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. It is also used to treat a rare lung disease called lymphangioleiomyomatosis.

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Put the oral syringe adaptor into the bottle. Use the amber oral syringes that come with this medicine 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 medicine 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 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.

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.

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 heartbeat

• feeling faint or lightheaded, falls

• high blood pressure

• pinpoint red spots on the skin

• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.

• swelling, water retention

• trouble passing urine

• unusual bleeding or bruising

• unusually weak

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

What may interact with this medicine?

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

• certain antibiotics like clarithromycin, erythromycin, telithromycin

• grapefruit juice

• medicines for fungal infections like itraconazole, ketoconazole, posaconazole, and voriconazole

• mifepristone, RU-486

• rifabutin, rifampin

This medicine may also interact with the following medications:

• boceprevir

• bromocriptine

• carbamazepine

• cimetidine

• cisapride

• clotrimazole

• cyclosporine

• danazol

• diltiazem

• fluconazole

• indinavir

• metoclopramide

• nicardipine

• phenobarbital

• phenytoin

• rifapentine

• ritonavir

• St. John's wort

• telaprevir

• troleandomycin

• vaccines

• verapamil

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 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. Protect from light. Bottles of this medicine may develop a slight haze in the refrigerator. To clear, let the bottles stay at room temperature and shake gently. Throw away any unused medicine 30 days after opening a bottle. If needed, opened bottles can be stored at room temperature at or below 25 degrees C (77 degrees F) for up to 15 days. Throw away any unopened bottles after the expiration date on the label.

A dose of this medicine 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 medicine. The medicine in the syringe can be stored at room temperature at or below 25 degrees C (77 degrees F) or in a refrigerator at 2 to 8 degrees C (36 to 46 degrees F) for up to 24 hours. If it is not used during this time, throw the dose in the syringe away. Throw away any unopened medicine after the expiration date.

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

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 medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

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 blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

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.