FDA Date: 3/7/11
Kaletra (lopinavir/ritonavir) FDA Drug Safety Communication
Serious Health Problems Seen in Premature Babies Given Kaletra (lopinavir/ritonavir) Oral Solution
FDA is notifying healthcare professionals of serious health problems that have been 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 increased risk for health problems because they have a decreased ability to eliminate propylene glycol; this could lead to adverse events such as serious heart, kidney, or breathing problems.
A safe and effective dose for babies <14 days of age (whether born premature or full term) has not been established.
Because the consequences of using Kaletra oral solution in babies immediately after birth can be severe or possibly fatal, the label is being revised to include a new warning. The use of Kaletra oral solution should be avoided in premature babies until 14 days after their due date, or in full-term babies <14 days of age unless a healthcare professional believes that the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the potential risks. In such cases, FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity.
Calculate the appropriate dose of Kaletra oral solution for each child based on body weight (kg) or body surface area (BSA) to avoid underdosing or exceeding the recommended adult dose.
Kaletra oral solution is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in pediatric patients 14 days of age (whether premature or full term) or older and in adults. Taking antiretroviral medications for HIV will not cure the infection, but can help children and adults with HIV-1 infection stay healthier for a longer period of time.