ARAVA

Drug Name: ARAVA

ARAVA DESCRIPTION:
LEFLUNOMIDE - ORAL (leh-FLEW-no-mide)

COMMON ARAVA BRAND NAME(S):
Arava

ARAVA SIDE EFFECTS:
Nausea, diarrhea, flu-like symptoms, mild dizziness, headache may occur. If these effects persist or worsen, notify your doctor promptly. Unlikely but report promptly: dark urine, yellowing eyes or skin, hair loss, stomach pain, chest pain, back pain, mouth sores, muscle cramping, numbness/tingling sensations, fever, persistent sore throat, easy bruising or bleeding. Very unlikely but report promptly: unusual lumps (lymph gland enlargement). If signs of infection (such as fever), anemia, or easy bruising/bleeding develop, leflunomide may need to be stopped. The elimination procedure using cholestyramine or charcoal may be required (see How to Use section). Consult your doctor or pharmacist for details. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

HOW TO USE ARAVA:
ARAVA: ARAVA is taken by mouth, generally once daily. Follow directions carefully, as it is generally recommended to start with a special higher dose for the first 3 days, then decrease to the regular dose thereafter. After treatment is stopped, cholestyramine may be given as directed, generally three times daily for 11 days. This procedure is used if you require a rapid removal of the drug from your system. Without the procedure the drug may persist for 2 years. Consult your doctor or pharmacist to learn whether you are a candidate for cholestyramine treatment (such as a couple planning to have children).

ARAVA WARNING:
Pregnancy must be excluded before the start of treatment with leflunomide. ARAVA must not be used during pregnancy, nor by women of childbearing age who are not using reliable birth control (contraception). Unless female leflunomide users go through a certain process to eliminate ARAVA from their body, pregnancy must be avoided for 2 years after ARAVA has been stopped.

ARAVA USES:
ARAVA is used to treat arthritis (rheumatoid type). It works by blocking the immune system's abnormal activity.

ARAVA PRECAUTIONS:
Tell your doctor your medical history, including: allergies, kidney or liver diseases, blood disorders, bone marrow problems, immune system disorders, uncontrolled infections. Vaccination with live vaccine products while using ARAVA 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. ARAVA 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 ARAVA is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using ARAVA is not recommended. Consult your doctor before breast-feeding. To minimize risk, men wishing to father a child should consider stopping ARAVA and using cholestyramine as directed (see How To Use). Consult your doctor. Use of ARAVA in children/teenagers under 18 years of age is not recommended.

ARAVA 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). Do not start or stop any medicine without doctor or pharmacist approval.

ARAVA OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately.

ARAVA NOTES:
Do not share ARAVA with others. Laboratory and/or medical tests (e.g., liver function and blood counts) will be performed periodically to monitor your progress.

MISSED ARAVA 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.

ARAVA STORAGE:
Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture. Your condition can cause complications in a medical emergency. For information on enrollment call Medic Alert(TM) at 1-800-854-1166. In Canada call 1-800-668-1507.