PATIENT INFORMATION
RIXUBIS
[Coagulation Factor IX (Recombinant)]
This leaflet summarizes important information about
RIXUBIS. 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 RIXUBIS. If you have any
questions after reading this, ask your healthcare provider.
What is RIXUBIS?
RIXUBIS 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 blood from clotting normally. RIXUBIS
is used to prevent and control bleeding in people with hemophilia B. Your
healthcare provider may give you RIXUBIS when you have surgery. RIXUBIS can
reduce the number of bleeding episodes when used regularly (prophylaxis).
Who should not use RIXUBIS?
You should not use RIXUBIS if you
- are allergic to hamsters
- are allergic to any ingredients in RIXUBIS.
Tell your healthcare provider if you are pregnant or
breastfeeding because RIXUBIS may not be right for you.
What should I tell my healthcare provider before using
RIXUBIS?
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 RIXUBIS passes into
your milk and if it can harm your baby
- are pregnant or planning to become pregnant. It is not
known if RIXUBIS may harm your unborn baby
- have been told that you have inhibitors to factor IX
(because RIXUBIS may not work for you).
How should I infuse RIXUBIS?
RIXUBIS is given directly into the bloodstream. RIXUBIS
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 RIXUBIS by
themselves or with the help of a family member.
Your healthcare provider will tell you how much RIXUBIS
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 RIXUBIS to be
sure that your blood level of factor IX is high enough to clot your blood. Call
your healthcare provider right away if your bleeding does not stop after taking
RIXUBIS.
What are the possible side effects of RIXUBIS?
Allergic reactions may occur with RIXUBIS. Call your
healthcare provider or get emergency treatment right away if you get a rash or
hives, itching, tightness of the throat, chest pain or tightness, difficulty
breathing, lightheadedness, dizziness, nausea or fainting. Some common side effects
of RIXUBIS were unusual taste in the mouth and limb pain. Tell your healthcare
provider about any side effects that bother you or do not go away. These are
not all the side effects possible with RIXUBIS. You can ask your healthcare
provider for information that is written for healthcare professionals.
What are the RIXUBIS dosage strengths?
RIXUBIS comes in five different dosage strengths: 250,
500, 1000, 2000 and 3000 international units. The actual strength will be
imprinted on the label and on the box. The five different strengths are color
coded, as follows:
 |
Dosage strength of approximately 250 international units
per vial |
 |
Dosage strength of approximately 500 international units
per vial |
 |
Dosage strength of approximately 1000 international units
per vial |
 |
Dosage strength of approximately 2000 international units
per vial |
 |
Dosage strength of approximately 3000 international units
per vial |
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 RIXUBIS?
- Store at refrigerated temperature 2° to 8°C (36° to 46°F)
for up to 24 months. Do not freeze.
- May store at room temperature not to exceed 30°C (86°F)
for up to 12 months within the 24 month time period. Write on the carton the
date RIXUBIS is removed from refrigeration. After storage at room temperature,
do not return the product to the refrigerator.
- Do not use after the expiration date printed on the
carton or vial.
- Reconstituted product (after mixing dry product with wet
diluent) must be used within 3 hours and cannot be stored or refrigerated.
Discard any RIXUBIS left in the vial at the end of your infusion.
What else should I know about RIXUBIS?
Your body may form inhibitors to factor IX. An inhibitor
is part of the body's defense system. If you form inhibitors, it may stop
RIXUBIS 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 IX.
Medicines are sometimes prescribed for purposes other
than those listed here. Do not use RIXUBIS for a condition for which it is not
prescribed. Do not share RIXUBIS with other people, even if they have the same
symptoms that you have.
Recredits at Baxter available to patients
For information on patient assistance programs that are
available to you, including the Baxter CARE Program, please contact the Baxter
Insurance Assistance Helpline at 1-888-229-8379.
