The Food and Drug Administration has granted accelerated approval to amprenavir (Agenerase: Glaxo-Wellcome), a new HIV protease inhibitor. Amprenavir is approved for use in children aged four years and older and in adults, in combination with other antiretrovirals for HIV infection.
Amprenavir is available as capsules or liquid. The two formulations are not interchangeable on a milligram per milligram basis. For many patients, amprenavir is taken twice a day. However, for some children, the dosing regimen is three times daily. This drug is not approved to be used alone. It must be used in combination with other antiretroviral drugs.
The most frequently reported adverse events among patients in clinical trials were nausea, diarrhoea, vomiting and rash. Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, have occurred in patients treated with amprenavir. Acute haemolytic anaemia, diabetes mellitus and hyperglycaemia may also be associated with amprenavir. Amprenavir can be taken with or without food, but it should not be taken with a high-fat meal because the fat content may decrease the absorption of the drug.
Reference: FDA Talk Paper T99-17 dated 16 April 1999.