Maraviroc (SELZENTRY®)

Usual Dosing (Adults)

INDICATIONS AND USAGE
SELZENTRY, in combination with other antiretroviral agents, is indicated for adult patients infected with only CCR5-tropic HIV-1.

This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of SELZENTRY in treatment-experienced subjects and one study in treatment-naïve subjects. Both studies in treatment-experienced subjects were conducted in clinically advanced, 3-class antiretroviral-experienced (NRTI, NNRTI, PI, or enfuvirtide) adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The following points should be considered when initiating therapy with SELZENTRY: Adult patients infected with only CCR5-tropic HIV-1 should use SELZENTRY. Tropism testing must be conducted with a highly sensitive tropism assay that has demonstrated the ability to identify patients appropriate for SELZENTRY use. 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. Use of SELZENTRY is not recommended in subjects with dual/mixed or CXCR4-tropic HIV-1 as efficacy was not demonstrated in a phase 2 study of this patient group. The safety and efficacy of SELZENTRY have not been established in pediatric patients. In treatment-naïve subjects, more subjects treated with SELZENTRY experienced virologic failure and developed lamivudine resistance compared to efavirenz.
DOSAGE AND ADMINISTRATION
Dose Recommendations for Patients with Normal Renal Function:
The recommended dose of SELZENTRY differs based on concomitant medications due to drug interactions (see Table 1). SELZENTRY can be taken with or without food. SELZENTRY must be given in combination with other antiretroviral medications. Table 1 gives the recommended dose adjustments.

Table 1 Recommended Dosing Regimen

Concomitant Medications	SELZENTRY Dose
Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including: protease inhibitors (except tipranavir/ritonavir) delavirdine ketoconazole, itraconazole, clarithromycin other potent CYP3A inhibitors (e.g., nefazodone, telithromycin)	150 mg twice daily
Other concomitant medications, including tipranavir/ritonavir, nevirapine, raltegravir all NRTIs and enfuvirtide	300 mg twice daily
Potent CYP3A inducers (without a potent CYP3A inhibitor) including: efavirenz rifampin etravirine carbamazepine, phenobarbital, and phenytoin	600 mg twice daily

Renal Dosing

Dose Recommendations for Patients with Renal Impairment

Table 2 provides dosing recommendations for patients based on renal function and concomitant medications.

Table 2 Recommended Dosing Regimens Based on Renal Function

Concomitant Medications*	SELZENTRY Dose Based on Renal Function
	Normal	Mild	Moderate	Severe	End Stage Renal Disease (ESRD)
	CrCl >80 mL/min	CrCl >50 and ≤80 mL/min	CrCl ≥30 and ≤50 mL/min	CrCl <30 mL/min	On Regular Hemo-dialysis
Potent CYP3A inhibitors (with or without a CYP3A inducer)*	150 mg twice daily	150 mg twice daily	150 mg twice daily	NR	NR
Other concomitant medications*	300 mg twice daily	300 mg twice daily	300 mg twice daily	300 mg twice daily^	300 mg twice daily^
Potent CYP3A inducers (without a potent CYP3A inhibitor)*	600 mg twice daily	600 mg twice daily	600 mg twice daily	NR	NR
*See Table 1 for the list of concomitant medications. ^The SELZENTRY dose should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension. NR = not recommended

Hemodialysis

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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