Sirolimus Generic Name:
Sirolimus (sir-OH-li-mus)Brand Name:
Sirolimus decreases the action of the immune system. This may increase your risk for infection. It may also increase your risk for developing certain types of cancer (eg, lymphoma). Tell your doctor right away if you notice signs of infection (eg, persistent sore throat, chills, fever) or unusual growths or lumps.
Sirolimus 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 in liver or lung transplant patients is not recommended.
Sirolimus 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 is an immunosuppressant. It blocks the action of certain blood cells (eg, T lymphocytes) that can cause the body to reject the transplanted organ.
Do NOT use Sirolimus if:
- you are allergic to any ingredient in Sirolimus
- you are pregnant
- you have had a liver or lung transplant
- you are taking astemizole, itraconazole, ketoconazole, a macrolide antibiotic (eg, erythromycin), rifabutin, rifampin, tacrolimus, telithromycin, terfenadine, or voriconazole
Contact your doctor or health care provider right away if any of these apply to you.
Before using Sirolimus :
Some medical conditions may interact with Sirolimus . 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 of childbearing age
- 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 a history of lung or breathing problems
- if you are on dialysis, have recently received 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
Some MEDICINES MAY INTERACT with Sirolimus . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril) because a serious side effect involving swelling of the mouth, face, lips, tongue, throat, and hands; trouble swallowing or breathing; and unexplained hoarseness may occur
- Aminoglycosides (eg, gentamicin), amiodarone, amphotericin B, azole antifungals (eg, fluconazole, itraconazole, ketoconazole, voriconazole), bromocriptine, cimetidine, cisapride, cyclosporine, danazol, diltiazem, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), metoclopramide, mibefradil, nicardipine, streptogramins (eg, dalfopristin), tacrolimus, telithromycin, troleandomycin, or verapamil because they may increase the risk of Sirolimus 's side effects, including kidney problems
- Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John's wort because they may decrease Sirolimus 's effectiveness
- Astemizole, calcineurin inhibitors (eg, tacrolimus), HMG-CoA reductase inhibitors (eg, atorvastatin), mycophenolate, or terfenadine because the risk of their side effects may be increased by Sirolimus
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sirolimus 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 :
Use Sirolimus as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- You may take Sirolimus by mouth on an empty stomach or with food. However, you must take it the same way each time for it to work best. If you take Sirolimus on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.
- Swallow Sirolimus whole. Do not break, crush, or chew before swallowing
- Wash your hands immediately after taking Sirolimus .
- If you are also taking cyclosporine, take Sirolimus 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 . Talk to your doctor before including grapefruit or grapefruit juice in your diet while taking Sirolimus .
- Sirolimus works best if it is taken at the same time each day. Continue to take Sirolimus even if you feel well. Do not miss any doses.
- Do not stop taking Sirolimus without first checking with your doctor.
- If you miss a dose of Sirolimus , 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 .
Important safety information:
- Do not change your dose of Sirolimus without first checking with your doctor.
- Sirolimus 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.
- Sirolimus may increase your risk for developing 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 . Talk with your doctor before you receive any vaccine.
- Sirolimus 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 without first checking with your doctor. The same doses may not be equally effective.
- Tell your doctor or dentist that you take Sirolimus before you receive any medical or dental care, emergency care, or surgery.
- If you may become pregnant, you must use an effective form of birth control before you start taking Sirolimus . You will need to continue to use birth control while you take Sirolimus and for 12 weeks after you stop taking it. If you have questions about effective birth control, talk with your doctor.
- Patients who take Sirolimus after an organ transplant may have an increased risk for developing high blood sugar or diabetes. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Lab tests, including blood counts, kidney function, urine protein, cholesterol levels, and sirolimus blood levels, may be performed while you use Sirolimus . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Sirolimus should be used with extreme caution in CHILDREN younger than 13 years old; safety and effectiveness in these children have not been confirmed.
- Sirolimus should be used with extreme caution in CHILDREN younger than 18 years old who are considered to be at high immunological risk; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Sirolimus may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sirolimus while you are pregnant. It is not known if Sirolimus is found in breast milk. Do not breast-feed while taking Sirolimus .
Possible side effects of Sirolimus :
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:
Acne; back pain; constipation; diarrhea; headache; joint pain; nausea; trouble sleeping; vomiting; weakness.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain or swelling; chest pain; dark urine; decreased urination; fast or irregular heartbeat; infection (fever, chills, sore throat, unusual vaginal discharge or odor, frequent or painful urination); mental or mood changes; muscle pain or tenderness; night sweats; red, swollen, blistered, or peeling skin; severe headache; shortness of breath; skin growths or discoloration; swelling of the hands, ankles, or feet; swollen glands or veins; tremor; unusual bleeding or bruising; unusual lumps; unusual tiredness or weakness; unusual weight gain or loss; vision changes; wound healing problems; yellowing of the skin or eyes.
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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Sirolimus :
Store Sirolimus at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sirolimus out of the reach of children and away from pets.
- If you have any questions about Sirolimus , please talk with your doctor, pharmacist, or other health care provider.
- Sirolimus 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.
This information is a summary only. It does not contain all information about Sirolimus . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Sirolimus Professional Patient Advice (Wolters Kluwer)
- sirolimus Concise Consumer Information (Cerner Multum)
- sirolimus Advanced Consumer (Micromedex) - Includes Dosage Information
- Rapamune Prescribing Information (FDA)