User Package Leaflet for Treosulfan 5 g Powder for Solution for Injection or Infusion

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1 User Package Leaflet for Treosulfan 5 g Powder for Solution for Injection or Infusion Please read this leaflet carefully, it is a summary of the information about treosulfan that could be important to you. If you have any questions, or are not sure about anything to do with your treatment, ask your doctor, nurse or hospital pharmacist for more information. Keep this leaflet in a safe place, you may want to refer to it again. 1. WHAT ARE THE GENERAL CHARACTERISTICS OF TREOSULFAN 5 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION? What is Treosulfan 5 g Powder for Solution for Injection or Infusion? This medicine contains an active ingredient called treosulfan which is contained in a sealed glass vial. Each vial contains 5 g of treosulfan. The powder for solution for injection or infusion is mixed with 100 ml water for injection resulting in a 50 mg/ml treosulfan solution which can be given by intravenous injection, administered by a drip given into a vein (intravenous infusion), or by intraperitoneal injection (an injection into your abdomen). Treosulfan belongs to the group of anticancer medicines called bifunctional alkylating agents. These agents influence the growth of malignant cells. Treosulfan vials are packed in boxes each containing 5 vials. Who markets this drug product? Who manufactures this drug product? m e d a c m e d a c Gesellschaft für klinische Gesellschaft für klinische Spezialpräparate mbh Spezialpräparate mbh Theaterstr. 6 Theaterstr. 6 D Wedel, Germany D Wedel, Germany 2. WHAT IS TREOSULFAN USED FOR? Treosulfan has been prescribed by your doctor for the treatment of all types of ovarian cancer or certain types of cancer resistant to conventional therapy. 3. WHEN WILL YOU NOT BE ADMINISTERED TREOSULFAN? Treosulfan will not be used if you have not enough blood cells (severe bone marrow depression). 4. WHAT MUST YOU DO BEFORE RECEIVING TREOSULFAN?

2 You will have blood tests to check that you have enough blood cells to receive treosulfan before each administration. 5. MAY TREOSULFAN BE TAKEN TOGETHER WITH OTHER MEDICINES? It is not advisable to use any medical treatment without telling your doctor as there may be interactions between treosulfan and other medicines. Tell your doctor if you are taking any medicine which has been prescribed for you or which you bought without prescription. 6. MAY TREOSULFAN BE ADMINISTERED DURING PREGNANCY OR WHILE BREAST-FEEDING? Treosulfan must NOT be administered if you are pregnant or if your are planning to become pregnant. You must take adequate contraceptive precautions during therapy. You must NOT breast-feed while you are treated with treosulfan. If you are thinking of or becoming pregnant or breast-feeding discuss it with your doctor first. 7. WHAT PRECAUTIONARY MEASURES / SPECIAL WARNINGS SHOULD BE OBSERVED? The use of treosulfan will be confined to hospital units specialised in the administration of cytotoxic chemotherapy and will only be administered under the supervision of a qualified oncologist. 8. MAY YOU DRIVE OR USE MACHINES IF YOU HAVE BEEN ADMINISTERED WITH TREOSULFAN? Your ability to drive or operate machines may be influenced because of nausea and vomiting. If you are affected in this way do not drive or operate machinery. 9. WHAT SHOULD YOU KNOW ABOUT THE ADMINISTRATION OF TREOSULFAN? Treosulfan will be given to you by an injection into your vein (intravenous injection), by an injection into your abdomen (intraperitoneal injection), or by a drip given into a vein (intravenous infusion). Doses of up to 1.5 g/m2 (into abdomen) or 3 g/m2 (into vein) will be given as an injection. Larger doses will be administered as a drip given into a vein (intravenous infusion) at a rate of 3 g/m2 every 5-10 minutes (8 g/m2 as a 30 minutes infusion).

3 The dose will depend on your blood counts and concurrent chemotherapy. The dose you are given depends on how big you are. It varies with your surface area. Technically, this is measured in square metres (m2), but actually is worked out from your height and weight. During the course of treosulfan therapy the injections will usually be given every 1 to 3 weeks. Your doctor will calculate your treosulfan dose in dependency on your blood counts measured. Your doctor reduces the dose if other cytotoxic drugs or radiotherapy are also given. Your doctor may change the dose and frequency of dosing depending on your blood test, your general condition, further therapies and your response to treosulfan. If you have any questions about your treatment, ask your doctor, nurse or hospital pharmacist. If you experience pain at the site of injection please tell your doctor or nurse immediately. This medicine is not recommended for use in children. Overdose: If too much medication has been given to you, your doctor may give you a transfusion of blood products and supportive measures if necessary. 10. DOES TREOSULFAN HAVE ANY SIDE EFFECTS? You must be aware that, as with other anticancer medicines, treosulfan will cause side effects. Your doctor will discuss these with you and will explain the risks and benefits of your treatment. The side effects could include: Very common: side-effects which may occur in more than 10 out of 100 patients Decrease in the number of white blood cells (which are important in fighting infections) and platelets, decreased haemoglobin values (summarised as myelosuppression). Hence the need for regular blood tests. Stomach upsets including nausea with or without vomiting Mild loss of hair. After your treatment, normal hair growth should return Skin pigmentation characterised by a bronze discoloration Common: side-effects which may occur in less than 1 out of 10 patients Infections caused by fungi, viruses or bacteria Uncommon: side-effects which may occur in less than 1 out of 100 patients Inflammation of oral mucosa (stomatitis) Rare: side-effects which may occur in less than 1 out of 1000 patients Allergic reactions

4 Very rare: side-effects which may occur in less than 1 out of 10,000 patients including isolated reports Generalised life-threatening infections (sepsis) Decrease in the number of red blood cells, white blood cells and platelets at the same time (pancytopenia) Leukaemia and myelodysplastic syndrome (a bone marrow disease) after long-term treatment Addison's disease, a condition where the adrenal glands do not work properly, leading to bronzed skin, stomach upset, low blood pressure (feeling faint) and a general feeling of weakness Sweat, trembling and hunger as a result of the decreased amount of glucose in your blood (hypoglycaemia) Pins and needles and a feeling of numbness (paraesthesia) Irregular heartbeat or a feeling of oppression (cardiomyopathy) Difficulty in breathing (allergic alveolitis, pneumonia and pulmonary fibrosis) Urticaria or hives, an itchy rash. Inflammation of the skin with or without scale formation (scleroderma and psoriasis) Inflammation of the bladder with or without bloody urine (haemorrhagic cystitis) Flu-like complaints Because of the possible inflammation of the bladder you may be advised by your doctor to drink more fluids for up to 24 hours after your infusion. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: Fax: Website: medsafety@hpra.ie 11. HOW SHOULD TREOSULFAN BE STORED AND WHAT IS ITS SHELF-LIFE? Keep out of the reach and sight of children. Do not store above 25 C. Once brought into solution the injection should be used immediately. The doctor or nurse giving you this medicine will make sure that it has not passed the expiry date shown on the label. 12. WHEN WAS THIS PATIENT LEAFLET PREPARED?

5 01/2015