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.

Adults

Therapy-Naive Adults

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LEXIVA 1,400 mg twice daily (without ritonavir).

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LEXIVA 1,400 mg once daily plus ritonavir 200 mg once daily.

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LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily.

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Dosing of LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily is supported by pharmacokinetic data [see Clinical Pharmacology (12.3)].

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

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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

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

Pregnancy

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

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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.

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).

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:

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do not support once-daily dosing of LEXIVA alone or in combination with ritonavir [see Clinical Studies (14.3)].

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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)].

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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

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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.

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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.

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.