LEXIVA- fosamprenavir calcium tablet, film coated LEXIVA- fosamprenavir calcium suspension

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

ViiV Healthcare Company

DCI (Denominação Comum Internacional):

FOSAMPRENAVIR CALCIUM

Composição:

FOSAMPRENAVIR 700 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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:     •    LEXIVA is contraindicated when coadministered with the following drugs:               o     Alpha 1-adrenoreceptor antagonist: Alfuzosin               o     Antiarrhythmics: Flecainide (with ritonavir), propafenone (with ritonavir)               o     Antimycobacterial: Rifampin               o     Antipsychotic: Lurasidone (with ritonavir), pimozide               o     Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine               o     GI motility agent: Cisapride               o     Herbal product: St. John’s wort (Hypericum perforatum )               o     Lipid modifying agents: Lomitapide, lovastatin, simvastatin               o     Non-nucleoside reverse transcriptase inhibitor: Delavirdine     

Resumo do produto:

LEXIVA tablets, 700 mg, are pink, film-coated, capsule-shaped, biconvex tablets, with “GX LL7” debossed on one face. Bottle of 60 with child-resistant closure (NDC 49702-207-18). 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. Bottle of 225 mL with child-resistant closure (NDC 49702-208-53). This product does not require reconstitution. Store in refrigerator or at room temperature (5° to 30°C; 41° to 86°F). Shake vigorously before using. Do not freeze.

Status de autorização:

New Drug Application

Características técnicas

LEXIVA- FOSAMPRENAVIR CALCIUM TABLET, FILM COATED
LEXIVA- FOSAMPRENAVIR CALCIUM SUSPENSION
VIIV HEALTHCARE COMPANY
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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, FOR ORAL USE
LEXIVA (FOSAMPRENAVIR CALCIUM) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
LEXIVA is an HIV protease inhibitor indicated in combination with
other antiretroviral agents for the treatment of HIV-1
infection. (1)
DOSAGE AND ADMINISTRATION
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Dosing Considerations
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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. (2.2)
Protease Inhibitor-Experienced Adults: LEXIVA 700 mg twice daily plus
ritonavir 100 mg twice daily. (2.2)
Pregnant Patients: LEXIVA 700 mg twice daily plus ritonavir 100 mg
twice daily should only be considered in women
who are already on a stable twice-daily regimen of LEXIVA/ritonavir
700 mg/100 mg prior to pregnancy and who are
virologically suppressed (HIV-1 RNA less than 50 copies per mL). (2.2)
Pediatric Patients (aged at least 4 weeks to 18 years): Dosage should
be calculated based on body weight (kg) and
should not exceed adult dose. (2.3)
Hepatic Impairment: Recommended adjustments for patients with mild,
moderate, or severe hepatic impairment.
(2.4)
LEXIVA tablets may be taken with or without food. (2.1)
LEXIVA suspension: Adults should take without food; pediatric patients
should take with food. (2.1)
700-mg tablets (3)
50-mg-per-mL oral suspension (3)
Hypersensitivity to LEXIVA or amprenavir (e.g., Stevens-Johnson
syndrome). (4)
Drugs highly dependent on cytochrome P450 (CYP)3A4 for clearance an