Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
SIROLIMUS (UNII: W36ZG6FT64) (SIROLIMUS - UNII:W36ZG6FT64)
Ascend Laboratories, LLC
ORAL
PRESCRIPTION DRUG
Sirolimus 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that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see Dosage and Administration (2.2)]. 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 (2.3), 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 dial
Since sirolimus tablet is not absorbed through the skin, there are no special precautions. Do not use sirolimus tablets after the expiration date. The expiration date refers to the last day of that month. Sirolimus tablets are available as follows: Sirolimus tablets should be stored at 20°C to 25°C (68°F to 77°F) [USP Controlled Room Temperature] . Use cartons to protect blister cards and strips from light. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
Ascend Laboratories, LLC ---------- MEDICATION GUIDE Sirolimus (sir OH li mus) Tablets What is the most important information I should know about sirolimus tablets? Sirolimus tablets can cause serious side effects, including: 1. Increased risk of getting infections. Serious infections can happen including infections caused by viruses, bacteria, and fungi (yeast). Your doctor may put you on medicine to help prevent some of these infections. Call your doctor right away if you have symptoms of infection including fever or chills while taking sirolimus tablets. 2. Increased risk of getting certain cancers. People who take sirolimus have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Talk with your doctor about your risk for cancer. Sirolimus tablets has not been shown to be safe and effective in people who have had liver or lung transplants. Serious complications and death may happen in people who take sirolimus tablets after a liver or lung transplant. You should not take sirolimus tablets if you have had a liver or lung transplant without talking with your doctor. See the section “What are the possible side effects of sirolimus?” for information about other side effects of sirolimus. What is sirolimus tablet? Sirolimus tablet is a prescription medicine used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant. Rejection is when your body’s immune system recognizes the new organ as a “foreign” threat and attacks it. Sirolimus tablet is used with other medicines called cyclosporine (Gengraf, Neoral, Sandimmune), and corticosteroids. Your doctor will decide: • if sirolimus is right for you, and • how to best use it with cyclosporine and corticosteroids after your transplant. It is not known if sirolimus tablet is safe and effective in children under 13 years of age. Sirolimus tablet is a prescription medicine also used to treat lymphangioleiomyomatosis (LAM). LAM is a rare progressive lung disease that affe Les hele dokumentet
SIROLIMUS - SIROLIMUS TABLET ASCEND LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SIROLIMUS TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIROLIMUS TABLETS. SIROLIMUS TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1999 WARNING: IMMUNOSUPPRESSION, USE IS NOT RECOMMENDED IN LIVER OR LUNG TRANSPLANT PATIENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF LYMPHOMA AND OTHER MALIGNANCIES MAY RESULT FROM IMMUNOSUPPRESSION (5.1). ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND MANAGEMENT OF RENAL TRANSPLANT PATIENTS SHOULD USE SIROLIMUS FOR PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS RECEIVING RENAL TRANSPLANTS. • THE SAFETY AND EFFICACY OF SIROLIMUS AS IMMUNOSUPPRESSIVE THERAPY HAVE NOT BEEN ESTABLISHED IN LIVER OR LUNG TRANSPLANT PATIENTS, AND THEREFORE, SUCH USE IS NOT RECOMMENDED (5.2, 5.3). -LIVER TRANSPLANTATION – EXCESS MORTALITY, GRAFT LOSS, AND HEPATIC ARTERY THROMBOSIS (5.2). -LUNG TRANSPLANTATION – BRONCHIAL ANASTOMOTIC DEHISCENCE (5.3). RECENT MAJOR CHANGES Warnings and Precautions, Cannabidiol Drug Interactions (5.21) 8/2022 INDICATIONS AND USAGE • Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o 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 tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3). DOSAGE AND ADMINISTRATION Renal Transplant Patients: Les hele dokumentet