SIROLIMUS- sirolimus tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

American Health Packaging

INN (International Name):

SIROLIMUS

Sammensetning:

SIROLIMUS 0.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see Dosage and Administration ( 2.2)].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

Produkt oppsummering:

Since sirolimus is not absorbed through the skin, there are no special precautions. However, if direct contact occurs with the skin or eyes, wash skin thoroughly with soap and water; rinse eyes with plain water. Do not use Sirolimus Tablets after the expiration date that is located on the blister. The expiration date refers to the last day of that month. Sirolimus Tablets, 0.5 mg are yellow, round, biconvex, coated tablets imprinted with "1" in black ink on one side and plain on other side and are supplied as follows: Unit dose packages of 30 (5 x 6) NDC 68084-956-25 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Use cartons to protect blister cards from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

American Health Packaging
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MEDICATION GUIDE
8295621/0818F
Sirolimus
(sir-OH-li-mus)
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 "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.
Who should not take sirolimus?
Do not take sirolimus if you are allergic to sirolimus or any of the
other ingredients in sirolimus. See the
end of this leaflet for a complete list of ingredients in siro

Preparatomtale

SIROLIMUS- SIROLIMUS TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
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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, Embryo-Fetal Toxicity ( 5.15) 1/2018
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 months 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).
DOSAGE AND ADMINISTRATION
Renal Transplant Patients
Administer once daily by mouth, consistently with or without food (
2).
Administer the initial dose as soon as possible afte