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FDA Approves Kaletra for HIV Infection

September 15, 2000

FDA today issued an accelerated approval for Kaletra, a protease inhibitor, for adults and children greater than 6 months of age with HIV. Kaletra is a combination of lopinavir and ritonavir, (a previously approved protease inhibitor). 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 its effectiveness against HIV.

The new drug is used in combination with other anti-HIV drugs. It should be taken with food to increase absorption into the blood stream. The usual dose for adults is three capsules or 5.0 mL twice a day. Dosing for children ages 6 months to 12 years, determined by the child's weight, is also given twice daily.

Side-effects associated with Kaletra are diarrhea, fatigue, headache, and nausea. Kaletra also produces increases in blood lipid levels (cholesterol and triglycerides) which in some patients may be large enough to require treatment. In addition, infrequent cases of pancreatitis have been observed among patients receiving antiretroviral regimens that included Kaletra. People with high levels of triglycerides in the blood can be at risk for pancreatitis.

As observed with other protease inhibitors, Kaletra may also be associated with other significant or serious adverse events including increases in blood glucose, redistribution of body fat, and potentially serious or life-threatening drug interactions. Healthcare providers and patients are strongly encouraged to find out about drugs that should not be taken with Kaletra and other antiretrovirals to prevent serious drug interactions or potential loss of drug effectiveness.

Kaletra was studied in six controlled and one expanded access clinical trials and is manufactured by Abbott Laboratories, North Chicago, IL.




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