Expanded Indication for Vimpat
November 3, 2017 – The U.S. FDA has approved an expanded indication for Vimpat® (lacosamide), manufactured by UCB, Inc., to treat partial onset seizures in patients four years of age and older. The drug was first approved for use in adults in 2009, and is available in both intravenous and oral forms. Only the oral forms (tablet or solution) are approved for use in pediatric patients. Recommended oral dosing for these patients is administered twice daily and based on body weight.
Treatment with Vimpat begins with a titration regimen, in which dosage is gradually increased, dependent on clinical response and patient tolerance, until a maintenance dosage is reached. Vimpat can be used as either a monotherapy or an adjunctive therapy. It should not be discontinued without a gradual withdrawal over a period of at least one week.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.