* Generic Name: leflunomide
* Brand Name: Arava
* What is leflunomide (Arava)?
* What are the possible side effects of leflunomide (Arava)?
* What is the most important information I should know about
leflunomide (Arava)?
* What should I discuss with my healthcare provider before taking
leflunomide (Arava)?
* How should I take leflunomide (Arava)?
* What happens if I miss a dose (Arava)?
* What happens if I overdose (Arava)?
* What should I avoid while taking leflunomide (Arava)?
* What other drugs will affect leflunomide (Arava)?
* Where can I get more information (Arava)?
What is leflunomide (Arava)?
Leflunomide affects the immune system and reduces swelling and
inflammation in the body.
Leflunomide is used to treat the symptoms of rheumatoid arthritis.
Leflunomide may also be used for purposes not listed in this medication
guide.
What are the possible side effects of leflunomide (Arava)?
Get emergency medical help if you have signs of an allergic reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or
throat.
Call your doctor at once if you have:
* signs of infection--sudden weakness or ill feeling, fever,
chills, sore throat, mouth sores, red or swollen gums,
trouble swallowing;
* sudden chest pain or discomfort, wheezing, dry cough, feeling
short of breath;
* easy bruising, unusual bleeding (nose, mouth, vagina, or
rectum), purple or red pinpoint spots under your skin;
* numbness, tingling, or burning pain in your hands or feet;
* liver problems--nausea, upper stomach pain, itching, tiredness,
loss of appetite, dark urine, clay-colored stools,
jaundice (yellowing of the skin or eyes); or
* severe skin reaction--fever, sore throat, swelling in your face
or tongue, burning in your eyes, skin pain, followed by a red or
purple skin rash that spreads (especially in the face or upper
body) and causes blistering and peeling.
Common side effects may include:
* nausea, diarrhea, stomach pain;
* headache;
* abnormal liver function tests;
* thinning hair;
* back pain;
* weakness;
* rash; or
* high blood pressure.
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
(Arava)?
Do not use leflunomide if you are pregnant, and stop taking this
medicine if you think you might be pregnant. Use birth control to
prevent pregnancy while you are taking leflunomide, and until you
complete a "drug elimination" procedure.
Leflunomide can cause severe or fatal liver damage. Tell your doctor if
you have a history of liver disease or if you also use other
medicines such as: pain or arthritis medicine (including aspirin,
Tylenol, and Advil/Motrin), medicines to treat tuberculosis
or other infections, seizure medication, hormonal birth control or
hormone replacement therapy, chemotherapy, cholesterol-lowering
medicine, heart medication, or blood pressure medicine.
Your liver function will need to be tested often, and you may need to
stop taking leflunomide based on the results of these tests.
Arava Patient Information including How Should I Take
Rheumatoid Arthritis Symptoms and Treatment
Rheumatoid Arthritis Slideshow
RxList
Take the RA Quiz
Rheumatoid Arthritis Exercises:Joint-Friendly Fitness Routines
Joint-Friendly Exercises Slideshow
What should I discuss with my healthcare provider before taking leflunomide
(Arava)?
You should not use this medicine if you are allergic to leflunomide or
teriflunomide, or if:
* you are pregnant (you will need to have a negative pregnancy
test before starting this treatment);
* you have severe liver disease; or
* you are also using teriflunomide.
Do not use leflunomide if you are pregnant or may become pregnant.
Avoid getting pregnant until after you stop taking leflunomide and
undergo a "drug elimination" procedure to help rid your body of this
medicine. Stop taking leflunomide and call your doctor right away if
you miss a period or think you might be pregnant.
To make sure leflunomide is safe for you, tell your doctor if you have:
* a history of liver disease or hepatitis (leflunomide can cause
severe liver problems);
* a severe or uncontrolled infection;
* kidney disease;
* nerve problems, such as neuropathy caused by diabetes;
* a history of tuberculosis;
* 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).
Use birth control to prevent pregnancy while you are taking this
medicine. After you stop taking leflunomide, continue using birth
control until you have received blood tests to make sure the drug has
been eliminated from your body.
