Sirolimus
Active ingredient · 3 therapeutic classes
Sold as Opsiria · HYFTOR · FYARRO · RAPAMUNE
- Drug class
- Mammalian Target Of Rapamycin (Mtor) Kinase Inhibitors
- Availability
- Prescription only
- Routes
- Oral, Intravenous
- Markets covered
- 4
- Products on record
- 15
- FDA reports (12 mo)
- 1,107
Overview
Plain-language summary, compiled from the cited regulatory records
Sirolimus is an immunosuppressant medication belonging to the drug class of mammalian target of rapamycin (mTOR) kinase inhibitors [1]. It is approved for preventing organ rejection in patients aged 13 years and older who have received a kidney transplant [1].
For patients considered at low- to moderate-immunologic risk, sirolimus is initially prescribed along with cyclosporine and corticosteroids. A recommended schedule involves withdrawing cyclosporine between 2 and 4 months after the transplant [1]. In patients identified as high-immunologic risk, sirolimus is used in combination with cyclosporine and corticosteroids for the initial 12 months following transplantation [1].
Sirolimus is available under various brand names, including FYARRO [1]. There were 1107 adverse event reports for sirolimus in the last 12 months [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 6 | January 30, 2026 |
| CA Canada | Health Canada | 4 | August 21, 2025 |
| US United States | FDA | 3 | May 19, 2026 |
| EU European Union | EMA | 2 | May 4, 2026 |
GBUnited Kingdom· MHRA
6 products
Uses
This medicine is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that sirolimus be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months.
1). 1).
How to take
CACanada· Health Canada
4 products
Uses
Rapamune (sirolimus oral solution and tablets) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants: • In patients at low to moderate immunological risk, it is recommended that Rapamune be used initially in a regimen with cyclosporine and corticosteroids.
Cyclosporine should be withdrawn 2 to 4 months after transplantation and the Rapamune dose should be increased to reach recommended blood concentrations (See 4 DOSAGE AND ADMINISTRATION). • In patients at high immunologic risk (defined as Black transplant recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high-panel reactive antibodies (PRA; peak PRA level > 80%), it is recommended that Rapamune be used in combination with cyclosporine and corticosteroids for the first year following transplantation (See 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
Thereafter, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient. 1 Pediatrics Pediatrics (<13 years of age): The safety and efficacy of Rapamune in pediatric patients below the age of 13 years have not been established; therefore, Health Canada has not authorized an indication for patients under the age of 13 years.
USUnited States· FDA
3 products
Uses
1 INDICATIONS AND USAGE FYARRO ® is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
( 1 )
How to take
EUEuropean Union· EMA
2 products
Uses
Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months.
1). 1).
How to take
Drug interactions
Known interactions involving Sirolimus. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 575. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB000571613 · revised January 30, 2026
- [2]Health Canada (DPD) · 02243237 · revised August 21, 2025
- [3]FDA DailyMed · 0f9bb784-53e2-46… · revised May 19, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/000273 · revised May 4, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.