SIROLIMUS tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Ascend Laboratories, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see Dosage and Administration (2.2)].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

Resumen del producto:

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. 

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Ascend Laboratories, LLC
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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

Fitxa tècnica

SIROLIMUS - SIROLIMUS TABLET
ASCEND LABORATORIES, LLC
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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:
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