FDA Approves Carnexiv Injection as Short-Term Replacement Treatment for Oral Carbamazepine

The FDA has approved Lundbeck’s Carnexiv, also known as carbamazepine, as a short-term (≤7 days) intravenous replacement treatment for adults with certain seizure types who cannot take the oral form of carbamazepine. Carnexiv is the first intravenous formulation of carbamazepine, and it is expected to be available in the United States in early 2017.

Patients who experience partial seizures with complex symptomatology, generalized tonic-clonic seizures, or mixed seizure patterns, which may include the above, or other partial or generalized seizures, may be treated with Carnexiv. Those who receive Carnexiv face an increased risk of serious dermatologic reactions during treatment, such as toxic epidermal necrolysis and Stevens-Johnson syndrome, as well as a risk of aplastic anemia and agranulocytosis.

“Carbamazepine has been an important treatment standard for people with epilepsy, but oral administration isn't always possible, especially during hospitalizations or other circumstances where they are temporarily unable to take medication by mouth,” said Peter Anastasiou, president of Lundbeck, in a press release. “As part of Lundbeck’s ongoing commitment to the epilepsy community, we are proud to offer Carnexiv to help meet the need for continuity of care for these patients.”

When switching from oral carbamazepine, the total daily dose of Carnexiv should be 70% of the total daily dose of oral carbamazepine. In addition, it should be divided equally into 4 separate 30-minute infusions separated by 6 hours.