What is the most important information I should know about Arava?

• Arava is in the FDA pregnancy category X. There is an increased risk of birth defects and death of the unborn baby while taking Arava. Do not take this medication if you are pregnant or could become pregnant during treatment. Notify your doctor immediately if you think you have become pregnant during treatment. Birth control must be used during treatment with Arava. Discuss with your doctor the procedure for removing Arava from the body following treatment before becoming pregnant. Without the proper drug elimination procedure, it may take up to two years before Arava is at sufficiently low levels in the body so as to reduce the risk of harm to an unborn baby. It is not known whether Arava imposes an increased risk of fetal harm when taken by a man. Men wishing to father a child while taking Arava should discuss their options with their doctor.

What is Arava?

• Arava affects the immune system and decreases inflammation.
• Arava is used to reduce the signs and symptoms of rheumatoid arthritis, reduce damage to the joints caused by rheumatoid arthritis, and to improve physical function in people with rheumatoid arthritis.
• Arava may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Arava?

• Before taking Arava, tell your doctor if you have
  • liver disease or a history of hepatitis;
  • a history of significant alcohol use;
  • kidney disease;
  • an immune system disease;
  • recently received a live vaccine;
  • poor bone marrow function; or
  • a current or chronic infection.
• You may not be able to take Arava, or you may require a dosage adjustment or special monitoring during your treatment if you have any of the conditions listed above.
• Arava is in the FDA pregnancy category X. There is an increased risk of birth defects and death of the unborn baby while taking Arava. Do not take this medication if you are pregnant or could become pregnant during treatment. Notify your doctor immediately if you think you have become pregnant during treatment. Birth control must be used during treatment with Arava. Discuss with your doctor the procedure for removing Arava from the body following treatment before becoming pregnant. Without the proper drug elimination procedure, it may take up to two years before Arava is at sufficiently low levels in the body so as to reduce the risk of harm to an unborn baby. It is not known whether Arava imposes an increased risk of fetal harm when taken by a man. Men wishing to father a child while taking Arava should discuss their options with their doctor.
• It is not known whether Arava passes into breast milk. There is a potential for serious side effects in a nursing baby from Arava. Do not take Arava if you are breast-feeding a baby.

How should I take Arava?

• Take Arava exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Arava can be taken with or without food or milk.
• It is important to take Arava regularly to get the most benefit.
• Your doctor may want you to have blood tests or other medical evaluations while taking Arava to monitor side effects and progress.
• Store Arava at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of a Arava overdose may include diarrhea, abdominal pain, blood problems, and liver problems.

What should I avoid while taking Arava?

• Discuss with your doctor the use of alcohol while taking Arava. Alcohol and Arava can both be damaging to the liver.
• Arava can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.

What are the possible side effects of Arava?

• If you experience any of the following serious side effects, stop taking Arava and seek medical treatment or contact your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • changes in liver function (may be detected by blood tests or cause symptoms such as yellowing of the skin or eyes; pale colored stools or dark colored urine; unusual fatigue; or abdominal pain);
  • decreased bone marrow function or blood problems (may be detected by blood tests or cause symptoms such as extreme or unusual fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); or
  • skin rash; or
  • sores in the mouth.
• Other, less serious side effects may be more likely to occur. Continue to take Arava and talk to your doctor if you experience
  • headache;
  • increased blood pressure;
  • muscle aches;
  • nausea;
  • diarrhea; or
  • hair loss.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Arava?

• Before taking Arava, tell your doctor if you are taking any of the following drugs:
  • cholestyramine (Questran, Prevalite, LoCHOLEST);
  • methotrexate (Rheumatrex); or
  • rifampin (Rifadin, Rimactane).
• You may not be able to take Arava, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Arava. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.