Denosumab (Prolia) for postmenopausal osteoporosis This Medicine Update is for women who are using, or thinking about using, denosumab. Summary Denosumab is a new medicine for women with osteoporosis. It is given as an injection once every 6 months. Denosumab prevents broken bones in women with osteoporosis. It s not known if denosumab is better at preventing broken bones than other osteoporosis medicines. Like all treatments for osteoporosis, denosumab has some common side effects. But it s a new medicine, so not all of its long-term side effects are known. Some women may prefer a denosumab injection to taking tablets. You will still need to take calcium and vitamin D if these have been prescribed for you. www.nps.org.au/medicineupdate Independent, not-for-profit and evidence based, NPS enables better decisions about medicines and medical tests. We are funded by the Australian Government Department of Health and Ageing.
Contents section What denosumab is...1 What denosumab is for... 2 Who can use denosumab... 3 How to use denosumab... 4 What does denosumab do?... 5 Important side effects to consider... 6 What else you should know about denosumab... 7 Other medicines available for osteoporosis... 8 How to decide between denosumab and other medicines for osteoporosis... 9 What does denosumab cost?...10 Other ways to help osteoporosis...11 Where to find more information...back page Asking the right questions about new medicines What is Medicine Update? Medicine Update provides independent information about new medicines and new listings on the PBS. It tells you about the possible benefits and harms of new medicines, who can and can't use them, and some of the other treatment options available. How to use Medicine Update Medicine Update is a tool to help you understand your treatment choices and to discuss them with your doctor. Medicine Update doesn t describe all possible side effects, precautions, or interactions with other medicines so you should always read the consumer medicine information (CMI) leaflet (see back page). Who is it for? Medicine Update is for anyone who is starting this medicine or thinking of starting it, and their carers. Where does Medicine Update come from? Medicine Update is written by NPS: Better choices, Better health in consultation with consumers and health professionals. NPS is an independent, not-for-profit, government-funded organisation. NPS takes reasonable care to ensure this information is accurate and up-to-date at the time of creation. It is for your information only and is not medical advice. NPS does not warrant its completeness and excludes liability where permitted by law. We recommend you seek advice from a health professional about your medical condition. 2
1. What denosumab is The active ingredient of this medicine is denosumab (pronounced den-os-u-mab). It is also known by the brand name Prolia. Denosumab is given as an injection under the skin. It is a type of medicine called an anti-resorptive. This means that it slows bone loss (thinning of the bones). Denosumab works in a completely different way from other anti-resorptive medicines. The active ingredient is the chemical in the medicine that makes the medicine work. Many medicines are known by their brand names as well as by the name of the active ingredient. Some medicines are available under several different brand names. 2. What denosumab is for Denosumab is used to treat osteoporosis in women who have passed the menopause (postmenopausal women). Osteoporosis is a condition in which cells in the bone break down faster than new ones can replace them. This causes a gradual loss of bone tissue and makes your bones brittle and prone to breaking easily. Your doctor or nurse might refer to a broken bone as a fracture. How do you know if you have osteoporosis? Your doctor will ask you to have a bone mineral density scan if they think you have osteoporosis. A bone mineral density scan, sometimes called a DEXA scan, measures the density of your bones. It compares your result to the bone density of an average young adult. It is quick and painless, like an x-ray. The result of your bone mineral density scan is called a T-score. If you have osteoporosis, your T-score will be minus 2.5 or lower. The lower your T-score, the more likely you are to break a bone in your hip, spine or wrist. For example, a T-score of minus 3 means that your bones are more brittle and prone to breaking than someone with a score of minus 2.5. 3. Who can use denosumab You can use denosumab if you have been diagnosed with postmenopausal osteoporosis. It is available through the Pharmaceutical Benefits Scheme (PBS) for: Talk with your doctor about all the treatment options for postmenopausal osteoporosis. women who are aged 70 years or older, and have a bone mineral density T-score of minus 3 or lower or women who have passed the menopause, and have osteoporosis, and have had a bone break more easily than expected (for example after a minor bump or fall). 3
4. How to use denosumab Denosumab is given as an injection under the skin of your thigh, abdomen, or back of your arm. The injection is given once every 6 months. Your doctor or nurse can give you the injection. You, or a carer, might be able to give the injection, but some training would be needed first. If you decide to use denosumab, you should: keep taking calcium and vitamin D if your doctor prescribed these for you talk to your doctor about stopping any other osteoporosis medicines (called anti-resorptives) before your first denosumab injection return any osteoporosis medicines that you no longer need to your pharmacist for safe disposal. 