ARAVA

Do NOT use Arava if:

• you are allergic to any ingredient in Arava
• you are pregnant, planning to become pregnant, or breast-feeding
• you may become pregnant and are not using effective birth control
• you have bone marrow problems; a severely weakened immune system; or a severe, uncontrolled infection
• you have liver problems (eg, hepatic insufficiency or failure), abnormal liver function tests prior to taking Arava, or a history of hepatitis B or C infection

Contact your doctor or health care provider right away if any of these apply to you.

Before using Arava:

Some medical conditions may interact with Arava. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a weakened immune system, an infection, a history of an infection that keeps coming back, or you have recently received a vaccination
• if you have a history of lung problems, tuberculosis (TB) or a positive TB test, high blood pressure, blood or bone marrow problems, liver problems, abnormal liver function tests, or if you drink alcoholic beverages
• if you have or have a history of kidney problems or you are on dialysis
• if you have recently taken methotrexate or another medicine that may suppress your immune system

Some MEDICINES MAY INTERACT with Arava. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Methotrexate because the risk of liver problems, blood problems, or infection may be increased
• Rifampin because it may increase the risk of Arava’s side effects
• Anticoagulants (eg, warfarin) because the risk of its side effects, including bleeding, may be increased by Arava
• Medicines that may suppress the immune system because the risk of infection or unusual bruising or bleeding may be increased. Ask your doctor if you are unsure if any of your medicines may suppress the immune system
• Cholestyramine because it may decrease Arava’s effectiveness
• Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if Arava may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Arava:

Use Arava as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Arava by mouth with or without food.
• It may take 4 weeks or more to notice any improvement while taking Arava.
• If you miss a dose of Arava, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Arava.

Important safety information:

• Arava may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Arava with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Drinking alcohol while you are taking Arava may increase the risk of liver problems. Talk with your doctor before drinking alcohol while taking Arava.
• Arava may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Arava may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Arava. Talk with your doctor before you receive any vaccine.
• The safety of Arava in patients with inactive TB has not been confirmed. You may need to have a TB skin test before you start Arava to determine if you have TB infection. Discuss any questions or concerns with your doctor.
• Serious and sometimes fatal liver problems have been reported with Arava. Contact your doctor right away if you develop symptoms such as dark urine, pale stools, yellowing of the skin or eyes, stomach pain, severe or persistent nausea or loss of appetite, or unusual tiredness.
• A serious and sometimes fatal lung problem (interstitial lung disease) has been reported with Arava. Contact your doctor right away if you develop new or worsening breathing problems, such as cough or shortness of breath.
• Serious and sometimes fatal skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been rarely reported with Arava. Contact your doctor right away if you develop a rash; red, swollen, blistered, or peeling skin; or blisters on the inside of the eyes, nose, or mouth.
• Lab tests, including liver function, blood pressure, and complete blood cell counts, may be performed to monitor your progress or check for side effects. Be sure to keep all doctor and lab appointments.
• Arava should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• Arava may remain in the body for 2 years or longer after you stop taking it. Your doctor may prescribe medicine to help remove Arava from your body more quickly after you finish treatment (drug elimination procedure). Talk with your doctor for more information.
• The risk of harm or death to a fetus fathered by a man using Arava is not known. Men who take Arava should talk with their doctor about the need to use a condom when having sex with a woman who may become pregnant. If you wish to father a child, talk with your doctor. You may need to stop Arava and complete the drug elimination procedure to remove it from your blood before you father a child.
• If you are able to become pregnant, you must not start Arava unless it has been confirmed that you are not pregnant. You will need to use an effective form of birth control while you take Arava and for as long as Arava remains in your body. If you plan to become pregnant, talk with your doctor about stopping Arava and completing the drug elimination procedure before you become pregnant. Talk with your doctor for more information or if you have questions about effective birth control.
• PREGNANCY and BREAST-FEEDING: Do not use Arava if you are pregnant. It may cause birth defects or fetal death. You must have a negative pregnancy test before you start treatment with Arava. Do not become pregnant while you are taking it. Contact your doctor at once if your period does not occur when expected or if you suspect that you are pregnant. It is not known if Arava is found in breast milk. Do not breast-feed while taking Arava.

Possible side effects of Arava:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; dizziness; hair loss; headache; indigestion; muscle aches; nausea; runny nose; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters on the inside of the eyes, nose, or mouth; chest pain; fast or irregular heartbeat; feelings of numbness or tingling; muscle cramps, including leg cramps; new or worsening breathing problems (eg, cough, shortness of breath); red, swollen, blistered, or peeling skin; severe or persistent vomiting; symptoms of high blood pressure (eg, severe or persistent headache or dizziness, vision changes); symptoms of infection (eg, fever, chills, sore throat, cough, increased or painful urination); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes, stomach pain, severe or persistent nausea or loss of appetite); unusual or easy bruising or bleeding; unusual tiredness; unusually pale skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

If OVERDOSE is suspected:

Contact your local Poison Control or emergency room immediately.

Proper storage of Arava:

Store Arava at room temperature at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in bathroom. Keep Arava out of the reach of children and away from pets.

General information:

• If you have any questions about Arava, please talk with your doctor, pharmacist, or other health care provider.
• Arava is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Arava. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.