LEXIVA- fosamprenavir calcium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOSAMPRENAVIR CALCIUM (UNII: ID1GU2627N) (AMPRENAVIR - UNII:5S0W860XNR)

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

FOSAMPRENAVIR CALCIUM

Composition:

FOSAMPRENAVIR CALCIUM 700 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LEXIVA® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with LEXIVA plus ritonavir in protease inhibitor-experienced patients: - The protease inhibitor-experienced patient study was not large enough to reach a definitive conclusion that LEXIVA plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)] . - Once-daily administration of LEXIVA plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients. LEXIVA is contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome) to any of the components of this product or to amprenavir. - when coadministered with drugs that are highly dependent on CYP3A4 for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatenin

Product summary:

LEXIVA Tablets, 700 mg, are pink, film-coated, capsule-shaped, biconvex tablets, with “GX LL7” debossed on one face. Store at controlled room temperature of 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Keep container tightly closed. LEXIVA Oral Suspension, a white to off-white grape-bubblegum-peppermint-flavored suspension, contains 50 mg of fosamprenavir as fosamprenavir calcium equivalent to approximately 43 mg of amprenavir in each 1 mL. This product does not require reconstitution. Store at 5° to 30°C (41° to 86°F). Shake vigorously before using. Do not freeze. This product is supplied by State of Florida DOH Central Pharmacy as follows:

Authorization status:

New Drug Application

Summary of Product characteristics

LEXIVA - FOSAMPRENAVIR CALCIUM TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEXIVA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LEXIVA.
LEXIVA (FOSAMPRENAVIR CALCIUM) TABLETS AND ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration, Patients With Hepatic Impairment (2.3)
4/2009
Warnings and Precautions (5.8) 9/2009
Warnings and Precautions, Nephrolithiasis (5.11) 9/2009
INDICATIONS AND USAGE
LEXIVA is an HIV protease inhibitor indicated in combination with
other antiretroviral agents for the treatment of HIV-1
infection. (1) (1)
DOSAGE AND ADMINISTRATION
Therapy-Naive Adults: LEXIVA 1,400 mg twice daily; LEXIVA 1,400 mg
once daily plus ritonavir 200 mg once daily;
LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily; LEXIVA
700 mg twice daily plus ritonavir 100 mg twice
daily. (2.1)
Protease Inhibitor-Experienced Adults: LEXIVA 700 mg twice daily plus
ritonavir 100 mg twice daily. (2.1)
Pediatric Patients (2 to 18 years of age): Dosage should be calculated
based on body weight (kg) and should not exceed
adult dose. (2.2)
Hepatic Impairment: Recommended adjustments for patients with mild,
moderate, or severe hepatic impairment. (2.3)
Dosing Considerations (2)
LEXIVA Tablets may be taken with or without food. (2)
LEXIVA Suspension: Adults should take without food; pediatric patients
should take with food. (2)
DOSAGE FORMS AND STRENGTHS
700 mg tablets and 50 mg/mL oral suspension (3) (3)
CONTRAINDICATIONS
Hypersensitivity to LEXIVA or amprenavir (e.g., Stevens-Johnson
syndrome). (4)
Drugs highly dependent on CYP3A4 for clearance and for which elevated
plasma levels may result in serious and/or
life-threatening events. (4)
Review ritonavir contraindications when used in combination. (4)
WARNINGS AND PRECAUTIONS
Certain drugs should not be coadministered with LEXIVA due to risk of
serious or life-threatening adverse reactions.
(5.1)