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Kaletra Oral Solution Label Changes Related to Toxicity in Preterm Neonates

February 2011

Label changes to Kaletra (lopinavir/ritonavir, LPV/r) oral solution were approved by the FDA due to postmarketing cases of life-threatening events in neonates (babies less than 4 weeks old) that received Kaletra oral solution. Life-threatening cases included:

  • cardiac toxicity (including complete AV block, bradycardia, and cardiomyopathy)
  • lactic acidosis
  • acute renal failure
  • central nervous system depression
  • respiratory complications

Of the 10 cases, there was one death due to cardiogenic shock related to a large overdose of Kaletra oral solution.

Kaletra oral solution contains 42.4% (v/v) alcohol and 15.3% (w/v) propylene glycol. Special attention should be given to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors, and overdose.

To read the FDA notice, click here.

Kaletra prescribing information is available at: http://www.rxabbott.com/pdf/kaletratabpi.pdf