Kovaltry Now Available
Horizons in Hemophilia, Summer, 2016
by Leigh Carpenter, RPh, Directory of Pharmacy
On March 17, the FDA approved Kovaltry, manufactured by Bayer. Kovaltry is a recombinant full-length factor VIII concentrate indicated for use in adults and children with hemophilia A. The approval is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials. Results of this study support the approval of Kovaltry for routine prophylaxis to reduce the frequency of bleeding episodes. The product can be used 2-3 times per week in adolescents and adults, and 2-3 times per week or every other day in children. In addition to prophylaxis, Kovaltry is indicated for use in on-demand treatment and perioperative management of bleeding. Recommended dosing in adults and adolescents is 20-40 IU per kg of body weight 2-3 times per week. For children 12 years of age and younger, the recommended dose is 25-50 IU per kg of body weight twice weekly, three times weekly or every other day, depending on individual requirements. Investigators in the LEOPOLD study state, “Kovaltry may offer appropriate patients a twice weekly prophylaxis dosing option.” Each patient’s dose should be based on clinical response.
Kovaltry is available in five different dosage strengths: 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU. The 250, 500 and 1000 IU sizes will be reconstituted with 2.5ml sterile water. The 2000 and 3000 IU sizes will be reconstituted with 5ml sterile water. Each size comes in a kit containing the vial adapter for needleless mixing. The product can be stored at room temperature (up to 77 degrees Fahrenheit) for up to one year. It may also be stored in the refrigerator (36-46 degrees Fahrenheit) for up to 30 months from the date of manufacture, as indicated by the expiration date printed on the vial. If you do store at room temperature, be sure to write the date on the carton when Kovaltry is removed from refrigeration. The starting date of room temperature storage should be clearly recorded on the unopened product carton. Once stored at room temperature, the product must not be returned to the refrigerator.
If you are interested in trying Kovaltry, please contact your Hemophilia Treatment Center. The product is available through the HoG and Beacon pharmacies.