देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
MARAVIROC (UNII: MD6P741W8A) (MARAVIROC - UNII:MD6P741W8A)
Camber Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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 case reports are not suffi
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 31722-579-60) 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 31722-580-60) Maraviroc film-coated tablets should be stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
MARAVIROC - MARAVIROC TABLET, FILM COATED CAMBER PHARMACEUTICALS, INC. ---------- 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 drug पूरा दस्तावेज़ पढ़ें