Amprenavir/ritonavir approved in US

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.