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IXINITY® [coagulation factor IX (recombinant)] • Lightheadedness

Brief Summary for the Patient • Dizziness
See package insert for full Prescribing Information. This product’s label may have been
updated. For further product information and current package insert, please visit • Nausea
www.IXINITY.com.
• Fainting
Please read this Patient Information carefully before using IXINITY. This brief summary does
not take the place of talking with your healthcare provider, and it does not include all of the Tell your healthcare provider about any side e ect that bothers you or does not go away.
important information about IXINITY.
The most common side e ect of IXINITY in clinical trials was headache.
What is IXINITY?
IXINITY is a medicine used to replace clotting factor (factor IX) that is missing in people with These are not all of the possible side e ects of IXINITY. You can ask your healthcare provider
hemophilia B. Hemophilia B is also called congenital factor IX de ciency or Christmas disease. for information that is written for healthcare professionals.
Hemophilia B is an inherited bleeding disorder that prevents clotting. Your healthcare
provider may give you IXINITY when you have surgery. Call your healthcare provider for medical advice about side e ects. You may report side
e ects to the FDA at 1-800-FDA-1088.
IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B.
How should I store IXINITY?
Who should not use IXINITY?
You should not use IXINITY if you: 250 IU strength only; store at 2 to 8°C (36 to 46°F). Do not freeze.

• Are allergic to hamsters 500, 1000, 1500, 2000 and 3000 IU strengths; store at 2 to 25°C (36 to 77°F). Do not freeze.

• Are allergic to any ingredients in IXINITY Do not use IXINITY after the expiration date printed on the label. Throw away any unused
IXINITY and diluents after it reaches this date.
Tell your healthcare provider if you are pregnant or breastfeeding because IXINITY may not be
right for you. Reconstituted product (after mixing dry product with Sterile Water for Injection) must be
used within 3 hours and cannot be stored or refrigerated. Discard any IXINITY left in the vial
What should I tell my healthcare provider before using IXINITY? at the end of your infusion.
You should tell your healthcare provider if you:
After reconstitution of the lyophilized powder, all dosage strengths should yield a clear,
• Have or have had any medical problems colorless solution without visible particles. Discard if visible particulate matter or discoloration
is observed.
• Take any medicines, including prescription and non-prescription medicines, such as over-
the-counter medicines, supplements, or herbal remedies What else should I know about IXINITY?

• Have any allergies, including allergies to hamsters Your body may form inhibitors to factor IX. An inhibitor is part of the body’s immune
system. If you form inhibitors, it may stop IXINITY from working properly. Consult with your
• Are breastfeeding. It is not known if IXINITY passes into your milk and if it can harm your baby healthcare provider to make sure you are carefully monitored with blood tests to check for
the development of inhibitors to factor IX. Consult your doctor promptly if bleeding is not
• Are pregnant or planning to become pregnant. It is not known if IXINITY may harm your baby controlled with IXINITY as expected.

• Have been told that you have inhibitors to factor IX (because IXINITY may not work for you) Medicines are sometimes prescribed for purposes other than those listed here. Do not use
IXINITY for a condition for which it is not prescribed. Do not share IXINITY with other people,
How should I infuse IXINITY? even if they have the same symptoms as you.
IXINITY is given directly into the bloodstream. IXINITY should be administered as ordered by
your healthcare provider. You should be trained on how to do infusions by your healthcare Always check the actual dosage strength printed on the label to make sure you are using the
provider or hemophilia treatment center. Many people with hemophilia B learn to infuse strength prescribed by your healthcare provider.
their IXINITY by themselves or with the help of a family member.
See the step-by-step instructions for infusing in the complete patient labeling. Manufactured by:
Aptevo BioTherapeutics LLC
Your healthcare provider will tell you how much IXINITY to use based on your weight, the Berwyn PA, 19312
severity of your hemophilia B, and where you are bleeding. You may have to have blood tests U.S. License No. 2054
done after getting IXINITY to be sure that your blood level of factor IX is high enough to stop
the bleeding. Call your healthcare provider right away if your bleeding does not stop after Part No: 1000973_1
taking IXINITY. CM-FIX-0078

What are the possible side e ects of IXINITY?
Allergic reactions may occur with IXINITY. Call your healthcare provider or get emergency
treatment right away if you have any of the following symptoms:

• Rash

• Hives

• Itching

• Tightness of the throat

• Chest pain or tightness

• Di culty breathing