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MEDICATION GUIDE

RAPAMUNE®
(RAAP-a-mune)
(sirolimus) Tablets & Oral Solution

Read this Medication Guide before you start taking Rapamune (sirolimus) and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor or other healthcare provider about your medical condition or your treatment.

What is the most important information I should know about RAPAMUNE (sirolimus) ?

Rapamune (sirolimus) can cause serious side effects, including:

1.  increased risk of getting infections
2.  increased risk of getting certain cancers

1. Increased risk of getting infections. Serious infections can happen including infections caused by viruses, bacteria, and fungi (yeast). Your doctor may put you on medicine to help prevent some of these infections.

Call your doctor right away if you have symptoms of infection including fever or chills while taking Rapamune (sirolimus) .

2. Increased risk of getting certain cancers. People who take Rapamune (sirolimus) have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Talk with your doctor about your risk for cancer.

RAPAMUNE (sirolimus) has not been shown to be safe and effective in people who have had liver or lung transplants. Serious complications and death may happen in people who take RAPAMUNE (sirolimus) after a liver or lung transplant. You should not take RAPAMUNE (sirolimus) if you have had a liver or lung transplant without talking with your doctor.

See the section "What are the possible side effects of RAPAMUNE (sirolimus) ?" for information about other side effects of RAPAMUNE (sirolimus) .

What is RAPAMUNE (sirolimus) ?

RAPAMUNE (sirolimus) is a prescription medicine used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant. Rejection is when your body's immune system recognizes the new organ as a "foreign" threat and attacks it.

RAPAMUNE (sirolimus) is used with other medicines called cyclosporine (Gengraf, Neoral, Sandimmune), and corticosteroids. Your doctor will decide:

• if RAPAMUNE (sirolimus) is right for you, and
• how to best use it with cyclosporine and corticosteroids after your transplant. It is not known if RAPAMUNE (sirolimus) is safe and effective in children 13 years or younger.

Who should not take RAPAMUNE (sirolimus) ?

Do not take RAPAMUNE if you are allergic to sirolimus or any of the other ingredients in RAPAMUNE (sirolimus) . See the end of this leaflet for a complete list of ingredients in RAPAMUNE (sirolimus) .

What should I tell my doctor before taking RAPAMUNE (sirolimus) ?

Before taking RAPAMUNE (sirolimus) , tell your doctor if you:

• have liver problems
• have skin cancer or it runs in your family
• have high cholesterol or triglycerides (fat in your blood)
• are pregnant or plan to become pregnant. You must use an effective method of birth control during treatment and for 12 weeks after you stop treatment with RAPAMUNE (sirolimus) . Tell your doctor right away if you become pregnant or think you are pregnant while taking RAPAMUNE (sirolimus) .
• It is not known whether RAPAMUNE (sirolimus) passes into breast milk. You and your doctor should decide if you will take RAPAMUNE (sirolimus) or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Using RAPAMUNE (sirolimus) with certain medicines may affect each other causing serious side effects.

RAPAMUNE (sirolimus) may affect the way other medicines work, and other medicines may affect how RAPAMUNE (sirolimus) works.

Especially tell your doctor if you take:

• a medicine to lower your cholesterol or triglycerides
• cyclosporine (including Gengraf, Neoral, Sandimmune) or tacrolimus (Prograf) or other medicines that suppress the immune system
• an antibiotic
• an antifungal medicine
• a medicine for high blood pressure or heart problems
• an anti-seizure medicine
• medicines used to treat stomach acid, ulcers, or other gastrointestinal problems
• bromocriptine mesylate (Parlodel, Cycloset)
• danazol
• an anti-HIV medicine
• St. John's Wort

How should I take RAPAMUNE (sirolimus) ?

