SIROLIMUS tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Zydus Pharmaceuticals USA Inc.

INN (Nama Antarabangsa):

SIROLIMUS

Komposisi:

SIROLIMUS 0.5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see Dosage and Administration (2.2) ].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

Ringkasan produk:

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. The expiration date refers to the last day of that month. Sirolimus Tablets, 0.5 mg are yellow, round, biconvex, coated tablets debossed with "1" in on one side and plain on other side and are supplied as follows: NDC 68382-520-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-520-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-520-01 in bottle of 100 tablets with child-resistant closure. NDC 68382-520-05 in bottle of 500 tablets NDC 68382-520-10 in bottle of 1000 tablets NDC 68382-520-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Sirolimus Tablets, 1 mg are white to off-white, round, biconvex, film-coated tablets debossed with 11 on one side and plain on other side and are supplied as follows: NDC 68382-351-01 in bottle of 100 tablets with child-resistant closure. NDC 68382-351-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Sirolimus Tablets, 2 mg are yellow, round, biconvex, coated tablets, debossed with 21 on one side and plain on other side and are supplied as follows: NDC 68382-352-01 in bottle of 100 tablets with child-resistant closure. NDC 68382-352-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage Store at 20°C to 25°C (68F° to 77°F) [See 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.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Zydus Pharmaceuticals USA Inc.
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SPL MEDGUIDE
MEDICATION GUIDE
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.
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 siroli

Ciri produk

SIROLIMUS- SIROLIMUS TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
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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 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).
Sirolimus is an mTOR inhibitor indicated for the treatment of patients
with lymphangioleiomyomatosis
(1.3).
DOSAGE AND ADMINISTRATION
Renal Transplant Patients:
Adm