urinate more often than usual.

If you experience symptoms of diabetes, talk with your doctor.

Muscle pain

Some people may experience muscle pain while taking Repatha. In one clinical study, people with heart disease received either Repatha or a placebo (a treatment with no active drug). Everyone also received a statin drug. The results showed that:

• 5% of people who took Repatha plus a statin drug had a muscle-related side effect
• 4.8% of people who took a placebo plus a statin drug had a muscle-related side effect

Muscle pain is also a possible side effect of statin drugs. Repatha is sometimes used with a statin for treating high cholesterol that can’t be lowered with a statin alone.

If you experience muscle pain while taking Repatha, talk with your doctor. They may have you try a different medication to treat your condition.

Weight loss

Weight loss wasn’t a side effect reported in clinical studies of Repatha. However, weight loss can be caused by gastroenteritis, which was a side effect seen in studies of Repatha. Gastroenteritis is swelling in your stomach and intestines that can cause diarrhea and abdominal (belly) cramps.

In clinical studies:

• 3% to 6.1% of people who took Repatha had gastroenteritis, depending on the condition treated
• 0% to 2% of people who took a placebo had gastroenteritis, depending on the condition treated

If you experience unexpected weight loss while taking Repatha, talk with your doctor.

Hair loss (not a side effect)

Hair loss isn’t a known side effect of Repatha. It wasn’t reported in clinical studies of the drug.

If you have concerns about hair loss during your treatment, talk with your doctor.

As with all medications, the cost of Repatha can vary. To find current prices for Repatha in your area, check out GoodRx.com.

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you may have to get Repatha at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively. Your insurance company may require you to use a specialty pharmacy to get Repatha.

Before approving coverage for Repatha, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Repatha, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Repatha, or if you need help understanding your insurance coverage, help is available.

Amgen, the manufacturer of Repatha, offers the RepathaReady program. This program includes access to the Repatha Copay Card, which may help lower the cost of the drug for you. For more information and to find out if you’re eligible for support, call 844-REPATHA (844-737-2842) or visit the manufacturer’s website.

Biosimilar version

Repatha is available only as a brand-name medication. It’s a biologic drug that isn’t currently available in generic or biosimilar form.

Biologic drugs are made using living cells. It’s not possible for drug companies to produce exact copies of these medications. A generic drug, by contrast, is an exact copy of a brand-name drug that’s made from chemicals.

A biosimilar drug is a bit like a generic version of a biologic drug. It’s a very similar version of the parent biologic drug, but it’s not identical. Biosimilar drugs are made to treat the same conditions as the parent drug. They’re considered to be as safe and effective as the parent drug.

The Repatha dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using Repatha to treat
• your preference for the size of your Repatha dose
• your preference for how often you want to receive your Repatha dose

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Repatha comes in three forms:

• Prefilled syringe.
• Prefilled SureClick autoinjector.
• Pushtronex system, which is a single-use, on-body infusor with prefilled cartridges. “On-body” means the infusor attaches to your body. It gives your Repatha injection over about 5 minutes.

Each of the three forms of Repatha contains a colorless or pale yellow liquid solution, which is given by subcutaneous injection (an injection under the skin).

Repatha is available in two strengths: 140 milligrams per milliliter (mg/mL) and 420 mg/3.5 mL. The 420 mg/3.5 mL strength is only available in the cartridges used with the Pushtronex system.

You’ll use Repatha at home after your doctor trains you or your caregiver on how to give the injections. If you take other injectable drugs, you shouldn’t inject those drugs into the same area where you inject Repatha.

See the “How to use Repatha” section below for information about using this drug.

Dosage for decreasing LDL cholesterol in adults with primary hyperlipidemia

Repatha is approved to decrease low-density lipoprotein (LDL) cholesterol in adults with primary hyperlipidemia (high cholesterol), including those with heterozygous familial hypercholesterolemia (HeFH).

For treating primary hyperlipidemia, the recommended dose of Repatha is either:

• 140 mg given by subcutaneous injection every 2 weeks
• 420 mg given by subcutaneous injection once every month

If your doctor prescribes the 140-mg dose, you’ll use either a prefilled syringe or the prefilled SureClick autoinjector for your dose.

If your doctor prescribes the 420-mg dose, you can use the Pushtronex system to inject a prefilled cartridge over 5 minutes. Or you can use the SureClick autoinjector or prefilled syringe to give three consecutive injections within 30 minutes.

Dosage for decreasing LDL cholesterol in adults and children with HoFH

For lowering LDL cholesterol in adults and children with homozygous familial hypercholesterolemia (HoFH), the recommended Repatha dosage is 420 mg given by subcutaneous injection once a month.

There are two options for receiving your dose:

• using the Pushtronex system to inject a prefilled cartridge over 5 minutes
• using the SureClick autoinjector or prefilled syringe to give three consecutive injections within 30 minutes

Dosage for reducing the risk of heart attack or stroke, and reducing the need for certain heart surgeries in adults with heart disease

Repatha is approved to lower the risk of heart attack or stroke, and to reduce the need for certain heart surgeries in adults with heart disease.

For these purposes, the recommended dose of Repatha is either:

• 140 mg by subcutaneous injection every 2 weeks
• 420 mg by subcutaneous injection once a month

If your doctor prescribes the 140-mg dose, you’ll use either a prefilled syringe or the prefilled SureClick autoinjector for your dose.

If your doctor prescribes the 420-mg dose, you can use the Pushtronex system to inject a prefilled cartridge over 5 minutes. Or you can use the SureClick autoinjector or prefilled syringe to give three consecutive injections within 30 minutes.

Pediatric dosage

The recommended Repatha dose for lowering LDL cholesterol in children with homozygous familial hypercholesterolemia (HoFH) is 420 mg by subcutaneous injection once a month.

There are two ways your child can receive their dose:

• using the Pushtronex system to inject a prefilled cartridge over 5 minutes
• using the SureClick autoinjector or prefilled syringe to give three consecutive injections within 30 minutes

Dosage questions

Below are answers to some questions you may have about taking Repatha.

What if I miss a dose?

If you miss your Repatha dose, take your dose within 7 days of the missed dose. Then go back to your original dosing schedule.

In some cases, you may not be able to take your missed dose within 7 days of the scheduled dose date. For example, this may happen if you’re traveling and accidentally leave the drug at home. What you should do depends on the Repatha dose your doctor prescribes.

If you’re taking Repatha every 2 weeks, you should skip the missed dose and wait to take your next Repatha dose as scheduled. If you’re taking Repatha once a month, go ahead and take your missed dose, even if it’s been more than 7 days. Then use that date to create your new dosing schedule.

If you’re unsure whether you should take your missed dose or not, call your doctor to check.

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Repatha is meant to be used as a long-term treatment. If you and your doctor determine that Repatha is safe and effective for you, you’ll likely take it long term.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Repatha, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for lowering LDL cholesterol in adults with primary hyperlipidemia

Examples of other drugs that may be used to lower low-density lipoprotein (LDL) cholesterol in adults with primary hyperlipidemia (high cholesterol) include:

• statin drugs,* such as:
• bile acid binding resins, such as:
  • cholestyramine (Prevalite)
• ezetimibe (Zetia)
• fibrates, such as:
  • fenofibrate (Antara, Lipofen, Tricor)
• other injectable medications, such as:

* Some of these drugs are also approved to reduce the risk of death from heart problems or stroke. For more information about your treatment options, talk with your doctor.

Alternatives for lowering LDL cholesterol in adults and children with HoFH

Examples of other drugs that may be used to treat homozygous familial hypercholesterolemia (HoFH) include:

• other injectable medications, such as
• bile acid sequestrants, such as:
  • cholestyramine (Prevalite, Questran)
• statins, such as:

Alternatives for reducing the risk of heart attack or stroke, and for reducing the need for certain heart surgeries in adults with heart disease

Other drugs are used to reduce the risk of heart attack or stroke, and to reduce the need for certain heart surgeries in adults with heart disease. Examples of these other drugs include:

• Statin drugs, such as:
• other injectable medications, such as:

You may wonder how Repatha compares with other medications that are prescribed for similar uses. Here we look at how Repatha and Praluent are alike and different.

Ingredients

Repatha contains the active drug evolocumab, which belongs to a class of medications known as PCSK9 inhibitors.

Praluent contains the active drug alirocumab, which is also a PCSK9 inhibitor.

Uses

Here is a list of conditions that the Food and Drug Administration (FDA) has approved Repatha and Praluent to treat.

• Both Repatha and Praluent are FDA-approved to:
• Repatha is also FDA-approved to:
  • Treat high cholesterol caused by a genetic condition called homozygous familial hypercholesterolemia (HoFH) in adults and children ages 13 to 17 years. For this purpose, Repatha is used with a healthy diet and other LDL-lowering treatments.

