The regimen with EMEND was compared with an active-control regimen
Study designa
a
Study design: Data from 2 multicenter, randomized, double-blind, parallel-group, controlled clinical trials that compared the regimen including EMEND with an active control regimen in chemotherapy-naive patients (N=1,105) receiving a chemotherapy regimen that included cisplatin >50 mg/m2. The most common primary diagnoses were respiratory and urogenital carcinomas.21,22
Significantly more patients on the regimen with EMEND achieved complete response as compared with those on an active-control regimen
Complete response (no vomiting, no rescue medicationb)–Study 1
b
Because patients could use rescue medication for nausea and/or vomiting, the end point “no use of rescue medication” is a surrogate for “no nausea.”21,22
- In Study 2, the percentage of patients on the regimen with EMEND who achieved complete response as compared with those on an active-control regimen was similar to Study 1 (63% vs 43%, P<0.001).
Selected Important Risk Information
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.
Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine. In clinical studies, EMEND 125 mg/80 mg was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions. In separate pharmacokinetic studies, EMEND 125 mg/80 mg did not influence the pharmacokinetics of docetaxel or vinorelbine.
Before prescribing EMEND and EMEND for Injection, please read the Prescribing Information. The Patient Information also is available.
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