Carnexiv (carbamazepine)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 2016

Specific Treatments:

seizures

Therapeutic Areas

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General Information

Carnexiv (carbamazepine) is a sodium channel blocker.

Carnexiv is specifically indicated as replacement therapy for oral carbamazepine formulations, when oral administration is temporarily not feasible, in adults with the following seizure types:

  • Partial seizures with complex symptomatology
  • Generalized tonic-clonic seizures
  • Mixed seizure patterns which include the above, or other partial or generalized seizures 

Carnevix is supplied as an injection for intravenous administration. The recommended total daily dose is 70% of the total daily dose of oral carbamazepine from which patients are being switched; divide the total daily dose of Carnexiv equally in four infusions separated by 6 hours; dilute each dose of Carnexiv in 100 mL of diluent and infuse intravenously over 30 minutes. Use of Carnexiv is not recommended for periods longer than 7 days.

Clinical Results

FDA Approval

The FDA approval of Carnexiv was based on  bioavailability studies comparing oral carbamazepine to Carnexiv.  Following adjustment of the intravenous dose by the 70% conversion factor, daily plasma exposures of carbamazepine following 15-minute or 30-minute infusions every 6 hours were comparable to those observed following oral dosing. The pharmacokinetics of carbamazepine-10,11-epoxide were similar following both intravenous and oral dosing.

Side Effects

Adverse effects associated with the use of Carnexiv may include, but are not limited to, the following:

  • dizziness
  • somnolence
  • blurred vision
  • diplopia
  • headache
  • infusion-related reaction
  • infusion site pain
  • anemia

Carnexiv comes with a black box warning of serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) and the risk of aplastic anemia and agranulocytosis, following the use of Carnexiv.

Mechanism of Action

Carnexiv (carbamazepine) is a sodium channel blocker. The mechanism by which carbamazepine exerts its anticonvulsant activity is unknown. The principal metabolite of carbamazepine, carbamazepine-10,11-epoxide, has demonstrated anticonvulsant activity in in vivo animal models of seizures. However, its contribution to the therapeutic effect of carbamazepine is unknown.

Additional Information

For additional information regarding Carnexiv, please visit http://lundbeck.com/global