• Take RAPAMUNE (sirolimus) exactly as your doctor tells you to take it.
• Your doctor will tell you how much RAPAMUNE (sirolimus) to take and when to take it. Do not change your dose of RAPAMUNE (sirolimus) unless your doctor tells you to.
• If you also take cyclosporine (Gengraf, Neoral, Sandimmune), you should take your RAPAMUNE (sirolimus) and cyclosporine about 4 hours apart.
• Do not stop taking RAPAMUNE (sirolimus) or your other anti-rejection medicines unless your doctor tells you to.
• Your doctor will check the levels of RAPAMUNE (sirolimus) in your blood. Your doctor may change your dose of RAPAMUNE (sirolimus) depending on your blood test results.
• RAPAMUNE (sirolimus) is taken by mouth once a day.
• Do not crush, chew, or split RAPAMUNE (sirolimus) tablets. Tell your doctor if you cannot swallow RAPAMUNE (sirolimus) tablets. Your doctor can prescribe RAPAMUNE (sirolimus) as a solution.
• Take each dose of RAPAMUNE (sirolimus) the same way, either with or without food. Food can affect the amount of medicine that gets into your bloodstream. Taking each dose of RAPAMUNE (sirolimus) the same way helps keep your blood levels of RAPAMUNE (sirolimus) more stable. Do not take RAPAMUNE (sirolimus) with grapefruit juice.
• RAPAMUNE (sirolimus) oral solution can develop a slight haze when it is refrigerated. If this happens, bring the RAPAMUNE (sirolimus) Oral Solution to room temperature and then gently shake the bottle until the haze goes away.
• See the end of this Medication Guide for detailed Instructions for Use about how to correctly prepare and take a dose of RAPAMUNE (sirolimus) oral solution.
• If you get RAPAMUNE (sirolimus) oral solution on your skin, wash the area with soap and water.
• If you get RAPAMUNE (sirolimus) oral solution in your eyes, rinse your eyes with water.
• If you have taken more medicine than you were told, contact a doctor or go to the nearest hospital emergency department right away.

What should I avoid while taking RAPAMUNE (sirolimus) ?

• Avoid receiving live vaccines while taking RAPAMUNE (sirolimus) . Some vaccines may not work as well while you are taking RAPAMUNE (sirolimus) .
• Limit your time in sunlight and UV light. Cover your skin with clothing and use a sunscreen with a high protection factor because of the increased risk for skin cancer with RAPAMUNE (sirolimus) .

What are the possible side effects of RAPAMUNE (sirolimus) ?

RAPAMUNE (sirolimus) may cause serious side effects, including:

• See "What is the most important information I should know about RAPAMUNE (sirolimus) ?"
• Serious allergic reactions. Tell your doctor or get medical help right away if you get any of following symptoms of an allergic reaction:
  • • swelling of your face, eyes, or mouth
  • trouble breathing or wheezing
  • throat tightness
  • chest pain or tightness
  • feeling dizzy or faint
  • rash or peeling of your skin
• Swelling (edema). Fluid may collect in your hands and feet and in various tissues of your body, including in the sac around your heart or lungs. Call your doctor if you have trouble breathing.
• Poor wound healing. RAPAMUNE (sirolimus) may cause your wounds to heal slowly or not heal well. Tell your doctor if you have any redness or drainage, your wound does not heal, or the wound opens up.
• Increased levels of cholesterol and triglycerides (lipids or fat) in your blood. Your doctor should do blood tests to check your lipids during treatment with RAPAMUNE (sirolimus) . Your doctor may prescribe treatment with diet, exercise, or medicine if your lipid levels are too high. During treatment with RAPAMUNE (sirolimus) , your blood levels of cholesterol and triglycerides may remain high even if you follow your prescribed treatment plan.
• Effects on kidney function. When RAPAMUNE (sirolimus) is taken with cyclosporine (Gengraf, Neoral, Sandimmune), the function of your transplanted kidney may be affected. Your doctor should regularly do tests to check your kidney function while you are taking RAPAMUNE (sirolimus) with cyclosporine (Gengraf, Neoral, Sandimmune).
• Increased protein in your urine. Your doctor may regularly test your urine protein.
• Increased risk for viral infections.
  • Certain viruses can live in your body and cause active infections when your immune system is weak. BK virus can affect how your kidney works and cause your transplanted kidney to fail.
  • A certain virus can cause a rare serious brain infection called Progressive Multifocal Leukoencephalopathy (PML). PML usually causes death or severe disability. Call your doctor right away if you notice any new or worsening medical problems such as:
    • confusion
    • sudden change in thinking, walking, strength on one side of your body
    • other problems that have lasted over several days.
• Lung or breathing problems. This can sometimes lead to death. Tell your doctor if you have a new or worsening cough, shortness of breath, difficulty breathing or any new breathing problems. Your doctor may need to stop RAPAMUNE (sirolimus) or lower your dose.
• Blood clotting problems. When RAPAMUNE (sirolimus) is taken with cyclosporine or tacrolimus, you may develop a blood clotting problem. Tell your doctor if you get any unexplained bleeding or bruising.

