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Palonosetron Hydrochloride (HCl) Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in adults for:
• Moderately emetogenic cancer chemotherapy: prevention of acute and delayed nausea and vomiting associated with initial and repeat courses. (1.1)
• Highly emetogenic cancer chemotherapy: prevention of acute nausea and vomiting associated with initial and repeat courses. (1.1)
• Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. (1.2) ]
Palonosetron Hydrochloride Injection is indicated in pediatric patients aged 1 month to less than 17 years for:
• Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. (1.2)
The most common adverse reactions in
• chemotherapy-induced nausea and vomiting (≥5%) are: headache and constipation. (6.1)
• postoperative nausea and vomiting (≥2%) are: QT prolongation, bradycardia, headache, and constipation. (6.1)
Serotonergic Drugs: Monitor for serotonin syndrome; if symptoms occur, discontinue Palonosetron Injection and initiate supportive treatment. (7.1)
Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other selective 5-HT3 receptor antagonists. (5.1)
• Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. (5.2, 7.1)