Prescription Drug Information: Fosamprenavir Calcium

FOSAMPRENAVIR CALCIUM- fosamprenavir calcium tablet, coated
Sun Pharmaceutical Industries, Inc.

1 INDICATIONS AND USAGE

Fosamprenavir calcium tablets are 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 fosamprenavir calcium tabletsplus ritonavir in protease inhibitor-experienced patients:

The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir calcium tabletsplus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)].
Once-daily administration of fosamprenavir calcium tabletsplus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients [see Dosage and Administration (2.2,2.3), Clinical Studies (14.2, 14.3)].
Dosing of fosamprenavir calcium tabletsplus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months [see Clinical Pharmacology (12.3)].

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

Fosamprenavir calcium tablets may be taken with or without food.

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

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

When fosamprenavir calcium tablets are used in combination with ritonavir, prescribers should consult the full prescribing information for ritonavir.

2.2 Adults

Therapy-Naive Adults

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

Fosamprenavir calcium tablets 700 mg twice daily plus ritonavir 100 mg twice daily.

Pregnancy

Fosamprenavir calcium tablets 700 mg twice daily plus ritonavir 100 mg twice daily.
Dosing of fosamprenavir calcium tablets 700 mg twice daily plus ritonavir 100 mg twice daily should only be considered in pregnant patients who are already on a stable twice-daily regimen of fosamprenavir calcium /ritonavir 700 mg/100 mg prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL). Lower exposures of amprenavir were observed during pregnancy; therefore, viral load should be monitored closely to ensure viral suppression is maintained [see Use in Specific Populations (8.1), Clinical Pharmacology (12.3)]. Data regarding use of other regimens of fosamprenavir calcium tablets (with or without ritonavir) in pregnancy are not available.

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

The recommended dosage of fosamprenavir calcium 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 (Aged 4 Weeks and Older) and for Protease Inhibitor-Experienced Pediatric Patients (Aged 6 Months and Older) Using Fosamprenavir Calcium Oral Suspension with Concurrent Ritonavir

Weight

Twice-Daily Dosage Regimen

< 11 kg

Fosamprenavir Calcium 45 mg/kg plus ritonavir 7 mg/kga

11 kg — < 15 kg

Fosamprenavir Calcium 30 mg/kg plus ritonavir 3 mg/kga

15 kg — < 20 kg

Fosamprenavir Calcium 23 mg/kg plus ritonavir 3 mg/kga

≥ 20 kg

Fosamprenavir Calcium 18 mg/kg plus ritonavir 3 mg/kga

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

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

Fosamprenavir calcium should only be administered to infants born at 38 weeks’ gestation or greater and who have attained a postnatal age of 28 days.

For pediatric patients, pharmacokinetic and clinical data:

do not support once-daily dosing of fosamprenavir calcium alone or in combination with ritonavir [see Clinical Studies (14.3)].
do not support administration of fosamprenavir calcium 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 fosamprenavir calcium 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 fosamprenavir calcium tablets 1,400 mg twice daily may be used for pediatric patients weighing at least 47 kg.

When administered in combination with ritonavir, fosamprenavir calcium 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.

2.4 Patients with Hepatic Impairment

See Clinical Pharmacology (12.3).

Mild Hepatic Impairment (Child-Pugh Score Ranging from 5 to 6)

Fosamprenavir calcium tablets 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)

Fosamprenavir calcium tablets 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)

Fosamprenavir calcium tablets 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

Fosamprenavir calcium tablets, 700 mg, are pink colored, coated, oval-shaped tablets with “RJ47 ” imprinted on one side with black ink and plain on the other side.

4 CONTRAINDICATIONS

Fosamprenavir calcium 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.
Fosamprenavir calcium is contraindicated when coadministered with drugs that are highly dependent on cytochrome P450 (CYP)3A4 for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs and other contraindicated drugs (which may lead to reduced efficacy of fosamprenavir calcium and possible resistance) are listed below [see Drug Interactions (7), Clinical Pharmacology (12.3)]. The list of contraindicated drugs applies to the use of fosamprenavir calcium with or without ritonavir, unless otherwise indicated. If fosamprenavir calcium is coadministered with ritonavir, reference should be made to the full prescribing information for ritonavir for additional contraindications.
Fosamprenavir calcium is contraindicated when coadministered with the following drugs:
Alpha 1-adrenoreceptor antagonist: Alfuzosin
Antiarrhythmics: Flecainide (with ritonavir), propafenone (with ritonavir)
Antimycobacterial: Rifampin
Antipsychotic: Lurasidone (with ritonavir), pimozide
Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine
GI motility agent: Cisapride
Herbal product: St. John’s wort (Hypericum perforatum)
Lipid modifying agents: Lomitapide, lovastatin, simvastatin
Non-nucleoside reverse transcriptase inhibitor: Delavirdine
PDE5 inhibitor: Sildenafil (REVATIO) (for treatment of pulmonary arterial hypertension)
Sedative/hypnotics: Midazolam, triazolam

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Serious Adverse Reactions Due to Drug Interactions

Initiation of fosamprenavir calcium/ritonavir, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A, or initiation of medications metabolized by CYP3A in patients already receiving fosamprenavir calcium/ritonavir may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of fosamprenavir calcium/ritonavir, respectively. These interactions may lead to:

clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications.
clinically significant adverse reactions from greater exposures of fosamprenavir calcium/ritonavir.
loss of therapeutic effect of fosamprenavir calcium/ritonavir and possible development of resistance.

See Table 6 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations [see Drug Interactions (7)]. Consider the potential for drug interactions prior to and during therapy with fosamprenavir calcium/ritonavir; review concomitant medications during therapy with fosamprenavir calcium/ritonavir, and monitor for the adverse reactions associated with the concomitant medications [see Contraindications (4), Drug Interactions (7)].

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