Sirolimus, Oral

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KEY POINTS

• This medicine is taken by mouth, along with other medicines, to prevent rejection of transplanted kidneys. Take all medicines exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may increase your risk of lymphoma and other cancers, especially skin cancer. You may get infections more easily when you are taking this medicine, including a serious brain infection.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: immunosuppressant

Generic and brand names: sirolimus, oral; Rapamune

What is this medicine used for?

This medicine is taken by mouth to prevent rejection of transplanted kidneys. It is usually used with cyclosporine (Sandimmune, Gengraf, or Neoral) and corticosteroid medicines such as prednisone or cortisone.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A liver or lung transplant. You should not take this medicine if you have had a liver or lung transplant.
• High cholesterol or high triglycerides
• Skin cancer

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Use effective birth control while you are taking this medicine, and for 12 weeks after you stop taking it. Talk with your healthcare provider about this. Do not breastfeed while taking this medicine without your healthcare provider’s approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check with your healthcare provider before using this medicine in children under age 13.

Take this medicine once a day, starting as soon as possible after your transplant. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

This medicine comes in the form of a tablet or a liquid. If you have the tablet, do not crush or chew it. Swallow it whole. If you have the tablets in the blister pack, do not remove the tablet from the blister pack until you are ready to take it. Take the tablet right away after you take it out of the blister pack. Do not store the removed tablet for future use.

If you have the liquid form of this medicine, carefully follow the instructions in the medicine package on how to withdraw the proper amount of medicine from the bottle, how to properly dilute it, and how to store the medicine. Use only the oral dosing syringes given to you by the pharmacist. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Do not get the liquid form of this medicine on your skin or in your eyes. If you accidentally get the liquid form of this medicine on your skin, wash the area with soap and water. If you get the it in your eyes, rinse your eyes with water.

You may take this medicine with or without food, as long as you take it the same way each time. Take this medicine with water or diluted in water or orange juice only. Do not take it with any other liquids. Do not take this medicine with grapefruit juice or eat grapefruit while taking this medicine.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: shortness of breath; chest pain; severe nausea or vomiting; fast or irregular heartbeat; severe weakness or tiredness; confusion, memory problems, problems walking or talking, balance problems, vision changes, unusual mood or behavior changes, severe dizziness or fainting.

What should I watch out for?

Your healthcare provider will check you regularly while you are taking this medicine. You need to have blood and urine tests frequently to see how this medicine is affecting you. Your healthcare provider may change the dose of this medicine depending on your blood test results. You should also have your blood pressure checked regularly. Keep all your appointments.

This medicine may increase your risk of lymphoma and other cancers, especially skin cancer. Talk to your healthcare provider about this. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. Ask your pharmacist for the most protective sunscreen lotion.

You may get infections more easily when you are taking this medicine. Your healthcare provider may put you on medicine to help prevent some of these infections. Stay away from people with colds, flu, or other infections. Do not have any vaccines without getting your healthcare provider's approval first. Call your healthcare provider right away if you have any symptoms of infection, such as fever or chills, while taking this medicine.

This medicine may cause an infection of the brain that may cause death. Contact your provider right away if you: are weak on one side of the body, are confused or having trouble thinking, or if you cannot control your muscles.

This medicine may delay wound healing. Talk with your healthcare provider about this.

This medicine may cause high blood sugar, even if you do not have diabetes. Contact your provider if you have:

• Unusual thirst
• Increased urination
• Increased appetite with weight loss

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Shortness of breath; new or worsening cough or breathing problems; chest pain; yellowing of your skin or eyes; dark urine; severe nausea or vomiting; fast or irregular heartbeat; unusual bruising or bleeding; pinpoint red spots on your skin; scaly skin; skin rash, redness, or peeling; fever, chills or sore throat; frequent or decreased urination; burning during urination; blood in the urine; confusion; memory problems; severe dizziness or fainting; unusual mood or behavior changes; severe tiredness; wounds that won't heal; pain, redness, warmth, or swelling in your legs or arms or any unexplained swelling; night sweats.

Other: Diarrhea, constipation, nausea, vomiting, acne, headache, stomach pain, back pain, muscle or joint pain, trouble sleeping.

What products might interact with this medicine?

Be sure to check with your healthcare provider or pharmacist before starting or stopping any other medicine or getting a vaccine. When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Also, using these medicines together might cause harmful side effects.

Caution: This medicine may interact with MANY other medicines. It is extremely important that you tell the healthcare provider who prescribed this medicine about any other medicines you are taking.

This medicine can also interact with natural remedies, such as St. John's wort. Do not take any other medicines, including nonprescription products, herbs, or supplements, unless your healthcare provider approves them.

The effects of this medicine may be increased if you take it with grapefruit or grapefruit juice. Talk with your healthcare provider about this.

The effects of this medicine may be dangerously increased if you drink grapefruit juice or eat grapefruit. Talk with your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the tablets at room temperature. Protect them from heat, moisture, and direct light. If you have the blister pack, keep the tablets in the original container.

Store the liquid bottle in the refrigerator and away from bright light. Always store the bottle in an upright position. Do not let the liquid freeze. When you open the bottle, use the medicine within 1 month. If you store the liquid at room temperature, you must use it within 15 days. When refrigerated, this medicine may develop a slight haze that will away when the medicine reaches room temperature and is gently shaken. This haze is not harmful.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.