From the official label (Apr 2024). Your prescription and pharmacist come first.
What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.
Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 - 4 months after transplantation ( 1.1 ). Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation ( 1.1 ). Safety and efficacy of CsA withdrawal has not been established in high risk patients ( 1.1 , 1.2 , 14.3 ). Sirolimus is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis ( 1.3 ). …
Oral Solution: 60 mg per 60 mL in amber glass bottle ( 3.1 ). 3.1 Sirolimus Oral Solution 60 mg per 60 mL in amber glass bottle.
Clinical studies of sirolimus oral solution did not include sufficient numbers of patients ≥ 65 years to determine whether they respond differently from younger patients. Data pertaining to sirolimus trough concentrations suggest that dose adjustments based upon age in geriatric renal patients are not necessary. Differences in responses between the elderly and younger patients have not been identified. …
Sirolimus is known to be a substrate for both cytochrome P-450 3A4 (CYP3A4) and p-glycoprotein (P-gp). Inducers of CYP3A4 and P-gp may decrease sirolimus concentrations whereas inhibitors of CYP3A4 and P-gp may increase sirolimus concentrations. Avoid concomitant use with strong CYP3A4/P-gp inducers or strong CYP3A4/P-gp inhibitors that decrease or increase sirolimus concentrations ( 7.4 , 12.3 ). Therapeutic drug monitoring and dose reduction for sirolimus should be considered when sirolimus is co-administered with cannabidiol ( 5.21 , 7.5 ). See full prescribing information for complete list of clinically significant drug interactions ( 12.3 ). …
Hypersensitivity Reactions ( 5.4 ) Angioedema ( 5.5 ) Fluid Accumulation and Impairment of Wound Healing ( 5.6 ) Hyperlipidemia ( 5.7 ) Decline in Renal Function ( 5.8 ) Proteinuria ( 5.9 ) Latent Viral Infections ( 5.10 ) Interstitial Lung Disease/Non-Infectious Pneumonitis ( 5.11 ) De Novo Use Without Cyclosporine ( 5.12 ) Increased Risk of Calcineurin Inhibitor-Induced Hemolytic Uremic Syndrome/ Thrombotic Thrombocytopenic Purpura/ Thrombotic Microangiopathy ( 5.13 ) Embryo-Fetal Toxicity: Can cause fetal harm. …
The following adverse reactions are discussed in greater detail in other sections of the label. Increased susceptibility to infection, lymphoma, and malignancy [ see Boxed Warning, Warnings and Precautions ( 5.1 ) ] Excess mortality, graft loss, and hepatic artery thrombosis in liver transplant patients [ see Boxed Warning, Warnings and Precautions ( 5.2 ) ] Bronchial anastomotic dehiscence in lung transplant patients [ see Boxed Warning, Warnings and Precautions ( 5.3 ) ] Hypersensitivity reactions [ see Warnings and Precautions ( 5.4 ) ] Exfoliative dermatitis [ see Warnings and Precautions ( 5.4 ) ] Angioedema [ see Warnings and Precautions ( 5.5 ) ] Fluid accumulation and impairment of w …
8.1 Pregnancy Risk Summary Based on animal studies and the mechanism of action, Sirolimus can cause fetal harm when administered to a pregnant woman [ see Data , Clinical Pharmacology ( 12.1 ) ]. There are limited data on the use of sirolimus during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. …
Reports of overdose with sirolimus have been received; however, experience has been limited. In general, the adverse effects of overdose are consistent with those listed in the adverse reactions section [ see Adverse Reactions ( 6 ) ]. General supportive measures should be followed in all cases of overdose. Based on the low aqueous solubility and high erythrocyte and plasma protein binding of sirolimus, it is anticipated that sirolimus is not dialyzable to any significant extent. In mice and rats, the acute oral LD 50 was greater than 800 mg/kg.
Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.
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Price of Sirolimus in: United Kingdom
Products with Sirolimus as the active ingredient. Names differ between countries.
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Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 - 4 months after transplantation ( 1.1 ). Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for (From the official U.S. FDA label.)
Follow your prescription or the leaflet in your pack. The official label says: Sirolimus Oral Solution is to be administered orally once daily, consistently with or without food [see Dosage and Administration ( 2.5 ), Clinical Pharmacology ( 12.3 )]. Renal Transplant Patients: Administer once daily by mouth, consistently with or without food ( 2 ). Administer the initial dose as soon as possible after transplantation and 4 hours after CsA ( 2.1 , 7.1 ). A…
Sirolimus Oral Solution is to be administered orally once daily, consistently with or without food [see Dosage and Administration , Clinical Pharmacology ].
Usually yes. Sirolimus is a prescription medicine in most countries. Rules differ by country.
Sirolimus is sold under names such as Rapamune, Fyarro, Hyftor, Felycin. Brand names differ between countries.
The official label lists: The following adverse reactions are discussed in greater detail in other sections of the label. Increased susceptibility to infection, lymphoma, and malignancy [ see Boxed Warning, Warnings and Precautions ( 5.1 ) ] Excess mortality, graft loss, and hepatic artery thrombosis in liver transplant patients [ see Boxed Warning, Warnings and Precautions ( 5.2 ) ] Bronchial anastomot… Tell your doctor about any side effect that bothers you or does not go away.
Renal Transplant The safety and efficacy of sirolimus in pediatric patients < 13 years have not been established. The safety and efficacy of sirolimus oral solution has been established for prophylaxis of organ rejection in renal transplantation in children ≥ 13 years judged to be at low- to moderate-immunologic risk. … Always use the dose for the child's age or weight on the pack or prescription.
8.1 Pregnancy Risk Summary Based on animal studies and the mechanism of action, Sirolimus can cause fetal harm when administered to a pregnant woman [ see Data , Clinical Pharmacology ( 12.1 ) ]. There are limited data on the use of sirolimus during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. … Ask your doctor or midwife first.
Sirolimus is known to be a substrate for both cytochrome P-450 3A4 (CYP3A4) and p-glycoprotein (P-gp). Inducers of CYP3A4 and P-gp may decrease sirolimus concentrations whereas inhibitors of CYP3A4 and P-gp may increase sirolimus concentrations. Avoid concomitant use with strong CYP3A4/P-gp inducers or strong CYP3A4/P-gp inhibitors that decrease or increase sirolimus concentrat… Use the free interaction checker before combining medicines.
Reports of overdose with sirolimus have been received; however, experience has been limited. In general, the adverse effects of overdose are consistent with those listed in the adverse reactions section [ see Adverse Reactions ( 6 ) ]. General supportive measures should be followed in all cases of o… Get medical help right away.
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This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.