SIROLIMUS SOLUTION - ORAL

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SIROLIMUS SOLUTION - ORAL

PHONETIC PRONUNCIATION: (sir-OH-li-mus)

COMMON BRAND NAME(S): Rapamune

GENERIC NAME(S): sirolimus

Uses

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).


How to use SIROLIMUS SOLUTION - ORAL

HOW TO USE: Read the Medication Guide and Instructions for Use 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. 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. Carefully measure the dose using the amber oral dose syringe provided. Do not use a household spoon because you may not get the correct dose. Mix the measured dose with at least 2 ounces (one-fourth cup/60 milliliters) of water or orange juice in a plastic or glass container. Do not mix with any other liquids. Stir well and drink all of the mixture right away. Refill the container with at least 4 more ounces (one-half cup/120 milliliters) of water or orange juice, stir well, and drink it right away. Do not prepare a supply in advance. The oral dose syringe should only be used once and thrown away. Use a new syringe for each dose. 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

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

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.

Interactions

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

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.

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Faq for SIROLIMUS SOLUTION - ORAL

Sirolimus Solution is an oral medication that belongs to a class of drugs called mTOR inhibitors. It is used to prevent organ rejection in patients who have received a kidney transplant.

Sirolimus Solution works by suppressing the body's immune system, preventing it from attacking the transplanted organ. It inhibits a protein called mTOR, which plays a role in the growth and division of cells involved in the immune response.

Common side effects of Sirolimus Solution may include mouth ulcers, diarrhea, nausea, headache, acne, and high cholesterol levels. It may also increase the risk of infection and decrease wound healing.

Sirolimus Solution should be taken exactly as prescribed by your doctor. It is usually taken once daily, either with or without food. It is important to take it at the same time each day. Do not crush or chew the tablets, swallow them whole with a glass of water.

It is generally recommended to avoid alcohol while taking Sirolimus Solution, as it can increase the risk of certain side effects such as liver damage and drowsiness.

If you miss a dose of Sirolimus Solution, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Sirolimus Solution may interact with certain medications, including other immunosuppressants, antifungal drugs, antibiotics, and some antidepressants. It is important to inform your doctor about all the medications you are currently taking to prevent any potential interactions.

Sirolimus Solution may be used in pediatric patients aged 13 years and older who have received a kidney transplant. However, the dosage and safety in younger children have not been established.

Sirolimus Solution is not recommended for use during pregnancy as it may harm the fetus. It is also not known if the medication passes into breast milk, so breastfeeding should be avoided while taking Sirolimus Solution.

Sirolimus Solution is usually taken once daily on an empty stomach, at least 4 hours after a meal. It is important to follow the dosage instructions provided by your healthcare provider. Do not crush or chew the solution, swallow it whole.

Common side effects of Sirolimus Solution may include mouth sores, diarrhea, nausea, vomiting, headache, and increased cholesterol levels. Serious side effects may include infection, fluid retention, increased risk of certain types of cancer, and kidney problems. Contact your doctor if you experience any unusual or severe side effects.

Sirolimus Solution may increase the risk of developing infections, including serious fungal and viral infections, and certain types of cancer. It may also cause birth defects if used during pregnancy. It is important to discuss your medical history and any current medications with your doctor before starting Sirolimus Solution.

The duration of Sirolimus Solution treatment will be determined by your doctor based on your individual circumstances. Most patients will need to take it indefinitely to prevent organ rejection after a kidney transplant.

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Warning

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.


Disclaimer

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.