P I ATIENT NFORMATION ON ERIPARATIDE

PATIENT INFORMATION ONTERIPARATIDE(Brand name: Forteo )This information sheet has been produced bythe Australian Rheumatology Association tohelp you understand the medicine that has beenprescribed for you. It includes importantinformation about: how you should take your medicine the possible side effects other precautions you should take while youare taking teriparatide.Please read it carefully and discuss it with yourdoctor.Important things to remember While taking teriparatide you should seeyour rheumatologist or other specialistregularly to make sure the treatment isworking and to minimise any possible sideeffects. If you are worried about any side effectsyou should contact your specialist as soonas possible. Teriparatide should not be taken withsome other osteoporosis medicines such asbisphosphonatese.g.alendronate(Fosamax, Alendro, Fosamax Plus),risedronate (Actonel, Actonel Combi,Actonel Combi D) and m (Protos) or raloxifene (Evista).These should be stopped before you startteriparatide.www.osteoporosis.org.au/ or phoneOsteoporosis Australia on 1800 242 141.Whatis teriparatide?Teriparatide (brand name: Forteo ) is amedicine used to treat severe osteoporosis.Osteoporosis is a common disease that causesbones to become fragile and brittle so that theybreak (fracture) more easily even as a result ofnormal activity (as distinct from a fall).Fractures are painful and restrict a person’sability to carry out their normal daily tasks.Teriparatide reduces the risk of a broken boneor fracture.How does it work?Bone is constantly changing with older bonebeing broken down and new bone being formedto take its place. This usually happens in abalanced way. If the cycle becomes unbalancedbone breaks down faster than it is replaced. Thisleads to osteoporosis.Teriparatide is a man-made form of a substancecalled parathyroid hormone, which is foundnaturally in the body and has an important rolein maintaining healthy bones. Teriparatideincreases bone formation thereby increasingbone strength and reducing the risk of fracture.For more information about OSTEOPOROSISsee the Osteoporosis Australia websiteTeriparatideAustralian Rheumatology Associationwww.rheumatology.org.auRevised February 20161

What benefit can you expect fromyour treatment?Since osteoporosis is usually not painful (until afracture occurs) you will not ‘feel’ anyimmediate benefit from your treatment withteriparatide.The treatment controls osteoporosis but doesnot cure it. It is therefore important to continueto use teriparatide even if you feel well.Do not stop using teriparatide until advised byyour doctor.You may be asked to have tests to check theeffect of treatment on your bones. For example abone mineral density test is usually done one ortwo years after first starting teriparatide. This isa type of X-ray that involves a very smallamount of radiation.dosing schedule. Never inject more than onedose per day.Do not use more or lessteriparatide or use it more often than prescribedby your doctor.Can other medicines be taken withteriparatide?It is safe to take most other medicines when youare taking teriparatide. However, teriparatideshould not be taken with some otherosteoporosis medicines (see Precautions).Your doctor will usually recommend that youtake calcium and vitamin D as additionaltreatment for osteoporosis. Do not stop takingthese medicines unless advised by your doctor.How long is the treatment continued?Tests of urine or blood are also sometimes usedto measure the effects of treatment on boneformation and breakdown.For osteoporosis, treatment with teriparatide isusually given continuously for up to 18 monthsand no longer. After that further treatment withan alternative medicine for osteoporosis isrecommended.How is teriparatide used?Are there any side effects?To make sure it is effective it is very importantthat you follow the instructions for usingteriparatide carefully, including the instructionsfor storage and disposal. Ask your doctor orpharmacist to explain anything you do notunderstand.Most people who take teriparatide do notexperience side effects. Tell your doctor if youare concerned about possible side effects.Teriparatide is given as an injection under theskin (subcutaneously). It is injected in the thighor abdomen once a day. It comes in a penshaped device to make the daily injection easier.The teriparatide pen contains enough medicinefor 28 doses.Most common possible side effectsThe most common side effects include: nausea, vomiting or constipation pain in joints or bones headache dizziness or lightheadedness: this can happenif you get up too quickly from a lyingposition. It is more common at the start oftreatment. By getting out of bed slowlyand resting your feet on the floor for a fewminutes before standing up you canreduce the risk. It is a good idea to have achair nearby when you give yourself theinjection so that you can sit down if youfeel dizzy. discomfort around the injection site can occurin up to 30% of people and may includepain, swelling, bruising, itching or a fewdrops of blood.It is important to use a new needle for eachinjection.What is the dosage and when should it begiven?The teriparatide daily dose is 20 micrograms.Use it at around the same time every day to helpyou remember. The best time to take it is atnight before going to bed.If a dose is missed use it as soon as possible thatday. However, if the day has already passed,skip the missed dose and continue your regularTeriparatideLess common or rare possible side effectsAustralian Rheumatology Associationwww.rheumatology.org.auRevised February 20162

