Fresenius Kabi Broadens Radiology Portfolio with its First-to-Market Authorized Generic, Sincalide for Injection

Therapeutically equivalent and fully substitutable to Kinevac^® (Sincalide for Injection)

Formulated, filled and packaged in the United States

Provides health care facilities with choice and value

Fresenius Kabi, a leading provider of injectable medicines, announced today it has launched the diagnostic pharmaceutical agent, Sincalide for Injection, an authorized generic for Bracco Diagnostics Inc.’s Kinevac^® (Sincalide for Injection) product. The new product broadens Fresenius Kabi’s radiology portfolio and is available immediately in the United States.

Sincalide for Injection is a diagnostic aid used to help diagnose certain problems of the gallbladder and pancreas. Sincalide for Injection is also used to speed up the transit of a barium meal, a contrast agent, given in preparation for an X-ray examination of the intestines.¹

"Fresenius Kabi is pleased to introduce Sincalide for Injection in the U.S. as our newest first-to-market authorized generic, demonstrating our commitment to supporting the radiology community and strengthening the U.S. supply chain of care," said John Ducker, president and CEO of Fresenius Kabi USA. "Diagnostic pharmaceutical agents like Sincalide play a critical role in patient diagnosis, and Fresenius Kabi's addition of Sincalide provides health care facilities nationwide with new options to ensure timely patient care."

Fresenius Kabi Sincalide for Injection is the third product added to the company’s radiology portfolio, an area the company entered last year.

Sincalide for Injection is available to order direct from the company and U.S. wholesalers in 5 mcg single-dose vials. Fresenius Kabi Sincalide for Injection is preservative-free, and the container closure is not made with natural rubber latex.

Fresenius Kabi manufactures Sincalide for Injection in the United States, where the company has invested nearly $1 billion on an advanced manufacturing and distribution network dedicated to serving U.S. hospitals and health systems. To learn more about how Fresenius Kabi is strengthening America’s supply chain of care, please visit More in America.

Please see Important Safety Information below for Sincalide for Injection.

Indications

Sincalide for Injection is indicated in adults to:

• stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals
• stimulate pancreatic secretion (especially in conjunction with secretin) prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology
• accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract

IMPORTANT SAFETY INFORMATION

Contraindications

Sincalide for Injection is contraindicated in patients with a history of hypersensitivity to sincalide, including anaphylaxis and anaphylactic shock, or in patients with intestinal obstruction.

Warnings and Precautions

Post-marketing anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have been reported during and within one hour following administration of sincalide. If anaphylaxis or other hypersensitivity reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment.

Stimulation of gallbladder contraction can lead to small gallbladder stone evacuation, resulting in lodging in the cystic duct or in the common bile duct.

Sincalide may cause adverse reactions such as nausea, vomiting, abdominal pain or cramping, dizziness, and flushing. To reduce the risk of adverse reactions, administer sincalide over 50 minutes for simulation of gallbladder contraction or over 30 minutes to accelerate transit of a barium meal through the small intestine.

Pregnant patients should be advised that sincalide can effect smooth muscle, which may cause spontaneous abortion or premature induction of labor.

The most common adverse reactions (≥ 20%) include abdominal discomfort or pain, and nausea.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information for Sincalide for Injection.

Kinevac is a registered trademark of Bracco Diagnostics Inc., which has approved Fresenius Kabi to manufacture and market Sincalide for Injection as an authorized generic in the United States.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at http://www.fresenius-kabi.com/us/join-us and follow us on LinkedIn.

References

1. Sincalide for Injection Package Insert, October 2022

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