Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
 |
Food and Drug Administration - 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:
A copy of the full prescribing information can be found here: Lexiva Prescribing Highlights.
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.
Therapy-Naïve 2 to 5 Years of Age:
Therapy-Naïve > 6 Years of Age:
Therapy-Experienced > 6 Years of Age:
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
Richard Klein | Office of Special Health Issues | Food and Drug Administration
Kimberly Struble | Division of Antiviral Drug Products | Food and Drug Administration
070618
FD070601
SOURCE: Food and Drug Administration (FDA).
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, Roche and Trimeris, and donations from users like you. Always watch for outdated information. This article first appeared in 2007. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2007. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .