TACROLIMUS capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

tacrolimus (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J)

Доступна с:

Ingenus Pharmaceuticals, LLC

ИНН (Международная Имя):

tacrolimus

состав:

tacrolimus 0.5 mg

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

TACROLIMUS- TACROLIMUS CAPSULE
INGENUS PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TACROLIMUS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TACROLIMUS.
TACROLIMUS CAPSULES
INITIAL U.S. APPROVAL: 1994
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOX WARNING_
INCREASED RISK OF DEVELOPMENT OF LYMPHOMA AND OTHER MALIGNANCIES,
PARTICULARLY OF THE SKIN, DUE TO
IMMUNOSUPPRESSION (5.2)
INCREASED SUSCEPTIBILITY TO BACTERIAL, VIRAL, FUNGAL, AND PROTOZOAL
INFECTIONS, INCLUDING OPPORTUNISTIC
INFECTIONS (5.3, 5.4, 5.5)
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF ORGAN TRANSPLANT
PATIENTS SHOULD PRESCRIBE TACROLIMUS (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Use with CYP3A4 Inhibitors and Inducers
Including Those That Prolong QT (5.13) 07/2012
INDICATIONS AND USAGE
Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for
Prophylaxis of organ rejection in patients receiving allogeneic liver,
or kidney transplants (1.1, 1.2)
Use concomitantly with adrenal corticosteroids; in kidney transplant,
use in conjunction with azathioprine or
mycophenolate mofetil (MMF) (1.1, 1.2)
Limitations of Use (1.4):
Do not use simultaneously with cyclosporine
Intravenous use reserved for patients who can not tolerate capsules
orally
Use with sirolimus is not recommended in liver transplant; use with
sirolimus in kidney transplant has not been
e stablishe d
DOSAGE AND ADMINISTRATION
Summary of Initial Oral Dosage Recommendation and Observed Whole Blood
Trough Concentrations (2.1, 2.2).
PATIENT POPULATION
RECOMMENDED
INITIAL
ORAL
DOSAGE (TWO DIVIDED DOSES EVERY
12 HOURS)
OBSERVED WHOLE BLOOD
TROUGH CONCENTRATIONS
Adult Kidney
transplant
In
combination
with
azathioprine
In combination with MMF/IL-2
receptor antagonist
0.2 mg/kg/day
0.1 mg/kg/day
month 1 to 3: 7 to 20 ng/mL
month 4 to 12: 5 to 15 ng/mL
month 1 to 12: 4 to 11 ng/mL
Adult Liver trans