Summary
Consider Kovaltry
- Kovaltry demonstrated efficacy data in ABR in children with routine prophylaxis1*
- Demonstrated 11.9 hours t1/2 (18.9) in children 1 to <12 years1†‡§
- An estimated 39,000 patient-years of exposure¶ with Kovaltry globally, available in Canada since 20162||
- Dosage for Kovaltry should be individualized and tailored for your patients1,6–8
- Kovaltry has a proven safety profile. The most frequently reported adverse reactions were pyrexia, headache and rash1
LEOPOLD Kids (Part A): A two-part, Phase III, multicentre, open-label trial examining the safety, efficacy and pharmacokinetics of Kovaltry in previously treated patients, pediatrics <12 years, with severe hemophilia A (<1%). Patients were given prophylaxis treatment of 25–50 IU/kg at least 2x/week for treatment of breakthrough bleeds and prevention bleeds during surgical procedures.1,5
† Half-life of pediatrics PTPs (<12 years) using the chromogenic assay.
‡ Clinical significance is unknown.
§ Geometric mean (%CV).
¶ Patient-years of exposure = International Units sold/annual dose per patient.
|| Reporting period is January 27, 2016 to August 31, 2020.
