MARAVIROC- 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:

XLCare Pharmaceuticals Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Maraviroc tablets are indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients 2 years of age and older weighing at least 10 kg. Limitations of Use: • Maraviroc tablets are not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 [see Microbiology ( 12.4)]. Maraviroc tablets are contraindicated in patients with severe renal impairment or ESRD (CrCl less than 30 mL per minute) who are concomitantly taking potent CYP3A inhibitors or inducers [see Warnings and Precautions ( 5.3)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to maraviroc during pregnancy. Physicians are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Limited data on the use of maraviroc during pregnancy from the APR and

Descriptif du produit:

Maraviroc film-coated tablets are available as follows: 150 mg white to off-white colored, oval, biconvex, film coated tablets debossed with 'J' on one side and '62' on the other side. Bottle of 60 tablets                                               (NDC 72865-231-60 ) 300 mg white to off-white colored, oval, biconvex, film coated tablets debossed with 'J' on one side and '63' on the other side. Bottle of 60 tablets                                               (NDC 72865-232-60) Maraviroc film-coated tablets should be stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

MARAVIROC - MARAVIROC TABLET, FILM COATED
XLCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MARAVIROC TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MARAVIROC
TABLETS.
MARAVIROC TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
WARNING: HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• HEPATOTOXICITY HAS BEEN REPORTED WHICH MAY BE PRECEDED BY SEVERE
RASH OR OTHER
FEATURES OF A SYSTEMIC ALLERGIC REACTION (E.G., FEVER, EOSINOPHILIA,
OR ELEVATED IGE). (
5.1)
• IMMEDIATELY EVALUATE PATIENTS WITH SIGNS OR SYMPTOMS OF HEPATITIS
OR ALLERGIC
REACTION. ( 5.1)
INDICATIONS AND USAGE
Maraviroc tablet is a CCR5 co-receptor antagonist indicated in
combination with other antiretroviral agents
for the treatment of only CCR5-tropic HIV-1 infection in adults and
pediatric patients 2 years of age and
older weighing at least 10 kg. ( 1)
Limitations of Use:
• Not recommended in patients with dual/mixed- or CXCR4-tropic
HIV-1. ( 1)
DOSAGE AND ADMINISTRATION
• Prior to initiation of maraviroc tablets for treatment of HIV-1
infection, test all patients for CCR5 tropism
using a highly sensitive tropism assay. ( 2.1)
• Maraviroc tablets are taken twice daily by mouth and may be taken
with or without food. Maraviroc
tablets must be given in combination with other antiretroviral
medications. ( 2.2)
Recommended Dosage in Adult Patients: ( 2.3)
Concomitant Medications
Dosage of Maraviroc
tablets
When given with potent cytochrome P450 (CYP)3A inhibitors (with or
without potent
CYP3A inducers) including PIs (except tipranavir/ritonavir) ( 2.3,
7.1)
150 mg
twice daily
With NRTIs, tipranavir/ritonavir, nevirapine, raltegravir, and other
drugs that are not
potent CYP3A inhibitors or CYP3A inducers ( 2.3, 7.1)
300 mg
twice daily
With potent and moderate CYP3A inducers including efavirenz (without a
potent
CYP3A inhibitor) ( 2.3, 7.1)
600 mg
twice daily
A more complete list of coadministered drugs