PACKAGE LEAFLET: INFORMATION FOR THE USER. InductOs 12 mg kit for implant dibotermin alfa

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1 PACKAGE LEAFLET: INFORMATION FOR THE USER InductOs 12 mg kit for implant dibotermin alfa Read all of this leaflet carefully before you are given this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What InductOs is and what it is used for 2. Before you receive InductOs 3. How InductOs is given 4. Possible side effects 5. How to store InductOs 6. Further information 1. WHAT INDUCTOS IS AND WHAT IT IS USED FOR InductOs contains the active substance, dibotermin alfa. This is a protein that helps bone to grow and is very similar to a protein that is already found in your body. InductOs may be used either in lower back spine fusion surgery or to repair fractures of the shin bone. Lower back spine fusion surgery If you have a lot of pain from a damaged disc in your lower back, and other treatments have not proven effective, you may be considered for lower back spine fusion surgery. InductOs is used instead of taking a bone graft from your hip; this avoids the problems and pain that can be caused by an operation to collect the bone graft. When used in lower back fusion surgery, InductOs is used in combination with a metal cage, which corrects the position of your spine. If you have any question about the cage, please ask your doctor. Fractures of the shin bone If you have broken your shin bone, InductOs is used to increase the chance that your broken bone will heal, to help your fracture heal faster, and to reduce the need for additional surgeries to help your fracture heal. InductOs is used in addition to standard treatment and care of shin bone fractures. 2. BEFORE YOU RECEIVE INDUCTOS You should not receive InductOs if you are allergic (hypersensitive) to dibotermin alfa or bovine collagen or any of the other ingredients of InductOs. if you are still growing (skeletally immature). if you have an active infection at the surgery site. if the doctor treating you decides that you have inadequate blood supply at the fracture site. for treating a fracture that is disease-related (e.g., fractures due to Paget s disease or cancer). if you have been diagnosed with or are being treated for cancer.

2 The following are precautions for use of InductOs to be discussed with your doctor You should inform your doctor if you have an autoimmune disease, such as rheumatoid arthritis, sytemic lupus erythematosus, scleroderma, Sjögren's syndrome or dermatomyositis/polymyositis. You should inform your doctor if you have any bone disease. You should inform your doctor of any history of cancer. The product should not be placed in direct contact with certain types of bones. Your surgeon will know which bones to avoid. Use of InductOs may cause bone formation (heterotopic ossification) in the surrounding tissues, which can result in complications. Some patients may develop antibodies (made by your body to fight a foreign protein) to InductOs. While no harmful effects have been noted, the long-term effects are unknown. You should inform your doctor if you have kidney or liver disease. Some patients may develop nerve pain due to localised fluid collection, which would require drainage or a surgical procedure to remove the fluid. Localised swelling, in some cases resulting in breathing difficulties, has been reported in patients when InductOs has been used in surgery of the upper (neck) region of the spine. The safety and effectiveness of InductOs in cervical spine surgery have not been established, and InductOs should not be used in this situation. Using InductOs with other medicines Some shin bone clinical trials have shown that if you are treated with InductOs and take pain medication, such as aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, for a longer period of time (e.g., for more than 14 days) more fluid may discharge from your wound. This additional fluid discharge has not been associated with problems in fracture or wound healing. Please inform your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription. Pregnancy and breast feeding The effects of InductOs on pregnancy are not known. The use of the product in pregnant women is not advised. Ask your doctor for advice if you become pregnant or intend to become pregnant. Your doctor should advise you about using contraception for one year after having been treated with InductOs. It is not known if InductOs passes into breast milk. Treatment with InductOs is not recommended in mothers who are breastfeeding an infant. Ask your doctor for advice before breast feeding your baby. Driving and using machines InductOs will not affect your ability to drive or operate machinery. Important information about some of the ingredients of InductOs Some patients may develop antibodies (made by your body to fight a foreign protein) against dibotermin alfa or against the collagen in the sponge. In clinical studies, the presence of antibodies was not associated with side effects, e.g., allergies, nor was it shown to decrease the effectiveness of InductOs.

