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Emend is an antiemetic, a medicine that prevents nausea (feeling sick) and vomiting. Emend is used in patients aged from 6 months to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer).
The indication applied for EMEND by the Applicant is “prevention of acute and delayed nausea and vomiting associated with initial and repeated courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin, in combination with other antiemetic agents”.
EMEND (aprepitant, MK-0869) is a substance P (NK1 receptor) antagonist, which in combination with other antiemetic agents, is indicated for prevention of acute and delayed nausea and vomiting in adults.
EMA/431270/2016. Annex VII – to guidance for the conduct of good clinical practice inspections – bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials. Adopted by GCP Inspectors Working Group (GCP IWG) 29 November 2017. Keywords.
Example: Test distribution “entirely contained” within reference distribution, regardless of differences in means and spread (variability); Reference Medicinal Product Biosimilar Candidate
EMEND należy przyjmować przez 3 dni w skojarzeniu z kortykosteroidem i antagonistą receptora 5-HT3. Zalecana dawka wynosi 125 mg, raz na dobę, podana doustnie na godzinę przed rozpoczęciem chemioterapii w 1. dniu oraz dawka 80 mg, raz na dobę, podana doustnie rano w 2. i 3. dniu.
EMEND® (aprepitant capsules) Page 6 of 40 Table 1 – All adverse experiences, regardless of causality (incidence ≥3%), occurring in patients receiving highly emetogenic chemotherapy who were treated with the aprepitant regimen for chemotherapy induced nausea and vomiting (CINV) in clinical studies (cycle 1)
