Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Entry and Fusion Inhibitors

Maraviroc

Last Updated: May 22, 2018; Last Reviewed: May 22, 2018

Maraviroc (MVC, Selzentry)
Maraviroc (MVC, Selzentry)
For additional information see Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Tablets: 25 mg, 75 mg, 150 mg, and 300 mg
Oral Solution: 20 mg/mL
Dosing Recommendations Selected Adverse Events
Neonate and Infant Dose:
  • Not approved for use in neonates or infants
Pediatric Dose:
  • Approved for use in treatment-experienced children aged ≥2 years and weighing ≥10 kg

Recommended Maraviroc Dose for Treatment-Experienced Children Aged ≥2 Years and Weighing ≥10 kg: Tablets or Oral Solution
Weight Band Twice-Daily Dosing Liquid 20 mg/mL Tablets
When given with potent cytochrome P (CYP) 3A inhibitors (with or without a potent CYP3A inducer), including elvitegravir/ritonavir (EVG/r) and protease inhibitors (PIs) (except tipranavir/ritonavir [TPV/r]):
10 kg to <20 kg 50 mg 2.5 mL Two 25-mg tablets
20 kg to <30 kg 75 mg 4 mL One 75-mg tablet
30 kg to <40 kg 100 mg 5 mL One 25-mg tablet and one 75-mg tablet
>40 kg 150 mg 7.5 mL One 150-mg tablet
When given with nucleoside reverse transcriptase inhibitors (NRTIs), enfuvirtide, TPV/r, nevirapine, raltegravir, and other drugs that are not potent CYP3A inhibitors or inducers:
10 kg to <20 kg Not recommended
20 kg to <30 kg Not recommended
30 kg to <40 kg 300 mg 15 mL One 300-mg tablet
>40 kg 300 mg 15 mL One 300-mg tablet
When given with potent CYP3A inducers including efavirenz and etravirine (without a potent CYP3A inhibitor):
Children in all weight bands Not recommended

Recommended Adult Maraviroc Dose: Tablets
When Co-Administered With: Dose
Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including PIs (except TPV/r) and EVG/r 150 mg twice daily
NRTIs, enfuvirtide, TPV/r, nevirapine, raltegravir, and other drugs that are not potent CYP3A inhibitors or inducers 300 mg twice daily
Potent CYP3A inducers, including efavirenz and etravirine (without a potent CYP3A inhibitor) 600 mg twice daily
  • Nausea, vomiting
  • Abdominal pain, diarrhea
  • Cough
  • Upper respiratory tract infections
  • Fever
  • Rash
  • Hepatotoxicity (which may be preceded by severe rash and/or other signs of systemic allergic reaction)
  • Postural hypotension (generally seen in patients with severe renal insufficiency)
  • Dizziness
Special Instructions
  • Maraviroc is recommended for patients with only CCR5-tropic HIV-1. Conduct testing with HIV tropism assay (see Drug-Resistance Testing in the Adult and Adolescent Guidelines) before using maraviroc to exclude the presence of CXCR4-tropic or mixed/dual-tropic HIV. Do not use maraviroc if CXCR4-tropic or mixed/dual-tropic HIV is present.
  • Maraviroc can be given without regard to food.
  • Instruct patients on how to recognize symptoms of allergic reactions or hepatitis.
  • Use caution when administering maraviroc to patients with underlying cardiac disease.
Metabolism/Elimination
  • Cytochrome P450 3A4 (CYP3A4) substrate
Maraviroc Dosing in Patients with Hepatic Impairment:
  • Use caution when administering maraviroc to patients with hepatic impairment; maraviroc concentrations may be increased.
Maraviroc Dosing in Adolescents and Adults with Renal Impairment:
  • Refer to the manufacturer’s prescribing information.
  • Data are insufficient to make dosing recommendations for use of maraviroc in children concomitantly receiving noninteracting medications and weighing <30 kg or in all children concomitantly receiving potent CYP3A inducers without a potent CYP3A inhibitor.

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