SIROLIMUS - sirolimus solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

SIROLIMUS (UNII: W36ZG6FT64) (SIROLIMUS - UNII:W36ZG6FT64)

Saadav alates:

Novitium Pharma LLC

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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Sirolimus Oral Solution be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see Dosage and Administration (2.2)].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 been studied in patients with Banff Grade  3 acute rejection or   vascular rejection prior to cyclosporine

Toote kokkuvõte:

Since sirolimus 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 that is located on the carton. The expiration date refers to the last day of that month.   Sirolimus Oral Solution is a yellow colored solution. Each Sirolimus Oral Solution carton, NDC 70954-075-10, 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°C to 8°C (36°F to 46°F). Once the bottle is opened, the contents should be used within one month. If necessary, the patient may store the bottles at room temperatures up to 25°C (77°F) 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 up to 25°C (77°F) 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.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

SIROLIMUS - SIROLIMUS SOLUTION
NOVITIUM PHARMA LLC
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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).
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity (5.15) 4/2019
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). (1)
DOSAGE AND ADMINISTRATION
Renal Transplant Patients: (2)
Administer once daily by mouth, consistently with or without food (2).
Administer the initial dose as soon as possible afte