Fresenius Kabi Targets Treatment of Certain Seizures with Launch of Generic Lacosamide Injection, USP

Further Broadens Portfolio of Critical Care Medicine

December 15, 2022

LAKE ZURICH, Ill., December 15, 2022 – Fresenius Kabi announced today the immediate availability in the U.S. of Lacosamide Injection, USP, a generic equivalent to VIMPAT®. Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in 200 mg per 20 mL single-dose vials.

“Fresenius Kabi is pleased to provide the clinicians and patients who rely on us with high quality and accessible choices for treating patients with certain seizures,” said John Ducker, president and CEO of Fresenius Kabi USA. 

Fresenius Kabi produces Lacosamide Injection, USP 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.”

 

Lacosamide

INDICATIONS AND USAGE

Fresenius Kabi Lacosamide Injection for intravenous use (CV) is indicated for the treatment of partial-onset seizures in patients 17 years of age and older.

Pediatric use information is approved for UCB, Inc.’s VIMPAT® (lacosamide) injection. However, due to UCB, Inc.’s marketing exclusivity rights, the Fresenius Kabi drug product is not labeled with that pediatric information.

IMPORTANT SAFETY INFORMATION

  • Monitor patients for suicidal behavior and ideation
  • Lacosamide may cause dizziness and ataxia
  • Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before beginning and after titration to steady-state maintenance is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction, clearly monitor these patients
  • Lacosamide may cause syncope
  • Lacosamide should be gradually withdrawn to minimize the potential of increased seizure frequency
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Discontinue if no alternate etiology

Adjunctive therapy: Most common adverse reactions in adults (≥ 10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence.

Monotherapy: Most common adverse reactions are similar to those seen in adjunctive therapy studies.

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/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

Pregnancy: Based on animal data, may cause fetal harm.

This Important Safety Information does not include all the information needed to use Lascosamide Injection, USP safely and effectively. Please see full prescribing information for Lacosamide Injection, USP at www.fresenius-kabi.com/us.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us), an operating company of Fresenius, specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition worldwide. The company’s products and services are used for the therapy and care of patients with critical and chronic conditions. 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 www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook.

  • VIMPAT® is a registered trademark of UCB, Inc.