For: Seizures
Marketing Status: Discontinued
Carnexiv (carbamazepine) is an intravenous injection formulation of the antiepileptic drug carbamazepine indicated as short-term replacement therapy for oral carbamazepine when oral administration is temporarily not feasible. These highlights do not include all the information needed to use CARNEXIV� safely and effectively. See full prescribing information for CARNEXIV.
CARNEXIV� (carbamazepine) injection, for intravenous use
Initial U.S. Approval: 1968
WARNING: SERIOUS DERMATOLOGIC REACTIONS and
APLASTIC ANEMIA AND AGRANULOCYTOSIS
See full prescribing information for complete boxed warning.
Serious Dermatologic Reactions
Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have occurred with carbamazepine. Discontinue CARNEXIV if these reactions occur (5.1)
Patients of Asian ancestry have a 10-fold greater risk of TEN/SJS, compared to other populations. Avoid use of CARNEXIV in genetically at-risk patients, including those positive for the HLA-B*1502 allele (5.1)
Aplastic Anemia and Agranulocytosis
Aplastic anemia and agranulocytosis can occur with CARNEXIV (5.2)
Obtain complete CBC prior to initiation of CARNEXIV. Consider discontinuing CARNEXIV if significant bone marrow depression develops (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Hypersensitivity (5.5) 12/2019
INDICATIONS AND USAGE
CARNEXIV is indicated as replacement therapy for oral carbamazepine formulations, when oral administration is temporarily not feasible, in adults with the following seizure types (1):
Partial seizures with complex symptomatology
Generalized tonic-clonic seizures
Mixed seizure patterns which include the above, or other partial or generalized seizures
DOSAGE AND ADMINISTRATION
CARNEXIV 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 (2.1, 2.2)
Use of CARNEXIV is not recommended for periods longer than 7 days (2.1)
Closely monitor patients with renal impairment; CARNEXIV should generally not be used in patients with moderate or severe renal impairment (2.3, 5.3)
DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/20 mL (10 mg/mL) single-dose vial (3)
CONTRAINDICATIONS
Bone marrow depression (4, 5.2)
Hypersensitivity to carbamazepine (4, 5.5)
Hypersensitivity to tricyclic antidepressants (4, 7.1)
Concomitant use of boceprevir (4, 7.1).
Use of MAOIs within the past 14 days (4, 7.3)
Concomitant use of nefazodone (4, 7.1)
Concomitant use with delavirdine or other non-nucleoside reverse transcriptase inhibitors (4, 7.1)
WARNINGS AND PRECAUTIONS
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Monitor for hypersensitivity; discontinue if another cause cannot be established (5.4)
Suicidal Behavior and Ideation: Monitor for depression, suicidal thoughts or behavior, and unusual changes in mood or behavior (5.6)
Embryofetal Toxicity: Advise women of childbearing potential of possible risks to the fetus (5.7, 8.1)
Abrupt Discontinuation and Seizure Risk: Do not discontinue CARNEXIV treatment abruptly (5.8)
Hyponatremia: Consider discontinuing CARNEXIV in patients with significant symptomatic hyponatremia (5.9)
Hepatic Toxicity; Hepatic Porphyria: Evaluate liver function before and periodically during treatment; avoid CARNEXIV use in patients with hepatic porphyria (5.11, 5.13)
ADVERSE REACTIONS
Most common adverse reactions with CARNEXIV (incidence greater than or equal to 2%) were dizziness, somnolence, blurred vision, diplopia, headache, infusion-related reaction, infusion site pain, and anemia (6.1)
The most common adverse reactions with oral carbamazepine were dizziness, drowsiness, unsteadiness, nausea, and vomiting (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Carbamazepine may reduce plasma concentrations of concomitant medications metabolized by CYP1A2, 2B6, 2C9/19, and 3A4 (7.1)
CYP3A4 inhibitors can increase plasma carbamazepine levels (7.2)
CYP3A4 inducers can decrease carbamazepine levels (7.2)
USE IN SPECIFIC POPULATIONS
Hepatic Impairment: monitor carbamazepine concentrations (8.7)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2019
