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Side effects of onglyza. Understanding Onglyza: Uses, Dosage, Side Effects, and Precautions

by alexxlab

How does Onglyza work to manage diabetes. What are the potential side effects of Onglyza. Who should be cautious when taking Onglyza. How should Onglyza be taken for optimal results. What interactions should be considered when using Onglyza.

What is Onglyza and How Does It Work?

Onglyza, also known by its generic name saxagliptin, is a medication used to manage type 2 diabetes. It belongs to a class of drugs called DPP-4 inhibitors, which work by increasing the levels of incretin hormones in the body. These hormones help regulate blood sugar levels by stimulating insulin production and reducing glucose production.

The primary function of Onglyza is to improve glycemic control in adults with type 2 diabetes mellitus. It does this by:

  • Increasing insulin release when blood sugar levels are high
  • Decreasing the amount of sugar produced by the liver
  • Slowing down the breakdown of incretin hormones

Is Onglyza effective for all types of diabetes? Onglyza is specifically designed for type 2 diabetes and is not indicated for the treatment of type 1 diabetes or diabetic ketoacidosis. It’s important to note that Onglyza is typically used in conjunction with diet and exercise for optimal blood sugar control.

Proper Usage and Dosage Guidelines for Onglyza

Administering Onglyza correctly is crucial for its effectiveness and safety. Here are the key points to remember:

  1. Onglyza is typically taken once daily, with or without food.
  2. The standard dosage is 2.5 mg or 5 mg, as prescribed by your healthcare provider.
  3. It’s important to take Onglyza at the same time each day to maintain consistent blood levels.
  4. The tablet should be swallowed whole and not split, crushed, or chewed.
  5. If you miss a dose, take it as soon as you remember, unless it’s almost time for your next dose.

Can the dosage of Onglyza be adjusted? Yes, your doctor may adjust your dosage based on your kidney function, overall health, and response to treatment. Never change your dosage without consulting your healthcare provider first.

Special Considerations for Onglyza Dosing

Certain factors may influence how Onglyza is prescribed:

  • Patients with moderate or severe renal impairment may require a lower dose of 2.5 mg once daily.
  • Onglyza should be taken at least 3 hours before or after an antacid.
  • If you’re also taking a strong CYP3A4/5 inhibitor, the recommended dose is 2.5 mg once daily.

Common and Serious Side Effects of Onglyza

While Onglyza can be an effective treatment for type 2 diabetes, it’s important to be aware of potential side effects. These can range from mild to severe:

Common Side Effects

  • Upper respiratory tract infection
  • Urinary tract infection
  • Headache
  • Nasopharyngitis (common cold)
  • Mild gastrointestinal discomfort

These common side effects are usually mild and may subside as your body adjusts to the medication. However, if they persist or worsen, it’s important to consult your healthcare provider.

Serious Side Effects

While less common, serious side effects of Onglyza can occur and require immediate medical attention:

  • Pancreatitis: Severe abdominal pain that may radiate to the back, with or without vomiting
  • Heart failure: Shortness of breath, rapid weight gain, swelling in extremities
  • Severe allergic reactions: Swelling of face, lips, throat; difficulty breathing; skin reactions
  • Severe joint pain
  • Bullous pemphigoid: A serious skin reaction causing blisters

How can you distinguish between common and serious side effects? While common side effects are usually mild and improve over time, serious side effects often come on suddenly and severely impact your well-being. If you experience any symptoms that concern you, especially those listed as serious side effects, seek medical attention immediately.

Interactions and Precautions When Taking Onglyza

Understanding potential drug interactions and necessary precautions is crucial when taking Onglyza. Here are some key considerations:

Drug Interactions

Onglyza may interact with various medications, potentially altering its effectiveness or increasing the risk of side effects:

  • Strong CYP3A4/5 inhibitors (e.g., ketoconazole, atazanavir): May increase Onglyza levels in the blood
  • Other diabetes medications: May increase the risk of hypoglycemia
  • Glucocorticoids: May reduce the effectiveness of Onglyza

Always inform your healthcare provider about all medications, supplements, and herbal products you’re taking to avoid potential interactions.

