Contraindicated in pregnant women and women of childbearing potential who are not using a reliable form of contraception. (See Fetal/Neonatal Morbidity and Mortality and also see Contraindications under Cautions.)
Pregnancy must be excluded prior to initiation of therapy.
Pregnancy must be avoided while the woman is receiving leflunomide and prior to completion of the drug elimination procedure following discontinuance of the drug. (See Drug Elimination Procedures Following Leflunomide Discontinuance under Dosage and Administration.)
Hepatotoxicity
Severe liver injury, including fatal liver failure, reported.
Do not use in patients with preexisting liver disease or baseline ALT >2 times ULN; use with caution in patients receiving other potentially hepatotoxic drugs. (See Hepatic Effects under Cautions.)
Regular monitoring of ALT during therapy required; ALT >3 times ULN warrants interruption of therapy while cause is investigated. (See Hepatic Effects under Cautions.)
Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. You will need frequent blood checks while you are receiving the medicine.
If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may increase your risk of getting an infection.
If you are a woman who has the potential to become pregnant, discuss birth control options with your doctor or health care professional. You must not be pregnant, and you must be using a reliable form of birth control. The medicine may harm an unborn baby. Immediately call your doctor if you think you might be pregnant.
Alcoholic drinks may increase possible damage to your liver. Do not drink alcohol while taking this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
cough
difficulty breathing or shortness of breath
fever, chills or any other sign of infection
redness, blistering, peeling or loosening of the skin, including inside the mouth
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture and light. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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