Your Mepact (mifamurtide) treatment and what to expect from it. Information for patients who have been prescribed mifamurtide for osteosarcoma.

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1 Your Mepact (mifamurtide) treatment and what to expect from it. Information for patients who have been prescribed mifamurtide for osteosarcoma.

2 Introduction to Mepact (mifamurtide) Mepact, also known as mifamurtide, is a medicine used to treat bone cancer (also called osteosarcoma) in children, adolescents and young adults. You have just been prescribed mifamurtide to help treat your bone cancer. Mifamurtide contains a special substance that stimulates the immune system (the part of the body that defends itself against germs and microorganisms) to help your body kill cancer cells. Understanding the benefits of mifamurtide This leaflet is designed to help you better understand the benefits of mifamurtide, and what to expect from it, so you will be better able to cope with your treatment and get on with your life. Please read the leaflet carefully. If you have any questions that are not covered in these pages, or would simply like to know a bit more about taking mifamurtide, or how mifamurtide can help you, don t hesitate to ask your doctor or nurse. Why do I have to take another treatment? You will already have undergone a number of tests for your disease, and will have experienced a combination of different treatments, among them chemotherapy, surgery, and maybe even radiotherapy. All this may have been extremely difficult and distressing for you, and you might be wondering why you need to take another treatment. This is because your doctor believes that mifamurtide may make a significant difference to your treatment outcome and your subsequent well-being.

3 When is mifamurtide used? Mifamurtide is used after you ve had surgery to remove your cancer. Mifamurtide is used together with chemotherapy to kill any remaining cancer cells that might still be around in your body, to reduce the risk of your cancer coming back. Mifamurtide and chemotherapy You will already be familiar with chemotherapy as it will have been given to you to shrink your cancer before it was removed by surgery. You will also be familiar with the kind of side effects that chemotherapy can cause. Mifamurtide is designed to work hand-in-hand with your chemotherapy, and there is no evidence of mifamurtide interfering with the effects of chemotherapy. The only additional side effects that might occur with mifamurtide tend to be mild to moderate in nature and these side effects are dealt with in the next section. If you do have any concerns about your next round of chemotherapy, talk to your doctor or nurse about it. What are the benefits of treatment with mifamurtide? The active substance in Mepact, mifamurtide, is an immunomodulator (i.e. changes the immune system). It works by activating macrophages and monocytes (types of white blood cell that form part of the immune system). The precise way that mifamurtide works in osteosarcoma is not fully understood, but it is thought to cause the white blood cells to release chemicals that kill the cancerous cells. When used with other anti-cancer medicines, mifamurtide increased how long patients survived without their disease coming back: 68% of the patients receiving mifamurtide (231 out of 338) survived without the disease coming back, compared with 61% of the patients who did not receive it (207 out of 340). The chances of surviving was improved in patients receiving Mepact.

4 Will I get any side effects from mifamurtide? Like all medicines, mifamurtide can cause side effects, although not everybody will get them. Chills, fever and feelings of nausea and tiredness are the most common side effects that may result from mifamurtide treatment. Other side effects that you may commonly experience include dizziness, vomiting, diarrahoea, constipation, headache, pain, sweating and a rapid heart beat. The good news is, these side effects are usually mild or moderate in nature, they do not last long, and they can usually be treated with simple medication by your doctor, e.g. with paracetamol for a fever. If you want to know more about mifamurtide s possible side effects, a full list of these is included on the leaflet that comes with your medicine. Contact your doctor immediately: - If you continue to have a fever or chills more than 8 hours after you take have received mifamurtide, as this could mean you have an infection - If you experience any breathing problems (like wheezing) - If you get any kind of a rash - If you experience any stomach problems - If you are concerned about any other symptoms Where will mifamurtide be given to me? Mifamurtide will be given to you in hospital, by a doctor or nurse, at the same time as your chemotherapy. As your treatment continues, it may well be given to you as an outpatient, which means visiting the hospital only at certain appointed times. How is mifamurtide given and will it hurt? Mifamurtide is given to you intravenously. This means it is given directly into your vein by infusion. As with other procedures involving injections, this may hurt a little at the point where the needle pierces the skin, but afterwards any pain should fade away. As is sometimes the case with injections, the area where the needle has penetrated the skin might be a bit sore afterwards.

