[coagulation factor IX (recombinant)]
This leaflet summarizes important information about IXINITY. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about IXINITY. If you have any questions after reading this, ask your healthcare provider.
What is IXINITY?
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 deficiency or Christmas disease. Hemophilia B is an inherited bleeding disorder that prevents clotting.
Your healthcare provider may give you IXINITY when you have surgery.
Who should not use IXINITY?
You should not use IXINITY if you:
- Are allergic to hamsters
- Are allergic to any ingredients in IXINITY
Tell your healthcare provider if you are pregnant or breastfeeding because IXINITY may not be right for you.
What should I tell my healthcare provider before using IXINITY?
You should tell your healthcare provider if you:
- Have or have had any medical problems
- Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies
- Have any allergies, including allergies to hamsters
- Are breastfeeding. It is not known if IXINITY passes into your milk and if it can harm your baby
- Are pregnant or planning to become pregnant. It is not known if IXINITY may harm your baby
- Have been told that you have inhibitors to factor IX (because IXINITY may not work for you)
How should I infuse IXINITY?
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 provider or hemophilia treatment center. Many people with hemophilia B learn to infuse their IXINITY by themselves or with the help of a family member.
See the step-by-step guide (Instructions for Use) provided at the end of this leaflet.
Your healthcare provider will tell you how much IXINITY to use based on your weight, the severity of you 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 you healthcare provider right away if your bleeding does not stop after taking IXINITY.
What are the possible side effects of IXINITY?
Allergic reactions may occur with IXINITY. Call your healthcare provider or get emergency treatment right away if you get any of the following symptoms: rash, hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.
Tell your healthcare provider about any side effect that bothers you or does not go away.
The most common side effect of IXINITY in clinical trials was headache.
These are not all the side effects possible with IXINITY. You can ask your healthcare provider for information that is written for healthcare professionals.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What are the IXINITY dosage strengths?
IXINITY comes in vials containing six different dosage strengths: 250, 500, 1000, 1500, 2000 and 3000 international units (IU). The actual strength will be printed on the label of the vial and on the box. The six different strengths in the vials are color coded as follows:
||Multi-kit (2 x 1000 IU)
||Multi-kit (2 x 1500 IU)
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 store IXINITY?
250 IU strength only; store at 2 to 8°C (36 to 46°F). Do not freeze.
500, 1000, 1500, 2000, and 3000 IU strengths; store at 2 to 25°C (36 to 77°F). Do not freeze.
Do not use IXINITY after the expiration date printed on the label. Throw away any unused IXINITY and diluents after it reaches this date.
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 at the end of your infusion.
What else should I know about IXINITY?
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 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 controlled with IXINITY as expected.
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, even if they have the same symptoms as you.
Resources available to patients
For information on patient assistance programs that may be available to you, please call our IXINITY Patient Care Center at 1-855-IXINITY (1-855-494-6489).
Instructions for Use
IXINITY [coagulation factor IX (recombinant)]
For intravenous use after reconstitution only
Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center.
Always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using IXINITY. If you are unsure of the procedures, please call your healthcare provider before using IXINITY. Your healthcare provider will prescribe the dose that you should take.
Before starting reconstitution and administration you will need the following items:
- One (or more) vial(s) of IXINITY 250, 500, 1000, 1500, 2000, or 3000 IU powder, as prescribed by your healthcare provider
- One (or more) 10 mL syringe(s), pre-filled with 5 mL of Sterile Water for Injection (Pre-filled Syringe) with plunger rod attached
- Sterile vial adapter with filter
- One sterile 20 mL LUER-LOK syringe (Administration Syringe)
- Sterile alcohol swabs
- Sterile infusion set
- Sterile gauze pad
- Sterile bandage
IXINITY is supplied in kits that include single-use vials which contain vials of IXINITY (250, 500, 1000, 1500, 2000, or 3000 IU of powder), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached (to be used for reconstitution only), a sterile vial adapter with filter and a sterile 20 mL LUER-LOK syringe (Administration Syringe).
Wash your hands and then clean a flat area before starting the steps for reconstituting IXINITY. Use an aseptic technique during reconstitution.
- Remove the Pre-filled Syringe and IXINITY vial from storage and allow them to reach room temperature before use. Check the expiration date on the IXINITY vial.
- Remove the plastic cap from the IXINITY vial and place the vial top up on the clean surface. You will see a rubber circle on the top of the vial.
- Wipe the top of the IXINITY vial with a sterile alcohol swab and allow it to dry. After cleaning, do not touch the rubber circle with your hands or allow it to touch another object.
- Peel back the paper cover of the vial adapter package. Be careful not to touch the LUER-LOK (tip) in the center of the vial adapter.Do not remove the adapter from the package.
- Leave the vial adapter in the package and place it open end up on the clean surface with the LUER-LOK pointing up.
- Twist off the tip cap counterclockwise from the Pre-filled Syringe. Do not touch the inside of the cap or the syringe tip.
- While firmly holding the package containing the adapter with one hand and the barrel of the Pre-filled Syringe with the other, connect the Pre-filled Syringe to the vial adapter by pushing the syringe tip down onto the LUER-LOK in the center of the vial adapter, turning clockwise until the syringe is secured.