Drug forms and administration

Both Repatha and Praluent come as a liquid that’s given as a subcutaneous injection (an injection under the skin).

Repatha and Praluent both come as prefilled syringes.

Repatha is also available in a SureClick autoinjector and as the Pushtronex system, which is a single-use, on-body infusor with prefilled cartridges.

Praluent also comes as a prefilled pen.

Side effects and risks

Repatha and Praluent have some similar side effects and others that vary. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Repatha and Praluent (when taken individually).

• Can occur with Repatha:
  • pain in your back or muscles
• Can occur with Praluent:
  • few unique mild side effects
• Can occur with both Repatha and Praluent:
  • bruising, pain, or redness at the injection site

Serious side effects

Here’s an example of a serious side effect that can occur with both Repatha and Praluent (when taken individually):

Effectiveness

Repatha and Praluent have different FDA-approved uses, but they’re both used to:

• lower LDL cholesterol in adults with primary hyperlipidemia (high cholesterol), when used with a healthy diet
• reduce the risk of cardiovascular problems (such as heart attack and stroke) in adults

These drugs haven’t been directly compared in clinical studies. However, studies have found both Repatha and Praluent to be effective for treating high cholesterol.

Costs

According to estimates on GoodRx.com, Repatha and Praluent generally cost about the same. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Repatha and Praluent are both biologic drugs that aren’t currently available in generic or biosimilar form.

Biologic drugs are made using living cells. It’s not possible for drug companies to produce exact copies of these medications. A generic drug, by contrast, is an exact copy of a brand-name drug that’s made from chemicals.

A biosimilar drug is a bit like a generic version of a biologic drug. It’s a very similar version of the parent biologic drug, but it’s not identical. Biosimilar drugs are made to treat the same conditions as the parent drug. They’re considered to be as safe and effective as the parent drug.

Repatha and Crestor are prescribed for similar uses. Here we look at how these drugs are alike and different.

Ingredients

Repatha contains the active drug evolocumab, which belongs to a class of medications known as PCSK9 inhibitors. Crestor contains the active drug rosuvastatin, which is a statin.

Uses

Here is a list of conditions that the Food and Drug Administration (FDA) has approved Repatha and Crestor to treat.

• Both Repatha and Crestor are FDA-approved to:
  • treat primary hyperlipidemia (high cholesterol) in adults, when used with a healthy diet
  • treat high cholesterol caused by homozygous familial hypercholesterolemia (HoFH) in adults and children,* when used with a healthy diet
• Crestor is also FDA-approved to treat:
  • primary dysbetalipoproteinemia (a genetic condition that causes high total cholesterol, high triglycerides, and low HDL levels)
  • heterozygous familial hypercholesterolemia (HeFH) in children ages 8 to 17 years

* For this purpose, Repatha can be used in children ages 13 to 17 years, while Crestor can be used in children ages 7 to 17 years.

Drug forms and administration

Repatha comes in three forms:

• prefilled syringe
• prefilled SureClick autoinjector
• Pushtronex system, which is a single-use, on-body infusor with prefilled cartridges

Crestor comes as a tablet that you take by mouth.

Side effects and risks

Repatha and Crestor have some similar side effects and other that vary. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Repatha and Crestor (when taken individually).

• Can occur with Repatha:
  • bruising, pain, or redness at the injection site
• Can occur with Crestor:
• Can occur with both Repatha and Crestor:

Serious side effects

These lists contain examples of serious side effects that can occur with Repatha, with Crestor, or with both drugs (when taken individually).

• Can occur with Repatha:
  • no unique serious side effects
• Can occur with Crestor:
• Can occur with both Repatha and Crestor:

Effectiveness

Repatha and Crestor have different FDA-approved uses, but they’re both used to:

• treat primary hyperlipidemia (high cholesterol) in adults, when used with a healthy diet
• treat high cholesterol caused by homozygous familial hypercholesterolemia (HoFH) in adults and children, when used with a healthy diet
• reduce the risk of cardiovascular problems (such as heart attack and stroke) in adults

These drugs haven’t been directly compared in clinical studies. However, studies have found both Repatha and Crestor to be effective for the conditions they’re approved to treat.

Costs

According to estimates on GoodRx.com, Repatha costs more than Crestor. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Repatha and Crestor are both brand-name drugs. Repatha is available only as a brand-name medication. It’s a biologic drug that isn’t currently available in generic or biosimilar form.

Biologic drugs are made using living cells. It’s not possible for drug companies to produce exact copies of these medications. A biosimilar is very similar version of the parent biologic drug, but it’s not identical. Biosimilar drugs are made to treat the same conditions as the parent drug.

Crestor is available as a generic drug called rosuvastatin. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug.

Biosimilars and generics tend to cost less than brand-name drugs.

The Food and Drug Administration (FDA) approves prescription drugs such as Repatha to treat certain conditions. Repatha may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Repatha for decreasing LDL cholesterol in adults with primary hyperlipidemia

Repatha is FDA-approved to decrease low-density lipoprotein (LDL) cholesterol in adults with primary hyperlipidemia (high cholesterol). For this purpose, Repatha can be used in people with heterozygous familial hypercholesterolemia (HeFH).

For treating primary hyperlipidemia, Repatha is used along with a healthy diet, as recommended by your doctor. Repatha can be used with other medications to treat your condition or used alone.

LDL cholesterol is sometimes referred to as “bad cholesterol.” Repatha works to lower LDL cholesterol by helping your body get rid of LDL more effectively.

Effectiveness for decreasing LDL cholesterol in adults with primary hyperlipidemia

A clinical study has shown Repatha is effective for decreasing LDL cholesterol levels in adults with primary hyperlipidemia.

The adults first took a statin drug for 4 weeks before the study began. Then in the study they were randomly assigned to take either 140 milligrams (mg) of Repatha every 2 weeks, 420 mg of Repatha once a month, or a placebo (a treatment with no active drug). Each person continued taking the statin they were randomly assigned to take before the study. The researchers wanted to see how the treatments compared at lowering LDL cholesterol.

After 12 weeks:

• people who received 140 mg of Repatha every 2 weeks with a statin had their LDL levels lowered by 63%
• people who received a placebo every 2 weeks had their LDL levels increased by 8%

In addition, after 12 weeks:

• people who received 420 mg of Repatha once a month had their LDL levels reduced by 59%
• people who received a placebo once a month had their LDL levels increased by 4%

Repatha for reducing the risk of heart attack or stroke, and reducing the need for certain heart surgeries in adults with heart disease

Repatha is FDA-approved to reduce the risk of heart attack or stroke, and to reduce the need for certain heart surgeries in adults with heart disease. People who may take Repatha for this purpose include those who:

Having high cholesterol raises your risk for complications from heart disease, like heart attack or stroke. By lowering your cholesterol levels, Repatha helps reduce your risk for complications from heart disease.

Effectiveness for reducing the risk of heart attack or stroke, and reducing the need for certain heart surgeries in adults with heart disease

In a clinical study, Repatha was effective at reducing the risk of heart attack or stroke in adults with heart disease. It was also effective at reducing the need for certain heart surgeries in adults with heart disease.

This study looked at adults who already had heart disease. Of these:

• 81% had previously had a heart attack
• 19% had previously had a nonhemorrhagic stroke (stroke not caused by a blood vessel in the brain breaking or leaking)
• 13% had peripheral vascular disease

People in the study were randomly chosen to get either Repatha or a placebo (a treatment with no active drug). They continued using other medications they were already taking. People who were assigned to get Repatha received either 140 mg every 2 weeks or 420 mg once a month.

The researchers compared the effectiveness of Repatha and a placebo by measuring the average time it took for a person in the study to experience any of the following:

The results below are reported in patient years. This shows how many people are expected to experience a result, depending on the number of people receiving treatment and their treatment length.

At the end of the study:

• heart attack, stroke, death from cardiovascular disease, hospitalization for unstable angina and certain types of heart surgery occurred at a rate of 4.5 per 100 patient years in people received Repatha. This means if 100 people took Repatha for 1 year, between 4 and 5 people would experience heart attack, stroke, or certain heart surgeries.
• heart attack, stroke, death from cardiovascular disease, hospitalization for unstable angina and certain types of heart surgery occurred at a rate of 5.2 per 100 patient years in people who received the placebo. This means if 100 people took Repatha for 1 year, about 5 people would experience heart attack, stroke, or certain heart surgeries.

Repatha for lowering LDL cholesterol in adults and children with HoFH

Repatha is also FDA-approved to lower LDL (“bad”) cholesterol in adults and children with a condition called homozygous familial hypercholesterolemia (HoFH).

