GENERIC NAME: SIROLIMUS - ORAL (sir-oh-LEE-muss)
BRAND NAME(S): Rapamune
WARNING: Sirolimus lowers the body's ability to fight an infection/disease (immunosuppression). This may increase your risk of developing an infection or certain types of cancer (e.g., skin cancer, lymphoma). To reduce the risk of these serious side effects, take this medication at the lowest effective dose as directed by your doctor. Keep all medical and laboratory appointments.
Tell your doctor immediately if you develop any of the following: unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, swollen glands, night sweats, unexplained weight loss, signs of infection (e.g., fever, persistent sore throat).
USES: Sirolimus is used with other medications to prevent rejection of a kidney transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.
HOW TO USE: Take this medication by mouth, usually once daily or as directed by your doctor. Swallow this medication whole. Do not crush, chew, or break the tablets. If you have nausea or an upset stomach, you may take this drug with food. However, you must choose one way (with food or without food) and always take this medication the same way so that your body always absorbs the same amount of drug. Consult your doctor or pharmacist for more details.Dosage is based on your weight, medical condition, blood test results (e.g., sirolimus trough levels), and response to treatment. Do not take more than 40 milligrams in any 24-hour period.Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased. Also, do not stop taking this medication without your doctor's approval.Take this medication regularly in order to get the most benefit from it. It is important to take all doses on time to keep the amount of medicine in your body at a constant level. Remember to take it at the same time each day.The tablet and solution forms of this medication may deliver different amounts of medication. Do not switch between the tablet and solution forms without your doctor's permission and directions.Other medications (e.g., antibiotics, immunosuppressants) may also be prescribed to help prevent infection in your body and to help prevent rejection of the transplanted organ. Take these additional medications exactly as prescribed by your doctor.Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details.Inform your doctor if your condition worsens.
SIDE EFFECTS: See also Warning section.Diarrhea, joint pain, shaking, acne, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle pain/cramps, bone pain, increased thirst/hunger, frequent urination, vision changes, hearing problems (e.g., hearing loss, ringing in the ears), unusual tiredness/weakness, fast/slow/irregular heartbeat, easy bruising/bleeding, mental/mood changes, swelling ankles/feet, severe headache, dizziness, stomach/abdominal pain.Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, frothy urine, chest pain, shortness of breath, pain/redness/swelling of arms or legs, dark urine, yellowing eyes/skin, persistent nausea/vomiting.Sirolimus may slow wound healing after surgery. Tell your doctor immediately if you have signs that your surgery wound is not healing well (e.g., redness, swelling, pain). The risk of poor wound healing is higher if you are obese.Sirolimus may cause your cholesterol/triglycerides to increase. You may be required to have your cholesterol/triglycerides checked periodically and/or take another medication to control your cholesterol/triglycerides.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.Sirolimus can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking sirolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (e.g., tacrolimus, erythromycin); or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, high cholesterol/triglyceride levels, any recent/current infections, cancer.This medication may increase your risk of developing skin cancer. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen with a high protection factor and wear protective clothing when outdoors.Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).This medication is not recommended for use during pregnancy. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women using this medication use two effective forms of birth control (e.g., condoms and birth control pills) before starting this medication, while taking this medication, and for 12 weeks after stopping this medication. Consult your doctor.This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.This drug should not be used with the following medication because very serious interactions may occur: voriconazole.If you are currently using the medication listed above, tell your doctor or pharmacist before starting sirolimus.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cisapride, drugs affecting liver enzymes that remove sirolimus from your body (such as certain azole antifungals including itraconazole, ketoconazole, certain calcium channel blockers including nifedipine, diltiazem, verapamil, macrolide antibiotics including erythromycin, cimetidine, danazol, bromocriptine, nefazodone, protease inhibitors including nelfinavir, ritonavir, rifamycins including rifampin, rifabutin, St. John's wort, certain anti-seizure medicines including carbamazepine, phenytoin), drugs affecting the kidneys (e.g., amphotericin B, cisplatin, ganciclovir, aminoglycosides such as gentamicin), metoclopramide, tacrolimus, temsirolimus.If you are also taking cyclosporine, then take sirolimus 4 hours after your cyclosporine dose. Consult your pharmacist for more information.Studies have shown when this drug is given with other specific immunosuppressants (mycophenolate, basiliximab) immediately after kidney transplant surgery, there is a greater risk of rejection. Therefore, this combination of drugs is not recommended. Discuss the details with your doctor.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.
NOTES: Laboratory and/or medical tests (e.g., kidney/liver function, cholesterol/triglyceride levels, urine tests for protein, sirolimus trough level) will be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.If you have had an organ transplant, it is recommended that you attend a transplant education class or support group. Learn the signs of organ rejection such as a feeling of being ill, fever, or tenderness/pain around the transplanted organ. Tell your doctor immediately if you notice any of these signs.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.