April 27, 2017
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Selzentry

"AIDS is caused by HIV, a retrovirus that attacks the immune system. The virus destroys CD4+ T cells, a type of white blood cell that's vital to fighting off infection. The number of these cells, known as a CD4+ count, is a key measure of immune s"...

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Selzentry




Indications
Dosage
How Supplied

INDICATIONS

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, Clinical Studies].
  • 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, Clinical Studies].

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 [see DRUG INTERACTIONS].

Table 1: Recommended Dosing Regimen

Concomitant Medications Dose of SELZENTRY

Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including:

  • protease inhibitors (except tipranavir/ritonavir)
  • delavirdine
  • elvitegravir/ritonavir
  • ketoconazole, itraconazole, clarithromycin
  • other potent CYP3A inhibitors (e.g., nefazodone, telithromycin)
  • boceprevir
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

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 Dose of SELZ ENTRY Based on Renal Function
Normal (CrCl > 80 mL/min) Mild (CrCl > 50 and ≤ 80 mL/min) Moderate (CrCl > 30 and ≤ 50 mL/min) Severe (CrCl < 30 mL/min) End-stage Renal Disease on Regular Hemodialysis
Potent CYP3A inhibitors (with or without a CYP3A inducer)a 150 mg twice daily 150 mg twice daily 150 mg twice daily NR NR
Other concomitant medicationsa 300 mg twice daily 300 mg twice daily 300 mg twice daily 300 mg twice dailyb 300 mg twice dailyb
Potent CYP3A Inducers (without a potent CYP3A inhibitor)a 600 mg twice daily 600 mg twice daily 600 mg twice daily NR NR
NR = Not recommended.
a See Table 1 for the list of concomitant medications.
b The dose of SELZENTRY should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

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

Bottle packs 150-mg tablets: 60 tablets (NDC 49702-223-18).
Bottle packs 300-mg tablets: 60 tablets (NDC 49702-224-18).

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

Manufactured for: ViiV Healthcare Research Triangle Park, NC 27709. by: Pfizer Manufacturing Deutschland GmbH Freiburg, Germany. Revised: Apr 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/21/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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