Common side effects with RAPAMUNE (sirolimus) include:

• high blood pressure
• pain (including stomach and joint pain)
• diarrhea
• headache
• fever
• urinary tract infection
• low red blood cell count (anemia)
• nausea
• low platelet count (cells that help blood to clot)

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

These are not all of the possible side effects of RAPAMUNE (sirolimus) . 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.

How should I store RAPAMUNE (sirolimus) ?

RAPAMUNE (sirolimus) tablets:

• Store RAPAMUNE (sirolimus) tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Blister cards and strips:
  • Keep the tablets in the original blister container and use the outer carton to protect blister cards and strips from light.
• Bottles
  • Keep the bottle of RAPAMUNE (sirolimus) tablets tightly closed.

RAPAMUNE (sirolimus) oral solution:

• Store bottles of RAPAMUNE (sirolimus) oral solution in the refrigerator at 36°F to 46°F (2°C to 8°C). Protect from light.
• If necessary, bottles of RAPAMUNE (sirolimus) oral solution can be stored at room temperature up to 77°F (25°C) for up to 15 days.
• When a bottle of RAPAMUNE (sirolimus) oral solution is opened, it should be used within 1 month.
• Use any diluted RAPAMUNE (sirolimus) oral solution right away.

Do not use RAPAMUNE (sirolimus) after the expiration date, which is located on the blister and carton. The expiration date refers to the last day of that month.

Safely throw away medicine that is out of date or no longer needed.

Keep RAPAMUNE (sirolimus) and all medicines out of the reach of children.

General Information about RAPAMUNE (sirolimus)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RAPAMUNE (sirolimus) for a condition for which it was not prescribed. Do not give RAPAMUNE (sirolimus) to other people even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about RAPAMUNE (sirolimus) . If you would like more information talk to your doctor. You can ask your pharmacist or doctor for information about RAPAMUNE (sirolimus) that is written for health professionals.

For more information, go to www.rapamune (sirolimus) .com or call 1-800-934-5556.

What are the ingredients in RAPAMUNE?

Active ingredients: sirolimus.

Inactive ingredients in RAPAMUNE (sirolimus) Oral Solution are: Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. RAPAMUNE (sirolimus) Oral Solution contains 1.5%-2.5% ethanol.

The inactive ingredients in RAPAMUNE (sirolimus) Tablets include: sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, d/-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.

PATIENT INSTRUCTIONS FOR RAPAMUNE (SIROLIMUS) ORAL SOLUTION Bottles

1. Open the solution bottle. Remove the safety cap by squeezing the tabs on the cap and twisting counterclockwise.
2. On first use, insert the adapter assembly (plastic tube with stopper) tightly into the bottle until it is even with the top of the bottle. Do not remove the adapter assembly from the bottle once inserted.
3. For each use, tightly insert one of the amber syringes with the plunger fully depressed into the opening in the adapter.
4. Withdraw the prescribed amount of Rapamune (sirolimus) Oral Solution by gently pulling out the plunger of the syringe until the bottom of the black line of the plunger is even with the appropriate mark on the syringe. Always keep the bottle in an upright position. If bubbles form in the syringe, empty the syringe into the bottle and repeat the procedure.
5. You may have been instructed to carry your medication with you. If it is necessary to carry the filled syringe, place a cap securely on the syringe - the cap should snap into place.
6. Then place the capped syringe in the enclosed carrying case. Once in the syringe, the medication may be kept at room temperature or refrigerated and should be used within 24 hours. Extreme temperatures (below 36°F and above 86°F) should be avoided. Remember to keep this medication out of the reach of children.
7. Empty the syringe into a glass or plastic cup containing at least 2 ounces (1/4 cup, 60 mL) of water or orange juice, stir vigorously for one (1) minute and drink immediately. Refill the container with at least 4 ounces (1/2 cup, 120 mL) of water or orange juice, stir vigorously again and drink the rinse solution. Apple juice, grapefruit juice, or other liquids are NOT to be used. Only glass or plastic cups should be used to dilute Rapamune (sirolimus) Oral Solution. The syringe and cap should be used once and then discarded.
8. Always store the bottles of medication in the refrigerator. When refrigerated, a slight haze may develop in the solution. The presence of a haze does not affect the quality of the product. If this happens, bring the Rapamune (sirolimus) Oral Solution to room temperature and shake until the haze disappears. If it is necessary to wipe clean the mouth of the bottle before returning the product to the refrigerator, wipe with a dry cloth to avoid introducing water, or any other liquid, into the bottle.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 1/10/2011
This monograph has been modified to include the generic and brand name in many instances.