Cinvanti Approved for Chemotherapy-Induced Nausea and Vomiting
The Food and Drug Administration (FDA) has approved Cinvanti (aprepitant; Heron Therapeutics), in combination with other antiemetic agents, for the 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 nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Cinvanti, a substance P/neurokinin-1 (NK1) receptor antagonist, is an injectable emulsion for intravenous (IV) infusion that helps address the low water solubility of aprepitant without the addition of polysorbate 80 or other synthetic surfactants. Polysorbate 80 has been associated with hypersensitivity reactions such as anaphylaxis and irritation of blood vessels.
The approval of Cinvanti was supported by Phase 2 bioequivalence data of Cinvanti and Emend IV (fosaprepitant dimeglumine; Merck), where patients treated with Cinvanti experienced fewer adverse events vs. patients treated with Emend IV, including substantially fewer infusion-site reactions. The findings supported its efficacy in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following highly and moderately emetogenic cancer chemotherapy.
Cinvanti will be available as a 130mg/18mL strength emulsion for IV infusion in single-dose vials. It is anticipated to be available on January 3, 2018.
For more information call (844) 437-6611 or visit Cinvanti.com.