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The FORTEO Customer Care program. Quick Start Pen Guide. Welcome. Remove this card and carry it with you. A few things to know about FORTEO: If you have any questions, call the FORTEO Customer Care program toll-free: 1.877.4FORTEO (1.877.436.7836). Prefilled FORTEO® pens can be picked up directly from your pharmacist or delivered to your home through the FORTEO Customer Care program. It builds new bone. FORTEO contains teriparatide, which is the same as the active part of the body’s natural parathyroid hormone. It builds new bone faster than old bone is lost. Affix card here. It is a self-injection. FORTEO is a once-a-day therapy you inject just under the skin. It is taken once a day. FORTEO can be taken at any time of day, with or Keep this magnet without food or drink. handy. Throughout treatment you’ll be supported. During your treatment with FORTEO, the FORTEO Customer Care program will support you each step of the way, to make sure you get the most out of your treatment. Affix magnet here. What is osteoporosis? How is bone health monitored? With osteoporosis, old bone is removed faster than new bone is formed. Over time, this causes bones to become thin and weak, putting you at greater risk for a fracture. Your bone health is measured by a bone mineral density test (BMD). These examples show the difference between bone with osteoporosis and healthy bone: Osteoporosis Healthy The result of this test is called a T-score. A normal T-score is considered to be +2.5 to –1.0. The lower the T-score, or bone mineral density, the weaker the bone is. +2.5 +2.0 +1.5 +1.0 +0.5 Normal Bone 0.0 T-score –0.5 –1.0 –1.5 –2.0 –2.5 –3.0 –3.5 Weaker Bone Severe Osteoporosis Why is it important to treat osteoporosis? Osteoporosis makes your bones thinner and weaker, putting you at risk for fractures. Even a sudden bump or fall may cause a broken bone. Your most vulnerable areas are your back, hips and wrists. Questions or comments about osteoporosis: Who can take FORTEO? How does FORTEO work? FORTEO is recommended for the treatment of postmenopausal women with severe osteoporosis who: It builds new bone. FORTEO builds new bone faster than old bone is lost. The medicinal ingredient in FORTEO is teriparatide, which is the same as the active part of your body’s natural hormone called parathyroid hormone or “PTH.” Teriparatide works by increasing the activity of the bone-building cells (osteoblasts). • are at high risk of fracture or • have been unable to take other medications or • have not been adequately helped by other treatments. FORTEO is also recommended for men with (primary or hypogonadal) severe osteoporosis who: • have been unable to take other medications or • have not been adequately helped by other treatments. FORTEO is also approved for the treatment of both men and women with severe osteoporosis related to the use of corticosteroid medication (such as prednisone) who: • are at high risk of fracture, including: – those with a history of broken bones or – those with a low bone mineral density (BMD). The FORTEO treatment. What is the FORTEO treatment? It is an injection. FORTEO is a once-a-day therapy you inject just under the skin. Bone-absorbing cells cause bone loss, like deep pits. FORTEO increases the activity of bone-forming cells. FORTEO helps new bone formation, filling in the pits. It’s treatment with support. The FORTEO Customer Care program is there to support you while you’re taking FORTEO. You should continue taking FORTEO for as long as your doctor prescribes it for you. After that, you and your doctor can decide on a program for your osteoporosis. You’ll find information about the FORTEO Customer Care program in the back of this booklet. After FORTEO. How can I get support? After finishing the FORTEO treatment, it’s important to continue habits that support good bone health. Speak with your doctor about developing a strategy for your osteoporosis that includes nutrition and exercise. You will be contacted regularly by a registered nurse. There’s no cost to register for the FORTEO Customer Care program. Once you do, you’ll receive regular, monthly calls over the entire course of treatment to help with: You can also call the FORTEO Customer Care program at 1.877.4FORTEO (1.877.436.7836) 7 days a week. • Payment • Pen training • Reminders • General help You can also call with questions at 1.877.4FORTEO (1.877.436.7836) 7 days a week. Your FORTEO Starter Kit. When you join the program, you will receive information and accessories to help make your treatment with FORTEO as comfortable and convenient as possible. Travel bag with gel pack: A compact solution to help keep your FORTEO organized and cool while travelling. Detailed information and instructions: These printed materials will give you information about FORTEO, the FORTEO Customer Care program and step-by-step instructions on the use of your FORTEO pen. FORTEO pen: A prefilled FORTEO pen completes your starter kit so that you have everything you need to begin treatment. And when it’s time to have your prescription refilled, you have the option to get your FORTEO pen directly from your pharmacist or have it delivered to your home. The FORTEO Starter Kit. Questions about the FORTEO Treatment and Customer Care Program Patient stories. I learned a lot about my osteoporosis. When I started with the FORTEO Customer Care program, I didn’t know what to expect and was a little anxious about my treatment. But the registered nurse I spoke to at the FORTEO Customer Care program was so patient; she helped me learn how to give myself injections. And she helped me learn a lot about taking care of myself, especially about things I can do to help my osteoporosis. Winnie B* Owen Sound, ON * Fictitious patient. May not be representative of all FORTEO