Questions about Kovaltry®
Like Kogenate FS, Kovaltry is an unmodified, full-length, standard half-life (SHL) rFVIII product. Kovaltry offers patients currently on Kogenate FS a cell bank derived from the Kogenate FS cell line, advancements to the manufacturing process including the removal of human – and animal – derived raw materials from the cell culture and the addition of the 20nm filtration step, and the potential to stay on the same dose and frequency, or the potential to reduce their dosing frequency.1
Yes. Kovaltry clinical trials evaluated efficacy and safety for on-demand treatment, perioperative management of bleeding, and routine prophylaxis in 142 previously treated adult and adolescent patients age ≥ 12 years to < 65 years in the Leopold I and Leopold II clinical trials. A post-hoc subgroup analysis was also completed to evaluate the 48 patients who transitioned from Kogenate FS to Kovaltry as part of these trials.*1,2 Click here for efficacy and safety data on these patients. Kovaltry clinical trials also evaluated efficacy and safety for routine prophylaxis and perioperative management of bleeding in 51 previously treated pediatric patients ages 12 and younger, in the Leopold Kids clinical trial. A post-hoc subgroup analysis was also completed to evaluate the 25 patients who transitioned from Kogenate FS to Kovaltry as part of this trial.*1,3 Click here for efficacy and safety data on these patients.
Kovaltry was approved by FDA in 2016 based on efficacy and safety data in pediatric, adolescent and adult patients.1 Click here for more details.
Kovaltry is manufactured with a cell bank derived from the Kogenate FS cell line. The Kovaltry manufacturing process incorporates advancements to the Kogenate FS manufacturing process, which includes the removal of human – and animal – derived raw materials from the cell culture and the addition of 20nm filtration step.1,4
Yes, both Kovaltry and Kogenate FS have the same Vial Adapter reconstitution device. Click here for more information on Kovaltry’s Vial Adapter reconstitution device.1
Yes, Kovaltry comes with a 25-gauge butterfly needle.1
Store Kovaltry under refrigeration at 36°F to 46°F for up to 30 months from the date of manufacture. Do not freeze. Within this period, Kovaltry may be stored for a single period of up to 12 months at temperatures up to +25°C or 77°F. Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature for 12 months, or after the expiration date on the product vial, whichever is earlier.1 Visit the Kovaltry HCP website for the full details on storing Kovaltry.
No, PK testing is not required for patients to transition from Kogenate FS to Kovaltry; however, eligible patients can receive up to $250 per year to offset out-of-pocket costs for laboratory testing of Kovaltry.†‡
- Click here to access the Kovaltry reimbursement for lab testing claim form for your patients.
The PK profiles of Kovaltry and Advate were compared in a single-dose, open-label, randomized cross-over study. Click here to review the study data and PK data.
Yes, Kovaltry is approved for perioperative bleeding management.1