Fresenius Kabi Introduces Simplist® Palonosetron Hydrochloride Injection Prefilled Syringe

LAKE ZURICH, Ill., October 22, 2018 - Fresenius Kabi announced today the immediate availability in the United States of the Simplist® Palonosetron Hydrochloride Injection. The Simplist® Palonosetron Hydrochloride Injection is available in a 0.25 mg per 5 mL single dose ready-to-administer prefilled syringe.

Fresenius Kabi offers the first and only FDA-approved prefilled delivery system for this medication.

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company is a leading developer, manufacturer and provider of injected and infused medicines in the United States with special expertise in producing high quality, affordable generic alternatives to more expensive brand-name drugs.

"The availability of Palonosetron Hydrochloride in a prefilled syringe is an important new option for clinicians treating people with cancer. Fresenius Kabi is pleased to be the first company to offer this medication in a ready-to-administer syringe," said John Ducker, president and CEO of Fresenius Kabi USA. "Ready-to-administer delivery systems like this are designed to help improve patient safety and streamline drug preparation. We are pleased to continue to expand our Simplist portfolio to meet the needs of clinicians and the patients they treat."

About Simplist Palonosetron Hydrochloride Injection

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.
• Highly emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses.

Palonosetron HCl 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.

IMPORTANT SAFETY INFORMATION

Palonosetron HCl Injection is contraindicated in patients known to have hypersensitivity to palonosetron or any of its components.

Do not use the prefilled syringe to administer a dose of less than 0.25 mg (5 mL).

Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other selective 5-HT3 receptor antagonists.

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 and initiate supportive treatment.

The most common adverse reactions in chemotherapy-induced nausea and vomiting (≥5%) are 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 Simplist Palonosetron Hydrochloride Injection safely and effectively. Palonosetron is a new addition to the Simplist portfolio and has slight differences from the glass syringes; please refer to the package insert (https://tinyurl.com/ycbjflwd) for features, administration and full prescribing information for Palonosetron prefilled syringe use. This information is also available at www.fresenius-kabi.com/us.

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