Frequently Asked Questions
FAQs, also known as frequently asked questions, provide a quick snapshot of information that can be most helpful to people who want to know the basics about a product or service. We have provided some basic information for you about Kogenate® FS, antihemophilic factor (recombinant) treatment.
Please consult your healthcare provider to determine if Kogenate FS is right for you.
Questions
- What is Kogenate FS?
- Who should not use Kogenate FS?
- What should I tell my healthcare provider before I use Kogenate FS?
- What are the possible side effects of Kogenate FS?
- How do I store Kogenate FS?
- What else should I know about Kogenate FS and hemophilia A?
Answers
What is Kogenate FS?
Kogenate FS 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 clotting normally.
Kogenate FS is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A. If you have hemophilia A, your healthcare provider may give you Kogenate FS when you have surgery. Kogenate FS can reduce the number of bleeding episodes when used regularly and reduce the risk of joint damage in children.
Kogenate FS is not used to treat von Willebrand's Disease.
Who should not use Kogenate FS?
You should not use Kogenate FS if you
- Are allergic to rodents (like mice and hamsters).
- Are allergic to any ingredients in Kogenate FS, such as; polysorbate 80, imidazole, or tri-n-butyl phosphate.
- Tell your healthcare provider if you are pregnant or breast-feeding because Kogenate FS may not be right for you.
What should I tell my healthcare provider before I use Kogenate FS?
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 overthe-counter medicines, supplements, or herbal remedies.
Tell your healthcare provider if you have been told that you have inhibitors to factor VIII (because Kogenate FS may not work for you).
What are the possible side effects of Kogenate FS?
You could have an allergic reaction to Kogenate FS. Call your healthcare provider right away and stop treatment if you get
- rash or hives
- itching
- tightness of the chest or throat
- difficulty breathing
- light-headed, dizziness
- nausea
- decrease in blood pressure
Your body can also make antibodies, called "inhibitors," against Kogenate FS, which may stop Kogenate FS 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.
Other common side effects with Kogenate FS include local reactions (irritation, pain, and swelling at infusion site) and injection device-related infections. Finding veins for injections may be difficult in young children. When frequent injections are required your child's 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. Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects with Kogenate FS.
You can ask your healthcare provider for information that is written for healthcare professionals.
How do I store Kogenate FS?
Do not freeze Kogenate FS.
Kogenate FS vials containing powdered product (without sterile diluent added) should be stored in a refrigerator (2°C-8°C [36°F-46°F]), or at room temperature (up to 25°C or 77°F) for up to 3 months.
If you choose to store Kogenate FS at room temperature, be sure to note on the carton the date that the product is removed from refrigeration. Store vials in their original carton and protect them from extreme exposure to light.
Reconstituted product (after mixing dry products with wet diluent) must be used within 3 hours and cannot be stored.
Throw away any unused Kogenate FS after the expiration date.
Do not use reconstituted Kogenate FS if it is not clear to slightly cloudy and colorless.
What else should I know about Kogenate FS and hemophilia A?
Medicines are sometimes prescribed for purposes other than those listed here. Do not use Kogenate FS for a condition for which it is not prescribed. Do not share Kogenate FS with other people, even if they have the same symptoms that you have.
This summarizes the most important information about Kogenate FS. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about Kogenate FS that was written for healthcare professionals.
