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COSENTYX Solution for Injection Secukinumab (Rch) Consumer Medicine Information

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COSENTYX Solution for Injection Secukinumab (Rch) Consumer Medicine Information ® COSENTYX solution for injection Secukinumab (rch) Consumer Medicine Information What is in this leaflet What COSENTYX is axial spondyloarthritis’ in adults. used for These conditions are inflammatory This leaflet answers some common diseases primarily affecting the spine which causes inflammation of the questions about COSENTYX. COSENTYX is used for the spinal joints. It does not contain all the available treatment of the following information. It does not take the inflammatory diseases: In patients with plaque psoriasis, psoriatic arthritis, and axial place of talking to your doctor or • Plaque psoriasis pharmacist. spondyloarthritis the body produces • Psoriatic arthritis increased amounts of a protein called The information in this leaflet was • Axial spondyloarthritis, IL-17A. This may lead to symptoms last updated on the date listed on the including ankylosing such as itching, pain, scaling in final page. More recent information spondylitis (axial psoriasis, swollen and tender joints in on the medicine may be available. spondyloarthritis with psoriatic arthritis, and pain in the You should ensure that you speak to radiographic damage) and spine in ankylosing spondylitis. your pharmacist or doctor to obtain non-radiographic axial COSENTYX contains the active the most up to date information on spondyloarthritis (axial substance secukinumab. This the medicine. You can also download spondyloarthritis without ingredient is a fully-human the most up to date Consumer radiographic damage) monoclonal antibody and belongs to Medicine Information (CMI) leaflet Plaque psoriasis a group of medicines called from www.medsafe.govt.nz COSENTYX is used to treat a skin interleukin (IL) inhibitors. Those updates may contain important condition called 'plaque psoriasis' in Monoclonal antibodies are proteins information about the medicine and adults. that recognise and bind specifically its use of which you should be aware. to certain proteins in the body. Plaque psoriasis causes inflammation COSENTYX works by neutralising All medicines have risks and of the skin. benefits. Your doctor has weighed the activity of the IL-17A protein, the risks of you taking COSENTYX COSENTYX is used in adults with which is present at increased levels in against the benefits they expect it moderate to severe plaque psoriasis. conditions such as psoriasis, psoriatic will have for you. Psoriatic arthritis arthritis, and axial spondyloarthritis. It will reduce the inflammation and If you have any concerns about COSENTYX is used to treat a other symptoms of the condition. taking this medicine, ask your doctor condition called ‘psoriatic arthritis’. or pharmacist. The condition is an inflammatory If you have any questions about how COSENTYX works or why this Keep this leaflet with the medicine. disease of the joints, often accompanied by psoriasis. medicine has been prescribed for You may need to read it again. you, ask your doctor, pharmacist or Axial spondyloarthritis, including healthcare provider. ankylosing spondylitis (axial spondyloarthritis with Ask your doctor if you have any questions about why this medicine radiographic damage) and non- radiographic axial has been prescribed for you. spondyloarthritis (axial Your doctor may have prescribed it spondyloarthritis without for another reason. radiographic damage) COSENTYX is not recommended for COSENTYX is used to treat a children and adolescents (under 18 condition called ‘ankylosing years of age) because it has not been spondylitis’ and ‘non-radiographic studied in this age group. COSENTYX® 1 COSENTYX may be used by people • you ever had an allergic reaction How COSENTYX is aged 65 years and over. to latex given COSENTYX is available only with a • you have ever been diagnosed doctor's prescription and is not with inflammatory bowel disease Follow all directions given to you by addictive. (Crohn’s disease or ulcerative your doctor, nurse, or pharmacist colitis) carefully. • you had a recent vaccination or if They may differ from the you will receive a live vaccine information contained in this leaflet. Before you have during treatment with Always use COSENTYX as your COSENTYX COSENTYX doctor has told you. You should Tell your doctor if you are pregnant, check with your doctor, nurse or When you must not take it think that you may be pregnant or are pharmacist if you are not sure. planning to have a baby. Do not take COSENTYX if you have COSENTYX is intended for had a severe allergic reaction to COSENTYX is not recommended subcutaneous use. This means that it secukinumab, or any of the other during pregnancy unless the benefits is injected into the fatty tissue just ingredients listed at the end of this clearly outweigh the potential risks. under the skin. leaflet. Tell your doctor if you are breast- The injection may