The medication EMEND (fosaprepitant dimeglumine), which is used as an injection, now has FDA approval to be used as a supplemental treatment in combination with other antiemetics to prevent delayed nausea from chemotherapy.
Single-dose EMEND (fosaprepitant dimeglumine) injection has now been approved by the FDA as a supplemental treatment to be used in combination with other antiemetic medicines for the prevention of delayed nausea in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC).
The approval was based on data from a phase 3 study showing that EMEND injection, with other anti-vomiting medicines, helped to prevent delayed nausea and vomiting following MEC compared with an active control regimen. A significant response rate of 78.9% was observed in patients treated with an EMEND regimen, versus a response rate of 68.5% with the control regimen.
The trial reported that patients receiving EMEND generally had a higher likelihood of adverse reactions compared with the control regimen, the most common being 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%).