Susoctocog alfa (recombinant coagulation factor VIII, porcine sequence) powder for
injection vial with diluent syringe
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before you start using OBIZUR.
This leaflet answers some common questions about OBIZUR. It does not contain all of
the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of using
your medicine against the benefit that it will have for you.
If you have any concerns about having this medicine, ask your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What OBIZUR is used for
OBIZUR is a recombinant DNA derived, anti-haemophilic factor used for the treatment
of bleeding episodes in adults with acquired haemophilia A.
It is possible that your doctor may give you OBIZUR for another reason.
Ask your doctor if you have any questions about why you are being given OBIZUR.
How does OBIZUR work
Under normal physiological conditions, factor VIII is essential for blood clotting
and therefore the control of bleeding.
Acquired haemophilia is a bleeding disorder that is not present a birth but develops
suddenly at some point in life due to an abnormality in the immune system. In patients
with acquired haemophilia A, factor VIII is not working properly because the patient
has developed antibodies which neutralise this blood clotting factor, and this prevents
blood from clotting.
OBIZUR belongs to a group of medicines called anti-haemophilic agents.
OBIZUR is a man-made clotting factor. It is similar to the naturally occurring protein
in the body.
OBIZUR works by temporarily replacing the inhibited human clotting factor VIII, so
that blood can clot normally.
Before you are given OBIZUR
When you must not be given OBIZUR
OBIZUR should not be given to you if you are:
allergic to any products of porcine or hamster origin;.
allergic to any ingredients in this product which are listed at the end of the 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 you are not sure, talk to your doctor before using OBIZUR.
Do not use this medicine in children.
The safety and effectiveness in children have not been established.
Do not use this medicine if the expiry date printed on the pack has passed or if the
packaging shows sign of tampering.
Before you are given OBIZUR
You should tell your doctor if you:
have or have had any medical problems;
have any allergies, including allergies to products that are of porcine or hamster
have had heart problems or blood clot in the past or you have any other conditions
that make you at risk of developing blood clots;
are on a controlled sodium diet;
are breast feeding (it is not known if OBIZUR passes into your milk and if it can
harm your baby);
are pregnant or planning to become pregnant (it is not known if OBIZUR may harm your
If you are breast feeding or if you are pregnant or planning to have a baby, ask your
doctor for advice before using OBIZUR.
Taking other medicines
Tell your doctor or pharmacist if you are using any other medicines including any
that you obtained without a prescription from your pharmacy, supermarket or health
Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while being given OBIZUR.
How OBIZUR is given
How much is given
Your doctor will decide the dose of OBIZUR you will receive. Each individual will
receive a different amount, which may vary between treatments.
The dose you receive will be based on:
your condition, e.g. in which sites the bleeding occurs (knees, muscle, etc.).
As a general guide, an initial first dose of 200 U per kilogram (U/kg) bodyweight
The frequency and duration of treatment will depend on how well OBIZUR is working
for you. Your doctor will adjust the dose and frequency of OBIZUR injections until
the bleeding stopped.
How OBIZUR is given
OBIZUR is usually given in a hospital so that you are under the care of a healthcare
OBIZUR is given by a slow injection directly into your vein.
Use aseptic technique to prepare OBIZUR for injection.
Use only the water for injections supplied with the pack to prepare OBIZUR for injection.
Do not mix OBIZUR with any other medicines or solvent.
Always inspect the solution after it is prepared for use and before injection.
The solution should be clear and colourless.
Do not inject if the solution is discoloured or cloudy or contains particles.
Use the solution straight away or within 3 hours after it is prepared.
Do not refrigerate the solution after it is prepared.
Use a new syringe and needle for each injection.
Do not mix OBIZUR with other medicines.
If you are given too much (overdose)
As OBIZUR will be given to you by a doctor/nurse, it is unlikely that you will be
given an overdose.
Your healthcare professional will regularly monitor your condition and test your blood
to prevent overdose.
Immediately telephone your doctor or the National Poisons Information (telephone 131
126), or go to accident and emergency at your nearest hospital, if you think that
you or anyone else may have been given too much OBIZUR.
Do this even if there are no signs of discomfort or poisoning.
While you are using OBIZUR
Things you must do
You will have your blood tested after the initial OBIZUR injection and also regularly
after subsequent injections to see how your treatment is working. This is to check
the your blood level of factor VIII to confirm that you have received adequate treatment.
Your doctor will also check if the bleeding is adequately controlled.
Your doctor may do additional blood tests to check if you have developed antibodies
to OBIZUR treatment.
Monitor your bleeding and tell your doctor or nurse if your bleeding gets worse.
Tell your doctor or pharmacist immediately if you experience any of the following
during the OBIZUR injection:
shortness of breath; wheezing; difficulty breathing; chest pain or discomfort;
changes in facial skin colour, puffiness or swelling of your face, lips, tongue, or
other parts of the body, rash or hives.
The above list includes signs and symptoms of a severe allergic response to the medicine.
The use of OBIZUR should be stopped immediately if any of the above occurs during
Tell your doctor or pharmacist as soon as possible if you do not feel well after using
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 these side effects.
Do not be alarmed by this list of possible side effects, you may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
The following list includes the common side effects for OBIZUR:
antibodies against OBIZUR detected in blood test results.
Tell your doctor or pharmacist of any suspected undesirable effect that is not mentioned
in this leaflet.
Other side effects not listed above may occur in some patients.
After using OBIZUR
Keep out of the reach and sight of children.
Store OBIZUR at 2°C - 8°C in a refrigerator. Do not freeze.
Keep OBIZUR in the pack until it is time to use it.
This will protect the vials from light. If the vials are not stored in the pack, the
product may not keep well.
Do not store the solution in the fridge after the powder is mixed with the diluent.
OBIZUR is for single use in single patient only.
Discard any unused solution left in the vial at the end of your infusion.
Dispose the used vials and all materials in an appropriate container.
Medicines should not be disposed of via wastewater or household waste. These measures
will help to protect the environment.
If your doctor tell you to stop using OBIZUR or the expiry date has passed, ask your
pharmacist or your Haemophilia Treatment Centre what to do with any medicine that
is left over.
Ask your doctor, pharmacist or Haemophilia Treatment Centre if you have any questions
about how to dispose OBIZUR.
What OBIZUR looks like
OBIZUR is a white powder supplied in a glass vial with a diluent prefilled syringe
After reconstitution, the solution is clear, colourless and free from foreign particles.
OBIZUR is packed in cartons of 1, 5 and 10 single-packs.
Each single-pack contains:
1 vial of OBIZUR powder for injection;
1 prefilled syringe of water for injections (used as the diluent to dissolve the OBIZUR
1 vial adapter (to help with transferring the diluent to prepare the solution for
Not all pack sizes may be marketed.
water for injections (diluent).
OBIZUR is supplied in Australia by:
Shire Australia Pty Limited
Level 39, 225 George Street
Sydney NSW 2000
Telephone: 1800 012 612
Australian registration numbers
AUST R 236475
Date of preparation
This leaflet was prepared in January 2019.
OBIZUR is a trademark or registered trademark of Baxalta Incorporated, a wholly-owned,
indirect subsidiary of Shire plc.
SHIRE and the Shire Logo are trademarks of Shire Pharmaceutical Holdings Ireland Limited
or its affiliates.