Oral Pediatric HIV Treatment Gets FDA Approval

The FDA recently approved a new formulation of ritonavir (Norvir) oral powder, 100-mg packet for the treatment of HIV-1. Ritonavir is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1, according to the FDA.

Mother-to-child transmission is a common way that pediatric patients become infected with HIV. These young patients must begin antiretroviral treatment to prevent lifelong complications.

On March 1, 1996, ritonavir was granted FDA approval as a monotherapy or in combination with a nucleoside analogue for patients with advanced disease. Since the original formulation contains alcohol, if a young child takes more than recommended, it could result in adverse events.

While the oral tablets and oral solution formulation of ritonavir are indicated for use in children, toxicities can happen if the optimal dose is not received. The newly approved oral powder does not contain alcohol or propylene, which makes it safer for use in young patients.

Common adverse reactions for ritonavir include diarrhea, nausea, vomiting, abdominal pain, paresthesia, oral paresthesia, rash, and fatigue, according to the prescribing information.

The labeling for the oral tablet and oral solution formulations was updated to reflect the new formulation, according to the FDA.