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EMEND® is a substance P/neurokinin 1 (NK1) receptor antagonist, indicated: • in combination with other antiemetic agents for the: o prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1) o prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1)
• for the prevention of postoperative nausea and vomiting (PONV) (1.2) Limitations of Use (1.3)
• Not studied for the treatment of established nausea and vomiting.
• Chronic continuous administration is not recommended.
• Clinical adverse experiences for the CINV regimen in conjunction with highly and moderately emetogenic chemotherapy (incidence >10% are: alopecia, anorexia, asthenia/fatigue, constipation, diarrhea, headache, hiccups, nausea. (6.1)
• Clinical adverse experiences for the PONV regimen (incidence >5%) are: constipation, hypotension, nausea, pruritus, pyrexia. (6.1)
Aprepitant is a substrate for CYP3A4; therefore, coadministration of EMEND with drugs that inhibit or induce CYP3A4 activity may result in increased or reduced plasma concentrations of aprepitant, respectively. (5.1, 7.1, 7.2).
• Aprepitant is an inducer of CYP2C9; therefore, coadministration of EMEND with drugs that are metabolized by CYP2C9 (e.g. warfarin, tolbutamide), may result in lower plasma concentrations of these drugs. (5.2, 7.1)
Coadministration of aprepitant with warfarin (a CYP2C9 substrate) may result in a clinically significant decrease in International Normalized Ratio (INR) of prothrombin time. (5.2) • The efficacy of hormonal contraceptives during and for 28 days following the last dose of EMEND may be reduced. Alternative or back-up methods of contraception should be used. (5.3, 7.1)
• EMEND is a dose-dependent inhibitor of CYP3A4, and should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. (5.1)
• Caution should be exercised when administered in patients with severe hepatic impairment. (2.5, 5.4, 12.3)
