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 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, lab tests, 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 last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using sirolimus before having any immunizations/vaccinations. 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 can affect fertility in males. Ask your doctor for more details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using sirolimus. Sirolimus may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 12 weeks after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication may pass into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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 protease inhibitors (such as indinavir), rifamycins (such as rifampin, rifabutin), ritonavir, 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. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as kidney/liver function, cholesterol/triglyceride levels, urine tests for protein, sirolimus trough level) will be done while you are taking this medication. Keep all medical and lab appointments. 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.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the refrigerator, away from light, in the upright position. Do not freeze. If necessary, this medication may also be stored at room temperature briefly. Check the product package for how long your brand can be stored at room temperature or ask your pharmacist. Once the bottle is opened, the medication should be used within 30 days. If the medication is stored in the oral syringe with the cap on, then the medication should be used within 24 hours. Do not store in the bathroom. Keep all medications away from children and pets.

When refrigerated, the medication in the bottle may develop a slight haze. If this haze occurs, allow the medication to stand at room temperature and shake gently until the haze disappears. The haze does not affect the quality of the drug.

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).