What are the primary uses of leflunomide 20 mg. How does leflunomide work to treat rheumatoid arthritis. What are the most common side effects of leflunomide. How should leflunomide be dosed for optimal effectiveness. What precautions should be taken when using leflunomide.

Understanding Leflunomide: A Powerful Treatment for Rheumatoid Arthritis

Leflunomide is a prescription medication primarily used to treat active rheumatoid arthritis (RA). Available as an oral tablet, it belongs to a class of drugs known as disease-modifying antirheumatic drugs (DMARDs). Leflunomide works by modulating the immune system and reducing inflammation, which helps alleviate joint pain and improve daily functioning for those with RA.

The drug is marketed under the brand name Arava but is also available as a generic medication. While the generic version typically costs less, it may not be available in all strengths or forms as the brand-name drug.

How does leflunomide work in the body?

Leflunomide targets the overactive immune response that characterizes rheumatoid arthritis. It blocks specific proteins and pathways in the body that contribute to inflammation, effectively dampening the immune system’s attack on the joints. This mechanism of action helps reduce pain, swelling, and joint damage associated with RA.

Leflunomide Dosage and Administration

The correct dosage of leflunomide is crucial for its effectiveness and safety. Typically, treatment begins with a loading dose followed by a maintenance dose.

• Loading dose: 100 mg once daily for 3 days
• Maintenance dose: 20 mg once daily

However, some patients may require dose adjustments based on their response to the medication and any side effects experienced. Always follow your doctor’s instructions regarding dosage and administration.

Can the dosage of leflunomide be adjusted?

Yes, the dosage of leflunomide can be adjusted. In some cases, a lower maintenance dose of 10 mg daily may be prescribed if the 20 mg dose is not well-tolerated. Your healthcare provider will determine the most appropriate dosage based on your individual needs and response to the medication.

Common Side Effects of Leflunomide

Like all medications, leflunomide can cause side effects. While not everyone experiences these effects, it’s important to be aware of the possibilities.

The most common side effects of leflunomide include:

• Diarrhea
• Nausea
• Headache
• Rash
• Stomach upset
• Abnormal liver tests

These side effects are usually mild and may resolve on their own within a few days or weeks. However, if they persist or become severe, it’s important to consult your healthcare provider.

How can patients manage the common side effects of leflunomide?

To manage common side effects, patients can try the following strategies:

1. Take the medication with food to reduce stomach upset
2. Stay well-hydrated to help with diarrhea
3. Use over-the-counter pain relievers for headaches, as approved by your doctor
4. Apply moisturizer to alleviate skin rashes
5. Report any persistent or severe side effects to your healthcare provider

Serious Side Effects and Precautions

While less common, leflunomide can cause serious side effects that require immediate medical attention. These include:

• Serious infections (e.g., pneumonia, tuberculosis)
• Severe skin reactions
• Low blood cell counts
• Worsening lung function
• Liver damage

It’s crucial to be aware of the symptoms associated with these serious side effects and seek medical help if they occur.

What are the warning signs of serious side effects from leflunomide?

Patients should watch for the following warning signs:

• Persistent fever or chills
• Unusual fatigue or weakness
• Severe skin rash or blistering
• Yellowing of the skin or eyes
• Difficulty breathing or persistent cough
• Unexplained bruising or bleeding

If any of these symptoms occur, it’s important to seek medical attention immediately.

FDA Warnings and Contraindications

Leflunomide carries several black box warnings from the FDA, which are the most serious warnings issued for prescription medications. These warnings highlight potential risks that healthcare providers and patients need to be aware of.

What are the main FDA warnings for leflunomide?

The primary FDA warnings for leflunomide include:

1. Pregnancy risk: Leflunomide is contraindicated during pregnancy due to the risk of serious birth defects.
2. Liver damage: The medication can cause severe liver injury, particularly in patients with pre-existing liver conditions.
3. Infection risk: Leflunomide can increase the risk of serious infections due to its immunosuppressive effects.

These warnings underscore the importance of close medical supervision and regular monitoring while taking leflunomide.

Drug Interactions and Precautions

Leflunomide can interact with various medications, potentially altering its effectiveness or increasing the risk of side effects. It’s crucial to inform your healthcare provider about all medications, supplements, and herbal products you’re taking.

Which medications may interact with leflunomide?

Some medications that may interact with leflunomide include:

• Other DMARDs (e.g., methotrexate)
• Certain antibiotics
• Warfarin (a blood thinner)
• Cholesterol-lowering medications
• Some antifungal drugs

Your doctor will carefully manage your medications to avoid potential interactions and may adjust dosages as needed.

Monitoring and Follow-up Care

Regular monitoring is essential when taking leflunomide to ensure its effectiveness and detect any potential side effects early. This typically involves periodic blood tests and clinical evaluations.

How often should patients taking leflunomide have follow-up appointments?

The frequency of follow-up appointments may vary, but generally includes:

• Monthly liver function tests for the first 6 months of treatment
• Blood cell count monitoring every 6-8 weeks
• Regular check-ups to assess RA symptoms and overall health
• Immediate appointments if any concerning symptoms arise

Your healthcare provider will establish a monitoring schedule tailored to your individual needs and risk factors.

Leflunomide in Combination Therapy

In some cases, leflunomide may be prescribed in combination with other RA treatments to enhance its effectiveness. This approach, known as combination therapy, can provide better symptom control for some patients.

Can leflunomide be used with other rheumatoid arthritis medications?

Yes, leflunomide can be used in combination with other RA treatments, including:

• Methotrexate
• Hydroxychloroquine
• Sulfasalazine
• Biologic DMARDs (in some cases)

However, combination therapy requires careful monitoring and should only be initiated under the guidance of a rheumatologist.

Leflunomide represents a valuable treatment option for individuals with active rheumatoid arthritis. Its ability to modulate the immune system and reduce inflammation can significantly improve quality of life for many patients. However, the potential for serious side effects and interactions necessitates careful consideration and close medical supervision.

When prescribed appropriately and monitored diligently, leflunomide can be an effective component of a comprehensive RA treatment plan. Patients should maintain open communication with their healthcare providers, report any concerning symptoms promptly, and adhere to recommended monitoring schedules to ensure the safe and effective use of this medication.

As research in rheumatology continues to advance, our understanding of leflunomide and its optimal use in RA treatment may evolve. Staying informed about the latest developments and maintaining a collaborative relationship with your healthcare team are key to maximizing the benefits of leflunomide therapy while minimizing potential risks.

Side Effects, Dosage, Uses, and More

Highlights for leflunomide

1. Leflunomide oral tablet is available as a generic drug and a brand-name drug. Brand name: Arava.
2. Leflunomide only comes as a tablet you take by mouth.
3. Leflunomide oral tablet is used to treat active rheumatoid arthritis.

FDA warnings

• This drug has black box warnings. A black box warning is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
• Pregnancy risk warning. You shouldn’t take this medication if you’re pregnant. In addition, you shouldn’t take it if you’re of childbearing age and not using effective birth control methods to prevent pregnancy. Avoid becoming pregnant while taking this medication. If you become pregnant, talk to your doctor.
• Liver damage warning. Liver damage can occur in anyone taking this drug. People with existing liver damage shouldn’t take this drug. Your doctor may do blood tests to measure liver function at least monthly for six months after starting this drug, and every six to eight weeks after that.

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Other warnings

• Infection warning: This drug isn’t recommended if you have a weak immune system or serious infections. If you get a serious infection, such as pneumonia or tuberculosis, talk to your doctor to find out if you should stop taking this medication.
• Nerve damage warning: This medication can damage the nerves in some people and cause numbness, tingling, or burning pain in the hands and feet. This can go away once the drug is stopped. However, some people continue to have symptoms.
• Blood cell level warning: Your doctor may monitor your blood cell levels regularly. Talk to your doctor if you experience fevers, unusual tiredness, frequent infections, or bruise or bleed easily.

Leflunomide is a prescription medication. It comes as a tablet you take by mouth.

