Generic Name: sirolimus (sir-OH-li-mus)
Brand Name: Rapamune
Sirolimus solution decreases the action of the immune system. This may increase your risk of infection. It may also increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Tell your doctor right away if you notice signs of infection (eg, persistent sore throat, chills, fever), any changes in the appearance or size of a mole, night sweats, unusual growths or lumps, or unusual tiredness or weakness.
Sirolimus solution may increase the risk of severe side effects, including death, when used with certain other immunosuppressants in liver or lung transplant patients. Use of sirolimus solution in liver or lung transplant patients is not recommended.
Sirolimus solution is used for:
Preventing organ rejection after a kidney transplant. It is used with other medicines. It may also be used for other conditions as determined by your doctor.
Sirolimus solution is an immunosuppressant. It works by blocking the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.
Do NOT use sirolimus solution if:
- you are allergic to any ingredient in sirolimus solution
- you have had a liver or lung transplant
- you are taking clarithromycin, enzalutamide, erythromycin, itraconazole, ketoconazole, mifepristone, posaconazole, rifabutin, rifampin, telithromycin, or voriconazole
Contact your doctor or health care provider right away if any of these apply to you.
Before using sirolimus solution:
Some medical conditions may interact with sirolimus solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver problems, kidney problems, high cholesterol or triglycerides, low blood platelet levels, diabetes or high blood sugar, or a history of lung or breathing problems
- if you are on dialysis, have recently received or are scheduled to receive a vaccine or have a history of tuberculosis (TB), or have ever had a positive TB skin test
- if you have had multiple organ transplants, an organ retransplanted, or a previous transplant that was rejected
- if you or a family member has a history of skin cancer
- if you previously took cyclosporin and have recently stopped taking it
- if you take medicines that may harm the kidney (eg, aminoglycosides [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], vancomycin). Ask your doctor or pharmacist if you are unsure if any of your medicines might harm the kidney
Some MEDICINES MAY INTERACT with sirolimus solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for abortion, cancer, Cushing syndrome, endometriosis, fibrocystic breast disease, hepatitis C, hereditary angioedema, high blood pressure, high blood prolactin levels, high cholesterol, HIV, immune system suppression, infections, irregular heartbeat or other heart problems, mental or mood problems, Parkinson disease, seizures, stomach acid, ulcers or other stomach or bowel problems), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) because they may interact with sirolimus solution. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with sirolimus solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if sirolimus solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use sirolimus solution:
Use sirolimus solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Sirolimus solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get sirolimus solution refilled.
- Take sirolimus solution by mouth. You may take it with or without food. However, you must take it the same way each time for it to work best. If you take sirolimus solution on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.
- Use the dosing syringe that comes with sirolimus solution to measure your dose. Keep the bottle upright while you measure your dose. If bubbles form in the syringe, empty the syringe into the bottle and start over. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Empty the measured medicine from the syringe into a glass or plastic container that has at least 2 oz (60 mL) of water or orange juice in it. Do not mix with any other liquid. Stir well and drink at once. Refill the container with at least 4 oz (120 mL) of water or orange juice, stir well, and drink at once.
- You may draw a dose into the syringe, cap the syringe, and keep the medicine in the syringe for up to 24 hours before using it. The syringe should be stored at room temperature, up to 77 degrees F (25 degrees C), or in the refrigerator. Once you have mixed the medicine in liquid, you must drink it right away.
- Throw away each syringe after 1 use.
- If you spill sirolimus solution on your skin, wash it off right away with soap and water. If you get sirolimus solution in your eyes, rinse at once with cool tap water.
- Sirolimus solution may become hazy when refrigerated. If this occurs, allow it to stand at room temperature and shake gently until the haze disappears. This will not affect the effectiveness of sirolimus solution.
- If it is necessary to wipe the mouth of the bottle, use a dry cloth so that no water or other liquid enters the bottle.
- If you are also taking cyclosporine, take sirolimus solution 4 hours after your cyclosporine dose, unless your doctor tells you otherwise.
- Grapefruit and grapefruit juice may increase the risk of side effects from sirolimus solution. Do not eat grapefruit or drink grapefruit juice while you take sirolimus solution.
- Sirolimus solution works best if it is taken at the same time each day. Continue to take sirolimus solution even if you feel well. Do not miss any doses.
- Do not stop taking sirolimus solution without first checking with your doctor.
- If you miss a dose of sirolimus solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use sirolimus solution.
Important safety information:
- Tell your doctor or dentist that you take sirolimus solution before you receive any medical or dental care, emergency care, or surgery.
- Do not change your dose of sirolimus solution without first checking with your doctor.
- Sirolimus solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Some patients treated with sirolimus solution have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or severe kidney problems associated with BK virus infection. In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Tell your doctor right away if you notice symptoms of PML (eg, confusion; disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine, difficult or painful urination, blood in the urine). Discuss any questions or concerns with your doctor.
- Sirolimus solution may increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Discuss any questions or concerns with your doctor.
- To decrease your risk of skin cancer, avoid using sunlamps or tanning booths. Limit your exposure to the sun. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking sirolimus solution. Talk with your doctor before you receive any vaccine.
- Sirolimus solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Do not switch between the tablet and solution forms of sirolimus solution without first checking with your doctor. The same doses may not be equally effective.
- Diabetes patients - Sirolimus solution may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- If you may become pregnant, you must use an effective form of birth control before you start taking sirolimus solution. You will need to continue to use birth control while you take sirolimus solution and for 12 weeks after you stop taking it. If you have questions about effective birth control, talk with your doctor.
- Decreased sperm production has occurred in some men taking sirolimus solution. Normal sperm production has usually returned when sirolimus solution was stopped. Discuss any questions or concerns with your doctor.
- Lab tests may be performed while you take sirolimus solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: Sirolimus solution may cause harm to the fetus. Do not become pregnant while you are taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking sirolimus solution while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking sirolimus solution.
Possible side effects of sirolimus solution:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; headache; joint pain; nausea; stomach pain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, eyes, lips, or tongue; unusual hoarseness; wheezing); calf or leg pain, redness, tenderness, or swelling; chest pain; fainting; fast or irregular heartbeat; menstrual changes; muscle pain, cramps, or tenderness; new or worsening breathing problems (eg, shortness of breath); new or worsening cough; night sweats; red, swollen, blistered, or peeling skin; severe or persistent headache or dizziness; skin growths or discoloration; swelling of the hands, ankles, feet, or stomach; swelling or soreness of the mouth or tongue; symptoms of high blood sugar (eg, confusion; drowsiness; flushing; fruit-like breath odor; increased thirst, hunger, or urination; rapid breathing); symptoms of infection (eg, chills, fever, frequent or painful urination, sore throat, unusual vaginal discharge or odor); symptoms of kidney problems (eg, change in the amount of urine, difficult or painful urination, blood in the urine); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); unusual bleeding or bruising; unusual lumps; unusual tiredness or weakness; unusual weight changes; vision changes; wound healing problems.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of sirolimus solution:
Store sirolimus solution in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do NOT freeze. If necessary, the bottle may be stored at room temperature, up to 77 degrees F (25 degrees C), for no more than 15 days. Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any unused medicine after the bottle has been open for 1 month. Keep sirolimus solution out of the reach of children and away from pets.
- If you have any questions about sirolimus solution, please talk with your doctor, pharmacist, or other health care provider.
- Sirolimus solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take sirolimus solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sirolimus solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sirolimus solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using sirolimus solution.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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- Drug class: mTOR inhibitors
Other brands: Rapamune