sirolimus

What is the most important information I should know about sirolimus?

What is sirolimus?

Sirolimus weakens your body's immune system, to help keep it from "rejecting" a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Sirolimus is used with other medicines to prevent organ rejection after a kidney transplant.

Sirolimus is also given without other medicines to treat a rare lung disorder called lymphangioleiomyomatosis (lim-FAN-gee-oh-LYE-oh-MYE-oh-ma-TOE-sis). This disorder happens mostly in women and causes lung tumors that are not cancerous but can affect breathing.

Sirolimus may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking sirolimus?

Tell your doctor if you have ever had:

• high cholesterol or triglycerides;
• cytomegalovirus (CMV);
• liver disease; or
• a family history of skin cancer (melanoma).

How should I take sirolimus?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Sirolimus is usually taken once a day. If you also take cyclosporine, take it at least 4 hours before you take sirolimus.

You may take sirolimus with or without food, but take it the same way every time.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Sirolimus oral liquid must be mixed only with water or orange juice, no other juices or liquids. Measure the liquid carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Sirolimus can increase your risk of infection by changing the way your immune system works. You will need frequent medical tests. Your dosing schedule may be delayed based on the results of these tests.

You should not stop using sirolimus without your doctor's advice. Stopping suddenly could make your condition worse.

If you are using sirolimus oral liquid with a disposable syringe, you may store a loaded syringe in the carrying case provided. Keep the case at room temperature and use the medicine within 24 hours. Use a disposable syringe only once and then throw it away.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking sirolimus?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Grapefruit may interact with sirolimus and lead to unwanted side effects. Avoid the use of grapefruit and grapefruit juice while taking sirolimus.

Do not receive a "live" vaccine while using sirolimus. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What are the possible side effects of sirolimus?

• redness, oozing, or slow healing of a skin wound;
• a new skin lesion, or a mole that has changed in size or color;
• unusual bleeding or bruising;
• sudden chest pain or discomfort, cough, feeling short of breath;
• tenderness around the transplanted kidney;
• signs of infection --fever, chills, painful mouth sores, skin sores, cold or flu symptoms, pain or burning when you urinate; or
• low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• fever, cold symptoms such as stuffy nose, sneezing, sore throat;
• mouth sores;
• nausea, stomach pain, diarrhea;
• headache, muscle aches;
• chest pain;
• dizziness; or
• acne.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sirolimus?

Tell your doctor about all your current medicines. Many drugs can interact with sirolimus, especially:

• bromocriptine (Cycloset, Parlodel);
• cyclosporine;
• danazol;
• St. John's wort;
• tacrolimus;
• cholesterol-lowering medication;
• an antibiotic or antifungal medicine;
• antiviral medicine to treat HIV or hepatitis C;
• heart or blood pressure medication;
• medicine to reduce stomach acid or treat an ulcer; or
• seizure medicine.

This list is not complete and many other drugs may affect sirolimus. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about sirolimus.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 9.01. Revision date: 2/15/2018.