LEXIVA

LEXIVA — fosamprenavir calcium tablet, film coated
State of Florida DOH Central Pharmacy

1 INDICATIONS AND USAGE

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 trial 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 [see Dosage and Administration (2.1, 2.2), Clinical Studies (14.2, 14.3)].
Dosing of LEXIVA plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months [see Clinical Pharmacology (12.3)].

2 DOSAGE AND ADMINISTRATION

LEXIVA Tablets may be taken with or without food.

Adults should take LEXIVA Oral Suspension without food. Pediatric patients should take LEXIVA Oral Suspension with food [see Clinical Pharmacology (12.3)]. If emesis occurs within 30 minutes after dosing, re-dosing of LEXIVA Oral Suspension should occur.

Higher-than-approved dose combinations of LEXIVA plus ritonavir are not recommended due to an increased risk of transaminase elevations [see Overdosage (10)].

When LEXIVA is used in combination with ritonavir, prescribers should consult the full prescribing information for ritonavir.

2.1 Adults

Therapy-Naive Adults:

LEXIVA 1,400 mg twice daily (without ritonavir).
LEXIVA 1,400 mg once daily plus ritonavir 200 mg once daily.
LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily.
Dosing of LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily is supported by pharmacokinetic data [see Clinical Pharmacology (12.3)].
LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily.
Dosing of LEXIVA 700 mg twice daily plus 100 mg ritonavir twice daily is supported by pharmacokinetic and safety data [see Clinical Pharmacology (12.3)].

Protease Inhibitor-Experienced Adults:

LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily.

2.2 Pediatric Patients (Aged at Least 4 Weeks to 18 Years)

The recommended dosage of LEXIVA in patients aged at least 4 weeks to 18 years should be calculated based on body weight (kg) and should not exceed the recommended adult dose (Table 1).

Table 1. Twice-Daily Dosage Regimens by Weight for Protease Inhibitor-Naive Pediatric Patients (Greater Than or Equal to 4 Weeks of Age) and for Protease Inhibitor-Experienced Pediatric Patients (Greater Than or Equal to 6 Months of Age) Using LEXIVA Oral Suspension With Concurrent Ritonavir

Weight

Twice-Daily Dosage Regimen

<11 kg

LEXIVA 45 mg/kg plus ritonavir 7 mg/kga

11 kg — <15 kg

LEXIVA 30 mg/kg plus ritonavir 3 mg/kga

15 kg — <20 kg

LEXIVA 23 mg/kg plus ritonavir 3 mg/kga

≥20 kg

LEXIVA 18 mg/kg plus ritonavir 3 mg/kga

a When dosing with ritonavir, do not exceed the adult dose of LEXIVA 700 mg/ritonavir 100 mg twice-daily dose.

Alternatively, protease inhibitor-naive children aged 2 years and older can be administered LEXIVA (without ritonavir) 30 mg per kg twice daily.

LEXIVA should only be administered to infants born at 38 weeks gestation or greater and who have attained a post-natal age of 28 days.

For pediatric patients, pharmacokinetic and clinical data:

do not support once-daily dosing of LEXIVA alone or in combination with ritonavir [see Clinical Studies (14.3)].
do not support administration of LEXIVA alone or in combination with ritonavir for protease inhibitor‑experienced children younger than 6 months [see Clinical Pharmacology (12.3)].
do not support twice-daily dosing of LEXIVA without ritonavir in pediatric patients younger than 2 years [see Clinical Pharmacology (12.3)].

Other Dosing Considerations:

When administered without ritonavir, the adult regimen of LEXIVA Tablets 1,400 mg twice daily may be used for pediatric patients weighing at least 47 kg.
When administered in combination with ritonavir, LEXIVA Tablets may be used for pediatric patients weighing at least 39 kg; ritonavir capsules may be used for pediatric patients weighing at least 33 kg.

2.3 Patients With Hepatic Impairment

See Clinical Pharmacology (12.3).

Mild Hepatic Impairment (Child-Pugh Score Ranging From 5 to 6): LEXIVA should be used with caution at a reduced dosage of 700 mg twice daily without ritonavir (therapy-naive) or 700 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced).

Moderate Hepatic Impairment (Child-Pugh Score Ranging From 7 to 9): LEXIVA should be used with caution at a reduced dosage of 700 mg twice daily without ritonavir (therapy-naive), or 450 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced).

Severe Hepatic Impairment (Child-Pugh Score Ranging From 10 to 15): LEXIVA should be used with caution at a reduced dosage of 350 mg twice daily without ritonavir (therapy-naive) or 300 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced).

There are no data to support dosing recommendations for pediatric patients with hepatic impairment.

3 DOSAGE FORMS AND STRENGTHS

LEXIVA Tablets, 700 mg, are pink, film-coated, capsule-shaped, biconvex tablets with “GX LL7” debossed on one face.

LEXIVA Oral Suspension, 50 mg per mL, is a white to off-white suspension that has a characteristic grape-bubblegum-peppermint flavor.

4 CONTRAINDICATIONS

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 cytochrome P450 3A4 (CYP3A4) for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (Table 2).
Table 2. Drugs Contraindicated With LEXIVA. (Information in the table applies to LEXIVA with or without ritonavir, unless otherwise indicated.)

Drug Class/Drug Name

Clinical Comment

Alpha 1-adrenoreceptor antagonist:

Alfuzosin

Potentially increased alfuzosin concentrations can result in hypotension.

Antiarrhythmics:

Flecainide, propafenone

POTENTIAL for serious and/or life-threatening reactions such as cardiac arrhythmias secondary to increases in plasma concentrations of antiarrhythmics if LEXIVA is co-prescribed with ritonavir.

Antimycobacterials:

Rifampina

May lead to loss of virologic response and possible resistance to LEXIVA or to the class of protease inhibitors.

Ergot derivatives:

Dihydroergotamine, ergonovine, ergotamine, methylergonovine

POTENTIAL for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.

GI motility agents:

Cisapride

POTENTIAL for serious and/or life-threatening reactions such as cardiac arrhythmias.

Herbal products:

St. John’s wort (Hypericum perforatum)

May lead to loss of virologic response and possible resistance to LEXIVA or to the class of protease inhibitors.

HMG co-reductase inhibitors:

Lovastatin, simvastatin

POTENTIAL for serious reactions such as risk of myopathy including rhabdomyolysis.

Neuroleptic:

Pimozide

POTENTIAL for serious and/or life-threatening reactions such as cardiac arrhythmias.

Non-nucleoside reverse transcriptase inhibitor:

Delavirdinea

May lead to loss of virologic response and possible resistance to delavirdine.

PDE5 inhibitor:

Sildenafil (REVATIO®) (for treatment of pulmonary arterial hypertension)

A safe and effective dose has not been established when used with LEXIVA. There is increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).

Sedative/hypnotics:

Midazolam, triazolam

POTENTIAL for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.

a See Clinical Pharmacology (12.3) Tables 10, 11, 12, or 13 for magnitude of interaction.

when coadministered with ritonavir in patients receiving the antiarrhythmic agents, flecainide and propafenone. If LEXIVA is coadministered with ritonavir, reference should be made to the full prescribing information for ritonavir for additional contraindications.

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