Lopinavir/Ritonavir (Kaletra) Oral Solution
March 9, 2011
FDA is notifying healthcare professionals of labeling changes to lopinavir/ritonavir (Kaletra) oral solution. Lopinavir/ritonavir oral solution is used in combination with other drugs to treat HIV-1 infection. Serious adverse effects have been reported in premature babies receiving lopinavir/ritonavir oral solution (Kaletra), an antiviral medication. The product contains alcohol and propylene glycol. Premature babies have diminished ability to metabolize propylene glycol resulting in increased risk of serious and potentially fatal adverse events including cardiac, renal, and respiratory complications. Therefore, a new warning is being added to the product label to include this information.
Avoid lopinavir/ritonavir oral solution in premature infants until 14 days after their due date and in full-term babies who are less than 14 days old. If this oral solution is used in these patients because a health care professional has determined the possible clinical benefit outweighs the risk, monitor patients for signs of toxicity including changes in serum osmolality and serum creatinine.
Additional information is available from the following links:
- FDA MedWatch Alert:
- FDA Drug Safety Communication:
March 9, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.