Ask your doctor if you should use a barrier form of birth control
(condom or diaphragm with spermicide). Using hormonal contraception
(birth control pills, injections, implants, skin patches, and vaginal
rings) may increase your risk of liver damage while taking leflunomide.
It is not known whether leflunomide passes into breast milk or if it
could harm a nursing baby. You should not breast-feed while using this
medicine.
How should I take leflunomide (Arava)?
Before you start treatment with leflunomide, your doctor may perform
tests to make sure you do not have tuberculosis or other infections.
Follow all directions on your prescription label. Your doctor may
occasionally change your dose. Do not use this medicine in larger or
smaller amounts or for longer than recommended.
Your blood pressure will need to be checked often.
Leflunomide can lower blood cells that help your body fight infections
and help your blood to clot. Your blood will need to be tested often.
Your leflunomide treatment may be stopped for a short time based on the
results of these tests.
Your liver function will also need to be tested often, and you may need
to stop taking leflunomide based on the results of these tests.
After you stop taking leflunomide, you may need to be treated with
other medicines to help your body eliminate leflunomide quickly. If you
do not undergo this drug elimination procedure, leflunomide could stay
in your body for up to 2 years. Follow your doctor's instructions.
You will also need to go through this drug elimination procedure if you
plan to become pregnant after you stop taking leflunomide.
Arthritis is often treated with a combination of drugs. Use all
medications as directed by your doctor. Read the medication guide or
patient instructions provided with each medication. Do not change your
doses or medication schedule without your doctor's advice.
Store at room temperature away from moisture, heat, and light.
Arava Patient Information including If I Miss a Dose
Rheumatoid Arthritis Symptoms and Treatment
Rheumatoid Arthritis Slideshow
RxList
Take the RA Quiz
Rheumatoid Arthritis Exercises:Joint-Friendly Fitness Routines
Joint-Friendly Exercises Slideshow
What happens if I miss a dose (Arava)?
Take the missed dose as soon as you remember. Skip the missed dose if
it is almost time for your next scheduled dose. Do not take extra
medicine to make up the missed dose.
What happens if I overdose (Arava)?
Seek emergency medical attention or call the Poison Help line at
1-800-222-1222.
Overdose symptoms may include diarrhea, stomach pain, pale skin,
easy bruising or bleeding, dark urine, or jaundice (yellowing of the
skin or eyes).
What should I avoid while taking leflunomide (Arava)?
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 using leflunomide, or you could
develop a serious infection. Live vaccines include measles,
mumps, rubella (MMR), polio, rotavirus,
typhoid, yellow fever, varicella (chickenpox), zoster
(shingles), and nasal flu (influenza) vaccine.
What other drugs will affect leflunomide (Arava)?
Leflunomide can cause severe or fatal liver damage. This effect is
increased when you also use certain other medicines, including:
* acetaminophen (Tylenol), aspirin, gout or arthritis medication
(including gold injections); an NSAID (non-steroidal
anti-inflammatory drug)--ibuprofen (Advil, Motrin), naproxen
(Aleve), celecoxib, diclofenac, indomethacin, meloxicam,
and others;
* an antibiotic, antifungal medicine, or sulfa drug; tuberculosis
medicine; antiviral or HIV/AIDS medication; medicine to treat
mental illness; seizure medication--carbamazepine,
phenytoin, valproic acid, and others;
* birth control pills or hormone replacement therapy; anabolic
steroids--methyltestosterone, "performance-enhancing drugs"; cancer
medication; or
* cholesterol-lowering medication--Crestor, Lipitor,
Vytorin, Zocor, and others; heart or blood pressure
medication.
This list is not complete and many other drugs can interact with
leflunomide. This includes prescription and over-the-counter medicines,
vitamins, and herbal products. Give a list of all your medicines to any
healthcare provider who treats you. Not all possible interactions are
listed in this medication guide.
Where can I get more information (Arava)?
Your pharmacist can provide more information about leflunomide.
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