SELZENTRY, in combination with other antiretroviral agents, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable, who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of SELZENTRY of 24 weeks duration. Both studies were conducted in clinically advanced, 3-class antiretroviral (NRTI, NNRTI, PI, or enfuvirtide) treatment-experienced adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The following points should be considered when initiating therapy with SELZENTRY:

• Tropism testing and treatment history should guide the use of SELZENTRY.
• Use of SELZENTRY is not recommended in patients 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 treatment-naïve adult patients or pediatric patients.

There are no study results demonstrating the effect of SELZENTRY on clinical progression of HIV-1.

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 [see DRUG INTERACTIONS].

Table 1 Recommended Dosing Regimen

Dosage Forms And Strengths

• 150 mg blue, oval film coated tablets debossed with “Pfizer” on one side and “MVC 150” on the other
• 300 mg blue, oval film coated tablets debossed with “Pfizer” on one side and “MVC 300” on the other

Storage and handling

SELZENTRY film-coated tablets are available as follows:

150 and 300 mg tablets are blue, biconvex, oval film-coated tablets debossed with “Pfizer” on one side and “MVC 150” or “MVC 300” on the other.

Bottle packs 150 mg tablets

• 60 tablets (NDC 0069-0807-60)

Bottle packs 300 mg tablets

• 60 tablets (NDC 0069-0808-60)

SELZENTRY film-coated tablets should be stored at 25oC (77oF); excursions permitted between 15o and 30oC (59o-86oF) [see USP Controlled Room Temperature].

Shelf life is 24 months.

Distributed by Pfizer Labs., Division of Pfizer Inc, NY, NY 10017. FDA rev date: 8/6/2007

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