FDA approves new dosing for amprenavir and ritonavir combination.

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 Ageneruse 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: www.fda.gov/cder/foi/label/2002/21007s0101bl.pdf