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Sirolimus tablets are indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. Therapeutic drug monitoring is recommended for all patients receiving sirolimus [see DOSAGE AND ADMINISTRATION (2.3), WARNINGS AND PRECAUTIONS (5.15)].
In patients at low- to moderate-immunologic risk, it is recommended that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see DOSAGE AND ADMINISTRATION (2.1)].
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 tablets be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see DOSAGE AND ADMINISTRATION (2.2), CLINICAL STUDIES (14.3)].
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 [see CLINICAL STUDIES (14.2)].
In patients at high-immunologic risk, the safety and efficacy of sirolimus tablets 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 [see CLINICAL STUDIES (14.3)].
In pediatric patients, the safety and efficacy of sirolimus tablets have not been established in patients < 13 years old, or in pediatric (< 18 years) renal transplant patients considered at high-immunologic risk [see ADVERSE REACTIONS (6.5), CLINICAL STUDIES (14.6)]. The safety and efficacy of de novo use of sirolimus tablets without cyclosporine have not been established in renal transplant patients [see WARNINGS AND PRECAUTIONS (5.12)].
The safety and efficacy of conversion from calcineurin inhibitors to sirolimus tablets in maintenance renal transplant patients have not been established [see CLINICAL STUDIES (14.4)].
There is currently no drug history available for this drug.
Sirolimus is an immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2- [(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26- hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 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 insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile.
Each sirolimus tablet intended for oral administration contains 0.5 mg of sirolimus. In addition, each tablet contains the following inactive ingredients: citric acid monohydrate, crospovidone, FD&C yellow #5 Aluminium Lake, glyceryl monooleate, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, poloxamer, polyethylene glycol, povidone, sucrose, talc, titanium dioxide and vitamin E acetate.