Generic equivalent of Sirolimus
5 SKUs available · Available to order · NABP accredited · DSCSA compliant
Sirolimus is the generic equivalent of the brand-name drug Sirolimus. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Sirolimus through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE 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 to 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 lymphangioleiomyom…
6 ADVERSE REACTIONS 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) ] Hypersen…
7 DRUG INTERACTIONS 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 consider…
2 DOSAGE AND ADMINISTRATION Sirolimus tablets are to be administered orally once daily, consistently with or without food [see Dosage and Administration ( 2.5 ), Clinical Pharmacology (12.3) ]. Tablets should not be crushed, chewed or split. Patients unable to take the tablets should be prescribed the solution and instructed in its use. Renal Transplant Patients: • Administer once daily by mouth, consistently with or without food (2) . • Administer the initial dose as soon as possible after tran…
17 PATIENT COUNSELING INFORMATION Advise patients, their families, and their caregivers to read the Medication Guide and assist them in understanding its contents. The complete text of the Medication Guide is reprinted at the end of the document. See FDA-Approved Medication Guide. 17.1 Dosage Patients should be given complete dosage instructions [see FDA-Approved Medication Guide ]. 17.2 Skin Cancer Events Advise patients that exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a broad spectrum sunscreen with a high protection factor becau…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| SIROLIMUS 0.5MG 100 TAB | 2-Day |
| SIROLIMUS 1MG 100 TAB | 2-Day |
| SIROLIMUS TABS 1 MG 100CT | 2-Day |
| 67877-0748-01 | 2-Day |
| SIROLIMUS TABS 2 MG 100CT | 2-Day |
Premier Pharma stocks 5 Sirolimus SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Sirolimus is the generic equivalent of Sirolimus. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Sirolimus in .5 mg/1, 1 mg/1, 2 mg/1 and TABLET, TABLET, FILM COATED.
Sirolimus carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
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