Context and Approval Date
In September 1999, the U.S. FDA approved Sirolimus as an antineoplastic medication to prevent kidney transplant rejection and treat sporadic lymphangioleiomyomatosis (lung disease).
Mechanism of Action of Sirolimus
Sirolimus, classified as an mTOR inhibitor, is an immunosuppressant medication. It acts by blocking mTOR, a crucial cell signaling component responsible for cell growth, proliferation, and metabolism. By inhibiting mTOR, sirolimus suppresses T cells and immunoglobulins, effectively dampening the immune system. You can prescribe it alone or in combination with other immunosuppressants.
All Substitutes
View All
| Product | Packaging Size | Company | Price |
|---|---|---|---|
| Siromus 1mg tablet | 6 tablets | Zydus Cadila | INR 550 |
| Rocas 1mg tablet | 6 tablets | Emcure Pharmaceuticals | INR 400 |
| Sirova 1mg tablet | 10 tablets | Intas Pharmaceuticals | INR 850 |
| Rapacan 1mg tablet | 10 tablets | Biocon Ltd | INR 890 |
Uses of Sirolimus
After kidney transplant surgery, sirolimus suppresses the immune system to prevent organ rejection. Additionally, it serves as a treatment for lymphangioleiomyomatosis, a rare condition affecting the lungs and lymph nodes.
Sirolimus administration guidelines and available dosage options
There are three doses of Sirolimus available: 0.5mg, 1mg, and 2mg. Take one tablet daily at a consistent time. Your doctor will determine the appropriate dosage and frequency tailored to your specific medical needs.
Information about sirolimus tablet
Sirolimus uses
We use sirolimus to prevent kidney transplant rejection.How Sirolimus works
Sirolimus is an immunosuppressant medication. It functions by dampening the immune system's reaction to an organ transplant (e.g., liver, kidney, or heart), enabling the body to recognize and embrace the new organ as part of its own.Common side effects of Sirolimus
Decreased white blood cell count (neutrophils)Stomatitis (inflammation of the mouth)Sepsis, kidney infections, Cytomegalovirus infection, Herpes zoster, Non-melanoma skin cancer, Hemolytic uremic syndrome, Hypersensitivity, Pericardial effusion, Venous thrombosis, pulmonary embolism, Pneumonitis, Pleural effusion, Nosebleeds, Pancreatic inflammation, Ascites (the accumulation of fluid in the abdominal cavity) Osteonecrosis (reduced blood flow to the bones)Ovarian cysts.1. You may be frequently monitored for renal function during concomitant administration of sirolimus and ciclosporin.
2. Sirolimus increase risk of infection and the risk of developing certain types of cancer (e.g., lymphoma, skin cancer). Seek immediate medical attention if you notice signs of infection (e.g., persistent sore throat, chills, and fever), any changes in the appearance or size of a mole, night sweats, unusual growths or lumps, or unusual tiredness or weakness.
3. Avoid the use of live vaccines during treatment, as the vaccination may be less effective when taking sirolimus. Use effective methods of contraception during sirolimus therapy and for 12 weeks after sirolimus has been stopped.
4. Consult your doctor if you develop any liver problems, kidney problems, high cholesterol or triglycerides, low blood platelet levels, diabetes or high blood sugar, or lung or breathing problems, or if you are considered to be at high risk for rejection, such as if you had a previous transplant that was lost to rejection.
5. Limit the exposure to sunlight and UV light by covering your skin with clothing and using a sunscreen with a high protection factor because of the increased risk of skin cancer, when receiving sirolimus.
6. Take sirolimus at the same time in relation to ciclosporin, and consistently with or without food, as its blood levels will be monitored.
2. Sirolimus increase risk of infection and the risk of developing certain types of cancer (e.g., lymphoma, skin cancer). Seek immediate medical attention if you notice signs of infection (e.g., persistent sore throat, chills, and fever), any changes in the appearance or size of a mole, night sweats, unusual growths or lumps, or unusual tiredness or weakness.
3. Avoid the use of live vaccines during treatment, as the vaccination may be less effective when taking sirolimus. Use effective methods of contraception during sirolimus therapy and for 12 weeks after sirolimus has been stopped.
