Designed with his future in mind
Proven efficacy and safety in adolescents and adults
with prophylaxis using as few as 2 infusions per week1
LEOPOLD I Trial1,2
Study
description
Dosing
Multinational, open-label, prospective trial evaluating
pharmacokinetics, efficacy, safety, and perioperative
management of bleeding with KOVALTRY®
Previously treated male patients (PTPs) aged 12 to 65 years
with severe hemophilia A (<1% FVIII) (n=73) studied for 1 year
Dosing regimens were determined by the investigators
to meet individual patients’ needs
2x/week prophylaxis: 20-50 IU/kg (n=18)
3x/week prophylaxis: 20-50 IU/kg (n=44)
Primary
efficacy endpoint
Annualized bleed rate (ABR) at 12 months
(n=62 for efficacy analysis)
After a single 50 IU/kg dose of KOVALTRY®, the demonstrated
half-life [mean ± standard deviation (SD)] in 26 previously
treated adolescent and adult patients was:
Pharmacokinetics
12 to 17 years
(n=5)
Chromogenic Assay
One-stage Assay
14.4 ± 5.5 hours
11.7 ± 1.1 hours
≥18 years
(n=21)
14.2 ± 3.5 hours
14.3 ± 3.7 hours
LEOPOLD=Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease.
SELECTED IMPORTANT SAFETY INFORMATION
Hypersensitivity reactions, including anaphylaxis, are possible with KOVALTRY®. Early signs
of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat
tightness, dizziness, mild hypotension and nausea. Discontinue KOVALTRY® if symptoms occur
and seek immediate emergency treatment.
KOVALTRY® may contain trace amounts of mouse and hamster proteins. Patients treated with
this product may develop hypersensitivity to these non-human mammalian proteins.
Please see additional Important Safety Information on following pages.
For additional important risk and use information, please see Brief Summary on following pages.