- Carefully lift up the combined syringe-and-vial-adapter and remove it from the plastic package and discard packaging.
- With one hand, continue to hold the combined syringe-and-vial-adapter. With the other hand, hold the IXINITY vial tightly on the clean, flat surface. Do not touch the top of the IXINITY vial or the filter spike of the combined syringe and vial adapter.
- Place the vial adapter over the IXINITY vial on the table; firmly push the filter spike of the vial adapter through the center of the IXINITY vial rubber circle until the clear plastic cap snaps onto the IXINITY vial.
- Slowly push the plunger rod down to transfer all of the liquid from the syringe into the IXINITY vial.
- With the syringe and the vial still attached, gently swirl, in a circular motion, the IXINITY vial until the product is fully dissolved. IXINITY is a clear, colorless solution without visible particles. Inspect the final solution for specks before administration. Do not use contents of vial if specks or particles persist after proper reconstitution.
- NOTE: If you use more than one vial of IXINITY per infusion, reconstitute each vial as per the previous instructions.
- Remove the diluent syringe from the vial adapter by turning syringe counterclockwise until it is completely detached. Do not touch the luer tip of the vial adapter.
- Remove the separate large 20 mL LUER-LOK syringe (Administration Syringe) from the sterile packaging, taking care to not touch the luer tip of the syringe. Attach to the reconstituted vial and vial adapter by turning syringe clockwise until it is securely attached.
- Press and keep the plunger down and turn the IXINITY vial/vial adapter/Administration Syringe upside down to transfer the solution. Draw up the solution into the Administration Syringe slowly until all solution is transferred into the syringe. Inspect the vial to confirm as much liquid as possible has been extracted into the Administration Syringe. NOTE: If you use more than one vial of IXINITY per infusion, extract reconstituted liquid from each vial, as per the previous instructions.
- Hold onto the vial adapter with one hand and firmly grasp the Administration Syringe with the other and unscrew the Administration Syringe from the vial adapter turning either counterclockwise. Do not touch the tip of the syringe to any object or surface. NOTE: If multiple reconstituted vials are required for infusion, do not detach the large LUER-LOK Administration Syringe from the first vial until you are ready to attach the next vial (with vial adapter attached).
- Prior to administering the solution, invert the Administration Syringe so that the tip is pointed toward the ceiling and express any air in the syringe. Place the Administration Syringe containing the IXINITY solution on the clean surface, making sure that the tip does not touch anything.
The reconstituted solution should be infused immediately or within 3 hours of storage at room temperature after reconstitution. NOTE: The luer tip of the syringe must not be touched by any objects or surfaces, when disconnecting the syringe from the vial adapter, and when transferring the Administration Syringe to the infusion set.
If you are using more than one vial, stop here and proceed to the Pooling Instructions.
POOLING is the process of combining two or more reconstituted vials into a larger Administration Syringe prior to intravenous administration.
If you are using more than three vials you may need a larger Administration Syringe (i.e. larger than 20 mL) which is not included.
Do notdetach the large LUER-LOK Administration Syringe until you are ready to attach the next vial (with vial adapter attached).
Follow the instructions above for reconstitution of the second vial.
- Remove the Administration Syringe from the first vial adapter by turning it counter clockwise until it is completely detached.
- Attach the Administration Syringe to the second reconstituted vial by turning clockwise until it is securely attached.
- Turn the IXINITY vial/vial adapter/Administration Syringe upside down, slowly pull on the plunger rod to draw the solution into the Administration Syringe (see Step 15 above).
Repeat this POOLING procedure with each vial you will be using.
Once you have pooled the required dose, proceed to administration using the Administration Syringe.
For intravenous use after reconstitution only.
IXINITY is administered by intravenous (IV) infusion after reconstitution with diluent (Sterile Water for Injection) supplied in the Pre-filled Syringe.
IXINITY must not be mixed with other medicinal products for infusion.
Reconstituted IXINITY must be pulled into the Administration Syringe prior to infusion.
IXINITY is normally administered intravenously over about 5 minutes at a maximum infusion rate of 10 mL per minute. The infusion rate should be adapted to the comfort level of each patient.
- Attach the Administration Syringe containing the reconstituted IXINITY solution to the luer end of the sterile infusion set. Inspect for and remove any air bubbles in the infusion set and Administration Syringe. NOTE: The luer tip of the Administration Syringe and the luer connection of the infusion set must not be touched by any object or surface, prior to connection of the Administration Syringe.
- Transfer IXINITY solution into the tube by pressing the syringe plunger until the tubing is completely filled. Once again, inspect for and remove any air bubbles in the infusion set and Administration Syringe.
- Perform venipuncture as directed by your healthcare provider.
- Limit the amount of blood entering the tubing. Blood must never enter the syringe. If blood is observed in the tubing or syringe, discard all material and resume administration with a new package.
- Following completion of the infusion, remove the infusion set, press the sterile gauze on the infusion site until bleeding has stopped, then apply a sterile bandage. The amount of drug product remaining in the infusion set should be minimal. Log the batch number of the IXINITY used; it is located on the container.
Dispose of all unused solution, empty vials, and used needles and syringes in an appropriate container for throwing away medical waste as it may hurt others if not handled properly.
Contact your healthcare provider or local hemophilia treatment center if you experience any problems.