Sirolimusdrug info
sirolimus 1 MG/ML Oral Solution
What it is used for
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.
Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation. Safety and efficacy of CsA withdrawal has not been established in high risk patients. Sirolimus is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis.
1.1 Prophylaxis of
Organ Rejection in Renal Transplantation Sirolimus Oral Solution is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. In patients at low-to moderate-immunologic risk, it is recommended that Sirolimus Oral Solution be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation. In patients at high-immunologic risk (defined as Black 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 Sirolimus Oral Solution be used in combination with cyclosporine and corticosteroids for the first year following transplantation.
1.2 Limitations of
Use in Renal Transplantation Cyclosporine withdrawal has not been studied in patients with Banff Grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, those with serum creatinine > 4.5 mg/dL, Black patients, patients of multi-organ transplants, secondary transplants, or those with high levels of panel-reactive antibodies. In patients at high-immunologic risk, the safety and efficacy of Sirolimus Oral Solution used in combination with cyclosporine and corticosteroids has not been studied beyond one year; therefore after the first 12 months following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient. In pediatric patients, the safety and efficacy of Sirolimus Oral Solution have not been established in patients < 13 years old, or in pediatric (< 18 years) renal transplant patients considered at high-immunologic risk. The safety and efficacy of de novo use of Sirolimus Oral Solution without cyclosporine have not been established in renal transplant patients. The safety and efficacy of conversion from calcineurin inhibitors to Sirolimus Oral Solution in maintenance renal transplant patients have not been established.
1.3 Treatment of
Patients with Lymphangioleiomyomatosis Sirolimus is indicated for the treatment of patients with lymphangioleiomyomatosis (LAM).
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective April 30, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3 S,6 R,7 E,9 R,10 R,12 R,14 S,15 E,17 E,19 E,21 S, 23 S,26 R,27 R, 34a S )-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a hexadecahydro-9,27-dihydroxy-3-[(1 R )-2-[(1 S,3 R,4 R )-4-hydroxy-3- methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27 epoxy-3 H -pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4 H,6 H,31 H )-pentone. Its molecular formula is C 51 H 79 NO 13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is practically insoluble in water, but freely soluble in acetone, dimethyl sulfoxide and methanol. Sirolimus is available for administration as an oral solution containing 1 mg/mL sirolimus. The inactive ingredients in Sirolimus Oral Solution are Phosal® 50 PG (alcohol, ascorbyl palmitate, phosphatidylcholine, propylene glycol, soy acid, soy lecithin, sunflower seed oil glyceride, and tocopherol) and polysorbate 80. Sirolimus Oral Solution contains 1.5% - 2.5% ethanol. structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective April 30, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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