Patient Death Prompts Kaletra Oral Solution Warning

August 17, 2007 – 1:31 pm | posted in Pharma Industry

An accidental overdose of Kaletra, or lopinavir and ritonavir, solution caused a 44-day-old infant born at 30 weeks’ gestation to die from cardiogenic shock, according to a letter from Abbott Laboratories (PDF) posted on the FDA website.

The letter urges health care professionals to pay “special attention . . . to accurate calculation of the dose, transcription of the medication order, dispensing information and dosing instructions.”

Kaletra oral solution is highly concentrated and contains 80 mg of lopinavir and 20 mg of ritonavir in each milliliter, according to the package insert (PDF).

The manufacturer’s labeling also states that Kaletra oral solution contains 42.4% alcohol and thus has the potential to cause significant alcohol-related toxicity and death.

According to the package insert, dosing of Kaletra oral solution for children is based on the patient’s weight.

In general, pediatric patients 12 years of age or younger up to 40 kg in weight should receive less than 5 mL of Kaletra oral solution per dose, unless they are also taking certain antiretroviral medications, according to Abbott.

The infant was given 6.5 mL of Kaletra oral solution, which was approximately 10 times the calculated volume for the appropriate dose, according to the letter from Abbott.

http://www.ashp.org

Popularity: 1% [?]