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LEFLUNOMIDE-ORAL (cont.)

PRECAUTIONS: This medication should not be used if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have: a severe immune system disorder, bone marrow problems (dysplasia), uncontrolled infections. Tell your doctor your medical history, including: any allergies, kidney or liver diseases, blood disorders. Vaccination with live vaccine products while using this drug is not recommended. Consult your doctor. Due to possible fetal harm or death, a pregnancy test is needed before starting treatment. Use of reliable birth control is necessary. Consult your doctor. This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. To minimize risk, men wishing to father a child should consider stopping this drug and using cholestyramine as directed (see How To Use). Consult your doctor. Use of this drug in children/teenagers under 18 years of age is not recommended.

DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription medication you may use, especially: cholestyramine, drugs affecting the liver (e.g., methotrexate, troglitazone), rifamycins (e.g., rifampin), drugs which depress the immune system (e.g., prednisone, cyclosporine). Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., liver function and blood counts-CBC/platelets) will be performed periodically to monitor your progress and check for side effects, especially if you are using this drug in combination with methotrexate.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

STORAGE: Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).


Last Editorial Review: 3/2/2005




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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