Precautions and Contraindications

Certain individuals should exercise caution or avoid using Onglyza:

  • Those with a history of pancreatitis
  • Patients with heart failure or at risk for heart failure
  • Individuals with severe renal impairment or end-stage renal disease
  • People with a history of allergic reactions to DPP-4 inhibitors

Does a history of allergies affect Onglyza use? If you have a history of allergic reactions, especially to other DPP-4 inhibitors, it’s crucial to inform your doctor before starting Onglyza. They may recommend alternative treatments or closely monitor you for potential allergic responses.

Monitoring and Managing Blood Sugar While on Onglyza

Effective diabetes management involves more than just taking medication. Here are key strategies for monitoring and managing your blood sugar while on Onglyza:

Regular Blood Glucose Testing

  • Test your blood sugar as recommended by your healthcare provider
  • Keep a log of your readings to track patterns and trends
  • Learn to recognize symptoms of high and low blood sugar

Lifestyle Modifications

  • Follow a balanced, diabetes-friendly diet
  • Engage in regular physical activity as approved by your doctor
  • Maintain a healthy weight
  • Manage stress through relaxation techniques or counseling

How often should you check your blood sugar while taking Onglyza? The frequency of blood sugar checks can vary based on individual factors. Generally, you may need to check your blood sugar more frequently when starting Onglyza or adjusting the dose. Your healthcare provider will give you specific guidelines based on your personal diabetes management plan.

Long-Term Considerations and Follow-Up Care for Onglyza Users

Managing diabetes with Onglyza is an ongoing process that requires regular follow-up and potential adjustments. Here are some long-term considerations:

Regular Medical Check-ups

  • Schedule regular appointments with your healthcare provider
  • Monitor A1C levels every 3-6 months
  • Undergo kidney function tests periodically
  • Have regular cardiovascular health assessments

Potential Long-Term Effects

While Onglyza is generally well-tolerated, be aware of potential long-term effects:

  • Increased risk of heart failure in some patients
  • Potential impact on kidney function over time
  • Possible increased risk of pancreatitis

How long can you safely take Onglyza? Onglyza is designed for long-term use in managing type 2 diabetes. However, the duration of treatment can vary based on individual factors and treatment response. Your healthcare provider will regularly assess the benefits and risks of continuing Onglyza as part of your overall diabetes management plan.

Alternatives and Complementary Treatments to Onglyza

While Onglyza can be an effective treatment for type 2 diabetes, it’s not the only option available. Understanding alternatives and complementary treatments can help you make informed decisions about your diabetes management:

Other Medication Options

  • Metformin: Often considered the first-line treatment for type 2 diabetes
  • Sulfonylureas: Stimulate insulin production in the pancreas
  • GLP-1 receptor agonists: Improve blood sugar control and may aid in weight loss
  • SGLT2 inhibitors: Help the kidneys remove excess sugar through urine
  • Insulin: Used when other medications don’t provide adequate control

Complementary Approaches

In addition to medication, several complementary approaches can support diabetes management:

  • Dietary changes: Following a balanced, low-glycemic diet
  • Regular exercise: Engaging in both aerobic and strength training activities
  • Stress management: Practicing relaxation techniques like meditation or yoga
  • Herbal supplements: Some herbs may have blood sugar-lowering effects (always consult with a healthcare provider before use)
  • Acupuncture: May help improve insulin sensitivity in some individuals

Can lifestyle changes replace the need for Onglyza? In some cases, particularly in the early stages of type 2 diabetes, significant lifestyle changes may be sufficient to manage blood sugar levels without medication. However, this varies greatly among individuals. It’s crucial to work closely with your healthcare provider to determine the most appropriate treatment approach for your specific situation.

Understanding the Cost and Insurance Coverage for Onglyza

The financial aspect of managing diabetes with Onglyza is an important consideration for many patients. Here’s what you need to know about costs and insurance coverage:

Pricing and Cost Factors

  • Brand-name Onglyza is typically more expensive than generic alternatives
  • Costs can vary depending on your location and pharmacy
  • Dosage strength and quantity prescribed can affect the price
  • Some patients may be eligible for manufacturer discount programs

Insurance Coverage

Insurance coverage for Onglyza can vary widely:

  • Many insurance plans cover Onglyza, but it may require prior authorization
  • Co-pays and deductibles can significantly impact out-of-pocket costs
  • Some plans may require trying other diabetes medications first (step therapy)
  • Medicare Part D typically covers Onglyza, but coverage can vary by plan

How can you reduce the cost of Onglyza if it’s not fully covered by insurance? There are several strategies to potentially lower your costs:

  • Ask your doctor about generic alternatives
  • Explore patient assistance programs offered by the manufacturer
  • Check if you qualify for Medicare Extra Help or Medicaid
  • Compare prices at different pharmacies, including online options
  • Consider using a prescription discount card

Remember to discuss any financial concerns with your healthcare provider. They may be able to suggest cost-effective alternatives or direct you to resources for financial assistance.

