Sirolimus is a kinase inhibitor sold in the U.S. under 4 brand and generic names, for lymphangioleiomyomatosis and perivascular epithelioid cell neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Sirolimus (application ANDA211406). Other sirolimus products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 ). Adjust the sirolimus maintenance dose to achieve sirolimus trough concentrations within the target-range ( 2.5 ). Hepatic impairment: Reduce maintenance dose in patients with hepatic impairment ( 2.7 , 8.6 , 12.3 ). In renal transplant patients at low-to moderate-immunologic risk : Sirolimus Oral Solution and CsA Combination Therapy: One loading dose of 6 mg on day 1, followed by daily maintenance doses of 2 mg ( 2.2 ). Sirolimus Oral Solution Following CsA Withdrawal: 2 to 4 months post-transplantation, withdraw CsA over 4 to 8 weeks ( 2.2 ). In renal transplant patients at high-immunologic risk: Sirolimus Oral Solution and CsA Combination Therapy (for the first 12 months post-transplantation): One loading dose of up to 15 mg on day 1, followed by daily maintenance doses of 5 mg ( 2.3 ). Lymphangioleiomyomatosis Patients: Administer once daily by mouth, consistently with or without food ( 2 ). Recommended initial sirolimus dose is 2 mg/day ( 2.4 ). Adjust the sirolimus dose to achieve sirolimus trough…
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 wound healing [ see Warnings and Precautions (5.6) ] Hypertriglyceridemia, hypercholesterolemia [ see Warnings and Precautions (5.7) ] Decline in renal function in long-term combination of cyclosporine with sirolimus [ see Warnings and Precautions (5.8) ] Proteinuria [ see Warnings and Precautions (5.9) ] Interstitial lung disease [ see Warnings and Precautions (5.11) ] Increased risk of calcineurin inhibitor-induced HUS/TTP/TMA [ see Warnings and Precautions (5.13) ]. Embryo-fetal toxicity [see Warnings and Precautions ( 5.15 )] Male infertility [see Warnings and Precautions ( 5.16 )] The most common (≥ 30%) adverse reactions observed with sirolimus in clinical studies for organ rejection…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 62/100 | Prescription | Solution | Generic | $49 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 1 | 0.5 mg | yellow | round | — |
| Y;7 | 0.5 mg | gray | round | — |
| Y;77 | 1 mg | white | round | — |
| Y;71 | 2 mg | yellow | round | — |
| RAPAMUNE;05;MG | 0.5 mg | brown | triangle | — |
| RAPAMUNE;1;MG | 1 mg | white |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Sirolimus oral solution is contraindicated in patients with a hypersensitivity to sirolimus [ see Warnings and Precautions (5.4) ]. Hypersensitivity to sirolimus ( 4 ).
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 ). 7.1 Use with Cyclosporine Cyclosporine, a substrate and inhibitor of CYP3A4 and P-gp, was demonstrated to increase sirolimus concentrations when co-administered with sirolimus. In order to diminish the effect of this interaction with cyclosporine, it is recommended that sirolimus be taken 4 hours after administration of cyclosporine oral solution (MODIFIED) and/or cyclosporine capsules (MODIFIED). If cyclosporine is withdrawn from combination therapy with sirolimus, higher doses of sirolimus are needed to maintain the recommended sirolimus trough concentration ranges [ see Dosage and Administration (2.2) , Clinical Pharmacology (12.3) ]. 7.2 Strong Inducers and Strong Inhibitors of CYP3A4 and P-gp Avoid concomitant use of sirolimus…
| Not yet rated |
| Prescription |
| Injectable |
| Generic |
| $49 |
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| 3 | Not yet rated | Prescription | Topical | Generic | $49 | View → |
| 4 | Not yet rated | Prescription | Solution | Generic | $49 | View → |
| triangle |
| — |
| RAPAMUNE;2;MG | 2 mg | yellow | triangle | — |
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