The Food and Drug Administration (FDA) has approved an expanded label for Cinvanti (aprepitant; Heron Therapeutics) to include the use of the 130mg single-dose regimen for patients receiving moderately emetogenic chemotherapy.
Cinvanti, in combination with other antiemetic agents, is now indicated for use in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy, including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy.
The approval of the supplemental New Drug Application standardizes the 130mg single-dose regimen for patients receiving highly emetogenic chemotherapy and/or moderately emetogenic chemotherapy as an injection over 2 minutes or an infusion over 30 minutes. In addition, the updated labeling removes the need for patients to take oral aprepitant on Days 2 and 3 following moderately emetogenic chemotherapy administration.
Cinvanti, a substance P/neurokinin-1 (NK1) receptor antagonist, is free of polysorbate 80 and other synthetic surfactants; polysorbate 80 has been associated with hypersensitivity reactions such as anaphylaxis and irritation of blood vessels. It is supplied as a 130mg/18mL strength emulsion in single-dose vials.
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