The Food and Drug Administration (FDA) has approved updating labeling for Epivir (lamivudine; ViiV).

The labeling for Epivir Oral Solution now recommends a higher total daily dosage from 8mg/kg/day to 10mg/kg/day in HIV-1 infected pediatric patients aged ≥3 months. Patients are recommended to take 5mg/kg orally twice daily or 10mg/kg orally once daily (up to a maximum of 300mg per day); this should be given in combination with other antiretroviral agents. The dosing interval should be determined based on the patient’s HIV-1 viral load and CD4+ cell count/percentage. 

The warnings and precautions section was revised to include interaction information with sorbitol-containing solutions based on data from a pharmacokinetic trial. The labeling now states: “Pediatric subjects who received Epivir Oral Solution (at weight band-based doses approximating 8mg per kg per day) concomitantly with other antiretroviral oral solutions at any time in the ARROW trial had lower rates of virologic suppression, lower plasma lamivudine exposure, and developed viral resistance more frequently than those receiving Epivir tablets.” 

The scored tablet is preferred for pediatric patients who weigh ≥14kg and for whom a solid dosage form is appropriate. An all-tablet regimen is recommended when possible to avoid a potential interaction with sorbitol. When administering Epivir Oral Solution, clinicians should consider more frequent monitoring of HIV-1 viral load. 

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Under Drug Interactions, the labeling states that coadministration of single doses of lamivudine and sorbitol caused a sorbitol dose-dependent decrease in lamivudine exposures. The use of sorbitol-containing drugs should be avoided with lamivudine when possible. The clinical pharmacology section has been updated to include clinical data from a pharmacokinetic study (n=210) that examined absolute and relative bioavailability of Epivir Oral Solution vs. tablets in children and adults. The data suggests an increase in the dosage of Epivir Oral Solution to “achieve sufficient concentrations of lamivudine.”

Epivir, a nucleoside analogue (reverse transcriptase inhibitor), is currently approved to treat HIV-1 infection, in combination with other antiretrovirals. It is available as 150mg and 300mg strength tablets as well as a 10mg/mL strength oral solution.

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