Side Effects of ONGLYZA® (saxagliptin)

Serious side effects can happen in people who take ONGLYZA, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before taking ONGLYZA, tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels. Stop taking ONGLYZA and contact your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Serious side effects can happen in people who take ONGLYZA, including heart failure. Before taking ONGLYZA, tell your doctor if you have ever had heart failure or problems with your kidneys. Contact your doctor right away if you have any of the following symptoms of heart failure: increasing shortness of breath or trouble breathing, especially when you lie down; an unusually fast increase in weight; swelling or fluid retention, especially in the feet, ankles, or legs; or unusual tiredness.

 

Serious allergic reactions can occur as possible side effects of ONGLYZA and may include:

  • Swelling of the face, lips, or throat
  • Difficulty swallowing or breathing
  • Swelling of the skin
  • Hives, rash, itching, flaking, or peeling

If you have these symptoms, stop taking ONGLYZA, and contact your doctor right away.

 

Low blood sugar (hypoglycemia)

Low blood sugar (hypoglycemia) may become worse in people who already take another medication to treat diabetes, such as a sulfonylurea or insulin. Tell your doctor if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low; then call your doctor. Follow your doctor’s instructions for treating low blood sugar.

Symptoms of low blood sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, or change in vision.

 

Joint pain

Some people who take medicines called DPP-4 inhibitors, like ONGLYZA, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.

 

Skin reaction (bullous pemphigoid)

Some people who take medicines called DPP-4 inhibitors, like ONGLYZA, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin.

 

Swelling or fluid retention

Swelling or fluid retention in your hands, feet, or ankles (peripheral edema) may become worse in people who also take a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to treat high blood sugar. If you have symptoms of peripheral edema, such as swelling of hands, feet, or ankles, call your doctor. If you do not know whether you are already on this type of medication, ask your doctor.

These are not all of the possible side effects of ONGLYZA. Tell your doctor if you have any side effects of ONGLYZA that bother you or that do not go away. For more information, ask your doctor.

 

Common side effects of ONGLYZA include:

  • Upper respiratory tract infection
  • Urinary tract infection
  • Headache

 

Learn more about possible side effects of ONGLYZA

View the Medication Guide »

Onglyza oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

How to use Onglyza

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using saxagliptin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

The manufacturer directs not to split/cut the tablet before taking it. However, many similar drugs (immediate-release tablets) can be split/cut. Follow your doctor’s directions on how to take this medication.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended.

Side Effects

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: joint pain, unusual skin blisters, signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Although saxagliptin by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with your doctor or pharmacist about all your diabetes medication(s).

Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Talk with your doctor or pharmacist about what to do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.

Get medical help right away if you have any very serious side effects, including: signs of disease of the pancreas (such as severe stomach/abdominal pain which may spread to the back, nausea/vomiting that doesn’t stop).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking saxagliptin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, disease of the pancreas (pancreatitis), risk factors for pancreatitis (such as stones in your gallbladder, regular use/abuse of alcohol, high levels of fats/triglycerides in the blood), heart failure.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar and pancreatitis.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Other medications can affect the removal of saxagliptin from your body, which may affect how saxagliptin works. Examples include azole antifungals (such as itraconazole, ketoconazole), HIV protease inhibitors (such as saquinavir), nefazodone, telithromycin, ritonavir, among others.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Does Onglyza interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.

Lab tests (such as kidney function tests, fasting blood glucose, hemoglobin A1c) should be done before you start taking this medication and while you are taking it. Keep all regular medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

Onglyza 2.5 mg tablet

Color: pale yellowShape: roundImprint: 2.5 4214

This medicine is a pale yellow, round, tablet imprinted with “2. 5″ and “4214”.

