What is leflunomide?
Leflunomide affects the immune system and reduces swelling and inflammation in the body.
Leflunomide is used to treat the symptoms of rheumatoid arthritis. Leflunomide also helps
reduce joint damage and improves physical functioning.
Leflunomide may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking leflunomide?
You should not use this medication if you are allergic to leflunomide, or if you are pregnant
or may become pregnant.
If you have any of these other conditions, you may need a dose adjustment or special tests to
safely take this medication:
-
liver disease or a history of hepatitis;
-
kidney disease;
-
any type of infection;
-
a history of tuberculosis;
-
a blood cell disorder (such as anemia, easy bruising or
bleeding);
-
a weak immune system or bone marrow disorder; or
-
if you are using any drugs that weaken your immune system
(such as cancer medicine or steroids).
FDA pregnancy category X. This medication can cause birth defects.
Do not use leflunomide if you are pregnant.
Your doctor may want you to have a
pregnancy test to make sure you are not pregnant before you start taking leflunomide.
Stop taking leflunomide if you miss a period, and tell your doctor right away if you become
pregnant during treatment. If you become pregnant while taking leflunomide, you will need to receive
medications to help your body eliminate the drug quickly. This will reduce the risk of harm to your
unborn baby. You will also need to go through this drug elimination procedure if you plan to become
pregnant after you stop taking leflunomide.
Use effective birth control while you are taking leflunomide. After your treatment ends,
continue using birth control until you have received the drug elimination medications.
If a man fathers a child during or after leflunomide treatment, the baby may have birth
defects. Use a condom to prevent pregnancy while you are taking leflunomide. After your treatment
ends, continue using condoms until you have received the medications to help your body eliminate
leflunomide.
It is not known whether leflunomide passes into breast milk or if it could harm a nursing
baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take leflunomide?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or
for longer than recommended. Follow the directions on your prescription label.
Before you start taking leflunomide, you may need a skin test to make sure you do not have
tuberculosis.
Your doctor may occasionally change your dose to make sure you get the best results from this
medication.
Leflunomide can lower blood cells that help your body fight infections. This can make it easier
for you to get sick from being around others who are ill. To be sure your blood cells do not get too
low, your blood will need to be tested on a regular basis. Your liver function may also need to be
tested. Do not miss any scheduled appointments.
After you stop taking leflunomide, you may need to be treated with other medications to
help your body eliminate leflunomide quickly. Without receiving this drug elimination procedure,
leflunomide could stay in your body for up to 2 years. Follow your doctor's instructions.
Rheumatoid arthritis is often treated with a combination of different drugs. To best treat your
condition, use all of your medications as directed by your doctor. Be sure to read the medication guide
or patient instructions provided with each of your medications. Do not change your doses or
medication schedule without advice from your doctor.
Store leflunomide at room temperature away from moisture, heat, and light.
What happens if I miss a dose of leflunomide?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait
until then to take the medicine and skip the missed dose.
Do not
take extra medicine
to make up the missed dose.
Where can I get more information about leflunomide?
Your pharmacist has information about leflunomide written for health professionals that you may read.
What are the possible side effects of leflunomide?
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;
-
cough, trouble breathing (you may also have a fever);
-
pain or burning when you urinate;
-
pale skin, easy bruising or bleeding, unusual weakness;
-
nausea, stomach pain, loss of appetite, itching, dark urine,
clay-colored stools, jaundice (yellowing of the skin or eyes); or
-
fever, sore throat, and headache with a severe blistering,
peeling, and red skin rash.
Less serious side effects may include:
-
mild stomach pain, diarrhea, loss of appetite;
-
weight loss;
-
headache, dizziness;
-
back pain;
-
numbness or tingling;
-
runny or stuffy nose, cold symptoms; or
-
mild itching or skin rash.
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
What is the most important information I should know about leflunomide?
This medication can cause birth defects.
Do not use if you are pregnant.
Your doctor may want you to have a pregnancy test to make sure you are not pregnant
before you start taking leflunomide.
Stop taking leflunomide and tell your doctor right away if you become pregnant during
treatment. You will need to receive medications to help your body eliminate the drug quickly and
reduce the risk of harm to your unborn baby.
Use effective birth control while you are taking leflunomide, whether you are a man or a
woman. After your treatment ends, continue using birth control until you have received the drug
elimination medications.
Before taking leflunomide, tell your doctor if you have liver disease, a history of hepatitis, kidney
disease, any type of infection, a history of tuberculosis, a blood cell disorder such as anemia or low
platelets, a bone marrow disorder, or if you are using any drugs that weaken your immune system (such
as cancer medicine or steroids).
Leflunomide can make it easier for you to get sick. Avoid being near people who have colds,
the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with leflunomide, and avoid
coming into contact with anyone who has recently received a live vaccine. There is a chance that the
virus could be passed on to you.
After you stop taking leflunomide, you may need to be treated with other medications to
help your body eliminate leflunomide quickly. Without receiving this drug elimination procedure,
leflunomide could stay in your body for up to 2 years. Follow your doctor's instructions.
What should I avoid while taking leflunomide?
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your
doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with leflunomide, and avoid
coming into contact with anyone who has recently received a live vaccine. There is a chance that the
virus could be passed on to you.
What other drugs will affect leflunomide?
Before taking leflunomide, tell your doctor if you are taking cholestyramine (Questran, Prevalite,
LoCHOLEST) or rifampin (Rifadin, Rimactane).
Also tell your doctor if you are using medications that can weaken your immune system, such
as:
-
methotrexate (Rheumatrex);
-
cancer medications;
-
cyclosporine (Neoral, Sandimmune, Gengraf);
-
sirolimus (Rapamune), tacrolimus (Prograf);
-
basiliximab (Simulect), efalizumab (Raptiva),
muromonab-CD3 (Orthoclone);
-
mycophenolate mofetil (CellCept); or
-
azathioprine (Imuran), leflunomide (Arava), etanercept
(Enbrel).
Leflunomide can be harmful to the liver, and this effect is increased when
leflunomide is used together with other medicines that can harm the liver. Tell your doctor if you are
also using:
-
acetaminophen (Tylenol);
-
tuberculosis medications;
-
birth control pills or hormone replacement therapy;
-
other arthritis medications such as auranofin (Ridaura) or
aurothioglucose (Solganol);
-
an ACE inhibitor such as benazepril (Lotensin), captopril
(Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril
(Accupril), and others;
-
an antibiotic such as dapsone or erythromycin (E.E.S.,
EryPed, Ery-Tab, Erythrocin);
-
an antifungal medication such as fluconazole (Diflucan),
itraconazole (Sporanox), or ketoconazole (Nizoral);
-
cholesterol medications such as niacin (Advicor),
atorvastatin (Lipitor), simvastatin (Zocor), and others;
-
HIV/AIDS medications such as
abacavir/lamivudine/zidovudine (Trizivir), lamivudine (Combivir, Epivir), nevirapine
(Viramune), tenofovir (Viread), or zidovudine (Retrovir);
-
an NSAID (non-steroidal anti-inflammatory drug) such as
ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren),
etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others; or
-
seizure medications such as carbamazepine (Carbatrol,
Tegretol), phenytoin (Dilantin), felbamate (Felbatol), valproic acid (Depakene).
This list is not complete and there may be other drugs that can interact with
leflunomide. Tell your doctor about all your prescription and over-the-counter medications, vitamins,
minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication
without telling your doctor.
What happens if I have an overdose of leflunomide?