Less common side effects include: muscle weakness heartburn leg cramps or back spasms depression chest pain or difficulty breathing lack of energy.There are a number of other uncommon sideeffects and precautions. These are described inthe leaflet that comes with the medicine. Readthis information and discuss any concerns withyour doctor.Warning of very rare side effectTeriparatide has been found to cause anincreased risk of bone cancer (sarcoma) whenused in animals in high doses continuously frombirth. It is for this reason that the maximumlifetime duration of teriparatide is only 18months. Because of these restrictions yourprescribing doctor will ask you to sign a formabout treatment with this medicine.should also mention your treatment whenyou see other health professionals. Teriparatide should not be taken with someother osteoporosis medicines such asbisphosphonates e.g. alendronate (Fosamax,Alendro,Fosamax Plus), risedronate(Actonel, Actonel Combi, Actonel Combi D)and zolendronate (Aclasta), or denosumab(Prolia), strontium (Protos) or raloxifene(Evista). These should be stopped before youstart teriparatide. Bisphosphonates may berecommencedfollowingtreatment. The risk of side effects from the low doses ofaspirin used to prevent heart attack andstrokes is not increased when taken withteriparatide.started orteriparatideWhat precautions are necessary?Blood tests Monitoring blood tests are not usuallyrequired for people taking teriparatide,although in certain situations these may beneeded.Other medical conditions Teriparatide should not be taken if youhave:- severe kidney disease or kidney failure- Paget’s disease or blood tests suggestiveof Paget’s disease- bone diseases other than osteoporosis- high parathyroid hormone levels- a history of bone cancer or- any previous radiotherapy.Use with other medicines You should tell your doctor (including yourgeneral practitioner, rheumatologist andothers) about all medicines you are taking orplan to take. This includes over the counteror herbal/naturopathic medicines. YouTeriparatideAustralian Rheumatology Associationwww.rheumatology.org.auRevised February 20163

How to store and dispose ofteriparatide Keep the medicine in the pen it came in withthe cap on and without a needle attached,tightly closed, and out of reach of children. Do not transfer the medicine to a syringe. Store it in the refrigerator but do not freezeit. Protect it from light. Throw away any medicine that is outdatedor no longer needed. Throw away the pen after 28 days of useeven if it is not empty. Dispose of used needles in a punctureresistant container (sharps box). Talk to yourdoctor or pharmacist about how to disposeofthesharpsbox.Questions?Your doctor’s contact detailsIf you have any questions or concerns write themdown and discuss them with your doctor.If you are taking teriparatide you should seeyour rheumatologist regularly to make sure thetreatment is working and to minimise anypossible side effects.The information in this sheet has been obtained from various sources and has been reviewed by the Australian Rheumatology Association. It isintended as an educational aid and does not cover all possible uses, actions, precautions, side effects, or interactions of the medicinesmentioned. This information is not intended as medical advice for individual problems nor for making an individual assessment of the risks andbenefits of taking a particular medicine. It can be reproduced in its entirety but cannot be altered without permission from the ARA. TheNHMRC publication: How to present the evidence for consumers: preparation of consumer publications (2000) was used as a guide indeveloping this publication.TeriparatideAustralian Rheumatology Associationwww.rheumatology.org.auRevised February 20164

TeriparatideAustralian Rheumatology Associationwww.rheumatology.org.auRevised February 20165

Teriparatide is given as an injection under the skin (subcutaneously). It is injected in the thigh or abdomen once a day. It comes in a pen-shaped device to make the daily injection easier. The teriparatide pen contains enough medicine for 28 doses. It is important to use a new needle for each injection.