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Issue No. 9 | February 25, 2011

News and Features

Lopinavir/ritonavir Oral Solution Label Updated with Changes Related to Toxicity in Preterm Neonates

“On February 24, 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 metabolize 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 to reflect the information. In addition a new Warning and Precautions was included to describe the toxicity in preterm neonates.”

The updated label will be available at the FDA Web site.

More information is available:

Nelfinavir Label Updated with Information on Drug-Drug Interaction Between Nelfinavir and Warfarin

“On February 24, 2011, FDA updated the Viracept (nelfinavir) label to include drug-drug interaction information between nelfinavir and wa[r]farin.

“Table 11 (Established and Other Potentially Significant Drug Interactions) of the Precautions section of the label was changed to add the following:

“Coadministration of wa[r]farin and Viracept may affect concentrations of wa[r]farin. It is recommended that the INR (international normalized ratio) be monitored carefully during treatment with Viracept, especially when commencing therapy.”

The updated label will be available at the FDA Web site.

More information is available:

Step Study Results Suggest Vaccine Elicits Cell-Mediated Immunity but Does Not Affect Disease Progression in HIV-Infected Males

“The Step study was a randomized trial to determine whether an adenovirus type 5 (Ad5) vector vaccine, which elicits T cell immunity, can lead to control of human immunodeficiency virus (HIV) replication in participants who became HIV-infected after vaccination. … We evaluated the effect of the vaccine on trends in HIV viral load, CD4+ T cell counts, time to initiation of antiretroviral therapy (ART), and AIDS-free survival in 87 male participants who became infected with HIV during the Step study and who had a median of 24 months of post-infection follow-up. ... There was no overall effect of vaccine on mean log(10) viral load (estimated difference between groups, -0.11; P = .47). In a subset of subjects with protective HLA types (B27, B57, B58), mean HIV-1 RNA level over time was lower among vaccine recipients. There was no significant difference in CD4+ T cell counts, time to ART initiation, or in AIDS-free survival between HIV-1-infected subjects who received vaccine versus those who received placebo. … HIV RNA levels, CD4+ T cell counts, time to initiation of ART, and AIDS-free survival were similar in vaccine and placebo recipients. There may have been a favorable effect of vaccine on HIV-1 RNA levels in participants with HLA types associated with better control of HIV-1.”

More information is available: