Coagulation Factor X
This Patient Information leaflet summarizes important
information about COAGADEX. Please read it carefully before using COAGADEX and
each time you get a refill, as there may be new information. This Patient
Information does not take the place of talking with your healthcare provider
about your medical condition or treatment, and it does not include all of the
important information about COAGADEX. If you have any questions about COAGADEX
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 center.
You must carefully follow your healthcare provider's instructions
regarding the dose and schedule for infusing COAGADEX so that your treatment
will work best for you.
What is COAGADEX?
COAGADEX is an injectable medicine used to replace the
clotting factor that is missing in people with Factor X deficiency. Factor X
deficiency is an inherited bleeding disorder that prevents blood from clotting
COAGADEX is used to treat and control bleeding in
patients aged 12 years and over with hereditary Factor X deficiency.
Your healthcare provider may give you COAGADEX when you
Who should not use COAGADEX?
You should not use COAGADEX if you are allergic
(hypersensitive) to any of the ingredients in COAGADEX.
Tell your healthcare provider if you are pregnant or
breast-feeding because COAGADEX may 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 problems
- Have any allergies
- Take any prescription and non-prescription medicines,
including over-the-counter medicines, supplements or herbal medicines
- Are breast-feeding. It is not known if COAGADEX passes
into your milk and if it can harm your baby
- Are pregnant or planning to become pregnant. It is not
known if COAGADEX may harm your unborn baby
- Have been told you have inhibitors to Factor X
How should I use COAGADEX?
You get COAGADEX as an infusion into your vein.
You may infuse COAGADEX 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 healthcare provider or hemophilia treatment center.
Many people with coagulation factor deficiencies learn to infuse their
treatment by themselves or with the help of a family member or caregiver.
Your healthcare provider will tell you how much COAGADEX
to use based on your weight, the severity of your Factor X deficiency, and
where you are bleeding from.
You may need blood tests done after using COAGADEX to be
sure that the level of Factor X in your blood is high enough to clot your
Call your healthcare provider right away if your bleeding
does not stop after using COAGADEX.
What are the possible side-effects of COAGADEX?
You can have an allergic reaction to COAGADEX.
Stop treatment and call your healthcare provider right
away if you have any of the following symptoms: difficulty breathing, chest
tightness, swelling of the face, rash or hives.
Common side effects of COAGADEX are infusion site
redness, infusion site pain, tiredness, and back pain.
Your body can also make antibodies, called
“inhibitors,” against COAGADEX, which may stop COAGADEX from working
properly. Your healthcare provider may give you blood tests to check for inhibitors.
These are not all of the possible side effects of
COAGADEX. Tell your healthcare provider about any side effects that bother you
or do not go away.
What are the COAGADEX dos age strengths ?
COAGADEX is packaged with a suitable volume (2.5 mL or 5
mL) of Sterile Water for Injection, and one Mix2Vial transfer device.
COAGADEX comes in two different dosage strengths:
Approximately 250 International Units (IU) - to be
reconstituted with 2.5 mL of sterile water.
Approximately 500 International Units (IU) - to be
reconstituted with 5 mL of sterile water.
The actual strength will be printed on the vial label and
on the box. Once dissolved, the concentrations in these two vials will be the
same, 100 IU per mL.
Always check the actual dosage printed on the label to
make sure you are using the vial size prescribed by your healthcare provider.
Always check the expiration date printed on the box. Do
not use the product after the expiration date printed on the box.
How do I store COAGADEX?
- Keep COAGADEX in its original package to protect it from
- Store COAGADEX in a refrigerator (not below 36°F [2°C])
or at room temperature (not to exceed 86°F [30°C]). Do not freeze.
- Do not use after the expiration date printed on the box.
The expiration date refers to the last day of that month.
- Do not use the sterile water if any small bits can be seen
- After reconstitution (mixing with the sterile water),
COAGADEX must be used within 1 hour. Discard any COAGADEX left in the vial at
the end of your infusion.
What else should I know about COAGADEX?
Medicines are sometimes prescribed for purposes other
than those listed here. Do not use COAGADEX for a condition for which it is not
prescribed. Do not share COAGADEX with other people, even if they have the same
symptoms or condition that you have.
