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AKYNZEO- netupitant and palonosetron capsuleAKYNZEO- fosnetupitant and palonosetron injection


Patient Information

Advise patients to read the FDA-approved patient labeling (Patient Information).

Administration

Advise patients to take AKYNZEO capsules with or without food approximately 1 hour prior to the start of chemotherapy[see Dosage and Administration (2.1)].

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions, including anaphylaxis, may occur in patients receiving AKYNZEO. Advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur while taking AKYNZEO[See Warnings and Precautions (5.1)].

Serotonin Syndrome

Advise patients of the possibility of serotonin syndrome especially with concomitant use of AKYNZEO and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms, with or without gastrointestinal symptoms[see Warnings and Precautions (5.2)].

Pregnancy

Inform female patients of reproductive potential that AKYNZEO may cause fetal harm and to inform their prescriber of a known or suspected pregnancy[see Use in Specific Populations (8.1)].

Manufactured by Helsinn Birex Pharmaceuticals, Dublin, Ireland for Helsinn Healthcare SA, Switzerland

Distributed by Helsinn Therapeutics (U.S.), Inc., Iselin, NJ08830, under license of Helsinn Healthcare SA, Switzerland

AKYNZEO is a registered trademark of Helsinn Healthcare SA, Lugano, Switzerland



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