Rx Item-Selzentry 150Mg Tab 60 By Viiv Healthcare

SELZENTRY- maraviroc tablet, film coated.

WARNING: HEPATOTOXICITY

Hepatotoxicity has been reported with use of SELZENTRY�. Severe rash or evidence of a systemic allergic reaction (e.g., fever, eosinophilia, or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of SELZENTRY should be evaluated immediately [see Warnings and Precautions (5.1)].
1 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 2 controlled trials of SELZENTRY in treatment‑experienced subjects and one trial in treatment‑naive subjects. Both trials in treatment-experienced subjects were conducted in clinically advanced, 3-class antiretroviral‑experienced (nucleoside reverse transcriptase inhibitor [NRTI], non-nucleoside reverse transcriptase inhibitor [NNRTI], protease inhibitor [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 on a current sample with a highly sensitive tropism assay that has demonstrated the ability to identify patients appropriate for use of SELZENTRY. 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 [see Microbiology (12.4), Clinical Studies (14.3)].
�
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 trial of this patient group.
�
The safety and efficacy of SELZENTRY have not been established in pediatric patients.
�
In treatment-naive subjects, more subjects treated with SELZENTRY experienced virologic failure and developed lamivudine resistance compared with efavirenz [see Microbiology (12.4), Clinical Studies (14.3)].

2 DOSAGE AND ADMINISTRATION
2.1 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.

RX ITEM-Selzentry 150Mg Tab 60 By Viiv H
NDC 49702-0223-18 UPC/GTIN No.3-49702-22318-9 Mfg.Part No.22318 MVC 150 tablet , film-coated , blue , oval oblong BiconvexDebossed

Selzentry 150Mg Tab 60 By Viiv Healthcar
BRAND: SELZENTRY NDC: 49702-0223-18,49702022318 UPC: 3-49702-22318-9,349702223189 Viiv Healthcare

MARAVIROC ORAL TABLET 150
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.