On February 5, 2002, the US Food and Drug Administration 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.
See Amprenavir - key research on this site for further details of studies of amprenavir/ritonavir.
The following revisions were also made to the Agenerase package insert
regarding the use of 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 can be viewed in PDF format here.