Onglyza 5 mg tablet

Color: pinkShape: roundImprint: 5 4215

This medicine is a pale yellow, round, tablet imprinted with “2.5” and “4214”.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Buy faces in Poltava – – Ongliza tablets. in / pliv. obol. 5 mg №30 (10×3)

SAXAGLIPTINUM A10B H03

AstraZeneca

COMPOSITION AND FORM OF RELEASE:

tab. p / captivity. shell 2.5 mg, № 30

Saxagliptin 2.5 mg

No. UA/10715/01/01 from 05/18/2010 to 05/18/2015

tab. p / captivity. shell 5 mg, № 30

Saxagliptin 5 mg

No. UA/10715/01/02 from 05/18/2010 to 05/18/2015

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics . Saxagliptin is a potent, selective, reversible competitive inhibitor of dipeptidyl peptidase-4 (DPP-4). In patients with type II diabetes mellitus, the use of Onglise results in inhibition of DPP-4 enzyme activity for 24 hours. After oral glucose loading, this inhibition of DPP-4 leads to a 3-fold increase in the level of circulating active incretin hormones, including glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide, a decrease in the concentration of glucagon and an increase in the glucose-dependent reaction of β-cells, which leads to an increase in the concentration of insulin and C-peptide. Insulin release from pancreatic β-cells and reduced glucagon release from pancreatic α-cells are associated with decreased fasting glucose concentrations and decreased glucose levels after glucose loading or meals. Ongliza improves glycemic control by lowering fasting glucose and postprandial glycemia in patients with type 2 diabetes mellitus.
When using Ongliza at a dose of ≥5 mg, the baseline HbA1c value was associated with a more adjusted average change in HbA1c compared to the baseline level. Ongliza therapy did not cause an increase in body weight from baseline, but a slight decrease in body weight was observed in the Ongliza 5 mg and placebo treatment groups.
Pharmacokinetics. The pharmacokinetics of saxagliptin and its major metabolite were similar in healthy volunteers and in patients with type II diabetes mellitus. Saxagliptin is rapidly absorbed after oral administration on an empty stomach, reaching C max saxagliptin and its main metabolite in blood plasma within 2 and 4 hours, respectively. C max and AUC of saxagliptin and its main metabolite increased in proportion to the increase in the dose of saxagliptin.
After a single oral dose of 5 mg saxagliptin to healthy volunteers, the mean end-point T ½ for saxagliptin and its major metabolite were 2.5 and 3.1 h, respectively, and the mean T ½ for plasma DPP-4 inhibition was 26.9h. Inhibition of DPP-4 plasma activity by saxagliptin for at least 24 hours after oral administration of saxagliptin occurs due to high power, affinity and broad binding to the active site. No appreciable accumulation of saxagliptin or its major metabolite under multiple once daily dosing conditions was observed at any dose level. There was no dose- and time-dependence of the clearance of saxagliptin and its main metabolite when taking saxagliptin once a day within a dose of 2.5 to 400 mg for 14 days.
Absorption. Saxagliptin can be taken on an empty stomach or with food. The amount of saxagliptin absorbed after an oral dose is at least 75%. Food had a relatively modest effect on the pharmacokinetics of saxagliptin in healthy volunteers. High-fat meals did not affect C max saxagliptin, while AUC increased by 27% compared with fasting. The time to reach C max (T max ) for saxagliptin increased by approximately 0.5 h when taken in combination with food compared with fasting. These changes were not considered clinically significant.
Distribution. In vitro protein binding of saxagliptin and its major metabolite in human serum is below detectable levels. Thus, changes in the level of blood proteins in various pathological conditions (for example, renal or hepatic insufficiency) do not affect the distribution of saxagliptin.
Metabolism. Metabolism of saxagliptin is mainly mediated by cytochrome P450 3A4/5 (CYP 3A4/5). The main metabolite of saxagliptin is also a selective, reversible, competitive inhibitor of DPP-4, it has 2 times less power than saxagliptin.
Removal. Saxagliptin is excreted by the kidneys and liver. Following a single dose of 50 mg 14 C-saxagliptin, 24%, 36%, and 75% of the dose was excreted in the urine as saxagliptin, its major metabolite, and total radioactivity, respectively. The mean renal clearance of saxagliptin (~230 ml/min) was greater than the mean estimated glomerular filtration rate (~120 ml/min), which is likely due to active renal excretion. For the main metabolite, the value of renal clearance was compared with the estimated value of glomerular filtration. In total, 22% of the administered radioactivity was detected in the feces, which corresponds to the part of saxagliptin that entered the bile and / or the part of the drug not absorbed in the gastrointestinal tract.
Characteristics of special patient groups

Renal failure. In patients with renal insufficiency classified by creatinine clearance of mild (>50 to ≤80 ml/min), moderate (30≤50 ml/min) and severe (<30 ml/min) degree, as well as in patients with terminal the stage of kidney disease on hemodialysis, the degree of impaired renal function did not affect C max saxagliptin and its main metabolite. In patients with mild renal insufficiency, the AUC values ​​of saxagliptin and its main metabolite were 1.2 and 1.7 times higher, respectively, than the AUC values ​​in individuals with normal renal function, an increase in these values ​​is not clinically significant. In patients with moderate and severe renal insufficiency or with end-stage kidney disease on hemodialysis, the AUC values ​​of saxagliptin and its main metabolite were 2.1 and 4.5 times higher, respectively, than the AUC values ​​in individuals with normal renal function.
Liver failure. There was no clinically significant difference in pharmacokinetic parameters in patients with mild, moderate and severe hepatic impairment.
Elderly patients. There was no clinically significant difference in pharmacokinetic parameters in elderly patients (65–80 years) compared with young patients (18–40 years).

INDICATION:

Monotherapy

Ongliza is indicated for patients with type II diabetes as an adjunct to diet and exercise to improve glycemic control.
An adjunct to ongoing therapy
Onglyza is indicated in patients with type II diabetes mellitus to improve glycemic control as an adjunct to metformin, thiazolidinedione (TZD) or sulfonylurea therapy when monotherapy with these drugs in combination with diet and exercise does not provide adequate glycemic control.
Initial combination therapy

Ongliza is indicated in patients with type II diabetes mellitus as initial combination therapy with metformin in addition to diet and exercise to improve glycemic control.

APPLICATION:

Monotherapy

The recommended dose of the drug as monotherapy is 5 mg 1 time per day.
Complementary therapy

The recommended dose of Onglyza as an adjunct to therapy with metformin, PPAR-γ agonists (thiazolidinediones), or sulfonylurea is 5 mg once daily.
Initial combination therapy

The recommended doses of Ongliza and Metformin for initial combination therapy are Ongliza 5 mg once daily and Metformin 500 mg daily.
In patients who fail to achieve glycemic control using initial doses, the dose of metformin should be increased according to approved dosing recommendations.
If the patient missed a dose, it should be taken as soon as he remembered about it. The dose should not be doubled.
Ongliza can be taken with or without food.
Patients with renal insufficiency. No dose adjustment recommendation for Ongliza in patients with mild renal impairment (creatinine clearance >50 ml/min, which approximates creatinine levels <150 µmol/L (< 1. 7 mg/dL) in men and <133 µmol/L (<1.5 mg/dl) in women), so no dose adjustment should be made.
For patients with moderate to severe renal impairment or end-stage renal disease requiring hemodialysis (creatinine clearance ≤50 ml/min, which is approximately 1.7 mg/dl in men and 1.5 mg/dl in women) ), the dose of Ongliza is 2.5 mg/day. Ongliza should be used after hemodialysis. The use of the drug in patients on peritoneal dialysis has not been studied.
Since there is a need to adjust the dose taking into account renal function, it is recommended to evaluate renal function before starting therapy and periodically during treatment with Ongliza. CC can be assessed by serum creatinine levels using the Cockcroft-Gault formula.
Patients with liver failure. Patients with mild, moderate and severe hepatic impairment do not require dose adjustment.
Patients taking strong inhibitors of CYP 3A4/5 . In case of concomitant use with potent inhibitors of CYP3A4/5 (such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin), the dose of Onglyse should be limited to 2. 5 mg/day.
Elderly patients. No recommendations for dose adjustment based on age. Since elderly patients often have reduced renal function, the dose for them must be selected taking into account kidney function.

CONTRAINDICATIONS:

hypersensitivity to the active substance or any of the components of the preparation; During pregnancy and breastfeeding; childhood.

SIDE EFFECTS:

Adverse reactions by organ system, according to a pooled analysis of five placebo-controlled clinical trials with the use of Ongliza, were grouped by frequency of occurrence and were regarded as: very often (> 1/10), often (> 1/100, <1/10) , sometimes (>1/1000, <1/100), rarely (>1/10,000, <1/1000), very rare (<1/10,000), including single messages.
Infections and invasions: often – infections of the upper respiratory tract, urinary tract, gastroenteritis, sinusitis.
From the gastrointestinal tract: often – vomiting.
From the side of the central nervous system: often – headache.
Adverse reactions associated with Onglise and combination therapy. In a study investigating the incorporation of Onglise into glibenclamide therapy, episodes of confirmed hypoglycemia were rated as uncommon (0.8%) for Onglise 5 mg and (0.7%) for placebo. The difference was not statistically significant. In two studies investigating monotherapy, one investigating the inclusion of Ongliza in metformin therapy, and a study investigating the inclusion of Ongliza in TZD therapy, the incidence of confirmed hypoglycemia in patients who received Ongliza 5 mg was the same as in patients receiving placebo. In a study investigating the inclusion of Ongliza in TZD therapy, cases of peripheral edema were regarded as frequent and their frequency was higher with Ongliza 5 mg compared with placebo (8.1 and 4.3%, respectively). All reported cases of peripheral edema were mild or moderate and did not lead to discontinuation of the drug. In a pooled analysis of two studies investigating monotherapy, one study investigating the inclusion of Ongliza in metformin therapy, and a study investigating the inclusion of Ongliza in glibenclamide therapy, the overall incidence of peripheral edema observed in patients who took Ongliza 5 mg was the same as in placebo use (1. 7 and 2.4%, respectively).
In combination therapy with Ongliza 5 mg and metformin, nasopharyngitis was reported as frequent and was higher with Ongliza + metformin (6.9%) compared with saxagliptin 10 mg (4.2%) or metformin alone (4.2%). 0%). Headache events were rated as frequent and their frequency was higher with the combination of Onglyza 5 mg + metformin (7.5%) compared with monotherapy with saxagliptin 10 mg (6.3%) or metformin (5.2%).
Cases of dizziness have been reported during treatment with saxagliptin.
Laboratory indicators. In clinical studies, the frequency of changes in laboratory parameters was similar in patients receiving Onglise 5 mg and placebo. Among those taking Ongliza, there was a slight decrease in the absolute number of lymphocytes. In a pooled analysis of five placebo-controlled clinical trials, there was a mean decrease in lymphocyte count of approximately 100 cells/μL from baseline mean absolute lymphocyte count, which was approximately 2200 cells/μL compared to placebo. The mean absolute lymphocyte count remained stable and within normal limits with daily use of the drug for 102 weeks. The decrease in the number of lymphocytes was not accompanied by any clinically significant adverse reactions. The clinical significance of the decrease in the number of lymphocytes compared with placebo is unknown.

SPECIAL INSTRUCTIONS:

General. Ongliza should not be used in patients with type 1 diabetes mellitus or in the treatment of diabetic ketoacidosis. Ongliza has not been studied in combination with insulin.
Patients with renal insufficiency. For patients with moderate to severe renal insufficiency or end-stage renal disease requiring hemodialysis, dose adjustment of Onglyza is recommended. Before starting therapy and periodically during treatment with the drug, it is recommended to monitor renal function.
Patients with liver failure. Saxagliptin should be used with caution in patients with moderate hepatic impairment; patients with severe hepatic impairment should not be given saxagliptin.
Use with drugs that may cause hypoglycemia. Sulfonylureas in the antihyperglycemic group may cause hypoglycemia. Therefore, to reduce the risk of hypoglycemia when used in combination with Ongliza, it may be necessary to reduce the dose of the sulfonylurea.
Hypersensitivity reactions. Onglise should not be used in patients who have had severe hypersensitivity reactions to DPP-4 inhibitors.
Elderly patients. No differences in safety or efficacy have been found between individuals aged 65 years and older and younger individuals. Clinical experience has not shown a difference in drug response between elderly and younger patients, however, the possibility that some elderly patients may be more sensitive to the drug cannot be ruled out.
Saxagliptin and its main metabolite are excreted in part by the kidneys. Since renal function is more likely to decrease in elderly patients, it is necessary to adjust the dose for the elderly, taking into account kidney function (see APPLICATION ).
Immunocompromised patients. Immunocompromised organ transplant patients or HIV-infected patients did not participate in Ongliza’s clinical trial program. Therefore, the efficacy and safety of Ongliza in this category of patients have not been established.
Excipients. This tablet contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pregnancy and lactation period. There are no adequate data on the use of Ongliza during pregnancy. Therefore, Ongliza should not be used during pregnancy.
It is not known whether saxagliptin passes into breast milk. During treatment with saxagliptin, breast-feeding should be discontinued.
Children. The safety and efficacy of the drug in children have not been established, so Onglyza is not used in pediatric practice.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. No studies have been conducted on the effect on the ability to drive vehicles and work with mechanisms. Given the presence of dizziness as an adverse reaction, during treatment with saxagliptin, it is necessary to refrain from driving vehicles or working with other mechanisms.

INTERACTIONS:

The clinical data described below indicate a low risk of clinically significant drug interactions with drugs given in combination.
Caxagliptin is metabolized predominantly with the participation of cytochrome P450 3A4/5 (CYP 3A4/5).
In vitro studies saxagliptin and its active metabolite did not inhibit CYP 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1 and 3A4 and did not induce CYP 1A2, 2B6, 2C9or 3A4. In clinical studies involving healthy volunteers, the pharmacokinetics of saxagliptin and its main metabolite did not change when metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, anticides, or famotidine were administered. In addition, saxagliptin did not alter the pharmacokinetics of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, diltiazem, or ketoconazole.
Potent inhibitors of CYP 3A4/5. Co-administration of saxagliptin with the potent inhibitor of CYP 3A4/5 ketoconazole resulted in an increase in C max saxagliptin by 62% and an increase in AUC of saxagliptin by 2.5 times, these figures for the active metabolite decreased by 95 and 88%, respectively.
When saxagliptin is used concomitantly with potent inhibitors of CYP3A4/5 (such as atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin), a similar increase in plasma concentrations of saxagliptin can also be expected. In the case of simultaneous use with potent inhibitors of CYP 3A4 / 5, the dose of Onglyza should be limited to 2.5 mg / day.
Moderate inhibitors of CYP 3A4/5. Simultaneous administration of saxagliptin with a moderate inhibitor of CYP 3A4 / 5 diltiazem led to an increase in C max saxagliptin by 63% and an increase in AUC of saxagliptin by 2.1 times, these figures for the active metabolite decreased by 44 and 34%, respectively. Diltiazem increases the exposure of saxagliptin. A similar increase in plasma saxagliptin concentrations can be expected in the presence of other mild inhibitors of CYP 3A4 / 5 (such as amprenavir, aprepitant, erythromycin, fluconazole, fosamprenavir, grapefruit juice and verapamil), but dose reduction of Onglyse is not required.
CYP 3A4/5 enzyme inducers. Rifampicin significantly reduces the systemic exposure of saxagliptin and does not affect the AUC of its active metabolite, hydroxysaxagliptin. At the same time, rifampicin does not affect the degree of inhibition of DPP-4 activity in blood plasma over a 24-hour dose interval. Dose adjustment of Onglyza is not required.
Concomitant use of saxagliptin and other CYP3A4/5 inducers such as carbamazepine, dexamethasone, phenobarbital and phenytoin has not been studied and may lead to a decrease in plasma concentrations of saxagliptin and an increase in the concentration of its main metabolite. It is necessary to carry out strict glycemic control while using saxagliptin and powerful inducers of CYP 3A4 / 5.
The effect of smoking, diet, consumption of herbal products and alcohol on the pharmacokinetics of saxagliptin has not been specifically studied.

OVERDOSE:

Oral Onglyza once daily was safe and well tolerated with no clinically significant effect on Q-Tc interval or heart rate at doses up to 400 mg/day for 2 weeks (80 times the maximum recommended dose) . In case of overdose, carry out symptomatic treatment according to the clinical condition of the patient. Saxagliptin and its main metabolite are eliminated by hemodialysis (23% of the dose in 4 hours).

STORAGE CONDITIONS:

below 30°C.

Ongliza – instructions for use, contraindications, side effects

Larisa, do you know that in your case, if hypoglycemic drugs do not help, do you need to prescribe insulin? How do you live with such sugars?!