SIROLIMUS tablet, sugar coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Greenstone LLC

INN (International Name):

SIROLIMUS

Sammensetning:

SIROLIMUS 0.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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that sirolimus be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see Dosage and Administration (2.2) ].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

Produkt oppsummering:

Since sirolimus is not absorbed through the skin, there are no special precautions. Do not use sirolimus 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 [USP Controlled Room Temperature] (68°F to 77°F). Dispense in a tight, light-resistant container as defined in the USP.

Autorisasjon status:

New Drug Application Authorized Generic

Informasjon til brukeren

Greenstone LLC
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MEDICATION GUIDE
Sirolimus Tablets
What is the most important information I should know about sirolimus?
Sirolimus 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.
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 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 "Error! Hyperlink reference not valid." 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 predominantly women of
childbearing age.
Who should not take sirolimus?
Do not take sirolimus if you are allergic to sirolimus

Preparatomtale

SIROLIMUS- SIROLIMUS TABLET, SUGAR COATED
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 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._
•
•
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