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Lexiva

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Lexiva

Indications
Dosage
How Supplied

INDICATIONS

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 study was not large enough to reach a definitive conclusion that LEXIVA plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies].
  • Once-daily administration of LEXIVA plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients.

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]. 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].

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

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].

  • 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].

Protease Inhibitor-Experienced Adults
  • LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily

Pediatric Patients (Aged 2 to 18 Years)

The recommended dosage of LEXIVA in patients aged greater than or equal to 2 years should be calculated based on body weight (kg) and should not exceed the recommended adult dose. The data are insufficient to recommend: (1) once-daily dosing of LEXIVA alone or in combination with ritonavir, and (2) any dosing of LEXIVA in therapy-experienced patients aged 2 to 5 years.

Therapy-Naive Aged 2 to 5 Years
  • LEXIVA Oral Suspension 30 mg/kg twice daily, not to exceed the adult dose of LEXIVA 1,400 mg twice daily.
Therapy-Naive Aged Greater Than or Equal to 6 Years
  • Either LEXIVA Oral Suspension 30 mg/kg twice daily not to exceed the adult dose of LEXIVA 1,400 mg twice daily or LEXIVA Oral Suspension 18 mg/kg plus ritonavir 3 mg/kg twice daily not to exceed the adult dose of LEXIVA 700 mg plus ritonavir 100 mg twice daily.
Therapy-Experienced Aged Greater Than or Equal to 6 Years
  • LEXIVA Oral Suspension 18 mg/kg plus ritonavir 3 mg/kg administered twice daily not to exceed the adult dose of LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily.
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.

Patients With Hepatic Impairment

See CLINICAL PHARMACOLOGY.

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).

HOW SUPPLIED

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/mL, is a white to off-white suspension that has a characteristic grape-bubblegum-peppermint flavor.

Storage And Handling

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 at 5° to 30°C (41° to 86°F). Shake vigorously before using. Do not freeze.

Manufactured for: ViiV Healthcare Research Triangle Park, NC 27709. Vertex Pharmaceuticals Incorporated, Cambridge, MA 02139 45 by: GlaxoSmithKline Research Triangle Park, NC 27709. Month 2012

Last reviewed on RxList: 3/1/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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