Leflunomide

By

Generic Name: Leflunomide Brand Name(s): Generics only. No brands available.

Uses

What is Leflunomide used for?

This medication is used to treat rheumatoid arthritis, a condition in which the body’s defense system (immune system) fails to recognize the body as itself and attacks the healthy tissues around the joints. Leflunomide helps to reduce the joint damage/pain/swelling and helps you to move better. It works by weakening your immune system and decreasing swelling (inflammation).

How should I take Leflunomide?

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. Take this medication exactly as prescribed. You may be instructed to take a higher dose for the first 3 days of treatment.

Dosage is based on your medical condition and response to therapy.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day.

After treatment is stopped, a different drug (cholestyramine) may be given as directed to help remove leflunomide from your body. This procedure is used if you need a rapid removal of the drug from your system (e.g., a female/male planning to have children, a person suffering from severe side effects). Without the procedure, the drug may stay in your body for up to 2 years. Consult your doctor or pharmacist for more details.

Inform your doctor if your symptoms persist or worsen.

How do I store Leflunomide?

Leflunomide is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Leflunomide in the bathroom or the freezer. There may be different brands of Leflunomide that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Leflunomide down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Leflunomide?

Before taking leflunomide, tell your doctor or pharmacist if you are allergic to it; or to teriflunomide; 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: immune system disorder (e.g., HIV infection), current/recent infection (e.g., tuberculosis), cancer, bone marrow/blood disorder, kidney disease, liver disease (e.g., hepatitis B or C), alcohol abuse, heart disease (e.g., congestive heart failure), high blood pressure, lung disease.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Alcohol may also cause liver disease.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

This medication must not be used during pregnancy. It may harm an unborn baby. Before starting this medication, women of childbearing age must have a negative pregnancy test before starting this medication. Men and women must use effective forms of birth control (e.g., condoms and birth control pills) while taking this medication. Consult your doctor for more details and to discuss reliable forms of birth control.

It is not known whether this medication affects the sperm. To minimize any possible risk, the manufacturer recommends that men wishing to father a child should consider stopping the medication and using another drug (cholestyramine) as directed to help this drug leave the body before attempting to father a child. Consult your doctor for more details.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Leflunomide during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Leflunomide. Leflunomide is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Leflunomide?

Diarrhea, nausea, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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: cough, numbness/tingling of hands/feet, hair loss, chest pain, fast/pounding heartbeat, increased thirst/urination, muscle cramp/pain, mental/mood changes, vision changes, easy bruising/bleeding, unusual growths/lumps, unexplained weight loss, unusual tiredness.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Get medical help right away if you have any signs of infection (such as sore throat that doesn’t go away, fever, swollen lymph nodes, chills).

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.

Leflunomide can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Leflunomide?

Some products that may interact with this drug include: warfarin, rifamycins (e.g., rifampin), drugs affecting the liver (e.g., methotrexate), cholestyramine, other drugs that weaken the immune system (e.g., tacrolimus, cyclosporine).

Because teriflunomide (used to treat multiple sclerosis) is very similar to this medication, do not take it while you are taking leflunomide.

Leflunomide may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Leflunomide?

Leflunomide may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Leflunomide?

Leflunomide may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Leflunomide.

What is the dose of Leflunomide for an adult?

Usual Adult Dose for Rheumatoid Arthritis

Loading dose: 100 mg orally once a day for 3 days

Maintenance: 20 mg orally once a day (If not well tolerated, the dose may be decreased to 10 mg orally once a day)

Comment:

-Hematology parameters and liver enzymes should be monitored.

Use:

For the treatment of active rheumatoid arthritis (RA):

-To reduce signs and symptoms

-To inhibit structural damage as evidenced by X-ray erosions and joint space narrowing

-To improve physical function

Renal Dose Adjustments

Caution is recommended

Liver Dose Adjustments

Not recommended

Dose Adjustments

-Due to the prolonged half-life of the active metabolite of this drug, patients should be carefully observed after dose reduction, since it may take several weeks for metabolite levels to decline.

-Reduced dosage may be necessary in patients with mild or moderate adverse reactions.

-The maintenance dosage for the treatment of rheumatoid arthritis depends on the severity (activity) of the disease.

-It may take several weeks for the active metabolite levels to decline due to its prolonged half-life. Patients should be carefully observed after dose reduction.

-If this drug is used in combination with methotrexate or other immunosuppressive agents, avoiding the loading dose may decrease the risk of adverse effects.

Dialysis

Studies have indicated that the active metabolite of leflunomide (M1) is not removed by hemodialysis.

Other Comments

Administration advice:

-The treatment should be initiated and supervised by specialists experienced in the treatment method.

-Tablets should be swallowed whole with sufficient liquid.

-This drug may be administered with or without food.

-Therapeutic effects become apparent after 4 to 6 weeks of therapy and symptoms may continue to improve for up to 4 to 6 months.

General:

-The primary active metabolite of this drug (M1) has a half-life of approximately 2 weeks.

-Doses should not exceed 20 mg per day. Studies have shown a greater incidence of side effects at 25 mg per day.

Baseline levels for platelets, white blood cell count and hemoglobin or hematocrit should be obtained on all patients beginning therapy, and then monthly for the first 6 months following initiation of therapy and every 6 to 8 weeks thereafter.

-In the event of any serious drug toxicity, including hypersensitivity, consult the manufacturer product information for the elimination procedure.

What is the dose of Leflunomide for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Leflunomide available?

Leflunomide is available in the following dosage forms and strengths:

  • Oral Tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Leflunomide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: March 14, 2018 | Last Modified: March 14, 2018

Sources
You might also like