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® 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 , 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 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 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 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 • 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. • , itching or 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 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 (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. just before you give the injection. month. Avoid areas with scars or stretch Gather together the necessary items Without a loading dose: The marks not included in the pack: recommended dose is 150 mg by • swabs subcutaneous injection every month. Injecting COSENTYX • clean, dry cotton swab or gauze yourself Do not exceed the recommended • proper disposal container for used dose. Discuss with your doctor whether or needles, syringe and vials not you will inject COSENTYX (sharps container). Choosing the injection sites yourself. The injection sites are where the skin Do not try to inject yourself if you will be pierced to administer the have not been properly trained or if subcutaneous injection. you are not sure how to do it. When you are ready to use the After proper training in injection prefilled syringes, wash your hands technique, your doctor will tell you thoroughly with soap and water. that you may inject it yourself. Find a clean, comfortable area. Using a circular motion, clean the injection site with an alcohol swab. Leave it to dry before injecting. 1. Remove the first prefilled syringe from the outer box and

COSENTYX® 3 take it out of the . Inspect the prefilled syringe. The liquid should be clear. Its colour may vary from colourless to slightly yellow. You may see a small air bubble, which is normal. Do NOT use if the liquid contains easily visible particles, is cloudy or distinctly brown, or if the

prefilled syringe is broken. In all these cases, return the entire 5. Keep the plunger fully pack to the pharmacy. depressed while you carefully lift the needle straight out from 2. Carefully remove the needle the injection site. cap from the prefilled syringe. Discard the needle cap.

9. Choose a different site and repeat steps 2 to 9 with the second prefilled syringe.

How to use the prefilled 6. Slowly release the plunger and pens You may see a drop of liquid at allow the syringe guard to the end of the needle. This is automatically cover the exposed Read ALL the way through needle. normal. these instructions before 3. Gently pinch the skin at the injecting. injection site and insert the These instructions will help you to needle as shown. Push the inject correctly using the pen. needle all the way in to ensure that the medication can be fully For a more comfortable injection, administered. take the carton containing two pens out of the refrigerator 15 to 30

minutes before injecting. 7. There may be a small amount This will enable them to reach room of blood at the injection site. temperature. COSENTYX should be You can press a cotton ball or administered within one hour after removal from 2°C to 8°C storage. gauze over the injection site and hold it for 10 seconds. Do not rub During the injection you will hear 2 4. Holding the prefilled syringe as the injection site. loud clicks. shown, slowly depress the You may cover the injection site The first click indicates that the plunger as far as it will go so with a small adhesive bandage, if injection has started. Several seconds that the plunger head is needed. later a second click will indicate that completely between the syringe the injection is almost finished.

guard wings. Keep the plunger You must keep holding the pen pressed fully down while you 8. Dispose of the used firmly against your skin until you see hold the syringe in place for 5 COSENTYX prefilled syringe a green indicator fill the window and seconds. in a sharps container (closable, stop moving. puncture resistant container). For the safety and health of you Gather together the necessary items and others, needles and used not included in the COSENTYX syringes must never be re-used. pack:

COSENTYX® 4 • alcohol swabs The green indicator shows the • clean, dry cotton swab or gauze progress of the injection. • sharps disposal container for used 7. Listen for the second click. needles, syringe and vials. This indicates the injection is 1. When you are ready to use the almost complete. pens, wash your hands thoroughly with soap and

water. Twist off the cap in the direction 2. Inspect the pens. of the arrows. Once removed, throw away the cap. The liquid should be clear. Its colour may vary from colourless Use the pen within 5 minutes of to slightly yellow. You may see a removing the cap. Do not try to small air bubble, which is normal. re-attach the cap. After the injection, check the 5. Hold the pen at 90 degrees to green indicator fills the window the cleaned injection site. and has stopped moving. The pen Ensure the inspection window can now be removed. on the pen is visible before injecting. 8. Check the green indicator fills the window. a. Needle This means the medicine has been b. Needle guard delivered. c. Cap Contact your doctor if the d. Inspection window green indicator is not visible.

e. Internal needle cover Do NOT use the pen(s) if the liquid contains easily visible particles, is cloudy or is distinctly brown. 3. Find a clean, comfortable area.

There may be a small amount of blood at the injection site.

You can press a cotton ball or 6. Press the pen firmly against the gauze over the injection site and skin to start the injection. hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed. Using a circular motion, clean the 9. Dispose of the used pen in a injection site with the alcohol sharps disposal container (i.e. a swab. puncture-resistant closable Leave it to dry before injecting. container, or similar). Never try Do not touch the cleaned area to reuse the spent pen. again before injecting.

4. Only remove the cap when you The first click indicates the are ready to use the pen. injection has started. Keep holding the pen firmly against your skin.

COSENTYX® 5 While you are taking Things you must not do COSENTYX Never leave the prefilled syringe or pen lying around where others might Things you must do tamper with it. Discontinue treatment and tell your Do not open the sealed box until you doctor or pharmacist immediately if are ready to use COSENTYX. you get any of these symptoms Do not use this medicine if the liquid during treatment with COSENTYX: contains easily visible particles, is Signs or symptoms of a potentially cloudy or is distinctly brown.

