HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use KOVALTRY safely and effectively. See full prescribing information for KOVALTRY.
KOVALTRY [Antihemophilic Factor (Recombinant)]
Lyophilized Powder for Solution for Intravenous Injection – Reconstitution with Vial Adapter
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
KOVALTRY®, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
•On-demand treatment and control of bleeding episodes
•Perioperative management of bleeding
•Routine prophylaxis to reduce the frequency of bleeding episodes
KOVALTRY is not indicated for the treatment of von Willebrand disease (1).
DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only.
Control of bleeding episodes and perioperative management (2.1)
•Required dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal or IU/dL) x reciprocal of expected/observed recovery (e.g., 0.5 for a recovery of 2 IU/dL per IU/kg).
•Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg).
Routine prophylaxis (2.1)
•Adults and adolescents: 20-40 IU/kg 2 or 3 times per week.
•Children ≤12 years old: 25-50 IU/kg 2 times per week, 3 times per week or every other day.
DOSAGE FORMS AND STRENGTHS
KOVALTRY is available as lyophilized powder in single-use vials containing nominally 250, 500, 1000, 2000, or 3000 IU . Each vial of KOVALTRY contains the labeled amount of recombinant Factor VIII in IU ( 3).
CONTRAINDICATIONS
Do not use in patients who have history of hypersensitivity reactions to the active substance, mouse or hamster protein, or other constituents of the product (4).
WARNINGS AND PRECAUTIONS
•Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment with KOVALTRY and administer appropriate treatment ( 5.1).
•Development of Factor VIII-neutralizing antibodies can occur. Perform an assay that measures Factor VIII inhibitor concentration if expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled as expected with administered dose ( 5.2, 5.5).
ADVERSE REACTIONS
The most frequently reported adverse reactions in clinical trials (≥3%) were headache, pyrexia, and pruritus (6).
To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare at 1-888-842-2937 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Pediatric Use: Due to higher clearance (body weight adjusted) in children ≤12 years of age, higher or more frequent dosing may be needed ( 8.4).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 3/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose
2.2 Preparation and Reconstitution
2.3 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Neutralizing Antibodies
5.3 Cardiovascular Risk Factors
5.4 Catheter-related Infections
5.5 Monitoring Laboratory Tests