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The US Food and Drug Administration (FDA) has approved a fixed-dose combination of the antiretroviral drug darunavir (800 mg) and the pharmacokinetic enhancer cobicistat (150 mg) for HIV"...
(Generic versions may still be available.)
AGENERASE (amprenavir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The following points should be considered when initiating therapy with AGENERASE:
In a study of NRTI-experienced, protease inhibitor-naive
patients, AGENERASE was found to be significantly less effective than indinavir
(see DESCRIPTION OF CLINICAL STUDIES).
Mild to moderate gastrointestinal adverse events led to discontinuation of AGENERASE primarily during the first 12 weeks of therapy (see ADVERSE REACTIONS).
There are no data on response to therapy with AGENERASE in protease inhibitor-experienced patients.
DOSAGE AND ADMINISTRATION
AGENERASE may be taken with or without food; however, a high- fat meal decreases the absorption of amprenavir and should be avoided (see CLINICAL PHARMACOLOGY: Effects of Food on Oral Absorption). Adult and pediatric patients should be advised not to take supplemental vitamin E since the vitamin E content of AGENERASE Capsules (amprenavir capsules) exceeds the Reference Daily Intake (adults 30 IU, pediatrics approximately 10 IU) (see DESCRIPTION).
Adults: The recommended oral dose of AGENERASE Capsules (amprenavir capsules) for adults is 1,200 mg (twenty- four 50- mg capsules) twice daily in combination with other antiretroviral agents.
Concomitant Therapy: If AGENERASE and ritonavir are used in combination, the recommended dosage regimens are: AGENERASE 1,200 mg with ritonavir 200 mg once daily or AGENERASE 600 mg with ritonavir 100 mg twice daily.
Pediatric Patients: For adolescents (13 to 16 years), the recommended oral dose of AGENERASE Capsules (amprenavir capsules) is 1,200 mg (twenty- four 50- mg capsules) twice daily in combination with other antiretroviral agents. For patients between 4 and 12 years of age or for patients 13 to 16 years of age with weight of < 50 kg, the recommended oral dose of AGENERASE Capsules (amprenavir capsules) is 20 mg/kg twice daily or 15 mg/kg 3 times daily (to a maximum daily dose of 2,400 mg) in combination with other antiretroviral agents. The recommended dose of AGENERASE for use in combination with ritonavir has not been established in pediatric patients.
Before using AGENERASE Oral Solution, the complete prescribing information should be consulted.
AGENERASE Capsules (amprenavir capsules) and AGENERASE Oral Solution are not interchangeable on a milligram-per-milligram basis (see CLINICAL PHARMACOLOGY).
Patients with Hepatic Impairment: AGENERASE Capsules (amprenavir capsules) should be used with caution in patients with moderate or severe hepatic impairment. Patients with a Child-Pugh score ranging from 5 to 8 should receive a reduced dose of AGENERASE Capsules (amprenavir capsules) of 450 mg twice daily, and patients with a Child-Pugh score ranging from 9 to 12 should receive a reduced dose of AGENERASE Capsules of 300 mg twice daily (see CLINICAL PHARMACOLOGY: Hepatic Insufficiency).
AGENERASE Capsules (amprenavir capsules) , 50 mg, are oblong, opaque, off-white to cream-colored soft gelatin capsules printed with “GX CC1” on one side.
Bottles of 480 with child-resistant closures (NDC 0173-0679-00).
Store at controlled room temperature of 25°C (77°F) (see USP).
AGENERASE Capsules (amprenavir capsules) are manufactured by R.P. Scherer Beinheim, France for GlaxoSmithKline, Research Triangle Park, NC 27709. Licensed from: Vertex Pharmaceuticals Incorporated, Cambridge, MA 02139. AGENERASE is a registered trademark of GlaxoSmithKline. May 2005. FDA rev date: 11/4/2005This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/16/2008
Additional Agenerase Capsules Information
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