Leflunomide oral tablet is available as the brand-name drug Arava. It’s also available in a generic version. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

Why it’s used

Leflunomide oral tablet is used to treat active rheumatoid arthritis (RA). It can help reduce the pain in your joints and help you perform daily tasks better.

How it works

Rheumatoid arthritis occurs when your immune system becomes overactive and attacks some parts of your body, such as your joints. Leflunomide works to block part of your immune system and proteins in your body that cause inflammation.

Leflunomide is a nonbiologic disease-modifying antirheumatic drug (DMARD).

Leflunomide oral tablet does not cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects of leflunomide include:

• diarrhea
• nausea
• headache
• rash
• stomach upset
• abnormal liver tests

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Serious infections, including pneumonia, tuberculosis, and complications from infections
• Serious skin disorder. Symptoms can include:
  • flu-like symptoms
  • painful red or purple rash
  • blisters
• Low blood cell counts. Your doctor may monitor this through blood tests.
• Worsening lung function. Symptoms can include:
  • cough
  • trouble breathing, with or without fever

If you experience a side effect with leflunomide, or are at risk for a serious side effect, you may receive other oral medications to help remove leflunomide from your body more rapidly. This can help prevent future side effects.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Leflunomide oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with leflunomide are listed below.

Disease-modifying antirheumatic drug

Combining methotrexate with leflunomide may increase your risk of liver damage.

Antibiotic

Combining rifampin with leflunomide may cause higher levels of leflunomide in your body. This may increase side effects of leflunomide.

Blood thinner

Combining warfarin with leflunomide may decrease the effect of warfarin on your blood. You may need to have blood tests performed more often or have your dose of warfarin changed while taking leflunomide.

Live vaccines

Talk to your doctor or pharmacist before receiving live vaccinations. Leflunomide decreases immune function. This may increase your risk of getting the disease the vaccine is designed to prevent. Live vaccines include:

• influenza nasal spray
• measles, mumps, and rubella vaccine
• chickenpox (varicella) vaccine

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergy warning

This drug can cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• swelling of your throat or tongue
• hives

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this medication again if you’ve ever had an allergic reaction to this drug or teriflunomide. Taking it again could be fatal.

Warnings for people with certain health conditions

For people with liver disease: If you have liver problems, using this drug may cause even more damage to your liver. This drug isn’t recommended if you have liver disease.

For people with kidney disease: Talk to your doctor about using this drug if you have kidney problems. Higher levels of the drug may stay in your body if your kidneys don’t work well. It’s unknown if this would cause more side effects.

For people with serious infection: This drug isn’t recommended if you have a weak immune system or serious infections. If you get a serious infection, such as pneumonia or tuberculosis, talk to your doctor to find out if you should stop taking this medication.

Warnings for other groups

For pregnant women: This drug should not be used in pregnant women because of the potential for harm to the fetus. A pregnancy registry monitors outcomes in women exposed to leflunomide during pregnancy. If this applies to you, you or your doctor can register by calling 1-877-311-8972.

For women who are breastfeeding: It isn’t known if this drug passes through breast milk. It isn’t recommended for women to breastfeed while using this drug. You and your doctor may need to decide whether you’ll breastfeed or take this drug.

For children: This drug is not approved for people under the age of 18 years.

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• the severity of your condition
• other medical conditions you have
• how you react to the first dose

Drug forms and strengths

Generic: Leflunomide

• Form: oral tablet
• Strengths: 10 mg, 20 mg, and 100 mg

Brand: Arava

• Form: oral tablet
• Strengths: 10 mg, 20 mg, and 100 mg

Dosage for active rheumatoid arthritis

Adult dosage (ages 18 years and older)

• Starting dosage: Some people receive a starting dose of one 100-mg tablet per day for 3 days. This is called a loading dose.
• Typical maintenance dosage: 20 mg per day. If you can’t tolerate this dosage, your doctor may lower it to 10 mg per day.
• Maximum dosage: Doses higher than 20 mg per day are not recommended.