HoFH is a rare condition caused by a genetic mutation (an abnormal change in a gene) in the genes that control how cholesterol is cleared from your body. The condition is called “homozygous” because the genes that cause it are inherited from both parents. People with HoFH have high levels of LDL cholesterol.

For treating HoFH, Repatha should be used along with the diet recommended by your doctor. In addition, your doctor may prescribe other LDL-lowering treatments, such as statin drugs, for use with Repatha.

Repatha is used in people with HoFH who’ve tried lowering their LDL cholesterol with diet and other treatments but still need help lowering their cholesterol.

Effectiveness for lowering LDL cholesterol in adults and children with HoFH

A 12-week clinical study comparing Repatha with a placebo found Repatha to be effective for lowering LDL cholesterol levels in adults and children with HoFH.

People in the study were randomly assigned to receive either 420 mg of Repatha or a placebo (a treatment with no active drug) once a month. They also continued taking any other treatments to lower cholesterol that they were using before the study.

Researchers measured LDL levels before the study and again after 12 weeks. They found that:

• people who received Repatha had their LDL levels lowered by 22%
• people who received the placebo had their LDL levels increased by 9%

Repatha and children

Repatha is FDA-approved for use in children ages 13 to 17 years with homozygous familial hypercholesterolemia (HoFH). To learn more, see the section directly above.

Here are answers to some frequently asked questions about Repatha.

Will Repatha cure my condition?

No, Repatha won’t cure your condition. Repatha treats several types of high cholesterol. It also reduces the risk of heart attack, stroke, and the need for certain heart surgeries in adults with heart disease.

However, Repatha isn’t a cure. There currently isn’t a known cure for any of the conditions that Repatha is approved to treat.

If you have questions about how Repatha works to treat your condition, talk with your doctor.

Is Repatha a statin?

No, Repatha isn’t a statin. Repatha belongs to a class of medications called PCSK9 inhibitors.

Statins lower cholesterol by preventing your liver from making new cholesterol. PCSK9 inhibitors, on the hand, help your body get rid of cholesterol by blocking a certain protein in your liver that allows cholesterol to build up in your blood. For more information, see the “How Repatha works” section below.

Your doctor may prescribe Repatha along with a statin drug. If you have questions about the differences between Repatha and statin drugs, talk with your doctor.

Does Repatha have to be used with a statin?

Whether you take Repatha with other drugs, including statins, depends on the condition you’re using Repatha to treat.

For treating primary hyperlipidemia (high cholesterol), including heterozygous familial hypercholesterolemia (HeFH), in adults, Repatha may be used alone. It may also be used with other drugs that lower your cholesterol, such as a statin.

For treating homozygous familial hypercholesterolemia (HoFH) in adults and children, Repatha should be used with other treatments for high cholesterol. This could include a statin, or it could include other types of medications that lower cholesterol. It could also include treatments besides medications, such as LDL apheresis. (LDL apheresis uses a machine to filter LDL cholesterol out of your blood.)

Repatha and statins have some side effects in common. However, statins can also cause other side effects, including joint pain, pancreatitis, and rhabdomyolysis (a serious condition that breaks down muscle tissue).

To learn more about other drugs that may be used with Repatha, see the “Repatha use with other drugs” section below. If you have questions about other treatments that may be used with Repatha, talk with your doctor.

Will Repatha reduce plaque in my arteries?

It’s possible that Repatha could reduce plaque (fatty deposits) in your arteries.

Repatha belongs to a class of medications known as PCSK9 inhibitors. These types of drugs are relatively new, and researchers are still learning about how they work and what conditions they may be able to treat.

In a clinical study, Repatha used with a statin reduced artery plaque better than a placebo used with a statin. However, more research is needed to fully understand the effects PCSK9 inhibitors such as Repatha have on plaque in your arteries.

If you have questions about reducing plaque in your arteries, talk with your doctor.

Could Repatha affect my kidneys or liver?

Repatha isn’t known to affect your kidneys or liver. In clinical studies, people taking Repatha didn’t have liver side effects, including changes in their levels of liver enzymes. There were also no cases of people taking Repatha developing kidney disease during treatment.

In addition, since Repatha was released onto the market, it hasn’t been reported to cause kidney or liver side effects.

However, kidney or liver side effects can occur with statin drugs. Your doctor may prescribe a statin for you to use with Repatha.

If you have questions about side effects of Repatha or other medications you may take with it, talk with your doctor or pharmacist. They can review your medications and determine if you have an increased risk for any side effects because of other drugs you’re taking.

There are no known interactions between Repatha and alcohol. However, excessive alcohol use can damage your liver over time. If you have a history of heavy alcohol use and take Repatha with a statin drug, you may have a higher risk for side effects from the statin. For more information, see “Could Repatha affect my kidneys or liver?” in the “Common questions about Repatha” section directly above.

If you drink alcohol, talk with your doctor about whether it’s safe for you to drink during your Repatha treatment. Also, if you have a history of heavy drinking or of liver damage, tell your doctor before you begin taking Repatha with a statin drug.

Repatha is FDA-approved to:

• Decrease low-density lipoprotein (LDL) cholesterol in adults with primary hyperlipidemia (high cholesterol), including those with heterozygous familial hypercholesterolemia (HeFH). For this purpose, Repatha is used with a healthy diet and may be used with other LDL-lowering drugs or on its own.
• Treat high cholesterol caused by a genetic condition called homozygous familial hypercholesterolemia (HoFH) in adults and children ages 13 to 17 years. For this purpose, Repatha is used along with a healthy diet and other LDL-lowering treatments.
• Reduce the risk of heart attack or stroke, and reduce the need for certain types of heart surgery in adults with heart disease.

What happens with high cholesterol

Cholesterol is a fatty substance found in the cells of your body. It’s made in your liver. Cholesterol can also be found in foods such as eggs, cheese, and meat.

Cholesterol itself isn’t a harmful substance. Your body uses cholesterol to make some vitamins, hormones, and fluids that help you digest food.

High cholesterol occurs when you have more cholesterol in your blood than your body needs. This may be caused by genetics, smoking, not getting enough physical activity, or eating too many foods that are high in cholesterol. High cholesterol can raise your risk for heart disease.

What Repatha does

Repatha works by attaching to an enzyme (a protein that helps certain reactions happen in the body). This enzyme, called PCSK9, is found in your liver. Repatha blocks this enzyme from working, which helps your body remove cholesterol more effectively.

Repatha for heart disease

The FDA has approved Repatha to reduce the risk of heart attack or stroke, and to reduce the need for certain heart surgeries in adults with heart disease. People who may take Repatha for this purpose include those who:

Having high cholesterol levels in your blood raises your risk for complications from heart disease, like heart attack or stroke. By lowering your cholesterol levels, Reatha helps reduce your risk for complications from heart disease.

How long does it take to work?

Repatha begins working as soon as you inject your dose. It takes about 4 hours after you take your dose for Repatha to start blocking the PCSK9 enzyme to its full ability.

However, you’re unlikely to notice the drug working in your body. This is because you can’t feel your cholesterol increasing or decreasing. Blood test results are the only way to tell if the drug is working.

You should take Repatha according to your doctor’s or healthcare provider’s instructions.

Repatha is given by subcutaneous injection (an injection under the skin) either every 2 weeks or once per month. Repatha comes in three forms:

• Prefilled syringe.
• Prefilled SureClick autoinjector.
• Pushtronex system, which is a single-use, on-body infusor with prefilled cartridges. “On-body” means the infusor attaches to your body. It gives your Repatha injection over about 5 minutes.

Your doctor or healthcare provider will train you or your caregiver on how to give Repatha injections at home. The drug manufacturer’s website also has step-by-step instructions for giving the Repatha injection.

What to do before your dose

Before using Repatha, take the drug out of the refrigerator and allow it to warm to room temperature (68°F to 77°F/20°C to 25°C). Repatha shouldn’t be warmed or heated by any other method. Warm the drug for the following times:

• If you’re using the prefilled syringe or the prefilled SureClick autoinjector, allow it to warm for at least 30 minutes before using it.
• If you’re using the prefilled cartridge with the Pushtronex system, it needs to warm at room temperature for at least 45 minutes.

Each form of Repatha contains a colorless or pale yellow liquid solution. Be sure to check for any discoloration or particles in your Repatha liquid before giving yourself an injection.

If the solution looks discolored or has particles floating in it, don’t use it. Instead, use a new Repatha dose. Then call 844-REPATHA (844-737-2842) to report this issue to the drug manufacturer.

When to use

You can give your Repatha injection at any time of day.

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Where to inject Repatha

Injection sites for Repatha include the abdomen (belly), upper arm,* or thigh. The injection site you use should be rotated for each injection. You’ll be able to use Repatha at home after your doctor trains you or your caregiver on how to give the injections.

