Sirolimus (patient information)

IMPORTANT WARNING:

Sirolimus may increase the risk of infection and lymphoma. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, frequent or painful urination, or other signs of infection.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to sirolimus.

Talk to your doctor about the risks of taking sirolimus.

Why is this medication prescribed

Sirolimus is used in combination with other medications to prevent rejection of kidney transplants. Sirolimus is in a class of medications called immunosuppressants. It works by suppressing the body's immune system.

How should this medicine be used

Sirolimus comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once a day, either always with food or always without food. To help you remember to take sirolimus, take it around the same time 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 sirolimus exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take sirolimus even if you feel well. Do not stop taking sirolimus without talking to your doctor.

To use the bottles of solution, follow these steps:

• Open the solution bottle. On first use, insert the plastic tube with stopper tightly into the bottle until it is even with the top of the bottle. Do not remove from the bottle.
• For each use, tightly insert one of the amber syringes with the plunger fully pushed in into the opening in the plastic tube.
• Draw up the amount of solution your doctor has prescribed by gently pulling out the plunger of the syringe until the bottom of the black line of the plunger is even with the correct mark on the syringe. Keep the bottle upright. If bubbles form in the syringe, empty the syringe into the bottle and repeat this step.
• Empty the syringe into a glass or plastic cup containing at least 2 ounces (1/4 cup) of water or orange juice. Do not use apple juice, grapefruit juice, or other liquids. Stir vigorously for 1 minute and drink immediately.
• Refill the cup with at least 4 ounces (1/2 cup) of water or orange juice. Stir vigorously and drink the rinse solution.
• Throw away the used syringe.

If you need to carry a filled syringe with you, snap a cap onto the syringe and put the syringe in the carrying case. Use the medication in the syringe within 24 hours.

To use the pouches of solution, follow these steps:

• Before opening the pouch, squeeze the pouch from the neck area to push the contents into the lower part of the pouch.
• Fold the marked area on the pouch and carefully cut with scissors.
• Squeeze the entire contents of the pouch into a glass or plastic cup containing at least 2 ounces (1/4 cup) of water or orange juice. Do not use apple juice, grapefruit juice, or other liquids. Stir vigorously for 1 minute and drink immediately.
• Refill the cup with at least 4 ounces (1/2 cup) of water or orange juice. Stir vigorously and drink the rinse solution.

Other uses for this medicine

Sirolimus also is used sometimes to treat psoriasis. Talk to your doctor about the possible risks of using this medication for your condition.

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

What special precautions should I follow

Before taking sirolimus:

• tell your doctor and pharmacist if you are allergic to sirolimus or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: amphotericin B (Abelcet, AmBisome, Amphocin, Fungizone); antifungals such as clotrimazole (Lotrimin), fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); bromocriptine (Parlodel); cimetidine (Tagamet); cisapride (Propulsid); clarithromycin (Biaxin); danazol (Danocrine); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin); metoclopramide (Reglan); nicardipine (Cardene); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); rifapentine (Priftin); troleandomycin (TAO); and verapamil (Calan, Covera, Isoptin, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking cyclosporine (Neoral) soft gelatin capsules or solution, take them 4 hours before sirolimus.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had high cholesterol or triglycerides or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use an effective method of birth control before starting to take sirolimus, while taking sirolimus, and for 12 weeks after stopping sirolimus. If you become pregnant while taking sirolimus, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sirolimus.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. *Sirolimus may increase your risk for skin cancer.
• do not have any vaccinations (e.g., measles or flu shots) without talking to your doctor.

What special dietary instructions should I follow

Avoid drinking large amounts of grapefruit juice while taking this medicine.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Mild side effects

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

• stomach pain
• weakness
• back pain
• headache
• constipation
• diarrhea
• upset stomach
• vomiting
• swelling of the hands, feet, ankles, or lower legs
• weight gain
• joint pain
• difficulty falling asleep or staying asleep
• tremor
• rash
• fever

Severe side effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• pale skin
• unusual bleeding or bruising
• cough
• shortness of breath

Sirolimus may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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 [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store tablets at room temperature and away from excess heat and moisture (not in the bathroom). Keep liquid medication in the refrigerator, closed tightly, and throw away any unused medication one month after the bottle is opened. Do not freeze. If needed, you may store the pouches for up to 24 hours and the bottles for up to 15 days at room temperature. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to sirolimus.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Rapamune®

Other names

• Rapamycin