Rapamune contains the active ingredient sirolimus, an mTOR inhibitor and immunosuppressive agent that is available in an oral solution form with a concentration of 1 mg/mL. Inactive ingredients in the solution include Phosal 50 PG, which consists of phosphatidylcholine, propylene glycol, sunflower seed oil glyceride, ethanol, soy fatty acids, ascorbyl palmitate, and tocopherol, along with polysorbate 80. This medication is commonly used to prevent organ transplant rejection, although this use is inferred from its drug class.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Put the oral syringe adaptor into the bottle. Use the amber oral syringes that come with this medication to measure each dose. Use a new amber oral syringe with each dose. Ask your pharmacist if you do not have enough. Household spoons are not accurate. Empty the measured amount of this medication into a glass or plastic container with at least 60 mL (2 ounces) of water or orange juice. Do not mix with grapefruit juice or any other liquids. Stir well and drink right away. Refill the container with at least 120 mL (4 ounces) of water or orange juice, stir, and drink. Use each syringe and cap only once. Throw away the syringe and cap after they are used. You can take this medication with or without food. You should always take it the same way. Keep taking this medication unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

If you are also taking cyclosporine, take this medication at least 4 hours after taking your cyclosporine dose.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 13 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator or at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

Refrigeration (preferred): Store in the refrigerator. Do not freeze. Protect from light. Bottles of this medication may develop a slight haze in the refrigerator. To clear, let the bottles stay at room temperature and shake gently. Get rid of away any unused medication 1 month after opening a bottle or after it expires, whichever comes first.

Room temperature: This medication can be stored at room temperature for up to 15 days. Get rid of any unused medication after 15 days or after it expires, whichever comes first.

A dose of this medication may be stored in an amber syringe with a cap. After measuring a dose, put the capped syringe in the carrying case that comes with this medication. The medication in the syringe can be stored at room temperature or in the refrigerator for up to 24 hours. If it is not used during this time, get rid of the dose in the syringe.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of the medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Dry cough, shortness of breath or trouble breathing
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Swelling of the ankles, hands, or feet, shortness of breath or trouble breathing, sudden weight gain
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Headache
• Joint pain
• Nausea
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Heart disease
• High cholesterol or triglycerides
• Infection
• Liver disease
• An unusual or allergic reaction to sirolimus, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Live virus vaccines
• Mifepristone
• Posaconazole
• Temsirolimus
• Voriconazole

This medication may also interact with the following:

• Bromocriptine
• Cannabidiol
• Certain antibiotics, such as clarithromycin, erythromycin, rifampin, rifabutin, telithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Certain medications for cholesterol, such as simvastatin
• Certain medications for fungal infections, such as clotrimazole, fluconazole, itraconazole, ketoconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Certain medications for stomach problems, such as cimetidine, cisapride, metoclopramide
• Cyclosporine
• Danazol
• Grapefruit juice
• Letermovir
• St. John's wort
• Tacrolimus

Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You may need blood work while you are taking this medication.

This medication can increase bad cholesterol and fats (such as LDL, triglycerides) and decrease good cholesterol (HDL) in your blood. You may need blood tests to check your cholesterol. Ask your care team what you can do to lower your risk of high cholesterol while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 12 weeks after the last dose. A reliable form of contraception is recommended while taking this medication and for 12 weeks after the last dose. Talk to your care team about reliable forms of contraception.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What are the most serious risks of this medication?

If you get this medicine for an organ transplant, it should be started in the hospital, a clinic, or in a healthcare treatment setting.

Taking this medicine can increase the risk of getting cancer.

This medicine can lower your body’s ability to fight infections. You may get more infections while taking this medicine. Any infection you get could become serious and even deadly.

This medicine should not be used for liver transplant.

This medicine should not be used for lung transplant.

This medicine should only be given by a healthcare provider who has experience in the use of transplant drugs.