Arava

Arava is a prescription medication used to treat rheumatoid arthritis. This medication belongs to a group of drugs called DMARDs (disease modifying antirheumatic drugs) which work by suppressing the excessive activity of the immune system.

Arava comes in tablet form. It is usually taken once daily, with or without food. 

Common side effects include diarrhea, nausea, vomiting, and headache.

Arava is a prescription medication used to treat rheumatoid arthritis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sanofi-Aventis U.S. LLC

Common side effects include:

• diarrhea
• vomiting
• heartburn
• headache
• dizziness
• weight loss
• back pain
• muscle pain or weakness
• pain, burning, numbness, or tingling in the hands or feet
• hair loss
• mouth sores

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Arava. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• acetaminophen (Tylenol)
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs such as ibuprofen [Advil, Motrin] and naproxen [Aleve, Naprosyn]
• cholesterol-lowering medications (statins)
• cholestyramine (Prevalite, Questran)
• colestipol (Colestid)
• etanercept (Enbrel)
• gold compounds such as auranofin (Ridaura) and aurothioglucose (Aurolate, Solganol)
• hydroxychloroquine
• iron products
• isoniazid (INH, Nydrazid, in Rifamate)
• medications to treat cancer
• methotrexate (Rheumatrex, Trexall)
• niacin (nicotinic acid)
• other medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf)
• rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)

 This is not a complete list of Arava drug interactions. Ask your doctor or pharmacist for more information.

• Taking Arava may increase your risk of developing an infection. If you experience any of the following symptoms during your treatment with Arava, call your doctor: fever; sore throat; cough; flu-like symptoms; area of warm, red, swollen, or painful skin; painful, difficult, or frequent urination; or other signs of infection. Your treatment with Arava may need to be interrupted if you have an infection.
• If you are already infected with tuberculosis (TB) Arava may make your infection more serious and cause you to develop symptoms, if you don't already have any. If you do have TB, your doctor will treat this infection with antibiotics before you begin taking Arava.
• Do not have any vaccinations without talking to your doctor.
• Severe liver damage, including fatal liver failure, has been reported in some patients treated with Arava. Tell your doctor if you experience any signs of liver problems, including:
  • extreme tiredness
  • stomach pain
  • yellowing of the whites of the eyes or skin (jaundice)
• Arava may cause high blood pressure. You should have your blood pressure checked before starting treatment and regularly while you are taking this medication.
• Arava may cause low blood cell counts and anemia.
• Rare cases of severe skin reactions have been reported. Tell your doctor if you experience a skin rash during your treatment.
• Ask your doctor about the safe use of alcoholic beverages while you are taking Arava.

Do not take Arava if you:

• are allergic to Arava or any of its ingredients
• are pregnant
• have liver disease

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Arava, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving this medication tell your doctor about all of your medical conditions including if you:

• have an infection now or if you have any signs of infection such as fever, cough, or flu-like symptoms
• have a weakened immune system
• have liver or kidney disease
• have high blood pressure
• have anemia
• have cancer
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• drink large amounts of alcohol

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Arava falls into category X. 

Do not take Arava if you are pregnant or plan to become pregnant. Arava may harm the fetus. You should not begin taking Arava until you have taken a pregnancy test with negative results and your doctor tells you that you are not pregnant. You must use an effective method of birth control before you begin taking Arava, during your treatment with Arava, and for 2 years after treatment. If your period is late or you miss a period during treatment with Arava, call your doctor immediately. Talk to your doctor if you plan to become pregnant within 2 years after stopping treatment with Arava. Your doctor can prescribe a treatment that will help to remove this medication more quickly from your body.

See FDA Warning.

Arava should not be used by nursing mothers. It is not known whether Arava is excreted in human milk. Many drugs are excreted in human milk, and there is a potential for serious adverse reactions in nursing infants from Arava. Therefore, a decision should be made whether to proceed with nursing or to initiate treatment with Arava, taking into account the importance of the drug to the mother.

• Take Arava exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
• Arava comes in tablet form.
• It is usually taken once daily.
• For the first 3 days of treatment, your doctor may tell you to take a larger dose of Arava.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

The recommended dose of Arava is 100 mg tablet per day for 3 days.

The recommended dose of Arava is 20 mg/day, thereafter.

If dosing at 20 mg/day is not well tolerated, your doctor may decrease your dose to 10 mg/day.

If you take too much Arava call your local Poison Control center or seek emergency medical attention right away.

• Store at room temperature between 15–30°C (59–86°F).
• Keep this and all medications out of the reach of children.

CONTRAINDICATIONS AND WARNINGS

Pregnancy

Pregnancy must be excluded before the start of treatment with Arava. Arava is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during Arava treatment or prior to the completion of the drug elimination procedure after Arava treatment.

Hepatotoxicity