XYNTHA® moroctocog alfa rch, also known as recombinant factor VIII Consumer Medicine Information

What is in this leaflet heartbeat, difficulty breathing, shortness of breath and/or a swollen This leaflet answers some of the face. common questions about XYNTHA. What XYNTHA is used Your doctor will not prescribe It does not contain all of the available for XYNTHA if you have von information. It does not take the Willebrand's disease. XYNTHA does People with place of talking to your doctor or not contain von Willebrand's factor. (congenital factor VIII deficiency or pharmacist. classic haemophilia) do not have Do not use XYNTHA after the If you have any concerns about enough coagulation factor VIII. expiry date (Exp) printed on the using XYNTHA, ask your doctor XYNTHA works by replacing factor pack. or pharmacist. VIII to enable blood to clot. Do not use XYNTHA if the Your doctor and pharmacist have XYNTHA is used for the control and packaging is torn or shows signs of more information. treatment of bleeding and the routine tampering. Keep this leaflet with your and surgical prevention of bleeding XYNTHA. You may need to read it in people with haemophilia A. Before you start to use it again. XYNTHA does not contain von Certain people must use XYNTHA Willebrand factor and so is not used with caution. Ask your doctor for to treat von Willebrand's disease advice. XYNTHA has been approved for use You must tell your doctor if: What XYNTHA is in haemophilia A. Ask your doctor if • You are pregnant or planning to you have any questions about why XYNTHA is a protein called become pregnant. XYNTHA has been prescribed for coagulation factor VIII protein It is not known whether you. product that is important for helping XYNTHA can affect your ability your blood clot. XYNTHA is There is no evidence that XYNTHA to have children or harm your produced by recombinant DNA is addictive. developing baby. technology and is made in a XYNTHA is not expected to affect • You are breast feeding. laboratory, rather than isolated from your ability to drive a car or operate It is not known whether human blood donors, which is where machinery. XYNTHA passes into breast plasma derived factor VIII comes milk. from. Mammalian cells, which have the DNA for human coagulation • You are on a low salt diet. factor VIII put in them, are grown in Before you use XYNTHA contains 29 mg large amounts in cell culture XYNTHA sodium per vial/dual chamber laboratories. These cells make syringe of reconstituted powder recombinant human factor VIII, When you must not use it and this should be taken into which is released into cell culture account in a controlled sodium media and then very highly purified. Do not use XYNTHA if you know diet. XYNTHA does not contain any you are allergic to moroctocog alfa, Your doctor will advise you whether human blood or preservatives and no hamster proteins or any of the or not to use XYNTHA or if you animal or human-derived materials ingredients of XYNTHA. need to adjust the dose, or adapt your have been used in the cell culture Signs of allergy include a skin rash, treatment. process, purification or final itching, chest tightness, wheezing, formulation of XYNTHA. dizziness, hives, faintness, rapid

