Lexiva
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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:
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- 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)].
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- 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)].
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- Dosing of LEXIVA plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months [see Clinical Pharmacology (12.3)].
History
There is currently no drug history available for this drug.
Other Information
LEXIVA (fosamprenavir calcium) is a prodrug of amprenavir, an inhibitor of HIV protease. The chemical name of fosamprenavir calcium is (3S)-tetrahydrofuran-3-yl (1S,2R)-3-[[(4-aminophenyl) sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy) propylcarbamate monocalcium salt. Fosamprenavir calcium is a single stereoisomer with the (3S)(1S,2R) configuration. It has a molecular formula of C25H34CaN3O9PS and a molecular weight of 623.7. It has the following structural formula:
Fosamprenavir calcium is a white to cream-colored solid with a solubility of approximately 0.31 mg per mL in water at 25°C.
LEXIVA Tablets are available for oral administration in a strength of 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir). Each 700 mg tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone K30. The tablet film-coating contains the inactive ingredients hypromellose, iron oxide red, titanium dioxide, and triacetin.
LEXIVA Oral Suspension is available in a strength of 50 mg per mL of fosamprenavir as fosamprenavir calcium equivalent to approximately 43 mg of amprenavir. LEXIVA Oral Suspension is a white to off-white suspension with a grape-bubblegum-peppermint flavor. Each one milliliter (1 mL) contains the inactive ingredients artificial grape-bubblegum flavor, calcium chloride dihydrate, hypromellose, methylparaben, natural peppermint flavor, polysorbate 80, propylene glycol, propylparaben, purified water, and sucralose.
Sources
Lexiva Manufacturers
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State Of Florida Doh Central Pharmacy
![Lexiva (Fosamprenavir Calcium) Tablet, Film Coated [State Of Florida Doh Central Pharmacy]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lexiva | State Of Florida Doh Central Pharmacy
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 AdultsTherapy-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
aWhen 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 ImpairmentSee 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.
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State Of Florida Doh Central Pharmacy
Lexiva | State Of Florida Doh Central Pharmacy
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 AdultsTherapy-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 (2 to 18 years of age)The recommended dosage of LEXIVA in patients ≥2 years of age 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 2 to 5 years of age.
Therapy-Naive 2 to 5 Years of Age
LEXIVA Oral Suspension 30 mg/kg twice daily, not to exceed the adult dose of LEXIVA 1,400 mg twice daily.Therapy-Naive ≥6 Years of Age
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 ≥6 Years of Age
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. 2.3 Patients With Hepatic ImpairmentSee 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).
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Remedyrepack Inc.
Lexiva | Remedyrepack Inc.
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.
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.
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
aWhen 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.
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.
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Viiv Healthcare Company
Lexiva | Viiv Healthcare Company
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 AdultsTherapy-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 (Aged 4 Weeks and Older) and for Protease Inhibitor-experienced Pediatric Patients (Aged 6 Months and Older) 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
aWhen 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 ImpairmentSee 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.
![Lexiva (Fosamprenavir Calcium) Tablet, Film Coated [State Of Florida Doh Central Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=009575f9-74e8-4a6d-9fa6-3cae72fd01c3&name=Lexiva700mg(GlaxoSmithKline).jpg)
![Lexiva (Fosamprenavir Calcium) Tablet, Film Coated [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a05ef847-96e1-4f95-b35f-92c907df1e1f&name=MM3.jpg)
![Lexiva (Fosamprenavir Calcium) Tablet, Film Coated Lexiva (Fosamprenavir Calcium) Suspension [Viiv Healthcare Company]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=24feb9be-32a6-45fd-a896-f3e202edd8a9&name=lexiva-spl-graphic-03.jpg)
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