AIDS Treatment News Issue #378, March 8, 2002
John S. James

The FDA sent the following email on February 6, 2002:

On February 5, 2002, FDA approved a new dosing regimen for Agenerase (amprenavir) and Norvir (ritonavir) used in combination. The Dosage and Administration section of the amprenavir package insert was revised to include the following statement:

Concomitant Therapy: If Agenerase and ritonavir are used in combination, the recommended dosage regimens are: Agenerase 1200 mg with ritonavir 200 mg once daily or Agenerase 600 mg with ritonavir 100 mg twice daily.

The following revisions were also made to the Agenerase package insert regarding the use of the Agenerase plus ritonavir.

• The Clinical Pharmacology section was revised to add information about the pharmacokinetics of amprenavir when it is co-administered with ritonavir.
  


• Table 8 (Established and Other Potentially Significant Drug Interactions) was revised to state that when amprenavir and ritonavir are co-administered, the dose of amprenavir should be reduced.
  


• The Precautions section was revised to provide additional information about possible cholesterol, triglyceride and liver transaminase elevations when amprenavir is co- administered with ritonavir.
  


• The Precautions section was also revised to provide information about the potential for lipid elevations; guidance on monitoring and managing these clinical chemistry abnormalities was included.
  


• The Adverse Reactions section was revised to include a table describing common adverse events observed in patients who received amprenavir 600mg + ritonavir 100mg BID (twice daily) and amprenavir 1200mg + ritonavir 200mg QD (once daily).
  

The label hyperlinked below in PDF format: http://www.fda.gov/cder/foi/label/2002/21007s010lbl.pdf

020308
ATN37805

Copyright © 2002 - AIDS Treatment News. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. Subscription lists are kept confidential. AIDS Treatment News, Subscription and Editorial Office: 1233 Locust St., 5th floor Philadelphia, PA 19107 800/TREAT-1-2 toll-free email: aidsnews@critpath.org  http://www.aidsnews.org

Subscription Information: Call 800/TREAT-1-2: Businesses, Institutions, Professionals: $270/year. Includes early delivery of an extra copy by email. Nonprofit organizations: $135/year. Includes early delivery of an extra copy by email. Individuals: $120/year, or $70 for six months. Special discount for persons with financial difficulties: $54/year, or $30 for six months. If you cannot afford a subscription, please write or call. Outside North, Central, or South America, add air mail postage: $20/year, $10 for six months. Back issues available. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U.S. funds: personal check or bank draft, international postal money order, or travelers checks. VISA, Mastercard, and purchase orders also accepted. ISSN # 1052-4207

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, iMetrikus, Inc., the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2002. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2002. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .