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(leflunomide) 10 mg, 20 mg, 100 mg Tablets
CONTRAINDICATIONS AND WARNINGS
Pregnancy must be excluded before the start of treatment with ARAVA. ARAVA is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. (See CONTRAINDICATIONS and WARNINGS.) Pregnancy must be avoided during ARAVA treatment or prior to the completion of the drug elimination procedure after ARAVA treatment.
Severe liver injury, including fatal liver failure, has been reported in some patients treated with ARAVA. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) > 2xULN before initiating treatment, should not be treated with ARAVA. Use caution when ARAVA is given with other potentially hepatotoxic drugs.
Monitoring of ALT levels is recommended at least monthly for six months after starting ARAVA, and thereafter every 6-8 weeks. If ALT elevation > 3 fold ULN occurs, interrupt ARAVA therapy while investigating the probable cause of the ALT elevation by close observation and additional tests. If likely leflunomide-induced, start cholestyramine washout and monitor liver tests weekly until normalized. If leflunomide-induced liver injury is unlikely because some other probable cause has been found, resumption of ARAVA therapy may be considered. (See WARNINGS – HEPATOTOXICITY.)
ARAVA® (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:
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;
- chest pain, dry cough, wheezing, feeling short of breath (you may also have a fever);
- pain or burning when you urinate;
- pale skin, easy bruising or bleeding, unusual...
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), high blood pressure, 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...
Last reviewed on RxList: 11/30/2012
This monograph has been modified to include the generic and brand name in many instances.
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