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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 • Nausea
updated. For further product information and current package insert, please visit
www.IXINITY.com. • Fainting

Please read this Patient Information carefully before using IXINITY. This brief summary does Tell your healthcare provider about any side e ect that bothers you or does not go away.
not take the place of talking with your healthcare provider, and it does not include all of the
important information about IXINITY. The most common side e ect of IXINITY in clinical trials was headache.

What is IXINITY? These are not all of the possible side e ects of IXINITY. You can ask your healthcare provider
for information that is written for healthcare professionals.
IXINITY is a medicine used to replace clotting factor (factor IX) that is missing in people with
hemophilia B. Hemophilia B is also called congenital factor IX de ciency or Christmas disease. Call your healthcare provider for medical advice about side e ects. You may report side
Hemophilia B is an inherited bleeding disorder that prevents clotting. Your healthcare e ects to the FDA at 1-800-FDA-1088.
provider may give you IXINITY when you have surgery.
How should I store IXINITY?
IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B.
250 IU strength only; store at 2 to 8°C (36 to 46°F). Do not freeze.
Who should not use IXINITY?
500, 1000, 1500, 2000 and 3000 IU strengths; store at 2 to 25°C (36 to 77°F). Do not freeze.
You should not use IXINITY if you:
Do not use IXINITY after the expiration date printed on the label. Throw away any unused
• Are allergic to hamsters IXINITY and diluents after it reaches this date.

• Are allergic to any ingredients in IXINITY 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
Tell your healthcare provider if you are pregnant or breastfeeding because IXINITY may not be at the end of your infusion.
right for you.
After reconstitution of the lyophilized powder, all dosage strengths should yield a clear,
What should I tell my healthcare provider before using IXINITY? colorless solution without visible particles. Discard if visible particulate matter or discoloration
is observed.
You should tell your healthcare provider if you:
What else should I know about IXINITY?
• Have or have had any medical problems
Your body may form inhibitors to factor IX. An inhibitor is part of the body’s immune
• Take any medicines, including prescription and non-prescription medicines, such as over- system. If you form inhibitors, it may stop IXINITY from working properly. Consult with your
the-counter medicines, supplements, or herbal remedies 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
• Have any allergies, including allergies to hamsters controlled with IXINITY as expected.

• Are breastfeeding. It is not known if IXINITY passes into your milk and if it can harm your baby 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,
• Are pregnant or planning to become pregnant. It is not known if IXINITY may harm your baby even if they have the same symptoms as you.

• Have been told that you have inhibitors to factor IX (because IXINITY may not work for you) Always check the actual dosage strength printed on the label to make sure you are using the
strength prescribed by your healthcare provider.
How should I infuse IXINITY?
Manufactured by:
IXINITY is given directly into the bloodstream. IXINITY should be administered as ordered by Aptevo BioTherapeutics LLC
your healthcare provider. You should be trained on how to do infusions by your healthcare Berwyn PA, 19312
provider or hemophilia treatment center. Many people with hemophilia B learn to infuse U.S. License No. 2054
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. Part No: 1000973_1
CM-FIX-0078
Your healthcare provider will tell you how much IXINITY to use based on your weight, the
severity of your hemophilia B, and where you are bleeding. You may have to have blood tests
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
taking IXINITY.

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