XYNTHA® 1 Taking other medicines Disposal Always follow your doctor's instructions carefully Tell your doctor if you are taking Dispose of all unused solution, any other medicines, including any empty vials and syringes, and used Tell all the doctors, dentists and that you buy without a needles into a sharps container. pharmacists who are treating you that you are using XYNTHA. prescription from your pharmacy, Medicines must not be disposed of supermarket or health food shop. down the toilet or via household If you are about to be started on Some medicines may be affected by waste. These measures help protect any new medicine, including XYNTHA, or may affect how well it the environment. medicines obtained without a works. You may need to use different prescription, tell your doctor and amounts of your medicine or you Overdose pharmacist that you are using may need to take different medicines. XYNTHA. Immediately telephone your doctor Your doctor will advise you. or the Poisons Information Centre If you become pregnant while you (in Australia; tel 13 11 26, or in are using XYNTHA, tell your doctor. New Zealand; tel 0800 POISON or 0800 764 766), or go to Accident Using XYNTHA and Emergency at your nearest Things you must not do hospital, if you think that you or Do not give XYNTHA to anyone How XYNTHA is given anyone else may have used too else, even if they have the same XYNTHA is given as an injection much XYNTHA. Do this even if condition as you. directly into your veins, usually by there are no signs of discomfort or Do not use XYNTHA to treat any either yourself, a doctor, nurse, or poisoning. Always take the other complaints unless your other trained person. labelled medicine carton with you, doctor tells you to. even if it is empty. XYNTHA is supplied as a freeze- Do not stop using XYNTHA or dried powder. Before it can be lower the dosage, without checking injected into your vein it must be with your doctor, unless you have mixed with 0.9% Sodium Chloride While you are using an allergic reaction. solution. XYNTHA should be injected using the infusion set XYNTHA provided in the kit. Things you must do Your doctor will show you how to Side Effects prepare and give an injection of Contact your doctor immediately XYNTHA. Once you have learned or seek emergency care if your Tell your doctor immediately if how to self-inject, you can follow the bleeding does not stop as expected you are using increasing amounts of XYNTHA in order to control a instructions for preparing and giving If bleeding is not adequately bleeding episode. an injection of XYNTHA at the end controlled with the usual dose, you of this leaflet. should be monitored in order to find During your treatment with out whether a factor VIII inhibitor is XYNTHA, your blood will be Dosage present. Some people receiving checked for inhibitors to factor VIII Your doctor will decide the dose of factor VIII products may sometimes activity. Inhibitors are antibodies XYNTHA you will receive. The dose develop antibodies or inhibitors to against factor VIII, which are made and duration will depend upon your factor VIII, which may prevent the by your immune system. The individual needs for replacement factor VIII product from working inhibitors stop the factor VIII from factor VIII therapy. properly. working as well as it used to. Your doctor may decide to change Stop the infusion immediately and Tell your doctor as soon as possible the dose of XYNTHA you receive contact your doctor, if you if you do not feel well while you are using XYNTHA. during your treatment. In the experience reactions such as: presence of an inhibitor, you may Headache, fever, chills, flushing, Injection of any medicine need higher doses or specific nausea, vomiting or allergic reactions intravenously may have side effects. treatment. Dosage adjustment for such as skin rash, itching, chest Often they are not serious but people with kidney or liver tightness, wheezing, dizziness, hives, sometimes they can be. You may impairment has not been studied in faintness, rapid heartbeat, difficulty need medical treatment if you clinical trials. breathing, shortness of breath and/or experience some side effects. a swollen face.

XYNTHA® 2 Tell your doctor if you notice any If any of the following signs of an XYNTHA can be stored at room of the following: allergic reaction happen suddenly, temperature for a single period of up Stomach or bowel problems such STOP using XYNTHA and tell to 3 months. Do not store XYNTHA as: your doctor immediately: above 25°C. After room temperature storage, XYNTHA can be returned to • nausea • a swollen face, lips, tongue or throat the refrigerator until the expiration • vomiting date. • difficulty breathing • loss of appetite Do not store XYNTHA at room • shortness of breath • stomach pain or cramps temperature and return it to • chest tightness refrigerated storage more than • diarrhoea. • wheezing once. Difficulty thinking or working Write the date on the package because of: • chills or feeling cold when you first store XYNTHA at • flushing • headache room temperature. • dizziness • dizziness Avoid exposure of XYNTHA to • • drowsiness feeling tired light. • • numbness feeling restless Keep XYNTHA (and kit contents) • where young children cannot reach • muscle weakness or pain nausea it. • joint pain • vomiting Do not use XYNTHA beyond the • faintness • excessive sweating date (month and year) printed on • • flushing rapid heartbeat the label after the letters 'Exp', • • fever hives even if it has been stored properly. • • feeling faint a skin rash Medicines cannot be stored • indefinitely. • chest pain headache

