Fosaprepitant Dimeglumine (EMEND) New Indication
On February 19th, 2016
Fosaprepitant dimeglumine for injection 150 mg is now indicated in adults in combination with other antiemetic agents for the prevention of delayed nausea and vomiting associated with initial and repeat courses of MEC. The approved dosage in adults is a single 150-mg intravenous (IV) infusion over 20 to 30 minutes approximately 30 minutes prior to chemotherapy on Day 1. The FDA approval of this new indication was based in part on findings from a randomized, parallel, doubleblind, active comparator-controlled study that evaluated fosaprepitant for injection as a single intravenous infusion in combination with ondansetron and dexamethasone (referred to as the EMEND regimen) (N=502) compared with ondansetron and dexamethasone alone (control regimen) (N=498) in patients receiving MEC. The primary endpoint was complete response (defined as no vomiting and no use of rescue therapy) in the delayed phase (25 to 120 hours following initiation of chemotherapy) of chemotherapy-induced nausea and vomiting. A 78.9% complete response rate was observed with the fosaprepitant dimeglumine regimen compared to 68.5% with the control regimen (P<0.001). The most common adverse reactions reported in the EMEND regimen versus control regimen were fatigue (15% vs 13%), diarrhea (13% vs 11%), neutropenia (8% vs 7%), asthenia (4% vs 3%), anemia (3% vs 2%), peripheral neuropathy (3% vs 2%), leukopenia (2% vs 1%), dyspepsia (2% vs 1%), urinary tract infection (2% vs 1%), and pain in extremity (2% vs 1%).
Indication fosaprepitant dimeglumine for injection, in combination with other antiemetic agents, is indicated in adults 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 delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Fosaprepitant dimeglumine for injection has not been studied for the treatment of established nausea and vomiting.
EMEND (fosaprepitant dimeglumine) is produced by Merck.
Fosaprepitant dimeglumine for injection 150 mg is now indicated in adults in combination with other antiemetic agents for the prevention of delayed nausea and vomiting associated with initial and repeat courses of MEC. The approved dosage in adults is a single 150-mg intravenous (IV) infusion over 20 to 30 minutes approximately 30 minutes prior to chemotherapy on Day 1. The FDA approval of this new indication was based in part on findings from a randomized, parallel, doubleblind, active comparator-controlled study that evaluated fosaprepitant for injection as a single intravenous infusion in combination with ondansetron and dexamethasone (referred to as the EMEND regimen) (N=502) compared with ondansetron and dexamethasone alone (control regimen) (N=498) in patients receiving MEC. The primary endpoint was complete response (defined as no vomiting and no use of rescue therapy) in the delayed phase (25 to 120 hours following initiation of chemotherapy) of chemotherapy-induced nausea and vomiting. A 78.9% complete response rate was observed with the fosaprepitant dimeglumine regimen compared to 68.5% with the control regimen (P<0.001). The most common adverse reactions reported in the EMEND regimen versus control regimen were fatigue (15% vs 13%), diarrhea (13% vs 11%), neutropenia (8% vs 7%), asthenia (4% vs 3%), anemia (3% vs 2%), peripheral neuropathy (3% vs 2%), leukopenia (2% vs 1%), dyspepsia (2% vs 1%), urinary tract infection (2% vs 1%), and pain in extremity (2% vs 1%).
Indication fosaprepitant dimeglumine for injection, in combination with other antiemetic agents, is indicated in adults 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 delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Fosaprepitant dimeglumine for injection has not been studied for the treatment of established nausea and vomiting.
EMEND (fosaprepitant dimeglumine) is produced by Merck.
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