OBIZUR® (recombinant coagulation factor VIII, porcine sequence) Consumer Medicine Information What is in this leaflet Do not use this medicine if the expiry date Do not inject if the solution is discoloured printed on the pack has passed or if the or cloudy or contains particles. Read this leaflet carefully before you start packaging shows sign of tampering. Use the solution straight away or within 3 using OBIZUR. Before you are given OBIZUR hours after it is prepared. This leaflet answers some common questions Do not refrigerate the solution after it is about OBIZUR. It does not contain all of the You should tell your doctor if you: prepared. available information. • have or have had any medical problems; Use a new syringe and needle for each It does not take the place of talking to your • have any allergies, including allergies to injection. doctor or pharmacist. products that are of porcine or hamster Do not mix OBIZUR with other All medicines have risks and benefits. Your origin; medicines. doctor has weighed the risks of using your • have had heart problems or blood clot in medicine against the benefit that it will have the past or you have any other conditions If you are given too much for you. that make you at risk of developing (overdose) If you have any concerns about having this blood clots; As OBIZUR will be given to you by a medicine, ask your doctor or pharmacist. • are on a controlled sodium diet; doctor/nurse, it is unlikely that you will be Keep this leaflet with your medicine. • are breast feeding (it is not known if given an overdose. You may need to read it again. OBIZUR passes into your milk and if it Your healthcare professional will can harm your baby); regularly monitor your condition and test What OBIZUR is used for • are pregnant or planning to become your blood to prevent overdose. pregnant (it is not known if OBIZUR OBIZUR is a recombinant DNA derived, Immediately telephone your doctor or the may harm your unborn baby). anti-haemophilic factor used for the National Poisons Information (telephone treatment of episodes in adults with If you are breast feeding or if you are 131 126), or go to accident and emergency acquired A. pregnant or planning to have a baby, ask at your nearest hospital, if you think that your doctor for advice before using you or anyone else may have been given It is possible that your doctor may give you OBIZUR. too much OBIZUR. OBIZUR for another reason. Taking other medicines Do this even if there are no signs of Ask your doctor if you have any questions discomfort or poisoning. about why you are being given OBIZUR. Tell your doctor or pharmacist if you are How does OBIZUR work using any other medicines including any that you obtained without a prescription While you are using OBIZUR Under normal physiological conditions, from your pharmacy, supermarket or Things you must do factor VIII is essential for blood clotting and health food shop. therefore the control of bleeding. You will have your blood tested after the Your doctor or pharmacist has more initial OBIZUR injection and also regularly Acquired haemophilia is a bleeding disorder information on medicines to be careful with after subsequent injections to see how your that is not present at birth but develops or to avoid while being given OBIZUR. treatment is working. This is to check your suddenly at some point in life due to an blood level of factor VIII to confirm that you abnormality in the immune system. In How OBIZUR is given have received adequate treatment. Your patients with acquired , factor doctor will also check if the bleeding is VIII is not working properly because the How much is given adequately controlled. patient has developed antibodies which Your doctor will decide the dose of OBIZUR Your doctor may do additional blood tests to neutralise this blood clotting factor, and this you will receive. Each individual will receive check if you have developed antibodies to prevents blood from clotting. a different amount, which may vary between OBIZUR treatment. OBIZUR belongs to a group of medicines treatments. Monitor your bleeding and tell your called anti-haemophilic agents. The dose you receive will be based on: doctor or nurse if your bleeding gets OBIZUR is a man-made clotting factor. It is • body weight; worse. similar to the naturally occurring protein in • your condition, e.g. in which sites the the body. Tell your doctor or pharmacist bleeding occurs (knees, muscle, etc.). immediately if you experience any of the OBIZUR works by temporarily replacing the As a general guide, an initial first dose of following during the OBIZUR injection: inhibited human clotting factor VIII, so that 200 U per kilogram (U/kg) bodyweight is blood can clot normally. • shortness of breath; wheezing; difficulty recommended. breathing; chest pain or discomfort; The frequency and duration of treatment will Before you are given OBIZUR • changes in facial skin colour, puffiness depend on how well OBIZUR is working for or swelling of your face, lips, tongue, or When you must not be given you. Your doctor will adjust the dose and other parts of the body, rash or hives. frequency of OBIZUR injections until the OBIZUR The above list includes signs and symptoms bleeding stopped. OBIZUR should not be given to you if you of a severe allergic response to the medicine. are: How OBIZUR is given The use of OBIZUR should be stopped • allergic to any products of porcine or OBIZUR is usually given in a hospital so immediately if any of the above occurs hamster origin;. that you are under the care of a healthcare during injection. • allergic to any ingredients in this product professional. which are listed at the end of the leaflet. OBIZUR is given by a slow injection directly Side effects Some of the symptoms of an allergic reaction into your vein. Tell your doctor or pharmacist as soon as may include: Use aseptic technique to prepare OBIZUR possible if you do not feel well after using • shortness of breath, wheezing or for injection. OBIZUR. difficulty breathing; Use only the water for injections supplied All medicines can have side effects. • swelling of the face, lips, tongue or other with the pack to prepare OBIZUR for Sometimes they are serious, most of the time parts of the body; injection. they are not. • rash, itching or hives on the skin Do not mix OBIZUR with any other You may need medical attention if you get medicines or solvent. If you are not sure, talk to your doctor before some of these side effects. using OBIZUR. Always inspect the solution after it is Do not be alarmed by this list of possible prepared for use and before injection. Do not use this medicine in children. side effects, you may not experience any of The solution should be clear and colourless. The safety and effectiveness in children have them. not been established.

OBIZUR® Published by MIMS January 2021 1 Ask your doctor or pharmacist to answer • sodium chloride; any questions you may have. • sucrose; The following list includes the common side • sodium citrate dihydrate; effects for OBIZUR: • calcium chloride dihydrate; • antibodies against OBIZUR detected in • trometamol; blood test results. • water for injections (diluent). A rapid increased production of antibodies in response to subsequent treatment with Sponsor OBIZUR have also been reported. OBIZUR is supplied in Australia by: Tell your doctor or pharmacist of any Takeda Pharmaceuticals Australia Pty Ltd suspected undesirable effect that is not Level 39 mentioned in this leaflet. 225 George Street Other side effects not listed above may occur Sydney NSW 2000 in some patients. Australia Telephone: 1800 012 612 After using OBIZUR www.takeda.com/en-au Australian registration numbers Storage AUST R 236475 Keep out of the reach and sight of children. Date of preparation Store OBIZUR at 2°C - 8°C in a refrigerator. Do not freeze. This leaflet was prepared in November 2020. Keep OBIZUR in the pack until it is time to use it. OBIZUR® is a registered trademark of This will protect the vials from light. If the Baxalta Incorporated. vials are not stored in the pack, the product TAKEDA® and the TAKEDA Logo® are may not keep well. registered trademarks of Takeda Do not store the solution in the fridge after Pharmaceutical Company Limited. the powder is mixed with the diluent. Disposal 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 tells 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.

Product Description What OBIZUR looks like OBIZUR is a white powder supplied in a glass vial with a diluent prefilled syringe for reconstitution. 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 powder); • 1 vial adapter (to help with transferring the diluent to prepare the solution for injection). Not all pack sizes may be marketed. Ingredients Active ingredient: • susoctocog alfa. Inactive ingredients:

OBIZUR® Published by MIMS January 2021 2