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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.

Patients With Hepatic Impairment

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