• rapid or irregular heartbeat • tingling After Reconstitution: • chills or feeling cold. • burning and stinging at the injection site. Use the made-up product as soon Respiratory problems such as: These can be very serious side as possible after dissolving the • shortness of breath effects. If you have them, you may powder. • coughing. have a serious allergic reaction to If the made-up solution is not used Changes in your sight, taste or XYNTHA and you may need urgent right away, it should be stored at touch such as: medical attention or hospitalisation. 2°C to 8°C and used within 3 These side effects are very rare. hours. • blurred vision Other side effects not listed above Only use solutions that are clear • altered taste may also occur in some patients. and colourless. Skin problems such as: Tell your doctor if you notice Use only the accessories provided • itching anything else that is making you in the box for reconstitution and • rash feel unwell. administration. • bruising or bleeding Do not be alarmed by this list of possible side effects. You may not • swelling of a vein from a blood experience any of them. clot. Product Description Other problems such as: Storage • difficulties in catheter access to a What it looks like Before Reconstitution: vein Keep XYNTHA in the refrigerator Prefilled Dual Chamber Syringe • injection site reaction, including (2°C to 8°C). XYNTHA must be XYNTHA is provided in a prefilled pain and swelling. used by the expiry date on the dual chamber syringe. The top These are all uncommon to very rare label. chamber contains XYNTHA powder side effects of XYNTHA injection. DO NOT freeze. for injection. The bottom chamber

XYNTHA® 3 contains Sodium Chloride Solution © Pfizer Australia Pty Ltd for injection. Australian Registration Numbers There are 5 strengths of XYNTHA XYNTHA 250 IU prefilled dual available in the prefilled dual chamber syringe: AUST R 174837 chamber syringe - 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU. XYNTHA 500 IU prefilled dual chamber syringe: AUST R 174838 The contents of the XYNTHA kit are: XYNTHA 1000 IU prefilled dual chamber syringe: AUST R 174839 • one prefilled dual chamber syringe XYNTHA 2000 IU prefilled dual chamber syringe: AUST R 174840 • one plunger rod for assembly XYNTHA 3000 IU prefilled dual • one vented sterile cap chamber syringe: AUST R 174841 • one sterile infusion set XYNTHA 250 IU vial and diluent: • two alcohol swabs AUST R 161714 • one sticking plaster XYNTHA 500 IU vial and diluent: • one sterile gauze pad AUST R 161715 XYNTHA 1000 IU vial and diluent: AUST R 161716 Vial and Diluent Syringe XYNTHA 2000 IU vial and diluent: XYNTHA is provided as a white AUST R 161717 powder for injection in a glass vial and a diluent is provided in a pre- Supplier filled syringe. XYNTHA is supplied in Australia There are 4 strengths of XYNTHA - by: 250 IU, 500 IU, 1000 IU and 2000 IU Pfizer Australia Pty Ltd The contents of the XYNTHA kit ABN 50 008 422 348 are: 38-42 Wharf Road • one vial of moroctocog alfa WEST RYDE NSW 2114 powder Toll Free Number: 1800 675 229 • one pre-filled syringe of diluent,

containing 4mL sterile sodium chloride 9mg/mL (0.9%) solution XYNTHA is supplied in New for injection for reconstitution Zealand by: • one sterile vial adapter Pfizer New Zealand Limited reconstitution device PO Box 3998 • one sterile infusion set Auckland • two alcohol swabs Toll Free Number: 0800 736 363 • one sticking plaster • one sterile gauze pad. The XYNTHA administration kit is manufactured by Wyeth Farma, Ingredients Algete, San Sebastian de los Reyes, Madrid, Spain. Active ingredients: Coagulation factor VIII (moroctocog alfa (rch)) Date of preparation Inactive ingredients: Sucrose, calcium chloride dihydrate, L- This leaflet was prepared in January histidine, sodium chloride and 2017. polysorbate 80. ® Registered Trademark

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