4. Consult your doctor if you develop any liver problems, kidney problems, high cholesterol or triglycerides, low blood platelet levels, diabetes or high blood sugar, or lung or breathing problems, or if you are considered to be at high risk for rejection, such as if you had a previous transplant that was lost to rejection.
5. Limit the exposure to sunlight and UV light by covering your skin with clothing and using a sunscreen with a high protection factor because of the increased risk of skin cancer, when receiving sirolimus.
6. Take sirolimus at the same time in relation to ciclosporin, and consistently with or without food, as its blood levels will be monitored.
Warning, Precautions, and Side Effects Associated with Sirolimus
Warning
If you notice symptoms like shortness of breath, chest pain, or a worsening cough, contact your doctor immediately. Throughout your Sirolimus treatment, your doctor may regularly monitor your white blood cell counts, platelets, blood sugar, electrolytes, and kidney function to prevent potential complications. Be aware that this medication can potentially lead to kidney issues, particularly when used alongside cyclosporine. Inform your doctor if you have a history of liver disorders, kidney problems, heart failure, high blood cholesterol levels, or hypertension before starting this treatment. Additionally, disclose any prior lung or liver transplantations, as sirolimus may not be suitable in such cases.Precautions
Sirolimus tablets tend to pose risks to an unborn fetus. Before beginning this treatment, inform your healthcare provider if you are pregnant or if you have a partner who could become pregnant. Your healthcare provider will likely conduct a pregnancy test before starting sirolimus tablet therapy. Discuss effective birth control methods with your healthcare provider, and use them throughout treatment and for 12 weeks following your last dose. We do not recommend breastfeeding during this treatment.Side effects
While on Sirolimus treatment, you may experience common side effects such as peripheral edema, high blood triglycerides, elevated 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. Should you encounter any allergic reactions like rashes, itching, worsening cough, flushing, chest pain or tightness, dizziness, or difficulty breathing or swallowing, promptly inform your doctor.FAQ - Sirolimus
1 What should you know before consuming sirolimus?
Before consuming sirolimus, knowing that your risk of getting a bacterial or viral infection increases with this treatment is important. During this treatment, tell your doctor if you have any active infections or symptoms, such as chest tightness, breathing trouble, confusion, or sudden changes in thinking.
2 What tests are required before treatment with the sirolimus tablet?
Before beginning treatment with Sirolimus Tablet, your healthcare provider will administer a pregnancy test and check for infections. Throughout your treatment, your physician will monitor your blood cholesterol levels, as well as liver and kidney function, and conduct urine tests for proteinuria.
3 Who should not take sirolimus?
People who are allergic to sirolimus and its ingredients should avoid taking tablets.
4 Is it safe to undergo surgery while on sirolimus treatment?
Inform your doctor if you plan to undergo surgery before starting or during Sirolimus treatment, as it may cause unusual bleeding and affect wound healing. Your healthcare provider may advise stopping Sirolimus tablets at least one week before scheduled surgery.
5 Does sirolimus affect fertility?
Before beginning Sirolimus treatment, discuss any concerns about fertility impairment with your healthcare provider, as it may affect both males and females.
6 What should you avoid while on sirolimus tablet treatment?
Before starting Sirolimus treatment, inform your healthcare provider about any prescription medications, vitamins, or herbal supplements you are taking, as Sirolimus tablets may interact with other medicines. Additionally, avoid receiving live vaccines and protect your skin from sun exposure during treatment.
References
1. Pfizer Limited, Electronic medicines compendium (emc), [ Revised on July 2021] [ 09th March 2023],https://www.medicines.org.uk/emc/files/pil.1368.pdf
2. Pfizer Limited, [ Revised on August 2023], [ Accessed on 09th March 2023],https://labeling.pfizer.com/showlabeling.aspx?id=139
3. Goodman & Gilman’s, The Pharmacological Basis of Therapeutics, Targeted therapies: Tyrosine kinase inhibitors, monoclonal antibodies, and cytokines, 12th edition, 2011, 1735.
2. Pfizer Limited, [ Revised on August 2023], [ Accessed on 09th March 2023],https://labeling.pfizer.com/showlabeling.aspx?id=139
3. Goodman & Gilman’s, The Pharmacological Basis of Therapeutics, Targeted therapies: Tyrosine kinase inhibitors, monoclonal antibodies, and cytokines, 12th edition, 2011, 1735.
