Fresenius Kabi Introduces Palonosetron Hydrochloride Injection

About Palonosetron Hydrochloride Injection

Palonosetron Hydrochloride (HCl) Injection is a 5-HT3 serotonin receptor indicated in adults for moderately emetogenic cancer chemotherapy - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses; highly emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses; and prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.

Important Safety Information

Palonosetron HCl Injection is contraindicated in patients with hypersensitivity to palonosetron or any of its components (e.g., anaphylaxis).

Serotonin Syndrome: Development of serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue Palonosetron HCl Injection.

The most common adverse reactions in chemotherapy-induced nausea and vomiting (≥5%) are headache and constipation.

The most common adverse reactions in postoperative nausea and vomiting (≥2%) are QT prolongation, bradycardia, headache, and constipation

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use Palonosetron Hydrochloride Injection safely and effectively. Please see full prescribing information for Palonosetron Hydrochloride Injection at https://tinyurl.com/y9hnc2bp or www.fresenius-kabi.com/us.