5. What does denosumab do? In clinical trials, denosumab slowed the breakdown of bone cells and increased bone mineral density. In another trial, women were less likely to break a bone if they received denosumab rather than a placebo (dummy medicine). It s not known if denosumab is any better at preventing broken bones than other medicines for osteoporosis. A clinical trial is a research study conducted with patients, which compares one treatment with one or more other treatments, or with no other treatment, to assess its effectiveness and safety. 6. Important side effects to consider Rash and itchy, dry and scaly skin are common side effects of denosumab treatment. They can affect the skin around the injection site, but often appear elsewhere. These side effects may clear up on their own, or they may need to be treated by your doctor. Some women might get a serious skin infection (called cellulitis) caused by bacteria. It s uncommon, but may need to be treated in hospital. Denosumab may lower the calcium levels in your blood. This is a rare side effect. Most people will not have any symptoms, but you should contact your doctor right away if you have cramps in your muscles or numbness in your fingers or toes. Denosumab may cause problems with your immune system or pancreas, but this hasn t been confirmed. The answer will only become clear when denosumab has been used by many more women. But in the meantime, you should tell your doctor if you have any of the following symptoms: fevers or chills hot or tender skin severe, long-lasting abdominal pain. Rarely, denosumab and some other medicines for osteoporosis can cause pain and weakening of bones in the jaw. You can reduce the chance of this happening by taking good care of your teeth and telling your dentist that you are using denosumab. All medicines can have side effects. Sometimes, the side effects are serious but most of the time they are not. Some side effects are common, while others are very rare. The terms common, uncommon and rare are used to describe the chance of getting a side effect. This is what they mean: common up to 1 in 10 people may get this side effect uncommon up to 1 in 100 people rare up to 1 in 1,000 people. For a list of possible side effects, see the consumer medicine information (CMI) leaflet for denosumab, available on the NPS website. You can also discuss side effects with a pharmacist by calling the Adverse Medicines Event (AME) Line on 1300 134 237 (Mon Fri, 9am 5pm). 4
7. What else you should know about denosumab Low levels of calcium in the blood can be a problem for people using denosumab. Your doctor may perform a blood test to check your calcium level before prescribing denosumab. Most people taking medicines for osteoporosis need to take a calcium supplement as well. Your doctor may also recommend a vitamin D supplement. 8. Other medicines available for osteoporosis Like denosumab, most medicines for osteoporosis work by slowing bone loss. They are called anti-resorptives, but they work in different ways. The anti-resorptives are: bisphosphonates including alendronate, etidronate, risedronate and zoledronic acid raloxifene strontium. Another osteoporosis medicine teriparatide works by increasing bone formation. Talk with your doctor about all the treatment options for osteoporosis. Medicine Updates are available for alendronate, zoledronic acid and strontium. Go to www.nps.org.au/consumers/ publications/medicine_update. Are these medicines used in the same way? All of the osteoporosis medicines listed above are available on the PBS. But they are prescribed in different ways and for different people. Your doctor will be able to tell you which osteoporosis medicines are available to you through the PBS. Bisphosphonates Alendronate (brand names Fosamax, Adronat, Alendrobell and Ossmax), etidronate (Didrocal) and risedronate (Actonel) are tablets. Some are taken daily, while others can be taken weekly or monthly. Zoledronic acid (Aclasta) is given as a drip into a vein in the arm (called an intravenous infusion) once a year. Raloxifene Raloxifene (Evista) is a tablet that prevents bone loss in a similar way to the hormone oestrogen. It can only be prescribed through the PBS if you have had a bone break due to osteoporosis. Strontium Strontium (Protos) comes as a powder that you dissolve in water. It is taken once a day at bedtime, at least two hours after eating or drinking milk. Teriparatide Teriparatide (Forteo) is used by people who have severe osteoporosis. It s given as an injection once a day into the thigh or abdomen. Teriparatide can only be prescribed through the PBS if you have had 2 or more broken bones caused by osteoporosis. 5
9. How to decide between denosumab and other medicines for osteoporosis Making a choice between medicines for osteoporosis can be difficult. There are some important questions to ask: What would happen if I didn t take this medicine? What are the likely benefits of taking this medicine? What risks, such as side effects, should I be aware of? What other treatment options are available? How do I take the medicine? How much is it going to cost? Think about what matters most to you, and discuss your preferences with your doctor. Convenience Some osteoporosis medicines can be difficult to take. You might have to sit upright after you ve swallowed the tablet (to avoid stomach problems), or remember to take your medicine once each week or month. Denosumab could be an alternative because it s given as an injection once every 6 months. Women who have already broken a bone are more likely to break another bone, so they may benefit most from using medicines for osteoporosis. A medicine that suits one person may not suit another. You may wish to avoid certain side effects or, if the medicine is working well, you may be willing to put up with the possible side effects. Zoledronic acid is also an injection. It s given as a drip into a vein once a year. You can read more about zoledronic acid here (http://www.nps.org.au/consumers/publications/ medicine_update/issues/zoledronic_acid). But less is known about denosumab Denosumab has not been used to treat osteoporosis for very long, so there is less experience with it than other osteoporosis treatments. It has some common side effects that can affect your skin, but denosumab will need to be used by many more women before doctors and pharmacists know all of its possible side effects. 