INSTRUCTIONS FOR USE
RIXUBIS
[Coagulation Factor IX (Recombinant)]
For intravenous use 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
RIXUBIS. If you are unsure of the procedures, please call your healthcare
provider before using RIXUBIS. Call your healthcare provider right away if
bleeding is not controlled after using RIXUBIS. Your healthcare provider will
prescribe the dose that you should take. Your healthcare provider may need to
take blood tests from time to time. Talk to your healthcare provider before
traveling. Plan to bring enough RIXUBIS for your treatment during this time.
Dispose of all materials, including any leftover reconstituted RIXUBIS product,
in an appropriate container.
1. Prepare a clean flat surface and gather all the
materials you will need for the infusion. Check the expiration date, and let
the vial with the RIXUBIS concentrate and the Sterile Water for Injection, USP
(diluent) warm up to room temperature. Wash your hands and put on clean exam
gloves. If infusing yourself at home, the use of gloves is optional.
2. Remove caps from the RIXUBIS concentrate and diluent
vials to expose the centers of the rubber stoppers.
3. Disinfect the stoppers with an alcohol swab (or other
suitable solution suggested by your healthcare provider or hemophilia center)
by rubbing the stoppers firmly for several seconds and allow them to dry prior
to use. Place the vials on a flat surface.
4. Open the BAXJECT II device package by peeling away the
lid, without touching the inside of the package. Do not remove the BAXJECT
II device from the package.
5. Turn the package with the BAXJECT II device upside
down and place it over the top of the diluent vial. Fully insert the clear
plastic spike of the device into the center of the diluent vial stopper by
pushing straight down. Grip the package at its edge and lift it off the device.
Be careful not to touch the white plastic spike. Do not remove the blue cap
from the BAXJECT II device. The diluent vial now has the BAXJECT II device
connected to it and is ready to be connected to the RIXUBIS vial.
6. To connect the diluent vial to the RIXUBIS vial, turn
the diluent vial over and place it on top of the vial containing RIXUBIS
concentrate. Fully insert the white plastic spike into the RIXUBIS vial stopper
by pushing straight down. Diluent will flow into the RIXUBIS vial. This should
be done right away to keep the liquid free of germs.
7. Swirl the connected vials gently and continuously
until the powder is completely dissolved. Do not shake. The
RIXUBIS solution should look clear and colorless. If not, do not use it and
notify Baxter immediately.
8. Take off the blue cap from the BAXJECT II device and
connect the syringe by screwing it clockwise until the syringe is secured. Do
not over tighten. Be careful to not inject air.
9. Turn over the connected vials so that the RIXUBIS vial
is on top. Draw the RIXUBIS solution into the syringe by pulling back the
plunger slowly. Disconnect the syringe from the BAXJECT II unscrewing it
counterclockwise.
10. If you are using more than one vial of RIXUBIS, the
contents of more than one vial may be drawn into the same syringe. Make sure
you mix each vial of RIXUBIS with the Sterile Water for Injection, USP that is
provided in the box (following Steps 1-9). You will need a separate BAXJECT
II device to mix each additional vial of RIXUBIS.
11. Attach the infusion needle to the syringe using a
winged (butterfly) infusion set, if available. Point the needle up and remove
any air bubbles by gently tapping the syringe with your finger and slowly and
carefully pushing air out of the syringe and needle.
12. Apply a tourniquet and get the infusion site ready by
wiping the skin well with an alcohol swab (or other suitable solution suggested
by your healthcare provider or hemophilia center).
13. Insert the needle into the vein and remove the
tourniquet. Slowly infuse the RIXUBIS. Do not infuse any faster than 10 mL
per minute.
14. Take the needle out of the vein and use sterile gauze
to put pressure on the infusion site for several minutes. Do not recap the
needle. Place it with the used syringe in a hard-walled sharps container
for proper disposal.
15. Dispose of the used vials and BAXJECT II system in
your hard-walled sharps container without taking them apart. Do not dispose of
these supplies in ordinary household trash.
16. Remove the peel-off label from the RIXUBIS vial and
place it in your logbook. Clean any spilled blood with a freshly prepared
mixture of 1 part bleach and 9 parts water, soap and water, or any household
disinfecting solution.
Important: Contact your healthcare provider or local
hemophilia treatment center if you experience any problems.