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 Talk to your doctor to see if Kovaltry may be right for you.
Yes, Kovaltry offers patients currently on Kogenate FS the potential to reduce their dosing frequency or stay on the same dose and frequency depending on individual treatment needs.1 Ask your doctor about the dose and frequency that is best for you.
Yes. Kovaltry clinical studies evaluated efficacy and safety in previously treated pediatric, adult and adolescent patients. Kovaltry clinical studies with adult and adolescent patients included 142 on-demand and prophylactic patients, 48 of whom were previously on Kogenate FS.* Kovaltry clinical studies with pediatric patients included 51 patients, 25 of whom were previously on Kogenate FS.*1,2,3 Click here to learn more about these patients.
Kovaltry was approved by the 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
Kovaltry offers patients currently on Kogenate FS the potential to stay on the same dosing frequency.1 Ask your doctor about the dose and frequency that is best for you.
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
If a dose requires more than one vial, first, reconstitute each vial as described in the Kovaltry Vial Adapter instructions with the diluent syringe provided. Then, use a larger plastic syringe (not provided) to combine the content of the vials into the syringe. Work with your doctor if you have any additional questions.
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 website for the full details on storing Kovaltry.
No, PK testing is not required to transition from Kogenate FS to Kovaltry; however, if your healthcare provider requests PK testing, Bayer offers patients reimbursement for lab testing through Access Services by Bayer that covers up to $250 in out-of-pocket laboratory testing costs per year.†‡
- Click here to learn how to submit your lab testing reimbursement form.
The PK profiles of Kovaltry and Advate were compared in a head-to-head PK study. Click here to review the study data, and talk to your doctor about the PK data.
Yes, your healthcare provider can also give you Kovaltry when you have surgery.1 Speak with your doctor about any upcoming medical procedures.