What is FOSAMPRENAVIR CALCIUM used for?

FOSAMPRENAVIR CALCIUM (brand name Fosamprenavir Calcium) is a Electrolyte / Mineral indicated for 2.3), Clinical Studies (14.2.

What are the most common side effects of FOSAMPRENAVIR CALCIUM?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for FOSAMPRENAVIR CALCIUM. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is FOSAMPRENAVIR CALCIUM the same as Fosamprenavir Calcium?

Fosamprenavir Calcium is a brand name for FOSAMPRENAVIR CALCIUM. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

FOSAMPRENAVIR CALCIUM

Q: How does FOSAMPRENAVIR CALCIUM work?

FOSAMPRENAVIR CALCIUM works through the following mechanism: 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..

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%

Community Discussions

No community discussions found for FOSAMPRENAVIR CALCIUM yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → FOSAMPRENAVIR CALCIUM openFDA label JSON → FOSAMPRENAVIR CALCIUM FAERS adverse-event reports → FOSAMPRENAVIR CALCIUM ClinicalTrials.gov → completed Phase 2+ trials of FOSAMPRENAVIR CALCIUM

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Formulations

Dosage Forms

Tablet

Route

Oral