Fresenius Kabi Targets Treatment of Certain Seizures with Launch of Generic Lacosamide Injection, USP
LAKE ZURICH, Ill.--(BUSINESS WIRE)--Dec 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.
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Now available: Fresenius Kabi Lacosamide Injection, USP. (Photo: Business Wire)
“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. ”
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- Lacosamide should be gradually withdrawn to minimize the potential of increased seizure frequency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 orwww.fda.gov/medwatch.
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 atwww.fresenius-kabi.com/us.
About Fresenius Kabi
Fresenius Kabi ( www.fresenius-kabi.com/us ) is a global health care company that specializes in medicines 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.
- VIMPAT ® is a registered trademark of UCB, Inc.
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CONTACT: Joanie Clougherty (614) 717-5741
KEYWORD: UNITED STATES NORTH AMERICA ILLINOIS
INDUSTRY KEYWORD: MENTAL HEALTH HOSPITALS CARDIOLOGY BIOTECHNOLOGY OTHER HEALTH MANAGED CARE HEALTH PHARMACEUTICAL GENERAL HEALTH
SOURCE: Fresenius Kabi
Copyright Business Wire 2022.
PUB: 12/15/2022 09:00 AM/DISC: 12/15/2022 09:02 AM