Coagulation Factor IX (Recombinant), GlycoPEGylated
Read the Patient Product Information and the
Instructions For Use that come with REBINYN before you start taking this
medicine and each time you get a refill. There may be new information.
This Patient Product Information does not take the place
of talking with your healthcare provider about your medical condition or
treatment. If you have questions about REBINYN after reading this information,
ask your healthcare provider.
What is the most important information I need to know
Do not attempt to do an infusion yourself unless you
have been taught how by your healthcare provider or hemophilia treatment
You must carefully follow your healthcare provider's
instructions regarding the dose and schedule for infusing REBINYN so that your
treatment will work best for you.
What is REBINYN?
REBINYN is an injectable medicine used to replace
clotting Factor IX that is missing in patients with hemophilia B. Hemophilia B
is an inherited bleeding disorder in all age groups that prevents blood from
REBINYN is used to treat and control bleeding in people
with hemophilia B.
Your healthcare provider may give you REBINYN when you
Who should not use REBINYN?
You should not use REBINYN if you
- are allergic to Factor IX or any of the other ingredients
- if you are allergic to hamster proteins
If you are not sure, talk to your healthcare provider
before using this medicine.
Tell your healthcare provider if you are pregnant or
nursing because REBINYN might not be right for you.
What should I tell my healthcare provider before I use
You should tell your healthcare provider if you
- Have or have had any medical conditions.
- Take any medicines, including non-prescription medicines
and dietary supplements.
- Are nursing.
- Are pregnant or planning to become pregnant.
- Have been told that you have inhibitors to Factor IX.
How should I use REBINYN?
Treatment with REBINYN should be started by a healthcare
provider who is experienced in the care of patients with hemophilia B.
REBINYN is given as an infusion into the vein.
You may infuse REBINYN at a hemophilia treatment center,
at your healthcare provider's office or in your home. You should be trained on
how to do infusions by your hemophilia treatment center or healthcare provider.
Many people with hemophilia B learn to infuse the medicine by themselves or
with the help of a family member.
Your healthcare provider will tell you how much REBINYN
to use based on your weight, the severity of your hemophilia B, and where you
are bleeding. Your dose will be calculated in international units, IU.
Call your healthcare provider right away if your
bleeding does not stop after taking REBINYN.
If your bleeding is not adequately controlled, it could
be due to the development of Factor IX inhibitors. This should be checked by
your healthcare provider. You might need a higher dose of REBINYN or even a
different product to control bleeding. Do not increase the total dose of
REBINYN to control your bleeding without consulting your healthcare provider.
Use in children
REBINYN can be used in children. Your healthcare provider
will decide the dose of REBINYN you will receive.
If you forget to use REBINYN
If you forget a dose, infuse the missed dose when you
discover the mistake. Do not infuse a double dose to make up for a forgotten
dose. Proceed with the next infusions as scheduled and continue as advised by
your healthcare provider.
If you stop using REBINYN
Do not stop using REBINYN without consulting your
If you have any further questions on the use of this
product, ask your healthcare provider.
What if I take too much REBINYN?
Always take REBINYN exactly as your healthcare provider
has told you. You should check with your healthcare provider if you are not
sure. If you infuse more REBINYN than recommended, tell your healthcare
provider as soon as possible.
What are the possible side effects of REBINYN?
Common Side Effects Include:
- swelling, pain, rash or redness at the location of
Other Possible Side Effects:
You could have an allergic reaction to coagulation Factor
IX products. Call your healthcare provider right away or get emergency
treatment right away if you get any of the following signs of an allergic
reaction: hives, chest tightness, wheezing, difficulty breathing, and/or
swelling of the face.
Your body can also make antibodies called “inhibitors”
against REBINYN, which may stop REBINYN from working properly. Your healthcare
provider may need to test your blood for inhibitors from time to time.
You may be at an increased risk of forming blood clots in
your body, especially if you have risk factors for developing blood clots. Call
your healthcare provider if you have chest pain, difficulty breathing, leg
tenderness or swelling.
These are not all of the possible side effects from
REBINYN. Ask your healthcare provider for more information. You are encouraged
to report side effects to FDA at 1-800-FDA-1088.
Tell your healthcare provider about any side effect that
bothers you or that does not go away.
What are the REBINYN dosage strengths?
REBINYN comes in three different dosage strengths. The
actual number of international units (IU) of Factor IX in the vial will be
imprinted on the label and on the box. The three different strengths are as
|Cap Color Indicator
||500 IU per vial
||1000 IU per vial
||2000 IU per vial
Always check the actual dosage strength printed on the
label to make sure you are using the strength prescribed by your healthcare
How should I store REBINYN?
Prior to Reconstitution (mixing the dry powder in the
vial with the diluent):
Store in original package in order to protect from light.
Do not freeze REBINYN.
REBINYN vials can be stored in the refrigerator (36-46°F
[2°C - 8°C]) for up to 24 months until the expiration date, or at room
temperature (up to 86°F [30°C]) for a single period not more than 6 months.
If you choose to store REBINYN at room temperature:
- Note the date that the product is removed from
refrigeration on the box.
- The total time of storage at room temperature should not
be more than 6 months. Do not return the product to the refrigerator.
- Do not use after 6 months from this date or the
expiration date listed on the vial, whichever is earlier.
Do not use this medicine after the expiration date which
is on the outer carton and the vial. The expiration date refers to the last day
of that month.
The reconstituted (the final product once the powder is
mixed with the diluent) REBINYN should appear clear without visible particles.
The reconstituted REBINYN should be used immediately.
If you cannot use the reconstituted REBINYN immediately,
it should be used within 4 hours when stored at or below 86°F (30°C). Store the
reconstituted product in the vial.
Keep this medicine out of the sight and out of reach of
What else should I know about REBINYN and hemophilia
Medicines are sometimes prescribed for purposes other
than those listed here. Do not use REBINYN for a condition for which it is not
prescribed. Do not share REBINYN with other people, even if they have the same
symptoms that you have.
For more information about REBINYN, please call Novo
Nordisk at 1-844-REB-INYN.
Instructions on how to use REBINYN® MixPro®
READ THESE INSTRUCTIONS CAREFULLY BEFORE USING REBINYN.
REBINYN is supplied as a
powder. Before infusion (administration) it must be mixed (reconstituted) with
the liquid diluent supplied in the syringe. The liquid diluent is a histidine
solution. The mixed REBINYN must be infused into your vein (intravenous
infusion). The equipment in this package is designed to mix and infuse REBINYN.
You will also need an infusion
set (tubing and butterfly needle), sterile alcohol swabs, gauze pads, and
Don't use the equipment
without proper training from your doctor or nurse.
Always wash your hands and
ensure that the area around you is clean.
When you prepare and infuse
medication directly into the veins, it is important to use a clean and germ
free (aseptic) technique. Improper technique can introduce germs that can
infect the blood.
Don't open the equipment
until you are ready to use it.
Don't use the equipment if
it has been dropped, or if it is damaged. Use
a new package instead.
Don't use the equipment if
it is expired. Use a new package instead.
The expiration date is printed on the outer carton and on the vial, the vial
adapter and the pre-filled syringe.
Don't use the equipment if
you suspect it is contaminated. Use a new
Don't dispose of any of the items
until after you have infused the mixed solution.
The equipment is for single
The package contains:
- Vial with REBINYN powder
- Vial adapter
- Pre-filled syringe with diluent
- Plunger rod (placed under the
1. Prepare the vial and the syringe
- Take out the number of REBINYN® packages
- Check the expiry date.
- Check the name, strength and color of the package,
to make sure it contains the correct product.
- Wash your hands and dry them properly using a clean towel or air dry.
- Take the vial, the vial adapter
and the pre-filled syringe out of the carton. Leave the plunger rod
untouched in the carton.
- Bring the vial and the
pre-filled syringe to room temperature.
You can do this by holding them in your hands until they feel as warm as your
- Remove the plastic cap from
the vial. If the plastic cap is loose or missing, don't use the vial.
- Wipe the rubber stopper with
a sterile alcohol swab and allow it to air
dry for a few seconds before use to ensure that it is as germ free as possible.
- Don't touch the rubber
stopper with your fingers as this can
2. Attach the vial adapter
- Remove the protective paper from the vial adapter.
Don't take the vial adapter
out of the protective cap with your fingers.
If you touch the spike on the vial adapter germs from your fingers can be
If the protective paper is
not fully sealed or if it is broken, don't use the vial adapter.
- Place the vial on a flat and
- Turn over the protective
cap, and snap the vial adapter onto the
Once attached, don't remove
the vial adapter from the vial.
- Lightly squeeze the
protective cap with your thumb and index finger as shown. Remove the
protective cap from the vial adapter.
Don't lift the vial adapter
from the vial when removing the protective
3. Attach the plunger rod and
- Grasp the plunger rod by the
wide top end and take it out of the carton. Don't touch the sides or the
thread of the plunger rod. If you touch the sides or the thread germs from
your fingers can be transferred.
- Immediately connect the plunger rod to the syringe by turning it
clockwise into the rubber plunger inside the pre-filled syringe until
resistance is felt.
- Remove the syringe cap from the pre-filled syringe by bending it down until the
Don't touch the syringe tip
under the syringe cap. If you touch the
syringe tip germs from your fingers can be transferred.
If the syringe cap is loose
or missing, don't use the pre-filled syringe.
- Screw the pre-filled syringe
securely onto the vial adapter until
resistance is felt.
4. Mix the powder with the
- Hold the pre-filled syringe
slightly tilted with the vial pointing
- Push the plunger rod to inject all the diluent into the vial.
- Keep the plunger rod pressed
down and swirl the vial gently until all
the powder is dissolved. Don't shake the vial as this
will cause foaming.
- Check the mixed solution. It must be clear and colorless. If you notice visible
particles or discoloration, don't use it. Use a new package instead.
REBINYN is recommended to be
used immediately after it is mixed.
If you cannot use the mixed
REBINYN solution immediately, it should be
used within 4 hours when stored at room temperature at or below 86°F (30°C).
Store the reconstituted product in the vial.
Do not freeze mixed REBINYN
solution or store it in syringes.
Keep mixed REBINYN solution
out of direct light.
If your dose requires more than
one vial, repeat step A to J with additional vials, vial adapters and
pre-filled syringes until you have reached your required dose.
- Keep the plunger rod pushed
- Turn the syringe with the vial upside down.
- Stop pushing the plunger rod
and let it move back on its own while the
mixed solution fills the syringe.
- Pull the plunger rod
slightly downwards to draw the mixed
solution into the syringe.
- In case you only need part of
the entire vial, use the scale on the syringe to see how much mixed solution
you withdraw, as instructed by your doctor or nurse.
- While holding the vial upside
down, tap the syringe gently to let any air bubbles rise to the top.
- Push the plunger rod slowly until all air bubbles are gone.
- Unscrew the vial adapter with the vial.
Don't touch the syringe tip. If you touch the syringe tip germs from your fingers can
Caution: The pre-filled
diluent syringe is made of glass with an internal tip diameter of 0.037 inches,
and is compatible with a standard Luer-lock connector.
Some needleless connectors for intravenous catheters
are incompatible with the glass diluent syringes (for example, certain
connectors with an internal spike, such as Clave®/MicroClave®,
InVision-Plus®, InVision-Plus CS®,
The use of these needleless
connectors can damage the connector and affect administration.
To administer REBINYN
through incompatible needleless connectors, withdraw reconstituted product into
a standard 10 mL sterile Luer-lock plastic syringe.
If you have encountered any
problems with attaching the pre-filled histidine diluent syringe to any Luer-lock compatible device, please contact Novo Nordisk at (844) 303-4448.
5. Infuse the mixed solution
REBINYN is now ready to infuse into
- Do not mix REBINYN with any
other intravenous infusions or medications.
- Infuse the mixed solution
slowly over 1 to 4 minutes as instructed by your doctor or nurse.
Infusing the solution via a
central venous access device (CVAD) such as a central venous catheter or
- Use a clean and germ free
(aseptic) technique. Follow the instructions for proper use for your connector
and central venous access device in consultation with your doctor or nurse.
- Infusing into a CVAD may
require using a sterile 10 mL plastic syringe for withdrawal of the mixed
solution and infusion.
- If necessary, use 0.9% Sodium
Chloride Injection, USP to flush the CVAD line before or after REBINYN
The peel-off label found on the
REBINYN vial can be used to record the lot number.
After infusion, safely
dispose of all unused REBINYN solution,
the syringe with the infusion set, the vial with the vial adapter, and other
waste materials in an appropriate container for throwing away medical waste.
Don't throw it out with the
ordinary household trash.
Don't disassemble the vial
and vial adapter before disposal.
Don't reuse the equipment.
Contact your healthcare
provider or local hemophilia treatment center if you experience any problems.