BUSULFEX® 60 mg/10 mL injection Busulfan

Consumer Medicine Information

What is in this leaflet Ask your doctor if you have any Therefore careful monitoring will questions about why BUSULFEX be performed. It is possible that use This leaflet answers some common has been prescribed for you. of BUSULFEX may increase the questions about BUSULFEX. It risk of suffering another cancer in does not contain all the available the future. information. Some of the Tell your doctor if you have information contained in this leaflet Before you are given allergies to any other medicines, may not apply to you. BUSULFEX foods, preservatives or dyes. It does not take the place of talking Tell your doctor if you have or When you must not be given to your doctor or pharmacist. have had any of the following it medical conditions: All medicines have risks and benefits. Your doctor has weighed You must not be given • liver, kidney, heart or lung the risks of you being given this BUSULFEX if you have an problem allergy to: medicine against the benefits they • history of seizures expect it will have for you. • busulfan, the active ingredient, • been taking other drugs If you have any concerns about or any of the other ingredients It may no longer be possible for you being given BUSULFEX, ask listed in this leaflet. to achieve a pregnancy after your doctor or pharmacist. Some of the symptoms of an treatment with busulfan. If you are Keep this leaflet with the medicine. allergic reaction may include: concerned about having children, You may need to read it again. • shortness of breath you should discuss this with your • wheezing or difficulty breathing doctor before treatment. BUSULFEX can also produce • swelling of the face, lips, tongue symptoms of menopause and in pre- or other parts of the body adolescent girls it can prevent the What BUSULFEX is • rash, itching or hives on the skin used for onset of puberty. BUSULFEX must not be given if Men treated with BUSULFEX are you are pregnant, or you think BUSULFEX is used in adults, new- you may be pregnant or are advised not to father a child during born infants, children and breastfeeding. and up to 6 months after treatment. adolescents as a treatment prior to Women should avoid becoming If you have not told your doctor transplantation of either bone pregnant during treatment with or pharmacist about any of the marrow or blood stem cells. It is BUSULFEX and up to 6 months above, tell them before you start used in combination with other after treatment. taking BUSULFEX. chemotherapeutic drugs, namely cyclophosphamide, melphalan or Women must not breast-feed during Taking other medicines fludarabine. their treatment with BUSULFEX. Tell your doctor or pharmacist if BUSULFEX contains the active Before you are given it you are taking any other ingredient, busulfan. Busulfan medicines, including any that you belongs to a group of medicines BUSULFEX is a powerful buy without a prescription from used to treat some cancers. cytotoxic drug (medicine to treat your pharmacy, supermarket or BUSULFEX destroys the original some cancers) that results in a huge health food shop. bone marrow before the transplant. decrease of blood cells. At the Some medicines and BUSULFEX recommended dose, this is the Your doctor may have prescribed may interfere with each other. desired effect. this medicine for another use. These include:

