Imuran

Azathioprine comes as a tablet to take by mouth. It is usually taken once or twice a day after meals. Take azathioprine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take azathioprine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are taking azathioprine to treat rheumatoid arthritis, your doctor may start you on a low dose and gradually increase your dose after 6-8 weeks and then not more than once every 4 weeks. Your doctor may gradually decrease your dose when your condition is controlled. If you are taking azathioprine to prevent kidney transplant rejection, your doctor may start you on a high dose and decrease your dose gradually as your body adjusts to the transplant.

Azathioprine controls rheumatoid arthritis but does not cure it. It may take up to 12 weeks before you feel the full benefit of azathioprine. Azathioprine prevents transplant rejection only as long as you are taking the medication. Continue to take azathioprine even if you feel well. Do not stop taking azathioprine without talking to your doctor.

Before taking azathioprine,

• tell your doctor and pharmacist if you are allergic to azathioprine, any other medications, or any of the ingredients in azathioprine tablets. Ask your doctor or pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications mentioned in the IMPORTANT WARNING section and any of the following: allopurinol (Zyloprim); aminosalicylates such as mesalamine (Apriso, Asacol, Pentasa, others), olsalazine (Dipentum), and sulfasalazine (Azulfidine); and anticoagulants ('blood thinners') such as warfarin (Coumadin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have any type of infection, or if you have or have ever had kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use birth control to be sure you or your partner will not become pregnant while you are taking this medication. Call your doctor if you or your partner become pregnant while you are taking azathioprine. Azathioprine may harm the fetus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking azathioprine.
• do not have any vaccinations during or after your treatment without talking to your doctor.

Azathioprine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately.

• rash
• fever
• weakness
• muscle pain

This medication may cause other side effects. Call your doctor if you have any unusual problems while you are taking azathioprine.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

GENERIC AVAILABLE: Yes

The initial dose for preventing organ rejection is 3 to 5 mg/kg (oral or IV) daily, starting at the time of transplantation or in some cases 1 to 3 days before transplantation. The initial off-label dose for treating rheumatoid arthritis is 1.0 mg/kg (50 to 100 mg, oral or IV) as a single dose or twice daily. Doses may be increased by 0.5 mg/kg daily up to a maximum dose of 2.5 mg/kg per day. Dosing for other off-label use may vary according to what disease is being treated; in general, off-label use should be done by an experienced medical specialist. Azathioprine should be taken with food.

If you take too much Imuran, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with azathioprine, especially:

• allopurinol;

• a blood thinner (warfarin, Coumadin, Jantoven); or

• blood pressure medicine (benazepril, captopril, enalapril, lisinopril, quinapril, ramipril, trandolapril, and others).

This list is not complete. Other drugs may interact with azathioprine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

For all uses of this medicine:

• If you have an allergy to azathioprine or any other part of Imuran.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have ever been treated with chlorambucil, cyclosporine, or melphalan in the past.
• If you are breast-feeding or plan to breast-feed.

Rheumatoid arthritis patients:

• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.

This is not a list of all drugs or health problems that interact with Imuran.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Imuran is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.

Renal Homotransplantation: Imuran is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of Imuran on these variables has not been tested in controlled trials.

Rheumatoid Arthritis: Imuran is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with Imuran. The combined use of Imuran with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of Imuran with these agents cannot be recommended.