País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
SIROLIMUS (UNII: W36ZG6FT64) (SIROLIMUS - UNII:W36ZG6FT64)
Torrent pharmaceuticals limited
ORAL
PRESCRIPTION DRUG
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sirolimus oral solution be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see Dosage and Administration ( 2.2)] .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 oral solution 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 be
Since sirolimus oral solution is not absorbed through the skin, there are no special precautions. However, if direct contact of the oral solution occurs with the skin or eyes, wash skin thoroughly with soap and water; rinse eyes with plain water. Do not use sirolimus oral solution after the expiration date. The expiration date refers to the last day of that month. Each Sirolimus Oral Solution carton, NDC 13668-658-87, contains one 2 oz (60 mL fill) amber glass bottle of sirolimus (concentration of 1 mg/mL), one oral syringe adapter for fitting into the neck of the bottle, sufficient disposable amber oral syringes and caps for daily dosing, and a carrying case. Sirolimus oral solution bottles should be stored protected from light and refrigerated at 2 o C to 8 o C (36 o F to 46 o F). Once the bottle is opened, the contents should be used within one month. If necessary, the patient may store the bottles at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature] for a short period of time (e.g. not more than 15 days for the bottles). An amber syringe and cap are provided for dosing, and the product may be kept in the syringe for a maximum of 24 hours at room temperatures at 20 o to 25°C (68 o to 77°F) [see USP Controlled Room Temperature] or refrigerated at 2°C to 8°C (36°F to 46°F). The syringe should be discarded after one use. After dilution, the preparation should be used immediately. Sirolimus oral solution provided in bottles may develop a slight haze when refrigerated. If such a haze occurs, allow the product to stand at room temperature and shake gently until the haze disappears. The presence of this haze does not affect the quality of the product.
Abbreviated New Drug Application
Torrent pharmaceuticals limited ---------- MEDICATION GUIDE Sirolimus (sir oh’ li mus ) Oral Solution What is the most important information I should know about sirolimus oral solution? Sirolimus oral solution 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 oral solution. 2. Increased risk of getting certain cancers. People who take sirolimus oral solution have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Talk with your doctor about your risk for cancer. Sirolimus oral solution 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 oral solution after a liver or lung transplant. You should not take sirolimus oral solution 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 oral solution?” for information about other side effects of sirolimus oral solution. What is sirolimus oral solution? Sirolimus oral solution 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 oral solution is used with other medicines called cyclosporine (Gengraf, Neoral, Sandimmune), and corticosteroids. Your doctor will decide: • if sirolimus oral solution is right for you, and • how to best use it with cyclosporine and corticosteroids after your transplant. It is not known if sirolimus oral solution is safe and effective in children under 13 years of age. Who sh Leia o documento completo
SIROLIMUS- SIROLIMUS SOLUTION TORRENT PHARMACEUTICALS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SIROLIMUS ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIROLIMUS ORAL SOLUTION. SIROLIMUS ORAL SOLUTION 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). INDICATIONS AND USAGE Sirolimus oral solution 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 recommended2 to 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). DOSAGE AND ADMINISTRATION 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 Leia o documento completo