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Efficacy

Highly Emetogenic Chemotherapy (HEC)
Compared with an active-control regimen, the regimen with EMEND provided superior and sustained efficacy in highly emetogenic chemotherapy.

Moderately Emetogenic Chemotherapy (MEC)
EMEND–Expanded evidence for a broad range of MEC regimens treating various tumor types, including1:

breast – colorectal – lung – ovarian

Pathophysiology
The regimen with EMEND targets both key emetic pathways.

EMEND and EMEND for Injection, in combination with other antiemetic agents, are indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin; and for prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Selected Important Risk Information

EMEND, when administered orally, is a moderate cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitor. Because fosaprepitant is rapidly converted to aprepitant, neither drug should be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions.

EMEND should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. Inhibition of CYP3A4 by EMEND could result in elevated plasma concentrations of these concomitant medications. Conversely, when EMEND is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated.

Because a small number of patients in clinical studies received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily by CYP3A4 that were not studied.

The most frequent adverse events reported in clinical trials of EMEND for highly emetogenic chemotherapy were asthenia/fatigue (17.8%), nausea (12.7%), hiccups (10.8%), constipation (10.3%), diarrhea (10.3%), and anorexia (10.1%).

The most frequent adverse events reported in clinical trials of EMEND for moderately emetogenic chemotherapy were alopecia (24.0%), fatigue (21.9%), headache (16.4%), constipation (12.3%), neutropenia (8.9%), dyspepsia (8.4%), stomatitis (5.3%), hot flush (3.0%), and pharyngolaryngeal pain (3.0%).

Before prescribing EMEND or EMEND for Injection, please read the Prescribing Information. The Patient Information also is available.

  1. Reference 1:Boice JA, Schmoll H, Brown C, Taylor A. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Presented at: Annual Meeting of the American Society of Clinical Oncology; May 29–June 2, 2009; Orlando, FL. Abstract 9626.
20906183(6)-11/09-EME