Child dosage (ages 0–17 years)

Dosage for people younger than 18 years hasn’t been established.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

After stopping treatment with leflunomide, a procedure to rapidly remove it from your blood is recommended. Otherwise, it can take up to two years to have undetectable blood levels after stopping the drug. Your doctor can tell you more.

Leflunomide is used for long-term treatment. It comes with risks if you don’t take it as prescribed.

If you stop taking the drug or don’t take it at all: Rheumatoid arthritis can cause severe pain and affect other organs in your body, especially if left untreated. It’s important to continue taking your medication as directed by your doctor, even if you feel better. This will give you the best chance of managing rheumatoid arthritis and improving your quality of life.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• diarrhea
• stomach pain
• changes in your blood cell levels (shown in tests your doctor can do)
• changes in your liver function (shown in tests your doctor can do)

You may need to take another medication to help get rid of excess leflunomide in your body more quickly.

If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 1-800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: If you miss a dose, take it as soon as you can. If it’s close to time for your next dose, skip the missed dose and take the next dose at the usual time. Don’t take more than one dose at a time or extra doses. Doing so could lead to more side effects.

How to tell if the drug is working: You should have less joint pain and be able to perform your daily tasks better.

Keep these considerations in mind if your doctor prescribes leflunomide for you.

General

Don’t cut, crush, or break apart this tablet.

Storage

• Store this medication at 77°F (25°C).
• Keep this drug away from light.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They won’t damage your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

This drug may affect your liver function and blood levels in your body. Your doctor may order blood tests monthly for the first six months of your treatment, and then every six to eight weeks after that.

A pregnancy test is required before starting this drug. If you think you’re pregnant while taking this drug, tell your doctor right away. You may need to take another pregnancy test.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline 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.

Leflunomide (Arava)

Leflunomide (Arava) is a drug approved to treat adult moderate to severe rheumatoid arthritis along with other rheumatic diseases. It belongs to a class of medications called disease-modifying antirheumatic drugs (DMARDs), which aim to decrease inflammation and permanent damage.

Leflunomide blocks the formation of DNA, which is important for replicating cells, such as those in the immune system. It suppresses the immune system to reduce inflammation that causes pain and swelling.

How to Take It

Leflunomide usually is given as a 20 mg tablet once a day. Sometimes, patients are given 10 mg, especially if they experienced side effects with the higher dose. Leflunomide should be taken with food. Complete benefits may not be experienced until 6–12 weeks after starting the medication.

It is important that you have regular blood tests, including those for liver function, while taking this medication. You should not take leflunomide if you have a pre-existing liver disease, such as hepatitis or cirrhosis. Because alcohol may increase the risk of liver damage from leflunomide, alcohol should be avoided.

Side Effects

The most common side effect of leflunomide is diarrhea, which occurs in approximately 20% of patients. This symptom frequently improves with time or by taking a medication to prevent diarrhea. If diarrhea persists, the dose of leflunomide may need to be reduced.

Less common side effects include nausea, stomach pain, indigestion, rash, and hair loss. In fewer than 10% of patients, leflunomide can cause abnormal liver function tests or decreased blood cell or platelet counts. Rarely, this drug may cause lung problems, such as cough, shortness of breath or lung injury.

Tell Your Rheumatology Provider

Leflunomide can cause serious birth defects. If you are pregnant or are considering having a child, you should discuss this with your rheumatology provider before beginning the medication. Breastfeeding while taking leflunomide is not recommended. Use of an effective form of birth control is critical throughout the course of this treatment. Men taking leflunomide who wish to have a child also should talk with their rheumatology provider about how to discontinue the medication. Cholestyramine is a medication you can take to help remove leflunomide from your system.

Live vaccinations should be avoided while taking this medication. Be sure to discuss any vaccines with your rheumatology provider before receiving them. It may be important to receive certain vaccines before starting this medication, such as the Pneumovax (pneumonia vaccine), hepatitis B, or tetanus booster for some patients.

Because this medication can lower your immunity, it is important you inform your rheumatologist if you have any infections or are planning to undergo any surgeries.