be given by your Some of the symptoms of an allergic feeding or plan to breast-feed. doctor or nurse or you may be taught reaction may include: If you have not told your doctor how to inject yourself with the • shortness of breath about any of the above, tell them medicine. • wheezing or difficulty breathing before you start taking COSENTYX. You and your doctor should decide if • swelling of the face, lips, tongue you should inject COSENTYX or other parts of the body Taking other medicines yourself. • rash, itching or hives on the skin Tell your doctor or pharmacist if you It is important not to try to inject If you think you may be allergic, ask are taking any other medicines, yourself until you have been trained your doctor for advice before using including any that you get without a by your doctor, nurse or pharmacist. COSENTYX. prescription from your pharmacy, A caregiver may also give you your supermarket or health food shop. COSENTYX injection after proper Do not take COSENTYX if you have training. an active infection which your doctor Tell your doctor or pharmacist if you: If you do not understand the thinks is important. • are taking a blood thinning instructions on the label ask your Do not take COSENTYX if there are medicine called warfarin. doctor or pharmacist for help. visible signs of deterioration. • are taking, have recently taken or Do not take this medicine after the might take any other medicines. How much is given expiry date printed on the pack or if • have recently had or are going to Your doctor will decide how much the packaging is torn or shows signs have a vaccination. You should COSENTYX you need. of tampering. not receive certain types of If it has expired or is damaged, return vaccines (live vaccines) while Plaque psoriasis it to your pharmacist for disposal. using COSENTYX. The recommended dose is 300 mg by If you are not sure whether you Such medicines may be affected by subcutaneous injection with initial should start taking this medicine, talk COSENTYX or may affect how well loading dose at weeks 0, 1, 2, 3, and to your doctor. it works. You may need different 4 followed by the same dose every amounts of your medicines, or you month. Each 300 mg dose is given as Before you start to have it may need to take different medicines. two sub-cutaneous injections of 150 If any of these apply to you, tell your Your doctor and pharmacist have mg. doctor or pharmacist before using more information on medicines to be COSENTYX: careful with or avoid while taking Psoriatic arthritis this medicine. • you currently have an infection or The recommended dose is 150 mg by subcutaneous injection with initial if you have long-term or dosing at Weeks 0, 1, 2, 3, and 4 repeated infections followed by the same dose every • you have tuberculosis month. Based on your response, your doctor may increase the dose to 300 mg. COSENTYX® 2 For patients who did not respond well to medicines called tumor The recommended site is the front of necrosis factor (TNF) blockers or your thighs. You may also use the patient who also have moderate to lower abdomen, but not the area five severe plaque psoriasis, the centimetres around the navel (belly recommended dose is 300 mg by button). If a caregiver is giving you subcutaneous injection with initial the injection, the outer upper arms dosing at Weeks 0, 1, 2, 3, and 4 may also be used (Shown in grey in followed by the same dose every the diagram for illustrative purposes) Read the following instructions on month. Each 300 mg dose is given as how to use the prefilled syringe two subcutaneous injections of 150 and/or pen all the way through mg. before removing COSENTYX COSENTYX may be administered from the refrigerator. These with or without methotrexate. instructions are to help you to inject correctly. Axial Spondyloarthritis Ankylosing spondylitis How to use the prefilled The recommended dose is 150 mg by syringes subcutaneous injection with initial Read ALL the way through these dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance instructions before injecting. dosing. Based on your response, your Choose a different site each time you For a more comfortable injection, doctor may increase the dose to 300 give yourself an injection. take the box containing the two mg. Each 300 mg dose is given as two subcutaneous injections of 150 mg. For a 300 mg dose injection, use two prefilled syringes out of the injection sites when administering refrigerator and leave it unopened for the two 150 mg doses. Use new about 15 to 30 minutes so that it Non-radiographic axial injection sites for each set of reaches room temperature. spondyloarthritis injections. COSENTYX should be administered With a loading dose: The within one hour after removal from recommended dose is 150 mg by 2°C to 8°C storage. subcutaneous injection with initial Do not inject into areas where the dosing at Weeks 0, 1, 2, 3, and 4 skin is tender, bruised, red, scaly or Do not remove the needle cap until followed by the same dose every hard.
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