The U.S. FDA approved Sirolimus as an antineoplastic medication to prevent kidney transplant rejection and treat sporadic lymphangioleiomyomatosis (lung disease) on September 1999.

Sirolimus has been developed to suppress the immune system after kidney transplant surgery to prevent organ rejection. It is also indicated to treat lymphangioleiomyomatosis, a rare condition of the lungs and lymph nodes.

Sirolimus is available in doses of 0.5mg, 1mg, and 2mg. Take one Sirolimus tablet at the same time each day. Your physician will choose the dosage and administration frequency based on your medical condition because it differs for each person.

The common side effects that are likely to occur while you are on the treatment with Sirolimus are peripheral edema, high blood triglycerides, high blood pressure, increased serum creatinine, stomach pain, mouth sores, diarrhea, headache, fever, urinary tract infection, anemia, nausea, arthralgia, pain, thrombocytopenia, acne, upper respiratory tract infection, and muscle pain. Suppose you experience any allergic reactions such as rashes, itching, worsening cough, flushing, chest pain/tightness, dizziness, trouble breathing, or swallowing. Report to your doctor immediately.

Contact your doctor immediately if you experience shortness of breath, chest pain, or worsening cough. During the Sirolimus treatment, your doctor may periodically monitor your white blood cell counts, platelets, blood sugar, electrolytes, and kidney parameters to prevent serious complications. This medicine has the potential to cause kidney problems, especially when taken along with cyclosporine. Report to your doctor if you have been diagnosed with liver disorders, kidney problems, heart failure, high blood cholesterol levels, or hypertension before starting this treatment. Notify your doctor if you have any history of lung or liver transplantation because Sirolimus is not recommended in such cases.

Sirolimus tablet tends to cause harm to the unborn fetus. Inform your healthcare provider before starting this treatment if you are pregnant, or have a partner who can become pregnant. Your health care provider will conduct a pregnancy test before you start treatment with Sirolimus Tablet. Discuss effective birth control methods with your healthcare provider and use them during treatment and for 12 weeks after your last dose. It is not recommended to breastfeed during this treatment.

Inform your doctor if you have a history of lung or liver transplantation or hypersensitivity. If you experience any symptoms mentioned as a side effect, consult your doctor immediately. Avoid live vaccines during the treatment with Sirolimus Tablet. Notify your doctor immediately if you took any. Use effective birth control during the treatment for at least twelve months, even after the last dose. This medicine can increase the risk of skin cancer, so use sunscreen protection.

1. Goodman & Gilman’s, The Pharmacological Basis of Therapeutics, Targeted therapies: Tyrosine kinase inhibitors, monoclonal antibodies, and cytokines, 12th edition, 2011, 1735.
2. Pfizer Limited, Electronic medicines compendium (emc), [ Revised on July 2021] [ 09th March 2023], https://www.medicines.org.uk/emc/files/pil.1368.pdf
3. Pfizer Limited,  [ Revised on August 2023], [ Accessed on 09th March 2023],https://labeling.pfizer.com/showlabeling.aspx?id=139.

The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.