* If you want to inject Repatha into your upper arm, you’ll need someone else to give you the injection.

When you get Repatha from the pharmacy, the pharmacist will add an expiration date to the label on the box. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Repatha prefilled syringes should be refrigerated at a temperature of 36°F to 46°F (2°C to 8°C) in the original carton. This helps protected the syringes from light. You shouldn’t put Repatha in the freezer.

You may also keep Repatha at room temperature (68°F to 77°F/20°C to 25°C) in the original carton. However, if you store Repatha this way, it must be used within 30 days. Any part of the drug that isn’t used within 30 days should be thrown away.

Disposal

Right after you’ve used a syringe, needle, or autoinjector, dispose of it in an FDA-approved sharps disposal container. This helps prevent others, including children and pets, from taking the drug by accident or harming themselves with the needle. You can buy a sharps container online, or ask your doctor, pharmacist, or health insurance company where to get one.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

Depending on the condition it’s being used to treat, Repatha may be used alone or with other medications.

Repatha can be used alone in adults with primary hyperlipidemia (high cholesterol), including heterozygous familial hypercholesterolemia (HeFH). It may also be used with other drugs that lower your cholesterol. Examples of drugs that may be used with Repatha to treat high cholesterol include ezetimibe (Zetia), and statins such as Lipitor or Crestor.

For treating homozygous familial hypercholesterolemia (HoFH) in adults and children, Repatha is used with other cholesterol drugs. This could include ezetimibe (Zetia) and statins such as Lipitor or Crestor.

Repatha is also used to reduce the risk of heart attack or stroke, and to reduce the need for certain heart surgeries in adults with heart disease. For this purpose, Repatha doesn’t have to be used with any specific medication. Your doctor will likely have you continue to take the drugs you use for other conditions, including heart disease.

If you have questions about using Repatha with other drugs, talk with your doctor or pharmacist.

Repatha isn’t known to interact with other medications. And it’s not known to interact with supplements or foods.

However, you should still talk with your doctor or pharmacist about possible interactions before taking Repatha. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid any potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

It’s not known whether Repatha is safe to use while pregnant. This drug hasn’t been studied during pregnancy. The drug didn’t appear to cause harm when studied in pregnant monkeys, but animal studies don’t always predict what will happen in people.

If you’re using Repatha and become pregnant, consider joining the Repatha pregnancy registry. This program helps collect data on the safety of using Repatha during pregnancy. You can learn more by visiting the program website or by calling 877-311-8972.

If you’re pregnant or planning a pregnancy, talk with your doctor about the risks and benefits of taking Repatha.

It’s not known if Repatha is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Repatha.

For more information about taking Repatha during pregnancy, see the “Repatha and pregnancy” section above.

It isn’t known if Repatha is safe to use while breastfeeding. This is because it’s not known if the drug passes into breast milk or the effect it could have on a child who is breastfed. In addition, no clinical studies of Repatha have involved lactating animals.

If you’re currently breastfeeding or planning to breastfeed, talk with your doctor about the risks and benefits of using Repatha.

Before taking Repatha, talk with your doctor about your health history. Repatha may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Latex or rubber allergy. If you have a latex or rubber allergy, you may not be able to use certain forms of Repatha. The needle covers used on Repatha prefilled syringes and the caps for the SureClick autoinjectors contain rubber. However, the Repatha single-use Pushtronex system is not made with natural rubber latex. Therefore, you may be able to use this form of the drug. Before taking Repatha, talk with your doctor about any allergies you may have.
• Allergic reaction. If you’ve had an allergic reaction to Repatha or any of its ingredients, you shouldn’t take Repatha. Ask your doctor what other medications may be better options for you.
• Pregnancy. It isn’t known if Repatha is safe to use during pregnancy. For more information, see the “Repatha and pregnancy” section above.
• Breastfeeding. It isn’t known if it’s safe to use Repatha while breastfeeding. For more information, see the “Repatha and breastfeeding” section above.

Note: For more information about the potential negative effects of Repatha, see the “Repatha side effects” section above.

Do not use more Repatha than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Repatha

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

The following information is provided for clinicians and other healthcare professionals.

Indications

Repatha is indicated by the FDA for:

• together with diet, treating primary hyperlipidemia (including heterozygous familial hypercholesterolemia) in adults, either alone or with other therapies to lower cholesterol
• together with diet, treating homozygous familial hypercholesterolemia (HoFH) in adults and children
• reducing the risk of heart attack, stroke, and certain types of heart surgery in adults with heart disease

Administration

Repatha is administered by subcutaneous injection either every 2 weeks or once monthly. Repatha injections may be given into the abdomen, upper arm, or thigh. This injection site should be rotated for each injection. People taking the drug or caregivers may be trained on preparing and injecting Repatha at home.

Prior to administering Repatha, allow the drug to warm at room temperature (68°F to 77°F/20°C to 25°C). This should be done at least 30 minutes before using the single-use prefilled autoinjector or prefilled syringe. For the single-use, on-body infuser plus prefilled cartridge, this should be done at least 45 minutes before use. Repatha should not be warmed or heated via any other method.

Repatha products should be visually checked for any particles or discoloration before use. If the Repatha solution appears cloudy, discolored, or contains particles, it should not be used.

If a dose is missed, Repatha should be administered within 7 days of the missed dose. Then the original dosing schedule can be resumed.

The 420-mg dose of Repatha may be administered by one of two methods:

• using the single-use, on-body infuser to inject a prefilled cartridge over 5 minutes
• giving three consecutive injections within 30 minutes, using the single-use prefilled autoinjector or prefilled syringe

Mechanism of action

The active drug in Repatha, evolocumab, is a monoclonal IgG2 antibody. It targets proprotein convertase subtilisin kexin type 9 (PCSK9), a protein that mediates LDL receptor degradation. Inhibition of PCSK9 increases the number of low-density lipoprotein (LDL) receptors available to remove LDL from the blood.

Pharmacokinetics and metabolism

After a single administration, Repatha reaches its median peak serum concentration after 3 to 4 days. Repatha reaches steady-state following 12 weeks of dosing.

Elimination of Repatha is primarily through a proteolytic pathway not susceptible to saturation. The estimated effective half-life is 11 to 17 days.

Contraindications

Repatha is contraindicated in people with a history of allergic or hypersensitivity reaction to Repatha or any of its ingredients.

Storage

Repatha prefilled syringes should be refrigerated at a temperature of 36°F to 46°F (2°C to 8°C). It should be stored in the original carton, which protects the syringes from light. Do not freeze Repatha.

Repatha may also be stored at room temperature (68°F to 77°F/20°C to 25°C) in the original carton. However, if Repatha is stored in this manner, it must be used within 30 days. Any syringes that aren’t used within 30 days should be discarded.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Repatha SureClick – Patient Information Leaflet (PIL)

Repatha 140 mg solution for injection in pre-filled pen

evolocumab

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Repatha is and what it is used for

2. What you need to know before you use Repatha

3. How to use Repatha

4. Possible side effects

5. How to store Repatha

6. Contents of the pack and other information

Repatha is a medicine that lowers levels of ’bad’ cholesterol, a type of fat, in the blood.

Repatha contains the active substance evolocumab, a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body). Evolocumab is designed to attach to a substance called PCSK9 that affects the liver’s ability to take in cholesterol. By attaching to, and mopping up PCSK9, the medicine increases the amount of cholesterol entering the liver and so lowers the level of cholesterol in the blood.

Repatha is used in addition to your cholesterol lowering diet if you are:

• an adult with a high cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia). It is given:
  
  • together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
  • alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.
• 12 years and older with a high cholesterol level in your blood because of a condition that runs in your family (homozygous familial hypercholesterolaemia or HoFH). It is given:
  
  • together with other cholesterol lowering treatments.
• an adult with a high cholesterol level in your blood and established atherosclerotic cardiovascular disease (a history of heart attack, stroke or blood vessel problems). It is given:
  
  • together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
  • alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.

Repatha is used in patients who cannot control their cholesterol levels with a cholesterol lowering diet alone. You should stay on your cholesterol lowering diet while taking this medicine. Repatha can help prevent heart attack, stroke, and certain heart procedures to restore blood flow to the heart due to a build-up of fatty deposits in your arteries (also known as atherosclerotic cardiovascular disease).

Do not use Repatha if you are allergic to evolocumab or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor, pharmacist or nurse before using Repatha if you have liver disease.

The needle cover of the glass pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause severe allergic reactions.

The use of Repatha has not been studied in children under 18 years of age being treated for primary hypercholesterolaemia and mixed dyslipidaemia.

The use of Repatha has not been studied in children under 12 years of age being treated for homozygous familial hypercholesterolaemia.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Repatha has not been tested in pregnant women. It is not known if Repatha will harm your unborn baby.

