MYFORTIC mycophenolic acid tablet delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

MYCOPHENOLATE SODIUM (UNII: WX877SQI1G) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)

Commercializzato da:

Avera McKennan Hospital

INN (Nome Internazionale):

MYCOPHENOLATE SODIUM

Composizione:

MYCOPHENOLIC ACID 180 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

MYFORTIC- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYFORTIC SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MYFORTIC.
MYFORTIC?? (MYCOPHENOLIC ACID) DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
USE DURING PREGNANCY IS ASSOCIATED WITH INCREASED RISKS OF PREGNANCY
LOSS AND CONGENITAL
MALFORMATIONS. FEMALES OF REPRODUCTIVE POTENTIAL MUST BE COUNSELED
REGARDING PREGNANCY
PREVENTION AND PLANNING. (5.1, 8.1, 8.6)
INCREASED RISK OF DEVELOPMENT OF LYMPHOMA AND OTHER MALIGNANCIES,
PARTICULARLY OF THE SKIN, DUE TO
IMMUNOSUPPRESSION. (5.4)
INCREASED SUSCEPTIBILITY TO BACTERIAL, VIRAL, FUNGAL, AND PROTOZOAL
INFECTIONS, INCLUDING OPPORTUNISTIC
INFECTIONS. (5.5, 5.6)
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF ORGAN TRANSPLANT
PATIENTS SHOULD PRESCRIBE MYFORTIC. (5.3)
RECENT MAJOR CHANGES
Warnings and Precautions, Embryofetal Toxicity (5.1)
10/2015
INDICATIONS AND USAGE
Myfortic is an antimetabolite immunosuppressant indicated for
prophylaxis of organ rejection in adult patients receiving
kidney transplants and in pediatric patients at least 5 years of age
and older who are at least 6 months post kidney
transplant. (1.1)
Use in combination with cyclosporine and corticosteroids. (1.1)
Limitations of Use:
Myfortic delayed release tablets and mycophenolate mofetil tablets and
capsules should not be used interchangeably.
(1.2)
DOSAGE AND ADMINISTRATION
In adults: 720 mg by mouth, twice daily (1440 mg total daily dose) on
an empty stomach, 1 hour before or 2 hours after
food intake. (2.1)
In children: 5 years of age and older (who are at least 6 months post
kidney transplant), 400 mg/m by mouth, twice
daily (up to a maximum of 720 mg twice daily). (2.2)
Do not crush, chew, or cut tablet prior to ingesti