10. What does denosumab cost? Cost to the Government The full cost of denosumab to the Australian Government is: $304.87 Each prescription is for a single denosumab injection once every 6 months. Cost to the individual If you get denosumab through the Pharmaceutical Benefits Scheme (PBS), the Australian Government pays most of the cost and you will pay only a part, called the co-payment. At the time of publication, the co-payment for people who are entitled to get denosumab through the PBS is: Most medicines prescribed by your doctor are covered by the PBS. This means that the Australian Government pays part of the cost of your medicine. You will need to pay the full price if the medicine is not available on the PBS, or is not available on the PBS for your specific condition. For more information see www.pbs.gov.au. $33.30 for people without a concession card $5.40 for concession card holders. If you re not eligible to get denosumab through the PBS, you will need to pay the full price for a prescription. 6
11. Other ways to help osteoporosis A healthy lifestyle regular exercise, calcium in the diet, some sunshine and no smoking is important to help prevent osteoporosis worsening and to manage it. Exercise Exercises for osteoporosis can improve fitness, strength and balance. They can also help to prevent broken bones. What type of exercise? Examples include brisk walking, tai chi, dancing, aqua aerobics and gentle lifting of weights. Recommendations may differ from person to person, so you should talk to your doctor or a physiotherapist about exercises that suit you. Avoid exercises that involve twisting, sudden severe movements or bending forward from the spine. These are not suitable if you have osteoporosis. Calcium About 3 4 serves of dairy products each day are recommended. One serve is: 250 ml glass of milk 200 g tub of yoghurt, or 40 g piece of cheese. Canned fish, tofu, soy beans, other beans and green leafy vegetables such as broccoli and bok choy also contain good amounts of calcium. If you can t get enough calcium in your diet, then you may need to take a supplement as well. Vitamin D sunshine and diet Vitamin D is also important as it helps the body to absorb calcium. You can get this from short periods in the sun, but take measures to protect your skin between 10am and 3pm. Ask your doctor about how to get enough sunshine safely. People who get little or no sunlight need a vitamin D supplement. Vitamin D is also found in oily fish (such as tuna or mackerel), eggs and liver, and is added to some milks and margarines. No smoking Smoking can cause the gradual loss of bone tissue quitting is extremely important, and not just for your bones. Call the Quitline on 131 848 if you want help. Preventing falls Reducing your chance of falling again may help you to prevent fractures. Your GP, physiotherapist or occupational therapist can help you work out your risk of falling and advise you about what you can do to keep yourself safe. 7
Where to find more information Read the consumer medicine information (CMI) leaflet The CMI for Prolia (denosumab) will tell you: who should not use the medicine which medicines should not be used at the same time (medicine interactions) how to use the medicine most of the possible side effects the ingredients. You can get the CMI leaflet for Prolia from: your doctor or pharmacist CMI search on the NPS website Amgen, the makers of Prolia (denosumab), on 1800 803 638. Information over the phone NPS works with healthdirect Australia to provide consumers with information on medicines. To get information about denosumab call 1300 MEDICINE (1300 633 424) from anywhere in Australia for the cost of a local call (excluding mobiles). Service is available Monday to Friday 9am 5pm EST except NSW public holidays. To report a side effect with denosumab Call the Adverse Medicines Event (AME) Line on 1300 134 237 (Mon Fri, 9am 5pm EST). The AME Line lets you report and discuss side effects that might be related to your medicine. The side effects of your medicine but not your personal details are reported to the Australian medicines regulatory agency (the Therapeutic Goods Administration or TGA for short). The information helps to improve the safe use of medicines. For more information about the AME Line visit www.nps.org.au/ame_line. More about taking medicines For more information on how new medicines are tested and approved in Australia see the NPS factsheet New medicines: are they always better? at www.nps.org.au/consumers/publications/factsheets. More information on understanding side effects is available from www.asmi.com.au. Date published: December 2010 Visit the NPS website to find out about our free activities and resources for consumers www.nps.org.au/consumers Independent, not-for-profit and evidence based, NPS enables better decisions about medicines and medical tests. We are funded by the Australian Government Department of Health and Ageing. 2010 National Prescribing Service Limited. This work is copyright. You may download, display print and reproduce this work in unaltered form only (retaining this notice) for non-commercial use either personally or within your organisation. Apart from any such use or otherwise as permitted under the Copyright Act 1968, all rights are reserved. Queries concerning reproduction and rights should be sent to copyright@nps.org.au. ABN 61 082 034 393 l Level 7/418A Elizabeth Street Surry Hills NSW 2010 l PO Box 1147 Strawberry Hills NSW 2012 Phone: 02 8217 8700 l Fax: 02 9211 7578 l email: info@nps.org.au l web: www.nps.org.au