Agenerase

Drug List

Agenerase

Drug Name

Agenerase (Amprenavir)

Manufactured By

GlaxoSmithKline LLC

Drug Savings


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Treats Disease/Condition

HIV

Uses

Amprenavir is an inhibitor of HIV-1 protease. Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.

How To Use

: 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: Effect 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 and Oral Solution exceeds the Reference Daily Intake (adults 30 IU, pediatrics approximately 10 IU) (see DESCRIPTION). Adults: The recommended oral dose of AGENERASE Capsules for adults is 1200 mg (eight 150-mg capsules) twice daily in combination with other antiretroviral agents. Pediatric Patients: AGENERASE Capsules: For adolescents (13 to 16 years), the recommended oral dose of AGENERASE Capsules is 1200 mg (eight 150-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 is 20 mg/kg twice daily or 15 mg/kg three times daily (to a maximum daily dose of 2400 mg) in combination with other antiretroviral agents. AGENERASE Oral Solution: The recommended oral dose of AGENERASE Oral Solution for patients between 4 and 12 years of age or for patients 13 to 16 years of age with weight <50 kg is 22.5 mg/kg (1.5 mL/kg) twice daily or 17 mg/kg (1.1 mL/kg) three times daily (to a maximum daily dose of 2800 mg) in combination with other antiretroviral agents. AGENERASE Capsules and AGENERASE Oral Solution are not interchangeable on a milligram per milligram basis (see CLINICAL PHARMACOLOGY). Patients with Hepatic Impairment: AGENERASE 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 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

Side Effects

: Rates of discontinuation of randomized therapy due to adverse events were 15% in amprenavir vs 3% in placebo recipients from Study 3001, and 16% in amprenavir vs 8% in indinavir recipients from Study 3006. In these studies, adverse events leading to amprenavir discontinuation included gastrointestinal events (11%), rash (3%), and paresthesias (<1%). Most gastrointestinal events (nausea, vomiting, diarrhea, and abdominal pain) that led to amprenavir discontinuation were graded as mild or moderate in severity. In all multidose studies in HIV-infected patients, skin rash occurred in 28% of patients treated with amprenavir. Rashes were usually maculopapular and of mild or moderate intensity, some with pruritus. Rashes had onsets ranging from 7 to 73 days (median: 10 days) after amprenavir initiation. With mild or moderate rash, amprenavir dosing was often continued without interruption; if interrupted, reintroduction of amprenavir generally did not result in rash recurrence (Phase 3 studies). Severe or life-threatening rash, including Stevens-Johnson syndrome, occurred in 1% of recipients of AGENERASE (4% of recipients who developed rash) (see WARNINGS). Amprenavir therapy should be discontinued for severe or life-threatening rashes and for moderate rashes accompanied by systemic symptoms.

Drug Interactions

Amprenavir is metabolized in the liver by the cytochrome P450 enzyme system. Amprenavir inhibits CYP3A4. Caution should be used when coadministering medications that are substrates, inhibitors, or inducers of CYP3A4, or potentially toxic medications that are metabolized by CYP3A4. Amprenavir does not inhibit CYP2D6, CYP1A2, CYP2C9, CYP2C19, CYP2E1, or uridine glucuronosyltransferase (UDPGT). Drug interaction studies were performed with amprenavir and other drugs likely to be coadministered or drugs commonly used as probes for pharmacokinetic interactions. The effects of coadministration of amprenavir on the AUC, Cmax, and C

In Case of Overdose

OVERDOSAGE: There is no known antidote for AGENERASE. It is not known whether amprenavir can be removed by peritoneal dialysis or hemodialysis. If overdosage occurs, the patient should be monitored for evidence of toxicity and standard supportive treatment applied as necessary.

In Case of Missed Dose

If you miss a dose of AGENERASE by more than 4 hours, wait and take the next dose at the regularly scheduled time. However, if you miss a dose by fewer than 4 hours, take your missed dose immediately. Then take your next dose at the regularly scheduled time. Do not take more or less than your prescribed dose of AGENERASE at any one time.

Storage

Store at controlled room temperature of 25°C (77°F) (see USP). AGENERASE Oral Solution, a clear, pale yellow to yellow, grape bubblegum peppermint-flavored liquid, contains 15 mg of amprenavir in each 1 mL. Bottles of 240 mL with child-resistant closures (NDC 0173-0687-00). This product does not require reconstitution. Store at controlled room temperature of 25°C (77°F) (see USP