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U.S. Department of Health and Human Services

For Consumers

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Prescription drug information for patients

8/12/2002

Please note that product labeling has been changed for AGENERASE (amprenavir) Capsules and AGENERASE (amprenavir) Oral Solution to reflect new precautions related to use of Agenerase with Methadone, and with oral (hormonal) contraceptives.

Methadone: Coadministration of amprenavir and methadone can decrease plasma levels of methadone. AGENERASE may be less effective due to decreased amprenavir plasma concentrations in patients taking these agents together. Alternative antiretroviral therapy should be considered. Dosage of methadone may need to be increased when coadministered with AGENERASE.
Oral contraceptives: (Ethinyl estradiol/norethindrone) Those taking AGENERASE should be instructed not to use hormonal contraceptives because some birth control pills (those containing ethinyl estradiol/norethindrone) have been found to decrease the concentration of amprenavir. This may lead to loss of virologic response and possible resistance to AGENERASE. Alternative methods of non-hormonal contraception are recommended.

The complete Agenerase label may be found at

http://www.fda.govhttp://www.accessdata.fda.gov/drugsatfda_docs/label/ 2002/21007s11,21039s10lbl.pdf

Richard Klein
Office of Special Health Issues
Food and Drug Administration