It is not known whether Repatha is found in breast milk.

It is important to tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Repatha, considering the benefit of breast-feeding to the baby and the benefit of Repatha to the mother.

Repatha has no or negligible influence on the ability to drive and use machines.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose depends on the underlying condition:

• for adults with primary hypercholesterolaemia and mixed dyslipidaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
• for adults or adolescents with homozygous familial hypercholesterolaemia the recommended starting dose is 420 mg once monthly. After 12 weeks your doctor may decide to increase the dose to 420 mg every two weeks. If you also receive apheresis, a procedure similar to dialysis where cholesterol and other fats are removed from the blood, your doctor may decide to start you on a dose of 420 mg every two weeks to coincide with your apheresis treatment.
• for adults with established atherosclerotic cardiovascular disease (a history of heart attack, stroke or blood vessel problems) the dose is either 140 mg every two weeks or 420 mg once monthly.

Repatha is given as an injection under the skin (subcutaneous).

If your doctor prescribes a dose of 420 mg you must use three pre-filled pens because each pre-filled pen only contains 140 mg of medicine. After reaching room temperature, all injections should be given within a 30 minute period.

If your doctor decides that you or a caregiver can give the injections of Repatha, you or your caregiver should receive training on how to prepare and inject Repatha correctly. Do not try to inject Repatha until you have been shown how to do it by your doctor or nurse.

See the detailed “Instructions for Use” at the end of this leaflet for instructions about how to store, prepare, and give your Repatha injections at home. If using the pre-filled pen, place the correct (yellow) end of the pen on the skin before injecting.

Before starting Repatha, you should be on a diet to lower your cholesterol. You should keep on this cholesterol lowering diet while taking Repatha.

If your doctor has prescribed Repatha along with another cholesterol lowering medicine, follow your doctor’s instructions on how to take these medicines together. In this case, please read the dosage instructions in the package leaflet of that particular medicine as well.

Contact your doctor or pharmacist immediately.

Take Repatha as soon as you can after the missed dose. Then, contact your doctor who will tell you when you should schedule your next dose, and follow the new schedule exactly as your doctor has told you.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

• Flu (high temperature, sore throat, runny nose, cough and chills)
• Common cold, such as runny nose, sore throat or sinus infections (nasopharyngitis or upper respiratory tract infections)
• Feeling sick (nausea)
• Back pain
• Joint pain (arthralgia)
• Injection site reactions, such as bruising, redness, bleeding, pain or swelling
• Allergic reactions including rash

Uncommon (may affect up to 1 in 100 people)

• Hives, red itchy bumps on your skin (urticaria)
• Flu-like symptoms

Rare: (may affect up to 1 in 1,000 people)

• Swelling of the face, mouth, tongue, or throat (angioedema)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GZR-1368 Gzira

Website: www.medicinesauthority.gov.mt

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Do not freeze.

Store in the original carton in order to protect from light.

Your pre-filled pen may be left outside the refrigerator to reach room temperature (up to 25°C) before injection. This will make the injection more comfortable. After removal from the refrigerator, Repatha may be stored at room temperature (up to 25°C) in the original carton and must be used within 1 month.

Do not use this medicine if you notice it is discoloured or contains large lumps, flakes or coloured particles.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

• The active substance is evolocumab. Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
• The other ingredients are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

Repatha is a solution which is clear to opalescent, colourless to yellowish, and practically free from particles.

Each pack contains one, two, three or six single use SureClick pre-filled pens.

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Marketing Authorisation Holder

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Manufacturer

Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland

Manufacturer

Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom

Amgen Limited

Tel: +44 (0)1223 420305

This leaflet was last revised in April 2020.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Repatha single use SureClick pre-filled pen

Before you use the Repatha pre-filled pen, read this important information:

• Do not freeze or use the Repatha pre-filled pen if it has been frozen.
• Do not remove the orange cap from the Repatha pre-filled pen until you are ready to inject.
• Do not use the Repatha pre-filled pen if it has been dropped on a hard surface. Part of the Repatha pre-filled pen may be broken even if you cannot see the break.

A Remove one Repatha pre-filled pen from the package.

1. Carefully lift the pre-filled pen straight up out of the box.

2. Put the original package with any unused pre-filled pens back in the refrigerator.

3. Wait at least 30 minutes for the pre-filled pen to naturally reach room temperature before injecting.

Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.

Do not leave the pre-filled pen in direct sunlight.

Do not shake the pre-filled pen.

Do not remove the orange cap from the pre-filled pen yet.

B Inspect the Repatha pre-filled pen.

Make sure the medicine in the window is clear and colourless to slightly yellow.

Check the expiration date.

• Do not use the pre-filled pen if medicine is cloudy or discoloured or contains large lumps, flakes, or particles.
• Do not use the pre-filled pen if any part appears cracked or broken.
• Do not use if the pre-filled pen has been dropped.
• Do not use the pre-filled pen if the orange cap is missing or not securely attached.
• Do not use the pre-filled pen if the expiration date has passed.

In all cases, use a new pre-filled pen

C Gather all materials needed for your injection.

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place the:

• New pre-filled pen.
• Alcohol wipes.
• Cotton ball or gauze pad.
• Plaster.
• Sharps disposal container.

D Prepare and clean your injection site.

You can use:

• Thigh.
• Belly, except for a 2 inch (5 centimetres) area around your belly button.
• Outer area of upper arm (only if someone else is giving you the injection).

Clean the injection site with an alcohol wipe. Let your skin dry.

• Do not touch this area again before injecting.
• Choose a different site each time you give yourself an injection. If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.
• Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

A Pull the orange cap straight off, only when you are ready to inject. Do not leave the orange cap off for more than 5 minutes. This can dry out the medicine.

It is normal to see a drop of liquid at the end of the needle or yellow safety guard.

• Do not twist, bend or wiggle the orange cap.
• Do not put the orange cap back onto the pre-filled pen.
• Do not put fingers into the yellow safety guard.

Important: Do not remove the orange cap from the pre-filled pen until you are ready to inject.

B Stretch or pinch your injection site to create a firm surface.

Stretch method

Stretch skin firmly by moving your thumb and fingers in the opposite direction, creating an area about 2 inches (5 centimetres) wide.

OR

Pinch method

Pinch skin firmly between your thumb and fingers, creating an area about 2 inches (5 centimetres) wide.

Important: It is important to keep skin stretched or pinched while injecting.

A Hold the stretch or pinch to create a firm surface. With the cap off, place the yellow end of the pre-filled pen on the skin at 90 degrees.

Do not touch the grey start button

B Firmly PUSH down the pre-filled pen onto the skin until it stops moving.

Important: You must push all the way down but do not touch the grey start button until you are ready to inject.

C When you are ready to inject, press the grey start button. You will hear a click.

D Keep PUSHING down on the skin. Then LIFT thumb. Your injection could take about 15 seconds.

Window turns yellow when the injection is done

NOTE: After you remove the pre-filled pen from your skin, the needle will be automatically covered.

A Discard the used pre-filled pen and orange needle cap.

Discard the used pre-filled pen and the orange cap in a sharps disposal container.

Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal.

Keep the pre-filled pen and the sharps disposal container out of the sight and reach of children.

• Do not reuse the pre-filled pen.
• Do not recap the pre-filled pen or put fingers into the yellow safety guard.
• Do not recycle the pre-filled pen or sharps disposal container or throw them into household rubbish.

B Examine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site. DO NOT rub the injection site. Apply a plaster if needed.

REPATHA Dosage & Rx Info

Drugs » Cardiovascular Disease

Hyperlipoproteinemias:

Indications for REPATHA:

To reduce the risk of MI, stroke, and coronary revascularization in adults with established cardiovascular (CV) disease. Adjunct to diet, alone or in combination with other lipid-lowering therapies, in adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce LDL-C. Adjunct to diet and other LDL-lowering therapies, in patients with homozygous familial hypercholesterolemia (HoFH) requiring additional lowering of LDL-C.

Adult Dosage:

Give by SC inj into abdomen, thigh, or upper arm; rotate inj sites. Primary hyperlipidemia, HeFH or CV disease: 140mg every 2 weeks or 420mg once monthly. HoFH: (≥13yrs): 420mg once monthly; measure LDL-C levels 4–8 weeks after initiation. To administer 420mg dose: give over 9 mins by using the on-body infusor or as 3 inj consecutively within 30 mins using the prefilled syringe or autoinjector.

Children Dosage:

Primary hyperlipidemia or HeFH: not established. HoFH: <13yrs: not established.

REPATHA Warnings/Precautions:

Do not inject into areas that are tender, bruised, red, or indurated. Discontinue if serious allergic reactions (eg, angioedema, rash, urticaria) occur. Severe hepatic impairment. Pregnancy. Nursing mothers.

REPATHA Classification:

Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor.

REPATHA Interactions:

Avoid co-administration with other injectable drugs at same inj site.

Adverse Reactions:

Nasopharyngitis, URTI, influenza, back pain, inj site reactions.

Generic Drug Availability:

How Supplied:

Single-use prefilled syringe—1; Single-use prefilled SureClick autoinjector—1, 2, 3; Single-use Pushtronex system—1

Pricing for REPATHA

1ml of 140mg/ml
sureclick

(Qty: 2)

Appx. price
$497

Evolocumab injection

What is this medicine?

EVOLOCUMAB (e voe LOK ue mab) is known as a PCSK9 inhibitor. It is used to lower the level of cholesterol in the blood. It may be used alone or in combination with other cholesterol-lowering drugs. This drug may also be used to reduce the risk of heart attack, stroke, and certain types of heart surgery in patients with heart disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Repatha

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an unusual or allergic reaction to evolocumab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or health care provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 13 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can if there are more than 7 days until the next scheduled dose, or skip the missed dose and take the next dose according to your original schedule. Do not take double or extra doses.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

You may need blood work while you are taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination
• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• nausea
• muscle pain
• pain, redness, or irritation at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

You will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Evolocumab Injection: MedlinePlus Drug Information

Evolocumab injection comes as a solution (liquid) in a prefilled syringe, a prefilled autoinjector, and in an on-body infusor with a prefilled cartridge to inject subcutaneously (just under the skin). When evolocumab injection is used to treat HeFH or cardiovascular disease or to reduce the risk of a stroke, heart attack, and coronary artery bypass surgery, it is usually injected every 2 weeks or once every month. When evolocumab injection is used to treat HoFH, it is usually injected once every month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use evolocumab injection exactly as directed. Do not use more or less of this medication or use it more often or for a longer period of time than prescribed by your doctor.

If you are using evolocumab injection once every month (420 mg dose), inject it once over 9 minutes with the on-body infusor and prefilled cartridge for each injection or inject 3 separate injections one after the other within 30 minutes, using a different prefilled syringe or prefilled autoinjector for each injection.

Evolocumab injection helps to control cholesterol levels and reduce the risk of a stroke, heart attack, or coronary artery bypass surgery, but it does not cure these conditions or eliminate these risks. Continue to use evolocumab injection even if you feel well. Do not stop using evolocumab injection without talking to your doctor.

Evolocumab injection comes in a prefilled autoinjector, prefilled syringes, and in an infusor with a prefilled cartridge that contain enough medication for one dose. Always inject evolocumab in its own prefilled autoinjector, syringe, or infusor with a prefilled cartridge; never mix it with any other medication. Dispose of used needles, syringes, and devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

You can inject evolocumab injection under the skin on your thighs or stomach area, except for the 2-inch area around your navel (belly button). If someone else will be injecting the medication for you, that person can also inject it into your upper arm. Use a different spot for each injection. Do not inject evolocumab injection into a spot that is tender, bruised, red, or hard. Also, do not inject into areas with scars or stretch marks.

Carefully read the manufacturer’s instructions for use that comes with the medication. These instructions describe how to inject a dose of evolocumab injection. Be sure to ask your pharmacist or doctor if you or the person who will be injecting have any questions about how to inject this medication. See Instructions for Use from the manufacturer at https://bit.ly/3jTG7cx.

Remove the prefilled syringe or prefilled autoinjector from the refrigerator and allow it to warm to room temperature for 30 minutes before using it. Remove the infusor with a prefilled cartridge from the refrigerator and allow it to warm to room temperature for 45 minutes before using it. Do not warm evolocumab injection in hot water, microwave, or place it in sunlight.

Before you use evolocumab injection, look at the solution closely. The medication should be clear to pale yellow and free of floating particles. Do not shake the prefilled syringe, prefilled autoinjector, or infusor with a prefilled cartridge containing evolocumab injection.

evolocumab | Cigna

How is evolocumab given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Evolocumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Evolocumab is available in a prefilled syringe, a SureClick prefilled autoinjector, or a Pushtronex on-body infusor with prefilled cartridge. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you have questions, or call the manufacturer at 1-844-737-2842.

The Pushtronex on-body infusor is a special device placed on the skin that delivers your evolocumab dose slowly. You will need to wear the device for about 9 minutes to get the full dose. While wearing the on-body infusor, you may perform moderate activities such as walking, bending, or reaching.

Your care provider will show you the best places on your body to inject evolocumab or place the on-body infusor. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Each single-use prefilled syringe, cartridge, or injection device is for one use only. Throw away after one use, even if there is still some medicine left inside. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Store evolocumab in the refrigerator in its original carton and protect from light and heat. Do not freeze. Throw away any evolocumab that has been frozen.

Take the medicine out of the refrigerator and let it reach room temperature for 30 to 45 minutes before injecting your dose. Do not heat a syringe or injection device.

You may also store evolocumab in the original carton at cool room temperature, away from light and heat. Use the medicine within 30 days if it is kept at room temperature.

Handle this medicine carefully. Dropping an injection device can cause it to break. Do not use an injection device that has been dropped onto a hard surface, even if you cannot see a break in it. Call your pharmacist for new medicine.

Do not shake this medicine. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You should not stop using evolocumab without your doctor’s advice, or your LDL cholesterol levels may increase.

Evolocumab is only part of a complete treatment program that also includes diet, statin medication, and regular blood testing. Follow your doctor’s instructions very closely.

Repatha Injectable in Russian – Item

State banks will repay the debt to the homeland – Newspaper Kommersant No. 16 (6496) dated 30.01.2019

The Supreme Court (SC) of Ukraine decided to reject appeals against the seizure of assets of the Ukrainian subsidiary banks of VEB, Sberbank and VTB. Also, the Armed Forces of Ukraine gave permission to implement the decision of the Arbitration Court of The Hague to recover compensation of $ 140 million from the Russian Federation at the expense of the property of these banks. Thus, in the near future, the procedure for the seizure and sale of their assets may begin in Ukraine.One – VTB Ukraine is already in the process of liquidation, it is possible that now Sberbank Ukraine and Prominvestbank (PIB) risk repeating its fate, however, in the future they can compensate for losses through claims in international courts, lawyers point out.

On Tuesday, the Supreme Court of Ukraine made a rather unexpected decision. Despite the unequivocal statements of the National Bank of Ukraine (NBU) that the assets of Ukrainian banks with Russian capital belong primarily to their depositors and other creditors, and their blocking interferes with the work of the entire financial sector of Ukraine, the Supreme Court supported the lower authority.He dismissed the complaint against the decision of the Kiev Court of Appeal of September 25, 2018 on the arrest of shares of Ukrainian VTB, Sberbank and PIB, aimed at ensuring the recovery of $ 140 million from the Russian Federation by the decision of the Hague Arbitration. Thus, the NBU’s hopes for the Ukrainian courts to review this practice did not materialize. The NBU did not respond to Kommersant’s request.

Moreover, as follows from the message of the Armed Forces of Ukraine, “the Supreme Court granted permission to execute the decision of the arbitration court to recover compensation from the Russian Federation for property expropriated in Crimea.”

In essence, this means that the Ukrainian executive authorities can begin to seize and sell the property and assets of Ukrainian subsidiaries of Russian state banks.

Of those banks with Russian state capital, at the moment there are two operating in Ukraine: the local Sberbank and PIB (they are in the top 10 in terms of assets and occupy the seventh and tenth places). As the first deputy chairman of the NBU, Ekaterina Rozhkova, noted in early January, since 2014, banks with Russian capital have significantly reduced their share in the Ukrainian banking market and by the end of 2018 it slightly exceeded 3.5% in total assets.VTB Ukraine, against the background of the seizure of assets, could not ensure the fulfillment of obligations to depositors; at the end of November 2018, the bank was declared insolvent by the NBU and is in a state of forced liquidation. “It is rather difficult to judge how the decision of the Armed Forces of Ukraine could affect the liquidation of VTB’s subsidiary,” notes Dmitry Shevchenko, partner of the Zamoskvorechye law bureau. to recover in a claim against a completely different person (a sovereign state in this case), occurs for the first time at least on the territory of the post-Soviet countries. “

Ekaterina Rozhkova, First Deputy Chairman of the National Bank of Ukraine, December 17, 2018

The owners own what remains of the assets when the bank can pay off all its obligations. I hope the court will understand that by blocking assets, they simply paralyze the work and this can lead to negative consequences

Given the ambiguous situation around VTB Ukraine, the Russian Sberbank and PIBU.Sberbank declined to comment. VEB.RF, which owns PIB, reported that they are using all available legal instruments to protect their investments in Ukraine. “Earlier, VEB.RF initiated an investment dispute with Ukraine in connection with the creeping expropriation of PIB shares, during which VEB.RF plans to seek compensation for the expropriation of an asset on the territory of Ukraine,” they explained. Ukrainian authorities will be given by the Stockholm International Court of Arbitration ”.

