SIROLIMUS solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Greenstone LLC

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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recommended that sirolimus be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see Dosage and Administration (2.2) ].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 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 dialysis-dependent, those

उत्पाद समीक्षा:

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 after the expiration date. The expiration date refers to the last day of that month. Each sirolimus oral solution carton, NDC 59762-1205-6, 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 oral syringes (amber color) 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). A syringe (amber color) 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.

प्राधिकरण का दर्जा:

New Drug Application Authorized Generic

सूचना पत्रक

Greenstone LLC
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: Aug 2022
MEDICATION GUIDE
Sirolimus Oral Solution
What is the most important information I should know about sirolimus?
Sirolimus can cause serious side effects, including:
•
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.
•
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 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 after a liver or lung
transplant. You should not take sirolimus 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?
Sirolimus 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 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 is safe and effective in children under
13 years of age.
Sirolimus is a prescription medicine also used to treat
lymphangioleiomyomatosis (LAM). LAM is a rare
progressive lung disease that affects predomi

उत्पाद विशेषताएं

SIROLIMUS- SIROLIMUS SOLUTION
GREENSTONE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIROLIMUS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIROLIMUS.
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._
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Cannabidiol Drug Interactions (5.21)
8/2022
INDICATIONS AND USAGE
Sirolimus is an mTOR inhibitor immunosuppressant indicated for the
prophylaxis of organ rejection in
patients aged ≥13 years receiving renal transplants:
•
•
Sirolimus is an mTOR inhibitor indicated for the treatment of patients
with lymphangioleiomyomatosis
(1.3).
DOSAGE AND ADMINISTRATION
Renal Transplant Patients:
•
•
•
•
_In renal transplant patients at low- to moderate-immunologic risk:_
•
•
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).
o
o
LIVER TRANSPLANTATION – EXCESS MORTALITY, GRAFT LOSS, AND HEPATIC
ARTERY
THROMBOSIS (5.2).
LUNG TRANSPLANTATION – BRONCHIAL ANASTOMOTIC DEHISCENCE (5.3).
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).
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 establi