FDA Approves Label Changes to HIV Drug

The US Food and Drug Administration has approved changes to lopinavir/ritonavir (Kaletra), a fixed dose combination medication for the treatment of HIV/AIDS.

According to an agency statement, lopinavir/ritonavir contains ethanol in an oral solution, so it’s labeling has been updated to state that it is not recommended for use with polyurethane feeding tubes due to potential incompatibility.

Additional changes to the drug’s labeling include an updated contraindication for anti-angina drug ranolazine, an updated drug interactions section, and new information in the medication guide.

More changes were made to the drug’s capsule label. Additionally, three subsections were updated to be compliant with the “Pregnancy and Lactation Labeling Rule” (PLLR). Moreover, section 12 and sub section 13 were updated with the pregnancy information.

Origianlly approved by the FDA in 2000, lopinavir/ritonavir is generally recommended for use with other antiretrovirals. It is taken orally as a tablet or solution, and can be used for prevention after HIV exposure by needle.

The drug’s updated labeling can be found at drugs@fda.

Earlier this month, ritonavir was approved in a new dosage that did not contain propylene glycol or alcohol, making it safer for pediatric patients, the agency said.