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FDA Approves New Dosing for Amprenavir and Ritonavir Combination

March 8, 2002

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 1,200 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 600 mg + ritonavir 100 mg BID (twice daily) and amprenavir 1,200 mg + ritonavir 200 mg QD (once daily).

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


ISSN # 1052-4207

Copyright 2002 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.


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