ine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about KOVALTRY. If you have any questions after reading this, ask your healthcare provider.
Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.
What is KOVALTRY?
KOVALTRY is a medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from cltting normally.
KOVALTRY is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you KOVALTRY when you have surgery. KOVALTRY can reduce the number of bleeding episodes in adults and children with hemophilia A when used regularly (prophylaxis).
KOVALTRY is not used to treat von Willebrand Disease.
Who should not use KOVALTRY?
You should not use KOVALTRY if you
•are allergic to rodents (like mice and hamsters).
•are allergic to any ingredients in KOVALTRY.
What should I tell my healthcare provider before I use KOVALTRY?
•Tell your healthcare provider about all of your medical conditions.
•Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies.
•Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.
•Tell your healthcare provider if you have been told that you have inhibitors to Factor VIII (because KOVALTRY may not work for you).
What are the possible side effects of KOVALTRY?
The common side effects of KOVALTRY are headache, fever and itchy rash.
Allergic reactions may occur with KOVALTRY. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, and nausea.
Your body can also make antibodies, called “inhibitors,” against KOVALTRY, which may stop KOVALTRY from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
These are not all the possible side effects with KOVALTRY. You can ask your healthcare provider for information that is written for healthcare professionals.
Tell your healthcare provider about any side effect that bothers you or that does not go away.
What are the KOVALTRY dosage strengths?
KOVALTRY with 2.5 mL or 5 mL Sterile Water for Injection (SWFI) comes in five different dosage strengths labeled as International Units (IU): 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU. The five different strengths are color-coded as follows:
Blue
250 IU with 2.5 mL SWFI
Green
500 IU with 2.5 mL SWFI
Red
1000 IU with 2.5 mL SWFI
Yellow
2000 IU with 5 mL SWFI
Gray
3000 IU with 5 mL SWFI
How do I store KOVALTRY?
Do not freeze KOVALTRY.
Store KOVALTRY at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, KOVALTRY may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F.
Record the starting date of room temperature storage clearly on the unopened product carton. Once stored at room te |