However, the international dispute does not change or postpone the execution of the decision of the Armed Forces of Ukraine. “VEB can apply to the Stockholm Arbitration Court on the basis of an agreement between Russia and Ukraine on the encouragement and mutual protection of investments in 1998,” notes BGP Litigation Advisor Ilya Sorokin. if the expropriation actually takes place ”. At the same time, according to him, if the arbitration supports VEB, the latter will be able to enforce the corresponding decision almost anywhere in the world where it finds the assets of Ukraine.”The subject of the claim and the main consequence of going to arbitration may be the recovery from Ukraine of compensation for expenses, losses and interest in favor of VEB for violating the rights of an investor – this sanction is provided for by the aforementioned agreement of 1998,” agrees Valery Glazunov, CEO of the legal company Glazunov and Semenov …

Ksenia Dementyeva, Andrey Raysky

collateral loan – Russian translation

Results of the capital week: Luzhkov-style water pipe or who needs the Kashagan fountain?

This week Kazakhstan was visited by the former mayor of the Mother See Yuri Mikhailovich Luzhkov, who met with the President of the country Nursultan Nazarbayev.One of the topics raised at this meeting, as reported by the RBC TV channel, was the possible construction of a water conduit in the Mangistau region to supply the region with fresh water.

“ We began to discuss this topic with Nursultan Abishevich, now we have prepared more thoroughly, and I think I dream about it, that it will be supported, that it will be a good project for people “, – RBC TV channel quotes Luzhkov. According to the former mayor of Moscow, we are talking about the construction of “, a fairly powerful water conduit ” with a length of about 200 kilometers, which should start from the northern part of the Caspian Sea and run along the bottom to the Mangyshlak Peninsula.During the Soviet era, a nuclear desalination plant was built in this region, but it provides very little water, mainly for drinking purposes.

“ Beautiful land, climatic and natural conditions – and there is no water. The western part of Kazakhstan has a lot of interesting prospects and does not have water. If there is water in the region, business and industry will certainly go into development there. In particular, agriculture and resort business “, – said Luzhkov. According to him, the cost of the project is estimated at 2 billion dollars – and it is designed for decades, despite the fact that (oh, you will laugh for a long time!) The project already has a potential investor.

“ We have found an international banking system, which, having studied this project, is ready to finance. Refund – payment for water “, – Luzhkov specified. Describing his role in the project, Luzhkov said that he offers “ completely organizational and technical performance, including with the maximum use of those products that are currently produced in Kazakhstan itself “. There are a number of wonderful moments in this interview, which are a real discovery for both Kazakhstanis and Muscovites.

Well, first of all, a low bow to the disgraced Moscow educator for the fact that the residents of Mangystau have finally learned that their salt marshes are “ beautiful land ” capable of sending agriculture uphill. “ Won che, Mikhalych! “, – the well-known miller Dulin from Nasha Rashi would have said to Luzhkov, if he lived and prospered in Mangyshlak: until now, the high cost of everything and everything in the west of the country was explained by the fact that not a damn thing grows on salt marshes – and even the water is imported there.But then he came to us, Yuri Mikhalych came to us on the road – and after Alexander Isaich he explained how to equip Kazakhstan (Russia, unlike Solzhenitsyn, is no longer allowed to equip Luzhkov!). It turns out that it is enough to use the advertising slogan of “Sprite” (“ Don’t let yourself dry up! “) – and in the west just stick a stick, it will immediately start to pineapple.

Here, however, the West Kazakhstani people, historically inclined to manifest displeasure with all sorts of unauthorized methods, may have a reasonable question – if it was only a water pipeline, why the hell hasn’t it been carried out to the oil-bearing region? Moreover, they will ask this not from the former Moscow mayor (from the fact that, in general, except for dispersing the clouds of a military parade, and not for non-standard sake, there is nothing to ask), but from the local and republican authorities.From this point of view, it is generally incomprehensible how Yuri Mikhalovich, with his ideas and projects that are harmful to immature minds, is still allowed into Kazakhstan – there is nothing Vladimir Vladimirovich warned whom we could listen to, and to whom is it better not to turn with a government wallet on Red Square?

Russians can be incredibly surprised that after the historical fall of the eagle and the falcon from the peaks of the Moksovo bohemia to the emigration bottom of the White Guard, some international banking system is ready to give him two yards for a third person, which in this case is the west of Kazakhstan.In general, the tale is good, but it is worth remembering that Yu.M. Luzhkov in 2009, while still the mayor himself, already told something similar, promising in every possible way to help turn the Siberian rivers towards Central Asia. Since then, a lot of water has flown under the bridge, the Irtysh has managed to shallow quite a bit, and Yu.M. everything is itching: he sleeps over the hill and sees how to get Kazakhstan to drink. Why don’t our powerful people stop this flow of eloquence? Well, firstly, no one in Kazakhstan is able to stop Yuri Mikhailovich in his desire to give someone an exclusive interview, even, scary to say, the first person of the state (here it is worth noting that there was no leakage about the water pipeline to the Kazakh media from Ak Orda , which clearly demonstrates the attitude of Ak Orda to Luzhkov’s projects).

And, secondly, our executive authorities are so accustomed to help from abroad that any offer, even if it is given away by divorce from it a mile away, is perceived as a kind of quite real opportunity. And the phrase “ international banking system ” on our government, spoiled by grants and soft loans from the EBRD and the PRC, has long been acting like a tea strainer for Ellochka the man-eating. That is, to say: “ Rude, lad! ” our officials, having heard about the international financial organization in the share, are simply not able to.And how can you tell the first zero to a guest? Not camilfo, you know …

In addition, while Yuri Mikhailovich proposes to pour water, the cabinet of ministers has more important concerns – the same Western oil, which the government can get up to the throat. The fact is that in September this year, Karim Kazhimkhanovich Massimov, while still prime minister, ordered Kashagan to run blood from his nose – and to ensure an increase in oil production by at least a million tons by the end of the year. The Ministry of Energy then saluted, although the corresponding gesture of its head Kanat Bozumbayev gave a certain skepticism and doom.And then Karim Kazhimkhanovich departed to defend the Motherland from terrorists in the KNB, and Bakytzhan Sagintayev, who remained on the farm, inherited the problem – what to do with Kashagan now?

The fact is that on Sunday morning the policy of the party and government in the field of oil production turned 180 degrees – after technical meetings of representatives of OPEC countries and countries outside the cartel in Vienna, Vice Minister of Energy of Kazakhstan Magzum Mirzagaliyev said that official Astana is ready to consider the possibility of freezing or decrease in oil production.” We are ready to discuss this issue so far only inside ourselves. We will work it out yet, it was important for us during today’s meeting to exchange views and hear the approaches of member countries and non-members of (cartel),” Magzumov said, answering the question journalists, what is the country’s position on a possible reduction and freezing of oil production.

Recall that at the end of September OPEC at an informal meeting in Algeria agreed to limit production in the range of 32.5-33 million barrels of oil per day, but there are no agreements on specific limits for each of the countries of the organization.Meanwhile, back on Thursday, Energy Minister Kanat Bozumbayev at a plenary session of the Senate of the Parliament reported to journalists that the order of the former Prime Minister was fulfilled, Kashagan was re-launched, and now the Kazakh authorities expect to receive from it from 500 thousand to one million tons of oil by the end of this year.

“ It can be considered that the Kashagan field was launched. We announced on the 23rd, but it turned out that the field was launched earlier, export oil went in the first half of October ,” Bozumbayev said.According to him, now the process of adjustment is underway, in general, oil “ is fairly stable ” is supplied to the oil pipelines of the Caspian pipeline consortium and KazTransOil. “We do not see any big problems. There are, of course, technical issues, but they always exist when launching such large fields,” the head of the Ministry of Energy said. And he added that if by the end of this year the ministry expects to receive at least 500 thousand tons of oil from Kashagan, and under a favorable scenario, production will amount to 1 million tons, then next year the forecast for Kashagan is set at the level of 4 to 7 million tons.

