fda说明书.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION • Serotonin syndrome has been reported with 5-HT3 receptor antagonists These highlights do not include all the information needed to use alone but particularly with concomitant use of serotonergic drugs (5.2) AKYNZEO® safely and effectively. See full prescribing information for AKYNZEO®. ADVERSE RE ACT IONS­ ® Most common adverse reactions (incidence ≥3% and greater than AKYNZEO (netupitant and palonosetron) capsules, for oral use palonosetron) are headache, asthenia, dyspepsia, fatigue, constipation and Initial U.S. Approval: 2014 erythema (6.1) I NDI CAT I ON S AN D US AGE­ To report SUSPECTED ADVERSE REACTIONS, contact EISAI at AKYNZEO is a fixed combination of netupitant, a substance P/neurokinin 1 1-888-422-4743 or FDA at 1-800-FDA-1088 or /medwatch. (NK ) receptor antagonist, and palonosetron, a serotonin-3 (5-HT ) receptor 1 3 antagonist indicated for the prevention of acute and delayed nausea and DRUG INTERACTIONS­ vomiting associated with initial and repeat courses of cancer chemotherapy, • CYP3A4 Substrates: inhibition of CYP3A4 by netupitant can result in including, but not limited to, highly emetogenic chemotherapy. Oral increased