250

2.5

0026-3821-25

Blue

500

2.5

0026-3822-25

Green

1000

2.5

0026-3824-25
Red

2000

5.0

0026-3826-50

Yellow
3000
5.0
0026-3828-50
Gray
Actual Factor VIII activity in IU is stated on the label of each KOVALTRY vial.
The product vial and diluent syringe are not made with natural rubber latex.
Storage and Handling
Product as Packaged for Sale
•Store KOVALTRY at +2°C to +8°C (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.
•Record the starting date of room temperature storage on the unopened product carton. 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.
•Do not use KOVALTRY after the expiration date indicated on the vial.
•Protect KOVALTRY from extreme exposure to light and store the vial with the lyophilized powder in the carton prior to use.
Product After Reconstitution
•Administer reconstituted KOVALTRY as soon as possible. If not, store at room temperature for no longer than 3 hours.
•Do not use KOVALTRY if the reconstituted solution is cloudy or has particulate matter.
•Use the administration set provided.
17 PATIENT COUNSELING INFORMATION
•Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
•Hypersensitivity reactions are possible with KOVALTRY [see Warnings and Precautions (5.1)]. Warn patients of the early signs of hypersensitivity reactions (including tightness of the chest or throat, dizziness, mild hypotension and nausea during infusion) which can progress to anaphylaxis. Advise patients to discontinue use of the product if these symptoms occur and seek immediate emergency treatment with resuscitative measures such as the administration of epinephrine and oxygen.
•Inhibitor formation may occur at any time in the treatment of a patient with hemophilia A [see Warnings and Precautions (5.2)]. Advise patients to contact their physician or treatment center for further treatment and/or assessment, if they experience a lack of clinical response to Factor VIII replacement therapy, as this may be a manifestation of an inhibitor.
•Advise patients to discard all equipment, including any unused product, in an appropriate container.
•Advise patients to consult with their healthcare provider prior to travel. Advise patients to bring an adequate supply of KOVALTRY while traveling based on their current regimen of treatment.
PATIENT PACKAGE INSERT
FDA-Approved Patient Labeling
Patient Information
KOVALTRY (KOH-vahl-tree)
Antihemophilic Factor (Recombinant)
This leaflet summarizes important information about KOVALTRY with vial adapter. Please read it carefully before using this medic