The Food and Drug Administration has approved single-dose fosaprepitant for injection, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy.
Fosaprepitant for injection is the first intravenous single-dose NK1 receptor antagonist approved in the United States for both highly emetogenic chemotherapy as well as moderately emetogenic chemotherapy.
Approval was based on a 78.9% complete response rate (no vomiting and no use of rescue therapy) during the delayed phase, 25-120 hours following initiation of moderately emetogenic chemotherapy, compared with a 68.5% complete response rate among those receiving the control regimen in a phase III trial (P less than .001). The treatment group of 502 patients received fosaprepitant for injection (150 mg) as a single intravenous infusion in combination with ondansetron and dexamethasone, compared with the control group of 498 patients who received ondansetron and dexamethasone alone, according to a statement released by Merck, developers of fosaprepitant (Emend).
The most-common adverse reactions reported among the patients receiving the fosaprepitant injection 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%), according to Merck.
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