Ruitaning® is the commercial brand name of Fosrolapitant and Palonosetron Hydrochloride for Injection, a fixed-combination antiemetic injection developed by Hengrui Medicine. It consists of fosrolapitant, a long-acting NK-1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, to block two key pathways of chemotherapy-induced nausea and vomiting.
Main Indications
Prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy in adult patients.
Clinical Research
The pivotal phase III trial in China demonstrated that the fixed combination achieved superior complete response rate for overall chemotherapy-induced nausea and vomiting compared with palonosetron monotherapy;
The study confirmed good tolerance and stable long-lasting antiemetic effect covering the acute and delayed phase;
Additional studies explored its application in moderately emetogenic chemotherapy settings.
Common Side Effects
Severe but important risks: Severe hypersensitivity reactions, bradycardia, QT interval prolongation;
Common mild adverse reactions: Headache, constipation, fatigue, dizziness, diarrhea and decreased appetite.
Approval Status in China
Original drug Ruitaning® (Fosrolapitant and Palonosetron Hydrochloride for Injection, specification: 218mg/0.25mg per vial) was officially approved for marketing in China in 2023. It is currently a prescription fixed-combination antiemetic agent.
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