SIROLIMUS tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Major Pharmaceuticals

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see Dosage and Administration (2.2) ].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

Resumen del producto:

Since sirolimus 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:

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

SIROLIMUS- SIROLIMUS TABLET, FILM COATED
Major Pharmaceuticals
----------
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
tablets 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 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
tablets?" for information about other side
effects of sirolimus tablets.
What is sirolimus tablets?
Sirolimus tablets are 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 tablets are used with other medicines called cyclosporine
(Gengraf, Neoral, Sandimmune), and
corticosteroids. Your doctor will decide:
•
if sirolimus tablets are right for you, and
•
how to best use it with cyclosporine and corticosteroids after your
transplant.
It is not known if sirolimus tablets are safe and effective in
children under 13 years of age.
Who should not take sirolimus tablets?
Do not take sirolimus tablets if you are allergic

Fitxa tècnica

SIROLIMUS- SIROLIMUS TABLET, FILM COATED
MAJOR PHARMACEUTICALS
----------
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._
•
•
•
•
INDICATIONS AND USAGE
Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated
for the prophylaxis of organ
rejection in patients aged ≥13 years receiving renal transplants:
•
•
DOSAGE AND ADMINISTRATION
Renal Transplant Patients:
•
•
•
•
_In renal transplant patients at low-to moderate-immunologic risk:_
•
•
_In renal transplant patients at high-immunologic risk:_
•
Therapeutic drug monitoring is recommended for all patients (2.5,
5.17).
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Hypersensitivity to sirolimus tablets (4).
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
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).
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 w