ARAVA-10 (Leflunomide-10mg) By Aventis
Arava is used in the treatment of rheumatoid arthritis. It reduces the pain, stiffness, inflammation, and swelling associated with this disease, and staves off the joint damage that ultimately results.
2. Most important fact about this drug You MUST NOT take Arava if you are pregnant; it can harm the developing baby. If you are still in your childbearing years, your doctor will want to see negative results from a pregnancy test before starting you on Arava. You’ll also need to use reliable contraceptive measures as long as you take the drug. If you become pregnant while taking Arava, your doctor will stop the drug immediately and prescribe a regimen of cholestyramine (Questran) in 8-gram doses 3 times a day for 11 days. Questran helps to clear Arava from the bloodstream, possibly preventing harm to the unborn child.
3. How should you take this medication? Your dosage of Arava will be decreased after the first 3 days. Never take more than your doctor prescribes.
–If you miss a dose… Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.
–Storage instructions.. Store at room temperature away from light.
4. What side effects may occur? Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Arava.
· More common side effects may include:
Abdominal pain, back pain, bronchitis, cough, diarrhea, dizziness, hair loss, headache, high blood pressure, indigestion, itching, joint disorders, loss of appetite, mouth ulcers, nausea, rash, respiratory infection, sore throat, stomach inflammation, tendon inflammation, urinary tract infection, vomiting, weakness, weight loss
· Less common side effects may include:
Abscess, acne, allergic reaction, anemia, angina, anxiety, asthma, blood in the urine, blurred vision, bone pain, bruising, bursitis, cataracts, chest pain, colitis, conjunctivitis (pinkeye), constipation, cysts, depression, dermatitis, diabetes, difficulty breathing, dry mouth, dry skin, eczema, eye problems, fever, flu-like symptoms, frequent urination, fungal infection of the mouth, fungal infection of the skin, gallstones, gas, general feeling of illness, gingivitis, hair discoloration, hernia, herpes infection, hyperthyroidism, insomnia, joint pain and inflammation, leg cramps, lung problems, menstrual disorders, migraine, mouth and throat inflammation, muscle aches, muscle cramps, nail disorders, nasal inflammation, neck pain, nosebleeds, prostate disorder, rapid heartbeat, sinus inflammation, skin bumps, pain, painful urination, palpitations, pelvic pain, pneumonia, purple spots on skin, skin discoloration, skin tingling, skin ulcers, sleep disorders, sweating, swelling, tarry stools, taste problems, tooth problems, vaginal fungal infection, varicose veins, vertigo
5. Why should this drug not be prescribed? Remember that you must not take Arava if you are pregnant or plan to become pregnant. You’ll also need to avoid this drug if it gives you an allergic reaction.
6. Special warnings about this medication Arava is potentially damaging to the liver. Your doctor will test your liver function before starting Arava therapy, and will conduct monthly blood tests for a while after therapy begins. If you have significant liver disease, including hepatitis, you’ll be unable to take Arava. If you develop liver problems while taking the drug, your dose will have to be reduced or eliminated. Theoretically, Arava may interfere with the body’s ability to fight off infection. The drug is therefore not recommended for people with cancer, bone marrow problems, severe infections, AIDS, or any other immune system problems. You should also avoid immunization with live vaccines while taking Arava. Arava has been known to cause rare but serious skin reactions. If you develop a skin rash or eruption, stop taking Arava and contact your doctor. Arava can also reduce your blood cell count. Notify your doctor promptly if any signs of this problem appear. Warnings include easy bruising, frequent infections, unusual fatigue, and paleness. Poor kidney function can increase the amount of Arava in your system. Your doctor will prescribe the drug cautiously if you’re subject to kidney problems. Arava does not appear to cause fetal harm when taken by the father prior to conception. Nevertheless, if you plan to father a child, your doctor will instruct you to stop taking Arava and will prescribe a regimen of cholestyramine to clear Arava from your system.
7. Possible food and drug interactions when taking this medication If Arava is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Arava with the following:
Cholestyramine (Prevalite, Questran)
Nonsteroidal anti-inflammatory drugs such as Advil, Aleve, Motrin, and Naprosyn
Rifampin (Rifadin, Rifamate, Rifater)
8. Special information if you are pregnant or breastfeeding Do not take Arava while pregnant or breastfeeding. Taken during pregnancy, the drug can cause birth defects. And although it is not known whether Arava appears in breast milk, there is good reason to suspect that it will cause serious side effects in nursing infants.
9. Recommended dosage
The recommended starting dose is one 100-milligram tablet daily for the first 3 days. The doctor will then reduce the dose to 20 milligrams a day. If side effects appear, the dose may be further decreased to 10 milligrams a day.
Arava is not recommended for children less than 18 years old.