Efmoroctocog alfa (recombinant coagulation factor VIII Fc fusion protein) 250, 500, 750, 1000, 1500,
2000, 3000 IU/vial
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about ELOCTATE.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
This leaflet was last updated on the
date at the end of this leaflet.
Speak to your doctor or your
Haemophilia Treatment Centre to
obtain the most up to date
information on this medicine.
You can also download the most
up to date leaflet from
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using ELOCTATE
against the benefits they expect it
will have for you.
If you have any concerns about using
this medicine, ask your doctor.
Keep this leaflet with the medicine.
You may need to read it again.
What ELOCTATE is
ELOCTATE is used for the
management of haemophilia A
(congenital factor VIII deficiency).
ELOCTATE is used to:
control and prevent bleeding
routinely prevent and reduce the
frequency of bleeding episodes
reduce bleeding before, during,
and after surgery.
Eloctate does not contain von
Willebrand factor and therefore is not
suitable for use in Von Willebrand’s
People with haemophilia A lack
sufficient factor VIII to control
bleeding. ELOCTATE works by
replacing factor VIII to enable blood
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
Do not give this medicine to anyone
It may harm them, even if their
symptoms are the same as yours.
Before you use
When you must not use it
Do not use ELOCTATE if you
have an allergy to:
ELOCTATE or other factor VIII
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue
or other parts of the body
rash, itching or hives on the skin.
If any of these signs occur, stop
using ELOCTATE and see your
Do not use this medicine after the
expiry date printed on the pack or
if the packaging is torn or shows
signs of tampering.
If it has expired or is damaged,
return it to your Haemophilia
Treatment Centre or Australian Red
Cross Blood Service for disposal.
Do not use ELOCTATE if the
medicine is cloudy, contains
particles or is discoloured.
It should be clear to slightly
opalescent and colourless.
If you are not sure whether you
should start using this medicine,
talk to your doctor.
Before you start to use it
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Tell your doctor if you are
pregnant or intend to become
There is no information on the use
of ELOCTATE during pregnancy.
Your doctor will discuss the risks
and benefits of using it if you are
Tell your doctor if you are breast-
feeding or planning to breastfeed.
It is not known whether ELOCTATE
passes into breast milk. Your doctor
will discuss the risks and benefits of
using it if you are breast-feeding.
If you have not told your doctor
about any of the above, tell them
before you start using
Taking other medicines
Tell your doctor or Haemophilia
Treatment Centre if you are taking
any other medicines, including any
that you get without a prescription
from your pharmacy, supermarket
or health food shop.
Your doctor or Haemophilia
Treatment Centre have more
information on medicines to be
careful with or avoid while using this
How to use
Follow all directions given to you
by your doctor carefully.
They may differ from the
information contained in this leaflet.
If you do not understand the
instructions on the box, ask your
doctor or Haemophilia Treatment
Centre for help.
How much to use
Your doctor will decide how much
ELOCTATE you use. This will
depend on your individual need for
replacement factor VIII therapy.
Your doctor may change the dose
you use during your treatment.
Do not stop using ELOCTATE or
change the dosage, without
checking with your doctor unless
you have an allergic reaction.
How to use it
ELOCTATE is given by slow
injection directly into your veins.
ELOCTATE is provided as a powder
and sterile water for injections
(diluent) which need to be mixed
together before use.
It is important to not shake
ELOCTATE when mixing it.
Shaking can damage this medicine.
Mix the ELOCTATE powder with
the diluent provided only when you
are ready to use it.
If you mix the powder and diluent
and are interrupted, you can keep
the mixed product for a maximum
of 6 hours when stored at room
temperature (below 30°C). Protect
the product from direct sunlight.
Do not put it in the freezer.
Always inspect ELOCTATE after
it has been mixed and before use.
The medicine should be clear to
slightly opalescent and colourless.
Do not inject if the solution is
discoloured or cloudy or contains
Refer to the leaflet in the pack for
step-by-step instructions about
how to prepare and inject
Use in one patient on one occasion
only. Dispose of all unused
solution, empty vials, and used
needles and syringes into a sharps
Talk to your doctor or Haemophilia
Treatment Centre, or telephone 1800
852 289 in Australia or 0800 852 289
in NZ, if you have any questions
about how to use ELOCTATE.
How long to use it
Continue using your medicine for
as long as your doctor tells you.
This medicine helps to control your
condition, but does not cure it.
If you forget to use it
Use your dose of ELOCTATE as
soon as you remember, and resume
your normal dosing schedule.
Do not use a double dose to make
up for the dose that you missed.
This may increase the chance of you
getting an unwanted side effect.
If you are not sure what to do, ask
your doctor or Haemophilia
If you use too much
Immediately telephone your doctor
or the Poisons Information Centre
(in Australia telephone 13 11 26, in
New Zealand telephone 0800 764
766) for advice, or go to
Emergency at the nearest hospital,
if you think that you or anyone else
may have used too much
ELOCTATE. Do this even if there
are no signs of discomfort or
You may need urgent medical
While you are using
Things you must do
Tell your doctor immediately if
bleeding is not controlled after
If you become pregnant while on
treatment with ELOCTATE,
immediately tell your doctor.
