LEXIVA

LEXIVA- fosamprenavir calcium tablet, film coated
LEXIVA- fosamprenavir calcium suspension
ViiV Healthcare Company

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 (2.2, 2.3), 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

2.1 General Dosing Information

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.

2.2 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 ritonavir 100 mg 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.

Pregnancy

LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily.
Dosing of LEXIVA 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 LEXIVA/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 LEXIVA (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 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 (Aged 4 Weeks and Older) and for Protease Inhibitor-Experienced Pediatric Patients (Aged 6 Months and Older) Using LEXIVA Oral Suspension with Concurrent Ritonavir
a When dosing with ritonavir, do not exceed the adult dose of LEXIVA 700 mg/ritonavir 100 mg twice-daily dose.

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

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 postnatal 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.

2.4 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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.