Sirolimus Oral solution

What is this medicine?

SIROLIMUS (sir OH li mus) is used to decrease the immune system's response to a transplanted organ.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

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

• heart disease
• high cholesterol or triglycerides
• infection
• liver disease
• an unusual or allergic reaction to sirolimus, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Empty the correct amount of this medicine into a glass or plastic container with at least 2 ounces or 1/4 cup of water or orange juice. Do not mix with grapefruit juice or any other liquids. Stir well and drink. Refill the container with at least 4 ounces or 1/2 cup of water or orange juice, stir, and drink.

You may take this medicine with or without food, but choose one way and always take each dose the same way. If you are also taking cyclosporine, take this medicine at least 4 hours after taking your dose of cyclosporine. Take your medicine at regular intervals. You must take the medicine at the same time each day. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 13 years old 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.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain antibiotics like clarithromycin, erythromycin
• grapefruit juice
• medicines for fungal infections like itraconazole, ketoconazole, posaconazole, and voriconazole
• rifabutin, rifampin

This medicine may also interact with the following medications:

• bromocriptine
• carbamazepine
• cimetidine
• cisapride
• clotrimazole
• cyclosporine
• danazol
• diltiazem
• fluconazole
• metoclopramide
• nicardipine
• phenobarbital
• phenytoin
• rifapentine
• some medicines for HIV
• St. John's wort
• vaccines
• verapamil

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 medicine?

Visit your doctor for regular checks on your progress. You will need frequent blood checks.

This medicine can cause your cholesterol or lipid levels to go up. You may need treatment for high cholesterol.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

This medicine may increase your risk of getting some cancers. Talk with your doctor.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Women who are able to have children should use effective birth control before, during, and for 12 weeks after stopping this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chills, fever, sore throat
• dark urine
• fast, irregular heart beat
• feeling faint or lightheaded, falls
• high blood pressure
• pinpoint red spots on the skin
• swelling, water retention
• trouble passing urine or change in the amount of urine
• unusual bleeding or bruising
• unusually weak or tired

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

• aches, pain
• acne
• diarrhea
• nausea, vomiting
• stomach upset
• tremor
• trouble sleeping

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store this medicine in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Bottles of this medicine can be stored at room temperature 25 degrees C (77 degrees F) for up to 15 days. Throw away any unused medicine 30 days after opening the bottle. Throw away any unopened medicine after the expiration date.

Bottles of this medicine may develop a slight haze in the refrigerator. To clear, let the bottles stay at room temperature and shake gently.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.