“ It all depends on how the wells behave, how the equipment behaves ,” Bozumbayev explained. Now, in the light of the promise to reduce oil production, it can be assumed that if no other opportunity is found to turn off the oil tap, it will be found that the wells are behaving differently, and the equipment is not right, and the overalls for the workers of the wrong world – but you never know on this light of opportunities to fulfill our international obligations? Yes, as in Brazil Pedrov – and do not count. Moreover, Bozumbayev, giving comments to journalists on Kashagan – a millionaire already this year, seemed to be ready to change the course.” Taking into account the current situation in the industry, we are now analyzing for ourselves in order to understand how we, as an oil-producing country, can be useful to the oil world community to raise prices ,” he stressed. And here the idea of ​​a water conduit by Yu.M. it turned up just in time: a reduction in production is either a reduction in part of the state, or a reduction in salaries for the entire state. And with the water pipeline, some of the oil workers can be detached for plowing salt marshes, relieving social tension. And whether the gardens will grow there or not – it doesn’t matter, the main thing is maneuvers …

However, OPEC will not spoil our government with either mass or dinner, because it celebrates GDP growth throughout the second half of the year, and by the end of the year it will generally arrange a Sabantuy on this matter.On Tuesday, the Prime Minister of Kazakhstan Bakytzhan Sagintayev said that the task set by the head of state to move the economy of Kazakhstan out of the negative zone into the growth zone of 0.5% at the end of this year is quite achievable. “ We see that following the results of 9 months we have positive trends and there is reason to believe that by the end of the year we must fulfill the instructions of the head of state for growth of 0.5%. There is probably no doubt that this is feasible “, – said Sagintayev at a government meeting on Tuesday.At the same time, he drew special attention of the National Bank and the financial and economic block of the government to the fact that inflation should not go beyond the planned corridor of 6-8%.

“ There is an instruction from the head of state, a specific instruction has been given so that we, together with the central authorities, together with akims, work on reserves, we have reserves, we know about them. Plus, it will be necessary to work out for each enterprise separately.” , – the head of government addressed the ministers.Then he instructed his deputy, Askar Mamin, to hold a conference call together with the ministries and akimats “ for each enterprise ” in the regions, in order to find out, “Who has what reserves so that we do not remain at the level of 0.5%, and crossed this level “. “ This is very important. We need to work on this and all the key indicators that we have just talked about, they must be fulfilled. There should be no questions here ,” Bakytzhan Sagintayev emphasized.

In general, that to us OPEC, when “ inflation processes slow down, the situation in the foreign exchange market stabilizes, business investment activity and the country’s international reserves grow, and the unemployment rate of remains low.” To complete the picture, only spaceships plying the Bolshoi Theater are missing – but this is for Yuri Mikhailovich. The mining and metallurgical complex, however, is playing pranks a little like a liver, having reduced the rate of production from 4.8% in 8 months to 4.4% in 9 months, and the domestic auto industry sank by 18 percent.But with the latter, the utilization fee introduced at the beginning of the year will still do its job – sooner or later, those citizens who do not have enough money for a foreign car will sit behind the wheel of a domestic car. But the akims, with the additional money allocated to them from the center, are not acting like a child, for which they received a scolding from their superiors.

“ If we talk about the use of financial resources, why do we endlessly repeat ourselves, because compared to the allocated funds at the beginning of the year, additional funds were allocated at the end of the year, on September 9 we allocated over 400 billion tenge.Therefore, we must carry out work on the timely implementation and development of each tenge “, – said Prime Minister Bakytzhan Sagintayev. Financial transgressions generally became a popular topic in our state bodies last week: on Thursday, the Prosecutor General of Kazakhstan, Zhakip Asanov, reproached the investigators involved in the investigation of financial crimes for the sluggishness.

“ Our detectives” hot on the trail “quickly disclose the most complex crimes, mainly against individuals. We know how to do it well, we are good at investigating thefts, murders, hooliganism. But we investigate financial crime very badly. Because the financial criminal is smart, technically educated , thinks faster, many steps forward , – Asanov said during a roundtable on the topic: “Development of a national system of financial investigations and return of stolen assets from abroad.”- More than $ 10 billion has been withdrawn abroad on criminal cases initiated over 10 years. I emphasize: this is only about crimes being investigated “, – he added. According to the Prosecutor General, instead of immediately finding and freezing the money, ensuring their return, the investigation is busy conducting examinations and calculating the damage, and at the same time” criminals transfer the stolen to offshore and calmly leave our country “.

” While the investigation was engaged in interrogations and other things, the cashiers of the former akim of the Atyrau region transferred the stolen half a billion dollars abroad and fled with them to England and live quietly there “, – noticed the attorney general.At the same time, he lamented that the countries where criminals from Kazakhstan are hiding do not always provide maximum assistance in their capture. “ Sometimes there is a feeling that (these countries – ed.) seem to be happy with them, they do not go abroad empty-handed “, – said the head of the supervisory department. This raises the question – is it possible to request from these same countries 2 billion for a water pipeline for the west of Kazakhstan as moral compensation? And Yu.M. then as a dubious intermediary will not be needed …

But what about the plunderers of workers’ funds, if our authorities cannot end the extortions in schools? On Thursday, it turned out that the problem of extortions in Astana schools is difficult to solve if the parents of the students do not officially complain about the administration of the educational institution, said the head of the Astana Department of Education, Kasymkhan Sengazyev.According to him, to date, the Astana Education Department has received 85 appeals, all from anonymous sources. By order of the city akim, a public commission was created, which has been considering complaints about extortions since October 15. “ The helpline has been operating since June 21 this year, during this time 560 complaints have been received, of which 85 complaints are against extortions in schools. All complaints are considered. funds to work point “, – said Sengazyev at a press conference.

For each of these requests, the commission received offers to meet with the parents, but did not receive a return answer. “ We leave for each appeal, we want to meet with the parents, talk, but all these appeals are asked not to pass. Now the commission will go around, meet with parental committees. Yesterday we were at school number 2, the director said that two teachers were reprimanded for illegal fundraising “, – added the head of the department. He explained that often the parents of students do not want to openly declare extortions, as they fear pressure from the school on the child.” If someone infringes on the rights of children, then I ask you to officially indicate the school number, the name of the class teacher or director, I ask you to write in my name. We will organize an inspection, connect the control department (Ministry of Education) to the inspection and jointly carry out the work. I ask you to openly point out such facts “, – Sengazyev explained.

According to him, now in each school there is a list where it is indicated what expenses the educational institution is obliged to bear. So, all schools are allocated funds for the purchase of office supplies for administrative personnel, components, detergents and household products to ensure cleanliness, the purchase of sports goods, building materials.In addition, money is allocated for food for primary school students, maintenance of the building, medical examination of teachers, disinfection and deratization of the building, maintenance of fire and burglar alarms, inspection of water, electricity and heat meters. Funds are also provided for food and school uniforms for orphans and children from low-income families.

In general, everything is great, the question remains unclear – with such a general coverage of all practically areas of school activity with money (according to the explanation of the Department of Education, legal fees are only parental expenses for the purchase of books for in-depth study in gymnasium classes and lyceums, the purchase of workbooks, yes classes in circles that are held after school hours and are not compulsory), why do teachers continue to collect money? And there is nothing without the go-ahead for that from school principals and the department of education itself? Even in the dashing 90s, very few dared to go wild without a “roof”, but in civilized “zero” with a constantly growing GDP, only some scumbags can do this.Who is recruiting such people to schools, if not by nightfall the mentioned department will be there?

Meanwhile, another scandal related to domestic healthcare is gaining momentum in our social network: on Tuesday, the Minister of Health and Social Development of Kazakhstan, Tamara Duisenova, had to comment on the deaths during the trial of a Kazakh anti-tuberculosis drug. We will remind that earlier the Prosecutor General’s Office of Kyrgyzstan reported that illegal clinical trials of the Kazakh anti-tuberculosis drug FS-1 led to the death of two people.” This anti-tuberculosis drug has just been developed, is being introduced by the scientific center producing this drug. This is a private organization. In order to put on sale and mass use, each drug undergoes various types of clinical trials for 15-20 years ,” Duissenova told reporters after government meetings. Kyrgyz prosecutors also found that the National Center for Phthisiology under the Ministry of Health of Kyrgyzstan, illegally, without accreditation, entered into an agreement with the Kazakh Scientific Center for Anti-Infectious Drugs JSC to conduct a clinical trial of the drug.

Subsequently, the center illegally conducted clinical studies of PS-1 on patients suffering from multidrug-resistant pulmonary tuberculosis. During the trial of the drug on 54 patients, ten of them developed side effects, there are also two facts of death. The supervisory authority opened a criminal case against officials of the National Center for Phthisiology and the Department of Medicines and Medical Technology. They were charged under the articles “Abuse of official position” and “Official forgery” of the Criminal Code of the Kyrgyz Republic.An investigation is underway – and it is not known what conclusions it will come to, so the consequences of Mukhamediuly’s statements about Kyrgyz citizens working in Moscow public latrines may still seem childish to us …

Andrey LOGINOV, Astana

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