Maraviroc Labeling Updated with New Dosing Recommendations

The changes include dosage updates for adults, pediatric patients, and patients with renal impairment
The changes include dosage updates for adults, pediatric patients, and patients with renal impairment

The Food and Drug Administration (FDA) has approved several labeling updates for Selzentry (maraviroc; ViiV Healthcare).  

Selzentry, a CCR5 co-receptor antagonist, is indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in patients age ≥2 years weighing ≥10kg.

The most recent changes include updates to the Dosage and Administration section regarding testing prior to initiating Selzentry and recommended dosages in adults, pediatric patients, and patients with renal impairment. 

Before starting treatment with Selzentry, patients should be tested for CCR5 tropism using a highly sensitive tropism assay. Selzentry is recommended for patients with only CCR5-tropic HIV-1 infection. ALT, AST, and bilirubin levels should be monitored before initiating Selzentry and at other time points during treatment as clinically indicated. 

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In general, Selzentry tablets and oral solution are taken twice daily by mouth with or without food. Selzentry must be given in combination with other antiretroviral medications and the recommended dosage of Selzentry differs based on concomitant medications due to drug interactions. 

The section on dosage for adults was updated to include a 300mg twice daily regimen for non-interacting concomitant medications—those that are not potent CYP3A inhibitors/inducers—including tipranavir/ritonavir, nevirapine, raltegravir, all nucleoside reverse transcriptase inhibitors (NRTIs), and enfuvirtide. 

The section on dosage for pediatrics now includes recommended dosage in patients aged ≥2 years weighing ≥10kg for both the tablets and oral solution. The recommended dosage should be based on body weight (kg) and should not exceed the recommended adult dose. Children should be assessed for the ability to swallow tablets prior to prescribing Selzentry; if unable to reliably swallow tablets, the oral solution should be prescribed. For specific dosage based on concomitant interactions, refer to the full labeling.

Lastly, for patients with renal impairment, the dosage recommendations table has been updated with concomitant medications including potent CYP3A inhibitors (with or without a CYP3A inducer), non-interacting concomitant medications (eg, tipranavir/ritonavir, nevirapine, raltegravir, all NRTIs, enfuvirtide), and potent CYP3A inducers (without a potent CYP3A inhibitor). There are no data to recommend specific doses in pediatric patients with mild or moderate renal impairment. For specific dosage recommendations, refer to the full labeling. 

Selzentry is available as 25mg and 75mg strength tablets in 120-count bottles, as 150mg and 300mg strength tablets in 60-count bottles, and as a 20mg/mL strength strawberry-flavored oral solution in 230mL bottles.

For more information call (877) 844-8872 or visit Selzentry.com.

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