maraviroc
Drug Details
- Generic Name
- maraviroc
- Brand Names
- SELZENTRY
- Application Number
- NDA022128
- Sponsor
- ViiV Healthcare Company
- NDC Codes
- 4
- Dosage Forms
- TABLET, FILM COATED, KIT
- Routes
- ORAL
- Active Ingredients
- MARAVIROC
Indications and Usage
1 INDICATIONS AND USAGE 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 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 )