This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems. DEFITELIO® defibrotide Consumer Medicine Information What is in this leaflet This medicine can be used in adults, • have heavy bleeding and need a and in adolescents, children and blood transfusion This leaflet answers some common infants over one month of age. • are undergoing surgery questions about DEFITELIO. It Ask your doctor if you have any • have problems with blood does not contain all the available questions about why this circulation because your body information. It does not take the medicine has been prescribed for cannot maintain a constant place of talking to your doctor. you. blood pressure. All medicines have risks and This medicine is available only with DEFITELIO is not recommended in benefits. Your doctor has weighed a doctor's prescription. children less than 1 month of age. the risks of you using DEFITELIO This medicine is not expected to If you are not sure if you should against the benefits they expect it affect your ability to drive a car or be given DEFITELIO talk to your will have for you. operate machinery. doctor. If you have any concerns about using this medicine, ask your Taking other medicines doctor. Tell your doctor if you are taking Keep this leaflet. Before you are given any other medicines including You may need to read it again. DEFITELIO medicines that you buy without a prescription from your When you must not be given pharmacy, supermarket or health this medicine food shop. What DEFITELIO is Tell your doctor if you are taking used for You must not be given DEFITELIO any of the following: if you: • medicines to break down blood DEFITELIO is a medicine that • are allergic to defibrotide or any clots, such as tissue contains the active substance of the other ingredients listed in plasminogen activators (e.g. defibrotide. this leaflet alteplase, reteplase). DEFITELIO is used to treat a • are using other medicines to • medicines used to thin your condition called hepatic veno- break down blood clots such as blood such as aspirin, heparin occlusive disease (or VOD), in tissue plasminogen activators sodium, warfarin, dabigatran which the blood vessels in the liver (e.g. alteplase, reteplase). etexilate, rivaroxaban, apixaban become damaged and obstructed by • non-steroidal anti-inflammatory Before you are given this blood clots. This can be caused by medicines such as ibuprofen, medicines that are given prior to a medicine naproxen, diclofenac and other stem cell transplantation. Tell your doctor if you have nonsteroidal anti-inflammatory DEFITELIO works by protecting allergies to any other medicines, medicines. the cells of the blood vessels and foods, preservatives or dyes. preventing or breaking down the Tell your doctor if you: blood clots. • are taking medicine that thins your blood or increases the risk of bleeding DEFITELIO® Published by MIMS December 2020 1 Pregnancy When it is given • bleeding from the infusion line or catheter If you are pregnant, think you You will receive this treatment four • bleeding at the site of injection may be pregnant or are planning times a day for at least 21 days or to have a baby, tell your doctor. until your symptoms resolve. • bleeding from the mouth Defitelio should not be used during • bleeding from the eye pregnancy unless there is a definite If you miss a dose • chest pain need. Your doctor will discuss with Tell your doctor or nurse • shortness of breath you the risk and benefit involved in immediately if you think you have • rapid heart beat using DEFITELIO during missed a dose of DEFITELIO. pregnancy. • fever or high temperature As you will be given this medicine • dizziness or light-headedness If you are sexually active and you by a doctor or a nurse it is unlikely • sudden signs of allergy such as or your partner could become that a dose will be missed. You pregnant, you both must use rash, itching or hives on the must not be given a double dose to effective contraception during skin, swelling of the face, lips, make up for a missed dose. treatment with DEFITELIO and tongue or other parts of the for 1 week after stopping the If you are given too much body, shortness of breath, treatment. wheezing or trouble breathing. (overdose) • feeling sick, also called nausea Breastfeeding As DEFITELIO is given to you • vomiting under the supervision of your doctor If you are breastfeeding, tell your • diarrhoea doctor. it is unlikely that you will be given • rash Your doctor can discuss with you too much. However, if you the risk and benefits involved. experience any side effects after • red or purple, flat, pinhead spots under the skin If you have not told your doctor being given DEFITELIO, tell your about any of the above, tell doctor immediately. • itching. him/her before you are given Other side effects not listed above DEFITELIO. may also occur in some people. Side effects How DEFITELIO is Like all medicines, DEFITELIO After you are given given can cause side effects, although not DEFITELIO everybody gets them. Your doctor will discuss these with you and The treatment with DEFITELIO Storage can be initiated and continuously explain the risks and benefits of supervised only by an experienced your treatment. It is unlikely that you will be asked doctor in a hospital or in a Ask your doctor or pharmacist to to store DEFITELIO yourself. It specialised centre for stem cell answer any questions you may will usually be stored in the transplantation. have. pharmacy or on the ward. Tell your doctor or nurse DEFITELIO is stored below 25°C. How much is given immediately if you notice any of It must not be frozen. the following as you may require The total dose of DEFITELIO that Keep this medicine out of reach medical attention: is given is calculated based on your and sight of children. body weight. The calculation of the • signs of increased or unusual Do not use DEFITELIO after the dose in children from one month to bleeding or bruising during or expiry date which is stated on the 18 years of age is the same as in after treatment carton and vial label after ‘EXP’. adults. • nosebleeds The expiry date refers to the last • passing of blood in the urine or day of the month. How it is given faeces DEFITELIO will be given via a • dark coloured faeces drip (a slow injection into your • bloody diarrhoea veins) over a 2-hour period. This is • vomiting blood or material that also called an intravenous infusion. looks like coffee grounds DEFITELIO® Published by MIMS December 2020 2 Product description What it looks like DEFITELIO is a clear light yellow to brown concentrated solution for infusion, free from particulate matter or turbidity. One carton contains 10 glass vials, each with 2.5 mL of concentrated solution for infusion. Ingredients The active substance in DEFITELIO is defibrotide. Each 2.5 mL vial contains 200 mg defibrotide and each mL of concentrated solution contains 80 mg defibrotide. DEFITELIO also contains: • sodium citrate dihydrate • hydrochloric acid • sodium hydroxide • water for injections. Name and address of the sponsor DEFITELIO is distributed in Australia by: Link Medical Products Pty Ltd 5 Apollo Street Warriewood NSW 2102 AUSTRALIA Australian registration number: AUST R 319221 Date of preparation July 2020. DEFITELIO® Published by MIMS December 2020 3.