Amprenavir/ritonavir approved in US

Keith Alcorn
Estimated reading time 2 minutes
This article is more than 23 years old.

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

Glossary

triglycerides

A blood fat (lipid). High levels are associated with atherosclerosis and are a risk factor for heart disease.

 

transaminase

An enzyme that can be measured in a blood sample that indicates the health of the liver, such as AST or ALT.

 

qd

Abbreviation of a Latin term meaning once every day.

lipid

Fat or fat-like substances found in the blood and body tissues. Lipids serve as building blocks for cells and as a source of energy for the body. Cholesterol and triglycerides are types of lipids.

cholesterol

A waxy substance, mostly made by the body and used to produce steroid hormones. High levels can be associated with atherosclerosis. There are two main types of cholesterol: low-density lipoprotein (LDL) or ‘bad’ cholesterol (which may put people at risk for heart disease and other serious conditions), and high-density lipoprotein (HDL) or ‘good’ cholesterol (which helps get rid of LDL).

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.

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