Product Summary

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PRESCRIPTION REQUIRED

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. SIROLIMUS - ORAL (sir-OH-li-mus) COMMON 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 (such as 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 right away 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 (such as sore throat that doesn\'t go away, fever). Sirolimus is not recommended for the prevention of rejection of liver or lung transplants because it has rarely caused very serious (possibly fatal) liver/lung problems in those cases.

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. Sirolimus may also be used to treat a certain lung disease (lymphangioleiomyomatosis-LAM).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used to reduce the risk of rejection of a heart transplant.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking sirolimus and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily. Swallow this medication whole. Do not crush, chew, or split the tablets. If you have nausea or an upset stomach, you may take this medication with food. However, it is important to choose one way (with food or without food) and take this medication the same way with every dose. Consult your doctor or pharmacist for more details. The dosage is based on your weight, medical condition, laboratory tests (such as sirolimus trough levels), and response to treatment. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Also, do not stop taking this medication without consulting your doctor. If you are also taking cyclosporine, take sirolimus 4 hours after your cyclosporine dose. Consult your pharmacist for more information. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. If you are taking this medication to treat LAM, tell 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, tell your doctor or pharmacist 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 right away if you have any serious side effects, including: nausea/vomiting that doesn\'t stop, yellowing eyes/skin, dark urine, muscle pain/cramps, bone pain, increased thirst/hunger, frequent urination, hearing problems (such as hearing loss, ringing in the ears), unusual tiredness, fast/slow/irregular heartbeat, easy bruising/bleeding, mental/mood changes, swelling ankles/feet, severe headache, dizziness, stomach/abdominal pain, missed/heavy/painful periods, signs of kidney problems (such as change in the amount of urine, frothy urine), pain/redness/swelling of arms or legs, swelling abdomen. Get medical help right away if you have any very serious side effects, including: chest pain, shortness of breath. This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these

SIDE EFFECTS: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes. Sirolimus may slow wound healing after surgery. Tell your doctor right away if you have signs that your surgery wound is not healing well (such as 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. Sirolimus can commonly cause a 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 reaction. Get medical help right away if you develop any rash. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. 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 or at www.fda.gov/medwatch. 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 temsirolimus; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, high cholesterol/triglyceride levels, cancer, any recent/current infections. Sirolimus can make you more likely to get infections or may worsen any current infections. Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication and for 12 weeks after treatment. Women must use reliable forms of birth control (such as condoms, birth control pills) before starting treatment, during treatment, and for 12 weeks after the end of treatment. If you become pregnant or think you may be pregnant, tell your doctor right away. This medication may pass into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: ACE inhibitors (such as benazepril, lisinopril), other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, tacrolimus). Other medications can affect the removal of sirolimus from your body, which may affect how sirolimus works. Examples include azole antifungals (such as itraconazole, ketoconazole, voriconazole), enzalutamide, macrolide antibiotics (such as clarithromycin, erythromycin), mifepristone, HIV and HCV protease inhibitors (such as indinavir, ritonavir, telaprevir), rifamycins (such as rifampin, rifabutin), St. John's wort, among others. Sirolimus is very similar to temsirolimus. Do not use medications containing temsirolimus while using sirolimus.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Laboratory and/or medical tests (such as 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 had an organ transplant, attend a transplant education class or support group to learn more about the signs of organ rejection such as a feeling of being ill, fever, or tenderness/pain around the transplanted organ. Tell your doctor right away 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. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). Information last revised March 2017. Copyright(c) 2017 First Databank, Inc.

Sirolimus 1mg Tablet