serious infection. These may include: Do not use the prefilled syringe or 10. Choose a different site and • fever, flu-like symptoms, night pen if either the seal on the outer box repeat steps 2 to 9 with the sweats or the seal of the blister are broken. second pen. • feeling tired or short of breath; It may not be safe for you to use. How long to take COSENTYX cough which will not go away Do not shake the prefilled syringe or This is a long-term treatment. Keep • warm, red and painful skin, or a taking this medicine for as long as painful skin rash with pen. your doctor tells you. • burning when passing urine Do not use the pen if it has been dropped with the cap removed. Your doctor will regularly monitor Signs or symptoms of an allergic your condition to check that the reaction. These may include: Do not take it to treat any other treatment is having the desired effect. • difficulty breathing or complaints unless your doctor tells swallowing you to. If you use more COSENTYX • low blood pressure, which can Do not give this medicine to anyone than you should (overdose) cause dizziness or light- else, even if they have the same headedness If you or anyone else accidentally condition as you. received more COSENTYX or • swelling of the face, lips, mouth sooner than according to the doctor’s or throat Things to be careful of • severe itching of the skin, with a prescription, immediately telephone The needle cap of the syringe may red rash or raised bumps your doctor or the Poisons contain dry rubber (latex), which Keep all of your doctor's Information Centre (telephone 0800 should not be handled by persons appointments so that your progress 764 766) for advice, or go to sensitive to this substance. Accident and Emergency at the can be checked. Be careful not to touch the syringe nearest hospital. Your doctor will do tests from time guard wings before use. Do this even if there are no obvious to time to make sure the medicine is signs of discomfort or poisoning. working and to prevent unwanted By touching them, the syringe guard side effects. may be activated too early. If you forget to have it Your doctor will decide if and when Dispose of the used COSENTYX prefilled syringe or pens immediately If you have forgotten to inject a dose you may restart the treatment. after use in a sharps container. of COSENTYX, inject the next dose If you need to be vaccinated, tell as soon as you remember. Then talk your doctor you are taking The COSENTYX prefilled syringe to your doctor to discuss when you COSENTYX before you have the should not be re-used. should inject the next dose. vaccination. If you are not sure what to do, ask Live vaccines will not be suitable for your doctor or pharmacist. you. If you stop using If you have trouble remembering to If you are about to be started on any COSENTYX have your medicine, ask your new medicine, remind your doctor pharmacist for some hints. and pharmacist that you are taking Do not stop taking your medicine or COSENTYX. change the dosage without checking Tell any other doctors, dentists, and with your doctor first. pharmacists who treat you that you are taking this medicine.

COSENTYX® 6 Side effects • Painful period After taking • Nausea, diarrhoea, vomiting, COSENTYX As with all medicines, patients abdominal pain and fever treated with COSENTYX may (symptoms of inflammatory Storage experience side effects, although not bowel disease) If you have to store COSENTYX: everybody gets them. • Keep it in a refrigerator at 2°C to Tell your doctor or pharmacist as Some side effects are rare (may 8°C out of the sight and reach of soon as possible if you do not feel affect in to 1 in 1,000 people) well while you are taking children • Severe allergic reaction with COSENTYX. • Do not freeze it (anaphylactic shock) All medicines can have side effects. • New cases of inflammatory bowel Store it in the carton in order to Sometimes they are serious, most of disease or “flare-ups” can happen protect it from light. the time they are not. with COSENTYX, and can • May be stored unrefrigerated (out You may need medical attention if sometimes be serious. If you have of fridge) at room temperature inflammatory bowel disease you get some of the side effects. for a single period up to a (ulcerative colitis or Crohn’s Do not be alarmed by the following disease), tell your doctor if you have maximum of 4 days at a lists of side effects. worsening symptoms during temperature not above 30°C. You may not experience any of them. treatment with COSENTYX or Do not store COSENTYX or any develop new symptoms of stomach Some side effects are very common other medicine in the bathroom, near pain or diarrhoea. (These side effects may affect more a sink, or leave it in the car or on a COSENTYX may affect the results than 1 in every 10 people) window sill. of some blood tests, including: • Upper respiratory tract infections A locked section of the refrigerator, • slight increase in blood with symptoms such as sore at least one-and-a-half metres above cholesterol and blood fat throat and stuffy nose the ground, is a good place to store (triglycerides) (nasopharyngitis, ) COSENTYX. • elevated liver enzymes Some side effects are common Disposal (These side effects may affect up to 1 in every 10 people) The frequency of some side effects If your doctor tells you to stop taking cannot be estimated from available • Cold sores (oral herpes) this medicine or the expiry date has data passed, ask your pharmacist what to • Diarrhoea • Fungal infections of the skin and do with any medicine that is left • Runny nose (rhinorrhoea) mucous membranes (thrush) over. • Hives • Headache In clinical trials, major adverse cardiovascular events were rarely • Nausea observed with COSENTYX. Product description • Itchy rash (urticaria) Ask your doctor or pharmacist to Some side effects are uncommon answer any questions you may have. What it looks like (These side effects may affect up to 1 COSENTYX solution for injection is in every 100 people) Tell your doctor if you notice anything else that is making you feel a clear liquid. Its colour may vary • Oral thrush (oral ) unwell. from colourless to slightly yellow. • Signs of low levels of white Other side effects not listed here or COSENTYX is available in packs blood cells such as fever, sore not yet known may happen in some containing 1 or 2 single-use pre-filled throat or mouth ulcers due to people. syringes or pens. infections (neutropenia)* • Athlete's foot (tinea pedis) Ingredients • Infection of the external ear (otitis Each COSENTYX pre-filled syringe externa) or pen contains 150 mg secukinumab as the active substance. • Discharge from the eye with itching, redness and swelling The other ingredients are: (conjunctivitis) • trehalose dihydrate

COSENTYX® 7 • histidine • histidine hydrochloride monohydrate • methionine • polysorbate 80 • water for injection This medicine does not contain sucrose, lactose, gluten, tartrazine or any other azo dyes.

Sponsor COSENTYX is supplied in New Zealand by: New Zealand Limited PO Box 99102 Newmarket Auckland 1149 New Zealand Telephone 0800 354 335

® = Registered Trademark

This leaflet was prepared in June 2021.

(cos090621cNZ based on DS cos090621iNZ)

COSENTYX® 8