The FDA notified healthcare professionals of serious health problems reported in premature babies receiving Kaletra (lopinavir/ritonavir) oral solution. Kaletra oral solution contains the ingredients alcohol and propylene glycol.
Premature babies may be at an increased risk for health problems because they have a decreased ability to eliminate propylene glycol, which could lead to adverse events such as serious heart, kidney or breathing problems. Since the consequences of using Kaletra oral solution in babies immediately after birth can be severe or possibly fatal, the label is being revised in order to include a new warning.
Kaletra oral solution is an antiviral medication indicated in combination with other antiretroviral drugs for treatment of HIV-1 infection in pediatric patients 14 days of age (premature or full-term) or older, and in adults.
The use of Kaletra oral solution should be avoided in premature babies until 14 days after their due date, or in full-term babies younger than 14 days of age unless healthcare professional believes that the benefit of using Kaletra oral solution immediately after birth outweighs the potential risks. In such cases, the FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity.