United States of America - An accelerated approval has been issued for Kaletra®, a combination of the protease inhibitors lopinavir and ritonavir for HIV infection in adults and children over 6 months of age. Lopinavir's antiviral properties are combined with a low dose of ritonavir that inhibits lopinavir's metabolism. This results in blood levels of lopinavir that enhance effectiveness.
Side effects associated with Kaletra® are diarrhoea, fatigue, headache, and nausea. It also produces increases in blood lipid levels which in some patients may be large enough to require treatment. Infrequent cases of pancreatitis have been observed among patients receiving antiretroviral regimens that included Kaletra® and, as observed with other protease inhibitors, may also be associated with adverse events including increase in blood glucose, redistribution of body fat, and potentially serious drug interactions.
Reference: FDA Talk Paper, T00-43 (2000).