For further information or if you have any questions
about COAGADEX, please contact BPL Inc. at the address below or through
Instructions for Use
Coagulation Factor X
Important: Do not attempt to give an infusion to
yourself unless you have been taught how to by your healthcare provider or
Always follow the specific instructions given by your
healthcare provider. The steps listed below are general guidelines for using
COAGADEX. If you are unsure of the procedures, please call your healthcare
provider before using.
Your healthcare provider will prescribe the dose that you
should take. Contact your healthcare provider right away if you accidentally
take more than the prescribed dose.
Your healthcare provider may need to take blood tests
from time to time.
Talk to your healthcare provider before travelling. Plan
to take enough COAGADEX for your treatment during this time.
Dispose of all materials, including any leftover
reconstituted COAGADEX product, in an appropriate container.
When should I inject Coagadex?
Inject COAGADEX when the first sign of bleeding occurs,
before surgery as a precaution, and before the onset of menstrual bleeding, if
appropriate and advised by your healthcare provider.
Repeat the injection at intervals of 24 hours to stop the
bleeding. Each individual bleed should be judged on its own severity.
Contact your healthcare provider right away if bleeding
does not stop after using COAGADEX.
How should I dissolve COAGADEX before use?
COAGADEX must be dissolved in the sterile water provided
with the product using the provided transfer device called Mix2Vial.
To administer this medicine you will also need a syringe
and suitable needle (not provided in the COAGADEX carton).
See below for step-by-step instructions for
- Bring the vials of COAGADEX and sterile water to room
temperature before mixing.
- Remove the cap from the vial of COAGADEX and clean the
top of the stopper with an alcohol swab.
- Repeat this step with the vial of sterile water.
- Peel back the top of the Mix2Vial package but leave the
device in the package.
- Place the blue end of the Mix2Vial on the sterile water
vial and push straight down until the spike penetrates the rubber stopper and
snaps into place.
- Remove the plastic outer packaging from the Mix2Vial and
discard it. Do not touch the exposed end of the device.
- Turn the sterile water vial upside down with the device
- Place the clear end of the Mix2Vial on the product vial
and push straight down until the spike penetrates the rubber stopper and snaps
- The sterile water will be pulled into the vial of COAGADEX
by the vacuum contained within it.
- Gently swirl the vial to make sure the powder is thoroughly
mixed. Do not shake the vial.
- A clear or slightly pearl-like solution should be obtained,
usually in less than 1 minute (5 minutes maximum).
Note: If the water is not pulled into the vial of COAGADEX.
This indicates a loss of vacuum in the vial. Do not use the product.
- Separate the empty sterile water vial and blue part from
the clear part by unscrewing counter-clockwise.
- Draw air into the syringe by pulling the plunger to the required
volume of sterile water added.
- Connect the syringe to the clear part of the Mix2Vial.
- Push the air in the syringe into the vial.
- Immediately invert the COAGADEX vial. The solution will
be drawn into the syringe.
- Disconnect the filled syringe from the device.
- Use the product immediately or within one hour of reconstitution.
Do not store the reconstituted product.
Note: If there are any particles in the syringe, or if
the solution is cloudy, or if a gel or clot forms, contact the manufacturer to
report the batch number printed on the vial.
If you have to use more than one vial of COAGADEX to make
up your dose, repeat steps 1 to 5 to reconstitute each vial and draw up all of
the solution into one syringe for your injection. You must use a new Mix2Vial
to draw the contents of each vial up into the plastic syringe.
How do I inject COAGADEX?
Inspect the solution before injection. Do not use if
there are any particles in the syringe, or if the solution is cloudy, or if a
gel or clot forms.
Do not add the solution to any other fluids and do not
mix it together with any other medicine.
To inject the medicine:
- Attach a suitable needle to the syringe containing
- Inject the dose at a suggested rate of 10 mL/min, but no
more than 20 mL/min into your vein.
Dispose of any solution that remains, along with used
syringes, needles and containers. Do not throw it out with the ordinary
Important: Contact your healthcare provider or local
hemophilia treatment center if you experience any problems.