Intravenous Carbamazepine Approved
October 4, 2016 - The U.S. FDA approved Carnexiv™ (carbamazepine), the first intravenous (IV) form of carbamazepine which is used to treat epilepsy. Carnexiv, manufactured by Lundbeck, is indicated for adults who need temporary replacement for oral epilepsy therapy of seven days or less. It is approved for patients who have generalized tonic-clonic seizures, partial seizures with complex symptomology, certain kinds of mixed seizure patterns and other generalized or partial seizures. All carbamazepine products, including Carnexiv, have a boxed warning about potentially life-threatening skin reactions, such as Stevens-Johnson syndrome, that they may cause, especially for patients of Asian backgrounds. Carnexiv will be dispensed as 200mg/20mL single-use vials and in anticipated to be available in early 2017. Recommended dosing is 70% of the daily oral dose that the patient had been taking divided into four infusions each given over 30-minutes at six-hour intervals.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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.