5 How long will the mifamurtide infusion last? The whole procedure of giving mifamurtide usually lasts about one hour, with the doctor or nurse monitoring you during that time. How often will I receive mifamurtide? Mifamurtide will be given to you twice a week, at least 3 days apart, for a period of 12 weeks. Mifamurtide will then be given once weekly for another 24 weeks. That s a total of 48 infusions over a period of 36 weeks. Counselling Having bone cancer is probably one of the most difficult things a young person will have to go through in their lives. As well as the shock of having the disease and the disruption it will have caused to your social life and schooling, the pain and discomfort of the surgery and chemotherapy will have been hard to cope with. Many different emotions may affect you. Anger, guilt, anxiety and fear are some of the most common feelings people in your situation have experienced. You may find you are restless and unable to sleep, or you may be depressed or have feelings of hopelessness. These are all perfectly normal reactions to your situation, but it is often difficult and distressing to share or admit to them. Because of this, you may feel that you want to talk to someone about your situation, or your feelings. As well as friends and family, there are qualified people available to help you. Some hospitals have their own emotional support services with specially-trained staff. Some of the nurses on the ward will have received training in counselling, but you may feel more comfortable talking to a counsellor outside the hospital environment. On a more practical level, while most people recover well after surgery and are able to move around quite quickly, some people take longer and may need extra help. Before you go home the medical staff will talk to you about your home situation. If you live alone or have several stairs to climb, you may need some help at home. Children and teenagers may also worry about falling behind at school. In some cases, home tutoring can often be arranged with the local education authority. The person responsible for your schooling while you are in hospital may be able to organise this for you. At the back of this leaflet are some organisations that you can contact for extra help, support and general advice.

6 Mifamurtide and adult patients Mifamurtide is given to children (2 years upwards), adolescents and young adults. The information already covered in this leaflet applies to all patients in this category. There are some issues, however, that apply only to adult patients, and these are covered in the following sections.

7 Driving or using machines No studies of the effects of mifamurtide on ability to drive or use machines have been performed. However, some side effects of mifamurtide treatment (such as dizziness, vertigo, fatigue and blurred vision) may have an effect on your ability to drive and use machines. Pregnancy and breastfeeding Because there are no data concerning the use of mifamurtide in pregnant patients, mifamurtide should not be used during pregnancy, nor in women not using effective contraception. You should always use effective contraception if you are being treated with mifamurtide, and it is important to tell your doctor if you think you may be pregnant, or are planning to get pregnant. For women breastfeeding, again there are no data as to whether mifamurtide is excreted in human milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of mifamurtide therapy to you. This is an issue best discussed with your doctor or nurse. Fertility No dedicated fertility studies have been conducted with mifamurtide. If you have any questions regarding any other aspect of your health that may be affected please consult your doctor or nurse. If you have any further questions not covered in this leaflet, ask your doctor or nurse. Also, if any of the side effects already mentioned gets serious, or if you experience any side effects not listed here or in the package leaflet, please tell your doctor. 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 the package leaflet. You can also report side effects directly via the Yellow Card Scheme at By reporting side effects you can help provide more information on the safety of this medicine.

8 Some useful organisations Bone Cancer Research Trust BCRT is a charity dedicated to improving outcomes for people affected by primary bone cancer, and they achieve this through research, awareness, information and support. They enable patients and their families to connect with each other and know that they are not alone. Website: Cancer52 An organisation that represents the less common cancers, giving member charities and those they represent a more powerful voice and the driving force of a larger group, as well as listening to the community and sharing information and experience. Website: CLIC Sargent CLIC Sargent is the UK s leading cancer charity for children and young people, and their families. They provide clinical, practical and emotional support to help them cope with cancer and get the most out of life. They are there from diagnosis onwards and aim to help the whole family deal with the impact of cancer and its treatment. Website: Rarer Cancers Foundation Rarer Cancers Foundation draws together people with rare and less common cancers, giving them a bigger collective voice to exact better services, and enabling them to support one another. It makes health professionals aware of issues related to rarer cancers and works with the Government, the NHS and Primary Care Trusts/Health Boards to ensure that people with rarer cancers have access to the best possible services across the UK. Website: Sarcoma UK Sarcoma UK is the only cancer charity in the UK focusing on all types of sarcoma. Sarcoma UK s mission is to increase knowledge and awareness of sarcoma through ground-breaking programmes that inspire involvement and transform the landscape for everyone affected by sarcoma. They initiate change to raise sarcoma awareness and improve standards of treatment and care, seek answers through research and provide support and information for the sarcoma community. Website: Teenage Cancer Trust Teenage Cancer Trust is the only UK charity dedicated to improving the quality of life and chances of survival for young people with cancer aged 13 to 24. Teenage Cancer Trust funds and builds specialist units in NHS hospitals and provides dedicated staff, bringing young people together so they can be treated by teenage cancer experts in the best place for them. Teenage Cancer Trust also educates young people in schools about cancer to help improve the speed and quality of diagnosis. Website: Other useful contacts Date of preparation: February 2014 ME110112a(1)

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