Selzentry approved for pediatric use
On Friday November 4, 2016, FDA approved Selzentry (maraviroc) 20 mg/mL oral solution, Selzentry (maraviroc) 25 mg and 75 mg tablets and updated the label to include use in pediatric patients 2 years of age and older weighing at least 10 kg. The major changes to the label are summarized below.
INDICATIONS AND USAGE
SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5 tropic human immunodeficiency virus type 1 (HIV 1) infection in patients 2 years of age and older weighing at least 10 kg.
Limitations of Use:
- SELZENTRY is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1
DOSAGE AND ADMINISTRATION
Testing prior to Initiation of SELZENTRY
Prior to initiation of SELZENTRY, test all patients for CCR5 tropism using a highly sensitive tropism assay. SELZENTRY is recommended for patients with only CCR5-tropic HIV-1 infection. Outgrowth of pre-existing low-level CXCR4- or dual/mixed tropic HIV 1 not detected by tropism testing at screening has been associated with virologic failure on SELZENTRY.
Monitor patients for ALT, AST, and bilirubin prior to initiation of SELZENTRY and at other time points during treatment as clinically indicated.