Always talk to your doctor or
Haemophilia Treatment Centre
before using any other medicine
while you are using ELOCTATE.
Do not use more than the
Tell any other doctors, dentists and
pharmacists who treat you that
you are using this medicine.
If you are about to have any blood
tests, tell your doctor that you are
Keep all of your doctor's
appointments so that your progress
can be checked.
Your doctor may do some blood tests
before you start your treatment and
from time to time during your
treatment to monitor your progress.
Things you must not do
Do not use ELOCTATE to treat
any other complaints unless your
doctor tells you to.
Do not give your medicine to
anyone else, even if they appear to
have the same condition as you.
Do not stop using your medicine or
change the dosage without
checking with your doctor.
Tell your doctor or Haemophilia
Treatment Centre as soon as possible
if you do not feel well while you are
All medicines can have side effects.
Sometimes they are serious, most of
the time they are not. You may need
medical attention if you get some of
the side effects.
Do not be alarmed by the following
lists of side effects. You may not
experience any of them.
Ask your doctor or Haemophilia
Treatment Centre to answer any
questions you may have.
Tell your doctor or Haemophilia
Treatment Centre if you notice any
of the following and they worry you:
joint pain or joint swelling
general discomfort (malaise)
aching muscles, muscle
tenderness or weakness, not
caused by exercise
taste disturbance or loss of taste
high blood pressure
low blood pressure (symptoms
include dizziness or feeling
slow heart beat (bradycardia)
The above list includes the more
common side effects of your
medicine. If any of these persist or
worsen, talk to your doctor.
If any of the following happen, tell
your doctor immediately or go to
Emergency at your nearest
swelling of your face, lips, tongue
or other parts of the body, rash or
shortness of breath, wheezing,
difficulty breathing, chest pain or
The above list includes very serious
side effects. You may need urgent
medical attention or hospitalisation.
These side effects are very rare.
ELOCTATE may increase the risk of
formation of abnormal blood clots in
your body if you have risk factors for
developing blood clots.
Your body can make antibodies
called “inhibitors” against
ELOCTATE, which may stop
ELOCTATE from working properly.
Tell your doctor or Haemophilia
Treatment Centre if you notice
anything that is making you feel
Keep your ELOCTATE in the
pack until it is time to use it.
This medicine should be protected
Keep ELOCTATE in the
refrigerator at 2°C to 8°C.
If necessary, you can keep
ELOCTATE out of the refrigerator
for a single 6 month period.
If out of the refrigerator, store the
sealed carton in a cool dry place
where the temperature stays below
30°C. The date that the product is
removed from the refrigerator should
be recorded on the carton.
Do not use any ELOCTATE that
has been out of the refrigerator for
more than 6 months (refer to
Once reconstituted, you can keep
ELOCTATE at room temperature
(below 30°C) for up to 6 hours.
Protect the product from direct
Do not store ELOCTATE or any
other medicine in the bathroom or
near a sink. Do not leave it on a
window sill or in the car.
Heat and dampness can destroy some
Do not freeze ELOCTATE.
Do not place in the freezer or
freezing compartment of a
Keep it where children cannot
A locked cupboard at least one-and-
a-half metres above the ground is a
good place to store medicines.
If your doctor tells you to stop using
this medicine or the expiry date has
passed, ask your Haemophilia
Treatment Centre what to do with
any medicine that is left over.
What it looks like
ELOCTATE comes as a white to off-
white powder to cake in a glass vial.
Each pack contains:
1 vial of sterile ELOCTATE
1 pre-filled syringe of diluent
1 sterile vial adapter
ELOCTATE is available in 7
strengths: 250 IU, 500 IU, 750IU,
1000 IU, 1500IU, 2000 IU and
ELOCTATE contains efmoroctocog
alfa as the active ingredient.
You can obtain more information
from your doctor or your
Haemophilia Treatment Centre,
or by telephoning 1800 852 289 in
Australia or 0800 852 289 in New
ELOCTATE is supplied in Australia
Biogen Australia Pty Ltd
Level 3, 123 Epping Road
North Ryde NSW 2113
ELOCTATE is supplied in New
Biogen NZ Biopharma Limited
54 Carbine Road
Mt Wellington, Auckland
= Registered Trademark or
This leaflet was prepared in
ELOCTATE 250 IU - AUST R
ELOCTATE 500 IU - AUST R
ELOCTATE 750 IU - AUST R
ELOCTATE 1000 IU - AUST R
ELOCTATE 1500 IU - AUST R
ELOCTATE 2000 IU - AUST R
ELOCTATE 3000 IU - AUST R
ELOCTATE® is a registered
trademark of Biogen.
BIOGEN® is a registered trademark
of Biogen MA Inc.