3 3. HOW INDUCTOS IS GIVEN The doctor treating you will administer InductOs during surgery. The medical staff will prepare InductOs in the operating room. If you are receiving InductOs for lower back spine fusion, your surgeon will remove the damaged disc that is causing the pain and replace it with two metal cages filled with InductOs. The metal cages correct the position of your spine, and InductOs encourages the bone to grow between the two vertebrae to join them permanently in the correct position. If you are receiving InductOs for a broken shin bone, your doctor will place InductOs around your broken bone when your fracture is treated. The doctor will determine how many kits of InductOs you will receive, depending on the size and number of fractures. Generally, one kit is used; however, a maximum of two kits may be used. 4. POSSIBLE SIDE EFFECTS Side effects specific to shin bone fracture surgery Like all medicines, InductOs can cause side effects, although not everybody gets them. The most frequent (likely to occur in more than 1 in 10 patients) events reported in clinical studies were similar to those due to the traumatic injuries sustained by the patients or to the surgery itself. These effects were pain, swelling, wound infection, and fever. Common side effects were (likely to occur in fewer than 1 out of 10 patients), headache, signs indicating malfunction of the pancreas (amylasaemia), decreased levels of magnesium in the blood, and a transient increase in heart rate. These were observed slightly more frequently in patients treated with InductOs for shin bone studies than in patients who did not receive the product. Side effects specific to spine surgery The most common (more than 1 in 10 patients) side effects observed in spinal fusion studies were: accidental injury, nerve pain, back pain and disorders of the bone, such as delayed healing. There have been reports of nerve pain due to localised fluid collection, which would require drainage or a surgical procedure to remove the fluid. Spinal nerve pain resulting in pain in arm, back or leg has been reported. Localised swelling, in some cases resulting in breathing difficulties, has been reported in patients when InductOs has been used in surgery of the upper (neck) region of the spine. After spinal fusion surgery, undesirable movement of the metal cage has been reported. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. HOW TO STORE INDUCTOS Keep out of the reach and sight of children. You will not be required to store this product. 6. FURTHER INFORMATION What InductOs contains The active substance in InductOs is dibotermin alfa (recombinant human Bone Morphogenetic Protein-2), 12 mg. The other ingredients are sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80, water for injections, and bovine Type I collagen.

4 What InductOs looks like and contents of the pack InductOs is supplied to your doctor as a kit for implanting during surgery. The kit contains 12 mg of dibotermin alfa powder, a solvent (water) and a sponge, which is made from a protein called collagen obtained from cattle (otherwise known as bovine Type I collagen). Dibotermin alfa is supplied in the kit as a white powder. For use during surgery, it must be dissolved in the water provided to form a solution, which is used to soak the sponge. The soaked sponge may then be placed where bone growth is desired. The sponge and dibotermin alfa solution will gradually disappear as bone is formed. Marketing Authorisation Holder Wyeth Europa Ltd. Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH Manufacturer New Lane Havant Hants, PO9 2NG For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. België/Belgique/Belgien Luxembourg/Luxemburg Pfizer S.A. / N.V. Tél/Tel: +32 (0) Česká republika Pfizer s.r.o. Tel: Danmark Pfizer ApS Tlf: Deutschland Pfizer Pharma GmbH Tel: +49 (0) България/Eesti/Latvija/Lietuva/ Slovenija Wyeth Whitehall Export GmbH Teл/Tel/Tãlr: Ελλάδα Pfizer Hellas A.E. Τηλ.: España Pfizer, S.A. Télf: France Pfizer Tél Magyarország Pfizer Kft. Tel: Malta Vivian Corporation Ltd. Tel: Nederland B.V. Tel: Norge Pfizer AS Tlf: Österreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0) Polska Pfizer Polska Sp. z o.o., Tel.: Portugal Laboratórios Pfizer, Lda. Tel: (+351) România Pfizer Romania S.R.L Tel: +40 (0)

5 Ireland Tel: Ísland Icepharma hf Tel: Italia Wyeth Lederle S.p.A. Tel: Kύπρος Wyeth Hellas (Cyprus Branch) AEBE T : Slovenská Republika Pfizer Luxembourg SARL, organizačná zložka Tel: Suomi/Finland Pfizer Oy Puh/Tel: +358 (0) Sverige Pfizer AB Tel: +46 (0) Tel: This leaflet was last approved in 08/2010 Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: