Protease Inhibitor Information: FDA Fact Sheet Available
Basic information on the four HIV protease inhibitors approved in the U.S. has been published in a fold-out brochure by the U.S. Food and Drug Administration, entitled The Protease Inhibitors Backgrounder. Copies are available without charge.The current edition, last updated in October, includes information on dosage, relation to food, storage requirements, warnings and precautions, most frequent adverse effects, pediatric use, medications that should not be used with each protease inhibitor, and drug interactions requiring dose adjustment. There is also a list of suspected interactions, especially with ritonavir (suspected due to the metabolism of the drugs, although clinical trials to check for these interactions have not been done), and advice on reducing risk if these combinations must be used. Some information on dosing when using two protease inhibitors simultaneously is provided in this section.
The reading level is appropriate for medical staff or informed patients.
Comment: This authoritative and non-promotional publication will help patients understand their options, and also help assure that instructions provided with protease-inhibitor prescriptions are correctly understood. Failure to follow instructions for use of drugs is a major problem in medicine, and the consequences are especially serious with HIV treatments, particularly protease inhibitors. Sometimes the instructions are not followed because the patient never understood them. And sometimes instructions are wrong, as when drugs are combined incorrectly. This brochure will help assure that patients understand the instructions, and may bring potential errors to the attention of medical staff.
The Protease Backgrounder is available on the World Wide Web under FDA's HIV/AIDS Therapeutic Index, found at: http://www.fda.gov/oashi/aids/piindex.html,
or by calling the FDA Office of Special Health Issues at 301-827-4460.
