Warnings & Recalls for Leflunomide
Black box warning
Not for women who are pregnant of have the potential of becoming pregnant because this drug can
harm the fetus. Leflunomide can increase the risk of severe liver injury which can be life threatening or deadly. The risk is higher for people who are taking medications known to
cause liver damage, and for people who already have liver disease. Tell you doctor if you drink heavily or have ever had hepatitis or any other type of liver disease.
Other warnings
Be sure to tell your doctor if you have any of the
pre-existing conditions such as tuberculosis, a blood cell disorder such as anemia, have a weak immune system, or are currently taking any
drugs that weaken your immune system such as cancer medication or steroids.
Drugs that may interact with Leflunomide
Tell your doctor if you are taking any of the following medications that can weaken your immune system:
- rifampin (Rifadin, Rimactane)
- cholestyramine (Questran, Prevalite LoCHOLEST)
- methotrexate (Rheumatrex, Trexall);
- cancer medications;
- cyclosporine (Neoral, Sandimmune, Gengraf);
- sirolimus (Rapamune), tacrolimus (Prograf);
- basiliximab (Simulect), muromonab-CD3 (Orthoclone);
- mycophenolate mofetil (CellCept); or
- azathioprine (Imuran), etanercept (Enbrel)
Leflunomide is harmful to your liver whose effect can be increased when combined with other medication that is also harmful to the liver such as:
- an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others
- acetaminophen (Tylenol, in other over-the-counter products)
- aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs such as ibuprofen [Advil, Motrin] and naproxen [Aleve, Naprosyn]
- cholesterol-lowering medications (statins), etanercept (Enbrel)
- hydroxychloroquine
- an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);
- other arthritis medications such as auranofin (Ridaura) or aurothioglucose (Solganol)
- tuberculosis medication
- iron products
- isoniazid (INH, Nydrazid, in Rifamate)
- HIV/AIDS medications such as abacavir/lamivudine/zidovudine (Trizivir), lamivudine (Combivir, Epivir), nevirapine (Viramune), tenofovir (Viread), or zidovudine (Retrovir);
- methotrexate (Rheumatrex)
- an antibiotic such as dapsone or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole);
- seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), felbamate (Felbatol), valproic acid (Depakene)
- niacin (nicotinic acid)
- cholesterol medications such as niacin (Advicor, Niaspan, Niacor, Slo-Niacin, and others), atorvastatin (Lipitor, Caduet), simvastatin (Zocor, Simcor, Vytorin), and others;
- birth control pills or hormone replacement therapy
- rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
Family planning
The FDA categorizes leflunomide as a
category X pregnancy. Do not take leflunomide if you are pregnant or plan to become pregnant. Leflunomide may harm the fetus. Your doctor will have you take a pregnancy test to get a negative result before he begins you on this medication.
You should have an effective form of birth control while taking leflunomide during treatment and up to 2 years after treatment. Tell your doctor immediately if you have a missed or late period. If you want to become pregnant within the 2 years after treatment be sure to talk to your doctor as there is an option for a treatment that will help to remove this medication more quickly from your body.
It is unknown if leflunomide passes into breast milk or if it could harm a nursing baby.
Do not breastfeed while on this medication. Men have the risk of passing on birth defects to any children that they father during and after this treatment. After treatment men should continue using contraceptives (condoms) until you have received medication to help your body flush out the leflunomide.
Leflunomide Treatment and Use
What is Leflunomide?
Leflunomide affects the immune system and reduces swelling and inflammation in the body.
How does Leflunomide work?
Leflunomide is used to decrease the symptoms of rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) and slow the damage to joints caused by the disease.
Dosage information
Take as exactly as directed by your doctor, no more or less. Comes in tablet form taken by mouth, 100 mg once daily for 3 days is the usual dose.