patients. Getting into a rhythm. The biggest challenges for me were changing the way I ate and getting enough exercise. But with the help of the FORTEO Customer Care program, I discovered that keeping a daily food and exercise journal made changing my habits much easier. I don’t get overwhelmed anymore; I just follow my daily checklist. It also took me a while to get the hang of taking my injections every day. I started off taking it at night, but I’d forget it when I worked odd hours. So the nurse suggested I take it every day, right before I brushed my teeth. It didn’t take long before it became a part of my morning routine. Fred H* Swift Current, SK * Fictitious patient. May not be representative of all FORTEO patients. Putting the “care” in the FORTEO Customer Care program. I have rheumatoid arthritis and my treatment includes taking prednisone. When I got osteoporosis, too, from my medication, I wondered how I would cope. But the nurse at the FORTEO Customer Care program knew what I needed and helped me through my FORTEO treatment. She taught me how to do my injections and kept in touch to make sure I was doing okay. Marie L* Winnipeg, MN * Fictitious patient. May not be representative of all FORTEO patients. I am happy to have the FCC support. My doctor put me on tablets for my osteoporosis a few years ago. I took them every day, but I felt like I was alone dealing with my bone health. After I broke my wrist, my doctor and I decided I should start FORTEO injections. I was really happy that there was another option for me, and that the FCC was there any time I had questions or needed some help with my insurance issues. It’s good to know that there is always someone to ask. Sandra P* Jonquière, QC * Fictitious patient. May not be representative of all FORTEO patients. Keeping it cool. I have chronic respiratory problems that are pretty well controlled with my medicine, but the medicine has made my bones weak. When my doctor and I talked about FORTEO injections for my osteoporosis, I wondered how I could fit it into my schedule. I sometimes travel for my work. But, I received a kit to carry my medication (with a gel pack to keep it cool) and all the information I need. I just take my whole kit with me and keep it in my hotel room refrigerator. And, no matter where I am in Canada, I know I can call the toll-free number if I have any problems. Robert M* Edmundston, NB * Fictitious patient. May not be representative of all FORTEO patients. One step at a time. My memory isn’t what it used to be, so I really appreciate the Quick Start Injection Guide. It reminds me, stepby-step, of the correct way to give myself my FORTEO injections. I keep it in the kitchen right next to the refrigerator, so it’s always handy when I need it. Agathe T* Trois-Rivières, QC * Fictitious patient. May not be representative of all FORTEO patients. The FORTEO Customer Care program helped me with my treatment. Yesterday, I gave myself my last injection after 24 months of treatment. When I started, the thought of giving myself a daily shot seemed daunting. But I learned a lot with the help of the FORTEO Customer Care program, and I’m proud that I was able to complete my treatment. Margaret E* New Westminster, BC * Fictitious patient. May not be representative of all FORTEO patients. Discuss your treatment goals with your doctor. Changes are easier to make when you have a clear idea of what your goals are. Discuss with your doctor where you see yourself after your treatment with FORTEO. Then your doctor can suggest steps to take, in addition to treatment with FORTEO, to help you get there. Information and support. How do I take FORTEO? Getting into a rhythm. For instructions on how to use the pen, see the Quick Start Pen Guide in the front pocket of this booklet. If you are injecting for the first time or are unsure, please call 1.877.4FORTEO (1.877.436.7836). Especially if you are taking more than one medication, it can be hard to get into a routine. If you link your FORTEO injection to something you do every day, like brushing your teeth or making a cup of tea, it may help you to remember. FORTEO is stored in the refrigerator (2°C – 8°C). It is a good idea to try to take it each day at about the same time. When you start out, read all the materials given to you, and refer to the Quick Start Pen Guide in this booklet. Give yourself as much time as you need to go through all of the materials. Over time, your FORTEO injection may become part of your daily routine. For example: 11 • Use each pen for 28 days only. • For simple troubleshooting solutions, check the back of your FORTEO Pen Quick Start Injection Guide. 1 10 3 Morning: Some people take FORTEO when they go to the refrigerator after getting up. 3 Evening: Other people take FORTEO just before a favourite television program or as they are getting ready for bed. 2 9 8 4 7 FORTEO Quick Tips • Always check the expiry date before using a new FORTEO pen. 12 11 6 12 5 1 10 2 9 8 4 7 6 5 What else should I do? Calcium It is still important to get a good amount of calcium to help strengthen your bones. You can take supplements and eat a diet that is high in calcium. Some foods high in calcium are: Dairy products: Dairy products, such as milk, cheese and yogurt contain high amounts of calcium that is easily absorbed. Calcium-fortified beverages: Fortified soy beverages and orange juices may contain as much calcium as milk (check the labels). Vegetables and fish: Vegetables, lentils, beans and canned fish also have some calcium. Exercise Exercise is important to help strengthen your bones. Be sure to talk to your doctor about exercises that are right for you, such as: Weight-bearing exercises: Any exercise where your feet and legs carry your weight, such as walking, jogging, aerobics, stair climbing and dancing. Resistance exercises: Exercises that involve moving objects or your own weight, such as free weights, weight-training machines or exercise bands. Exercise and nutrition considerations: Some useful resources: Osteoporosis Canada www.osteoporosis.ca Tel: 1.800.463.6842 This well-organized site features high-calcium recipes, free publications, exercise information, and diagnosis and treatment discussions. Active Living Coalition for Older Adults www.alcoa.ca Tel: 1.800.549.9799 This group is a partnership of organizations and individuals dedicated to the promotion of active living and quality of life for older adults. The site features information about projects, as well as resources and publications. The Canadian Orthopaedic Foundation www.canorth.org Tel: 1.800.461.3639 The Foundation is a registered Canadian charity dedicated solely to helping people maintain and restore their bone and joint health. The site features patient stories, education information and resources. www.menopauseandu.ca This website is managed by the Society of Obstetricians and Gynaecologists of Canada. It provides science-based, easy-to-understand information about menopause and osteoporosis, including videos and answers to frequently asked questions. Frequently asked questions. What happens if I miss a dose? You should take your dose every day on a regular schedule. But if you miss once, don’t worry. Take the next dose at the usual time the next day. Do not take more than one injection in the same day. If you miss more doses, talk to your doctor. How do I know I did the injection correctly? If you injected correctly, the black injection button should be all the way down, and the yellow shaft should not be seen. If you are in doubt, please call 1.877.4FORTEO (1.877.436.7836). What if there is liquid left in the pen after 28 injections? You should not use it. The pen should be properly disposed of after 28 days of first use, even if it is not completely empty. How many pens will I need for my treatment? For the full treatment period of 24 months, you will need 26 pens. Each pen contains enough FORTEO for 28 days, taking one injection every day. Why do I have to count 5 seconds when I inject? FORTEO injections are given with a small needle. So it’s important to count to 5 slowly as it may take this long for all of the medication to be released through the needle. What are the side effects of FORTEO? Most of the side effects of FORTEO are mild. The most common side effects are dizziness and leg cramps. Your doctor and pharmacist need this information to help keep you from taking a combination of products that may harm you. If you become dizzy, do not drive or operate machinery; you should sit or lie down until the symptoms go away. If they continue or get worse, you should call your doctor before continuing treatment. You should not take FORTEO if you: • Have had an allergic reaction to teriparatide or any of its ingredients. You should also call a healthcare provider if you have continuing nausea, vomiting, constipation, low energy or muscle weakness. These may be signs of too much calcium in your blood. • Have kidney problems (severe renal impairment). If you have any problems or questions while taking FORTEO, ask your doctor, nurse or pharmacist for more information. Do any medications interact with FORTEO? Tell your healthcare provider and pharmacist about all the medicines you are taking when you start taking FORTEO, and if you start taking a new medicine after you start FORTEO treatment. Tell them about all the medicines you take, with prescriptions and without prescriptions, as well as herbal or natural remedies. • Have high levels of calcium (pre-existing hypercalcemia) or alkaline phosphatase. • Have other bone diseases, or have had radiation therapy involving your bones. • Have ever been diagnosed with bone cancer or other cancers that have spread to your bones. • Are a child, growing adult, or if you are pregnant or breastfeeding. • Have trouble injecting yourself and do not have someone who can help you. Serious Warnings and Precautions As part of drug testing, teriparatide, the active ingredient in FORTEO, was given to rats for a significant part of their lifetime. In these studies, teriparatide caused some rats to develop osteosarcoma, a bone cancer. The potential to cause osteosarcoma in rats was increased with higher doses and longer periods of treatment. Osteosarcoma in humans is a serious but very rare cancer. Osteosarcoma occurs in about 4 out of every million people each year. None of the patients in the clinical trials or post-treatment follow-up developed osteosarcomas, but it is not known whether humans treated with FORTEO would have an increased chance of getting osteosarcoma. You should discuss any safety concerns you have about the use of FORTEO with your doctor. Notes: The FORTEO Customer Care program. Quick Start Pen Guide. This section contains your membership card for the FORTEO Customer Care program. You should carry this card with you, should you need to contact us with questions. This section also contains a magnet, so you can keep the FORTEO Customer Care program number in an easy-to-find place. Remove this card and carry it with you. FORTEO Customer Care Call toll-free 1.877.4FORTEO Affix 7card here. (1.877.436.7836) Call days a week. ® Registered trademark owned by Eli Lilly and Company; used under license. © 2010 Eli Lilly Canada Inc. Toronto, Ontario M1N 2E8. Keep this magnet handy. FORTEO Customer Care Call toll-free 1.877.4FORTEO x magnet (1.877.436.7836)Affi Call 7 days here. a week. ® Registered trademark owned by Eli Lilly and Company; used under license. © 2010 Eli Lilly Canada Inc. Toronto, Ontario M1N 2E8. ® Registered trademark owned by Eli Lilly and Company; used under license. © 2010 Eli Lilly Canada Inc. Toronto, Ontario M1N 2E8. www.lilly.ca FTCAD02320210S(R)