BUSULFEX® Published by MIMS September 2018 1 • itraconazole/metronidazole the levels of BUSULFEX in your Ask your doctor or pharmacist to (used for certain types of blood. answer any questions you may have. infections). BUSULFEX will be given 1 to 4 • ketobemidone (used to treat times a day for up to 4 days prior to Tell your doctor, nurse or pharmacist if you notice any of pain), because this may increase transplant. the side-effects. the following and they worry you: Before receiving BUSULFEX you • decrease of blood circulating Your doctor may ask you to stop will be given a medicine to prevent cells (red and white) and taking medicines before receiving seizures (anticonvulsive drugs) (for platelets. BUSULFEX. This may include iron example phenytoin and antiemetic chelating agents (medicines used to drugs to prevent vomiting. • infections, fever, chills. reduce iron levels). • sleeplessness, anxiety, dizziness, Paracetamol should be used with If you are given too much and depression. caution during the 72 hours prior to (overdose) • loss of appetite, decrease in being given, and while being given magnesium, calcium, potassium, As BUSULFEX is given to you in BUSULFEX . phosphate in blood and increase hospital under the supervision of in blood sugar. These medicines may be affected by your doctor, it is unlikely that you • increase in heart rate, increase or BUSULFEX, or may affect how will receive an overdose. well it works. Your doctor may decrease of blood pressure, However, if you experience any widening of the blood vessels need to adjust your dose of side effects after being given (vasodilation) and blood clots. BUSULFEX or of the other BUSULFEX, tell your doctor medicine. immediately, or the Poisons • shortness of breath, runny nose Your doctor or pharmacist may Information Centre (telephone 13 (rhinitis), sore throat, cough, have more information on 11 26), or go to Accident and hiccup, nosebleeds, abnormal medicines to be careful with or Emergency at your nearest breath sounds. hospital. avoid while taking BUSULFEX. • nausea, inflammation of the Symptoms of a BUSULFEX mucosa of the mouth, vomiting, overdose include the side effects stomach pain or discomfort, listed below in the Side Effects diarrhoea, constipation, heart How BUSULFEX is section, but are usually of a more burn, anus discomfort, liquid in given severe nature. the stomach. • enlarged liver, jaundice. How much is given • rash, itching, hair loss. • back, muscle and joint pain. Adults Side Effects The dose will be calculated • increase in creatinine according to your body weight. Tell your doctor or pharmacist as elimination, discomfort in soon as possible if you do not feel urination, and decrease in urine The recommended dose of well while you are taking output. BUSULFEX is up to 3.2 mg per kg BUSULFEX. • headache, weakness, pain, of body weight per day, in allergic reaction, swelling combination with All medicines can have side effects. (oedema), general pain or cyclophosphamide, melphalan or The most serious side effects may inflammation at injection site, fludarabine. include decrease in circulation blood cell counts (intended effect of chest pain, inflammation of the New-born infants, children and the drug to prepare you for your mucosa. adolescents (0 to 17 years) transplant infusion), infection, liver • elevated liver enzymes, The recommended dose is based on disorders including blocking of a increased weight. body weight and may be up to 4.8 liver vein, graft versus host disease These side effects of BUSULFEX mg/kg/day. (the graft attacks your body) and are very common (reported in more BUSULFEX is given by a qualified complications relating to the lung. than 1 patient out of 10). healthcare professional as a central Your doctor will monitor your Less common side effects (reported intravenous infusion, after dilution blood counts and liver enzymes in 1 to 10 patients out of 100 of the individual vial. Each infusion regularly to detect and manage patients) are as follows: will last 2 to 3 hours. Blood these events. samples may be taken for testing • confusion. • low blood sodium.

BUSULFEX® Published by MIMS September 2018 2 • changes and abnormalities in After using BUSULFEX heart rhythm, fluid retention or inflammation around the heart, Storage decrease heart output. • increase in breath rhythm, BUSULFEX injection will be respiratory failure, bleeding in stored at 2°C - 8°C in a refrigerator the lungs (alveolar (do not freeze) in the Pharmacy. haemorrhages), asthma, collapse of small portions of the lung, Disposal fluid around the lung. Any unused medicine must be • inflammation of the food pipe, disposed of appropriately by the paralysis of the gut, vomiting medical staff. blood. • skin colour disorder, redness of the skin, peeling of the skin. • increase in the amount of Product Description nitrogen components in the blood stream, blood in urines, What it looks like moderate change in kidney BUSULFEX appears as a clear function (renal insufficiency). colourless solution. It is a sterile Uncommon side effects (reported in solution that contains no 1 to 10 patients out of 1000 antimicrobial agent. BUSULFEX is patients) include: for single use in one patient only. • severe confusion, nervousness, BUSULFEX is supplied in cartons hallucination, agitation, each containing 8 single-dose 10 abnormal brain function, brain mL clear glass vials (type I). haemorrhage, and seizure. • blood clots (thrombosis) in the Ingredients femoral artery (a large artery in the thigh), extra heart beats, Each vial contains 10mL for a decrease in heart rate, diffuse single injection. Each mL of leak of fluid from the capillaries suspension contains 6 mg busulfan. (small blood vessels). It also contains dimethylacetamide • decrease in blood oxygen. and Macrogol 400. • bleeding in the stomach and/or the gut. Supplier Lack of white blood cells associated Otsuka Australia Pharmaceutical with high fever (febrile Pty Ltd neutropenia), metabolic Suite 2.03, Level 2, 9 Help Street disturbances (tumor lysis Chatswood NSW 2067 syndrome), unusual bleeding or Australia bruising under the skin (thrombotic Under licence from Otsuka micro-angiopathy (TMA)), severe Pharmaceutical Co., Ltd. bacterial, viral and fungal www.otsuka.com.au infections, sepsis and changes in tooth hardness (tooth hypoplasia) Australian Registration have also been observed during treatment. Number Tell your doctor or pharmacist if BUSULFEX 60 mg/10 mL: you notice anything that is AUST R 150612 making you feel unwell. This leaflet was revised in July Other side effects not listed above 2018. may also occur in some people.

BUSULFEX® Published by MIMS September 2018 3