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FDA Approval of Lexiva Oral Suspension and Label Changes for Pediatric Patients and Patients With Hepatic Impairment

June 18, 2007

On June 14, 2007, the Food and Drug Administration approved a new formulation of Lexiva. Lexiva (fosamprenavir calcium) is now available as an oral suspension (50-mg/mL). The package insert was updated to include information on this new formulation and to provide dosing information for pediatric patients and patients with hepatic impairment as follows:

Click here for a copy of the full prescribing information.


Dosage and Administration

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.

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  • 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 30mg/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 plus ritonavir 100 mg twice daily.

    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 of pediatric patients weighing at least 39 kg; ritonavir capsules may be used for pediatric patients weighing at least 33 kg.


Patients With Hepatic Impairment

  • 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 PI-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 (therapy-naive) without ritonavir, or 450 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or PI-experienced).

  • Severe Hepatic Impairment (Child-Pugh Score Ranging From 10 to 12):
    LEXIVA should be used with caution at a reduced dosage of 350 mg twice daily without ritonavir (therapy-naive). There are no data on the use of LEXIVA in combination with ritonavir in patients with severe hepatic impairment.


  
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This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
 
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