FDA Nofitications

FDA approves new formulation of Lexiva

On June 14, 2007, FDA approved a new formulation of fosamprenavir calcium (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:

A copy of the full prescribing information is attached.

DOSAGE AND ADMINISTRATION:

Pediatric Patients (2 to 18 years of age): The recommended dosage of fosamprenavir calcium 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 fosamprenavir alone or in combination with ritonavir, and (2) any dosing of fosamprenavir in therapy-experienced patients 2 to 5 years of age.

Therapy-Naïve 2 to 5 Years of Age: Fosamprenavir Oral Suspension 30 mg/kg twice daily, not to exceed the adult dose of fosamprenavir, 400 mg twice daily.

Therapy-Naïve > 6 Years of Age: Either fosamprenavir Oral Suspension 30mg/kg twice daily not to exceed the adult dose of fosamprenavir 1,400 mg twice daily or fosamprenavir Oral Suspension 18 mg/kg plus ritonavir 3 mg/kg twice daily not to exceed the adult dose of fosamprenavir 700 mg plus ritonavir 100 mg twice daily.

Therapy-Experienced > 6 Years of Age: Fosamprenavir Oral Suspension 18 mg/kg plus ritonavir 3 mg/kg administered twice daily not to exceed the adult dose of fosamprenavir 700 mg plus ritonavir 100 mg twice daily.

When administered without ritonavir, the adult regimen of fosamprenavir tablets, 1,400 mg twice daily, may be used for pediatric patients weighing at least 47 kg.

When administered in combination with ritonavir, fosamprenavir 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): Fosamprenavir should be used with caution at a reduced dosage of 700 mg twice daily without ritonavir (therapy-naïve) or 700 mg twice daily plus ritonavir 100 mg once daily (therapy-naïve or PI-experienced).

Moderate Hepatic Impairment (Child-Pugh score ranging from 7 to 9):

Fosamprenavir should be used with caution at a reduced dosage of 700 mg twice daily (therapy-naïve) without ritonavir, or 450 mg twice daily plus ritonavir 100 mg once daily (therapy-naïve or PI-experienced).

Severe Hepatic Impairment (Child-Pugh score ranging from 10 to 12):

Fosamprenavir should be used with caution at a reduced dosage of 350 mg twice daily without ritonavir (therapy-naïve). There are no data on the use of fosamprenavir in combination with ritonavir in patients with severe hepatic impairment.