FOSAMPRENAVIR CALCIUM

Electrolyte / Mineral

Brand names: Fosamprenavir Calcium

Oral

Mechanism of Action

12.1 Mechanism of Action Fosamprenavir is an HIV-1 antiretroviral agent [see Microbiology (12.4) ] . Mechanism of Action Fosamprenavir is a prodrug that is rapidly hydrolyzed to amprenavir by cellular phosphatases in the gut epithelium as it is absorbed. Amprenavir is an inhibitor of HIV-1 protease. Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral Gag and Gag-Pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.

Indications

2.3)

Clinical Studies (14.2

Contraindications

• 4 CONTRAINDICATIONS • Fosamprenavir calcium tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g.
• Clinical Pharmacology (12.3)]. The list of contraindicated drugs applies to the use of fosamprenavir with or without ritonavir
• unless otherwise indicated. If fosamprenavir is coadministered with ritonavir
• propafenone (with ritonavir ) o Antimycobacterial: Rifampin o Antipsychotic: Lurasidone (with ritonavir )
• pimozide o Ergot derivatives: Dihydroergotamine

FDA Warnings

5 WARNINGS AND PRECAUTIONS • The concomitant use of fosamprenavir with ritonavir and certain other drugs may result in known or potentially significant drug interactions
Patients with hepatitis B or C are at increased risk of transaminase elevations
1 Risk of Serious Adverse Reactions Due to Drug Interactions Initiation of fosamprenavir/ritonavir, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A, or initiation of medications metabolized by CYP3A in patients already receiving fosamprenavir/ritonavir may increase plasma concentrations of medications metabolized by CYP3A
These interactions may lead to: • clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications

Known Side Effects

2 documented side effects by frequency

Vomiting

1-10%

Muscle Pain

1-10%

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Formulations

Dosage Forms

Tablet

Route

Oral