Lopinavir/r oral solution
On 24 February 2011, FDA approved changes to the Kaletra (lopinavir/ritonavir) Oral Solution product label related to toxicity in preterm neonates secondary to adverse events related lopinavir and/or the inactive ingredients propylene glycol and ethanol.
This label change was made after review of 10 postmarketing cases with life-threatening events reported in neonates (babies less than 4 weeks old) that received Kaletra oral solution. Postmarketing life-threatening cases included cardiac toxicity (including complete AV block, bradycardia, and cardiomyopathy), lactic acidosis, acute renal failure, central nervous system depression, and respiratory complications. Of the 10 cases, there was one death due to cardiogenic shock related to a large overdose of Kaletra oral solution.
Reduced metabolism by the liver and reduced kidney function in newborns can lead to an accumulation of lopinavir (the active ingredient), as well as alcohol and propylene glycol. Preterm babies may be at increased risk for health problems because they cannot metabolise propylene glycol; this could lead to accumulation and adverse events such as serious heart, kidney, or breathing problems.
The Dosage and Administration section 2.2 and the Overdosage section 10 were revised and a new Warning and Precautions was included to describe the toxicity in preterm neonates.
Please refer to the full label for details.
Source: FDA listserve (24 Feb 2011).
Kaletra (lopinavir/ritonavir) oral solution label changes related to toxicity in preterm neonates.