SELZENTRY maraviroc tablet film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Maraviroc (UNII: MD6P741W8A) (Maraviroc - UNII:MD6P741W8A)

Disponible depuis:

Pfizer Laboratories Div Pfizer Inc

DCI (Dénomination commune internationale):

Maraviroc

Composition:

Maraviroc 150 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

SELZENTRY- MARAVIROC TABLET, FILM COATED
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SELZENTRY SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SELZENTRY.
SELZENTRY (MARAVIROC) TABLETS
INITIAL U.S. APPROVAL: 2007
WARNING: HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
HEPATOTOXICITY HAS BEEN REPORTED WHICH MAY BE PRECEDED BY EVIDENCE OF
A SYSTEMIC ALLERGIC REACTION
(E.G., PRURITIC RASH, EOSINOPHILIA OR ELEVATED IGE).
IMMEDIATELY EVALUATE PATIENTS WITH SIGNS OR SYMPTOMS OF HEPATITIS OR
ALLERGIC REACTION. (5.1)
RECENT MAJOR CHANGES
Indication and Usage (1)
11/2009
Dosage and Administration (2.2)
05/2010
Contraindications (4)
05/2010
Warnings and Precautions (5.2)
05/2010
Warnings and Precautions (5.1), (5.2), (5.4), (5.5)
11/2009
INDICATIONS AND USAGE
SELZENTRY is a CCR5 co-receptor antagonist indicated for combination
antiretroviral treatment of adults infected with
only CCR5-tropic HIV-1.
In treatment-naïve subjects, more subjects treated with SELZENTRY
experienced virologic failure and developed
lamivudine resistance compared to efavirenz [see _Microbiology (12.4)
Clinical Studies (14.3)_].
Tropism testing with a highly sensitive tropism assay is required for
the appropriate use of SELZENTRY (1).
DOSAGE AND ADMINISTRATION
When given with potent CYP3A inhibitors (with or without potent
CYP3A inducers) including PIs (except tipranavir/ritonavir),
delavirdine (2, 7.1)
150 mg twice
daily
With NRTIs, tipranavir/ritonavir, nevirapine, raltegravir, and other
drugs that are not potent CYP3A inhibitors or CYP3A inducers (2,
7.1)
300 mg twice
daily
With potent CYP3A inducers including efavirenz (without a potent
CYP3A inhibitor) (2, 7.1)
600 mg twice
daily
A more complete list of coadministered drugs is listed in _Dosage and
Administration (2)._
Dose adjustment may be necessary in patients with renal impairment.
(2.2).
DOSAGE FORMS AND STRENGTHS
Tablets: 150 mg and 300 mg (3)