Arava

DRUG DESCRIPTION

ARAVAź (leflunomide) is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4??-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.2 and the following structural formula:

ARAVAź (leflunomide) Structural Formula Illustration

ARAVA is available for oral administration as tablets containing 10, 20, or 100 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, talc, titanium dioxide, and yellow ferric oxide (20 mg tablet only).

What are the possible side effects of leflunomide (Arava)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using leflunomide and call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • chest pain;
  • cough, trouble breathing (you may also have a fever);
  • pain or burning when you urinate;
  • pale skin, easy...

Read All Potential Side Effects and See Pictures of Arava »

What are the precautions when taking leflunomide (Arava)?

Before taking leflunomide, 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: 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), lung disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities...

Read All Potential Precautions of Arava »


Arava Consumer (continued)

SIDE EFFECTS: 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 immediately if any of these unlikely but serious side effects occur: cough, numbness/tingling of hands/feet, hair loss, chest pain, fast/pounding heartbeat, increased thirst/urination, muscle cramp/pain, mental/mood changes, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, unusual growths/lumps, swollen glands (lymph nodes), unexplained weight loss, unusual tiredness.

This medication can lower the body's ability to fight an infection. Tell your doctor immediately if you develop any signs of an infection such as fever, chills, or persistent sore throat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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. Therefore, seek immediate medical attention if you develop any rash.

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.

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 leflunomide, 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: 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), lung disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages since they can make you dizzy and 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 two 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. (See also Warning section.)

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. (See How to Use section.) 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.


Arava Patient Information Including Side Effects

Brand Names: Arava

Generic Name: leflunomide (Pronunciation: le FLOO noe mide)

  • What is leflunomide (Arava)?
  • What are the possible side effects of leflunomide (Arava)?
  • What is the most important information I should know about leflunomide (Arava)?
  • What should I discuss with my healthcare provider before taking leflunomide (Arava)?
  • How should I take leflunomide (Arava)?
  • What happens if I miss a dose (Arava)?
  • What happens if I overdose (Arava)?
  • What should I avoid while taking leflunomide (Arava)?
  • What other drugs will affect leflunomide (Arava)?
  • Where can I get more information?

What is leflunomide (Arava)?

Leflunomide affects the immune system and reduces swelling and inflammation in the body.

Leflunomide is used to treat the symptoms of rheumatoid arthritis. Leflunomide also helps reduce joint damage and improves physical functioning.

Leflunomide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of leflunomide (Arava)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using leflunomide and call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • chest pain;
  • cough, trouble breathing (you may also have a fever);
  • pain or burning when you urinate;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • mild stomach pain, diarrhea, loss of appetite;
  • weight loss;
  • headache, dizziness;
  • back pain;
  • numbness or tingling;
  • runny or stuffy nose, cold symptoms; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about leflunomide (Arava)?

This medication can cause birth defects. Do not use if you are pregnant. Your doctor may want you to have a pregnancy test to make sure you are not pregnant before you start taking leflunomide.

Stop taking leflunomide and tell your doctor right away if you become pregnant during treatment. You will need to receive medications to help your body eliminate the drug quickly and reduce the risk of harm to your unborn baby.

Use effective birth control while you are taking leflunomide, whether you are a man or a woman. After your treatment ends, continue using birth control until you have received the drug elimination medications.

Before taking leflunomide, tell your doctor if you have liver disease, a history of hepatitis, kidney disease, any type of infection, a history of tuberculosis, a blood cell disorder such as anemia or low platelets, a bone marrow disorder, or if you are using any drugs that weaken your immune system (such as cancer medicine or steroids).

Leflunomide can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with leflunomide, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

After you stop taking leflunomide, you may need to be treated with other medications to help your body eliminate leflunomide quickly. Without receiving this drug elimination procedure, leflunomide could stay in your body for up to 2 years. Follow your doctor's instructions.

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