mperature, do not return the product to the refrigerator. The product then expires after storage at room temperature for 12 months, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light.
Administer reconstituted KOVALTRY as soon as possible. If not, store at room temperature for no longer than 3 hours.
Throw away any unused KOVALTRY after the expiration date.
Do not use reconstituted KOVALTRY if it is not clear.
What else should I know about KOVALTRY and hemophilia A?
Finding veins for injections may be difficult in young children. When frequent injections are required, your healthcare provider may propose to have a device surgically placed under the skin to facilitate access to the bloodstream. These devices may result in infections.
Medicines are sometimes prescribed for purposes other than those listed here. Do not use KOVALTRY for a condition for which it is not prescribed. Do not share KOVALTRY with other people, even if they have the same symptoms that you have.
This leaflet summarizes the most important information about KOVALTRY. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about KOVALTRY that was written for healthcare professionals.
Instructions for Use
KOVALTRY (KOH-vahl-tree)
Antihemophilic Factor (Recombinant)
IFU Graphics
Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.
You should always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using KOVALTRY. If you are unsure of the procedures, please call your healthcare provider before using.
Call your healthcare provider right away if bleeding is not controlled after using KOVALTRY.
Your healthcare provider will prescribe the dose that you should take.
Your healthcare provider may need to take blood tests from time to time.
Talk to your healthcare provider before traveling. You should plan to bring enough KOVALTRY for your treatment during this time.
See the step-by-step instructions below for reconstituting KOVALTRY with vial adapter. Follow the specific infusion instruction leaflet included with the infusion set provided.
Carefully handle KOVALTRY. Dispose of all materials, including any leftover reconstituted KOVALTRY product, in an appropriate container.
Reconstitution
Always work on a clean surface and wash your hands before performing the following procedure. Use only the components for reconstitution and administration that are provided with each package of KOVALTRY. If a package is opened or damaged, do not use this component. If these components cannot be used, please contact your healthcare provider.
Prepare a clean flat surface and gather all the materials needed for the infusion.
1. Warm the unopened diluent syringe and the concentrate vial to a temperature not to exceed 37°C or 99°F.
2. Remove protective cap from the vial (A). Aseptically cleanse the rubber stopper with a sterile alcohol swab, being careful not to handle the rubber stopper.
2AA
3. Place product vial on a firm, non-skid surface. Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Holding the adapter housing, place over the product vial and firmly press down (B). Th
