® STELARA INJECTION Ustekinumab (rmc)

Consumer Medicine Information What is in this leaflet monoclonal antibody. Do not use STELARA if the Monoclonal antibodies are packaging is torn or shows signs This leaflet answers some proteins that recognise and bind to of tampering, or if the liquid is common questions about other unique proteins. discoloured or cloudy. STELARA (pronounced stel-ahr- Ustekinumab blocks the action of Do not use STELARA beyond the uh). It does not contain all the two proteins in your body called expiry date (month and year) available information. It does not interleukin 12 (IL-12) and printed on the pack. take the place of talking to your interleukin 23 (IL-23). IL-12 and Do not use STELARA if you doctor, nurse or pharmacist. IL-23 are made by your body's know or think that it may have All medicines have risks and immune system. In people with been exposed to extreme benefits. Your doctor has weighed psoriasis, psoriatic arthritis, temperatures (such as being the risks of you using STELARA Crohn’s disease or ulcerative accidentally frozen or heated). against the benefits this medicine colitis, IL-12 and IL-23 can cause is expected to have for you. their immune system to attack Before you start to use it normal healthy parts of their body If you have any concerns about like the skin and nails. You must tell your doctor about all using STELARA, ask your doctor Ustekinumab can block IL-12 and of your medical conditions before or pharmacist. IL-23 from causing the immune each treatment, including if you: It is important that you read this system to attack the skin and nails. • have any kind of infection, leaflet. Keep this leaflet with your Ask your doctor if you have any even if it is very minor medicine. You may need to read it questions about why this medicine • have an infection that won't go again. has been prescribed for you. Your away or a history of infection doctor may have prescribed it for that keeps coming back another reason. • have had TB (tuberculosis), or This medicine is available only if you have recently been near What STELARA is with a doctor’s prescription. anyone who might have TB used for • have or have had any type of cancer STELARA is a prescription • have any new or changing medicine that is used to treat: Before you use STELARA lesions within psoriasis areas • adults with moderate to severe or on normal skin plaque psoriasis that is chronic • When you must not use it have recently received or are (doesn’t go away), scheduled to receive a • adults with active psoriatic Do not use STELARA if you vaccine. Patients receiving arthritis, an inflammatory have an allergy to: STELARA should not receive disease of the joints that is • ustekinumab, the active live vaccines. Tell your usually accompanied by ingredient in the medicine doctor if anyone in your house psoriasis, • any of the other ingredients in needs a vaccine. The viruses in some vaccines can spread to • adults with moderately to STELARA. See Product severely active Crohn’s Description at the end of this people with a weakened Disease, an inflammatory leaflet for a list of ingredients. immune system, and can cause serious problems disease of the bowel Symptoms of an allergic reaction • are receiving allergy • may include rash, itching or adults with moderate to severe immunotherapy. ulcerative colitis, an hives on the skin, shortness of • inflammatory disease of the breath, wheezing or difficulty are pregnant, planning to bowel. breathing, swelling of the face, become pregnant, or breastfeeding. Adequate lips, tongue or other parts of the STELARA contains the active contraception should be used ingredient ustekinumab, a body. to avoid falling pregnant.

STELARA (200603) ACMI NZ 1 CCDS191010 STELARA should only be you may be able to administer • if you know, or think that it used during a pregnancy if STELARA under the skin yourself may have been exposed to needed. Women who are if you wish, after proper training in extreme temperatures (such as breastfeeding should talk to injection technique. (See being accidentally frozen or their doctor about whether or Injecting STELARA under the heated). not to use STELARA. skin yourself.) Do not shake STELARA at any • have an allergy to latex. It is important to remember that time. Prolonged vigorous shaking Your doctor will examine you for the first dose of STELARA for the may damage the product. If tuberculosis (TB). If your doctor treatment of Crohn’s Disease or STELARA has been shaken feels that you are at risk for TB, ulcerative colitis vigorously, don’t use it. you may be treated with medicine (intravenous infusion) will always STELARA is not to be mixed with for TB before you begin treatment be administered by your healthcare other liquids for injection. with STELARA and during provider. treatment with STELARA. How to inject STELARA from a pre-filled syringe If you have not told your doctor or How much to use pharmacist about any of the above, • Your doctor will determine the To reduce the risk of accidental tell them before you start using or correct dose of STELARA for needle stick injuries to users, each are given STELARA. you and how often you should pre-filled syringe is equipped with receive it. Make sure to a needle guard that is Taking other medicines discuss with your doctor when automatically activated to cover Tell your doctor or pharmacist if you will receive injections and the needle after complete delivery you are taking any other to come in for all your of the syringe content. medicines, including medicines scheduled follow-up 1. PREPARING FOR PRE- you can buy without a prescription appointments. FILLED SYRINGE USE from a pharmacy, supermarket or health food shop. Injecting STELARA under the skin yourself Your healthcare provider may

decide that it is right for you or Take the syringe(s) out of the your caregiver to learn how to Using STELARA refrigerator. Make sure that it is inject STELARA under the skin the right dose. If your dose is 45 For the treatment of psoriasis or (subcutaneously) yourself. If you mg you will receive one 45 mg psoriatic arthritis STELARA is would like to self-inject syringe. If your dose is 90 mg, given by injection just under the STELARA under your skin, you you will receive two 45 mg skin (subcutaneously). must be trained by a healthcare syringes. If you receive two 45 professional to prepare an For the treatment of Crohn’s mg syringes for a 90 mg dose, you injection and give it to yourself. If Disease or ulcerative colitis, the will need to give yourself two you have not been trained, please first dose of STELARA will be injections one right after the other. contact your healthcare provider to given by an intravenous infusion, Check with your healthcare schedule a training session. Call which means that the medicine provider. will be given to you through a your healthcare provider if you needle placed in a vein. After this have any questions about giving Check Expiration Date starting dose, all future doses of yourself an injection. Open the box and remove the STELARA are given by injection STELARA is given alone and not syringe. Check the expiration date just under the skin mixed with other liquids for on the pre-filled syringe and the (subcutaneously). injection. label of the box. If the expiration date has passed, don’t use it.

All STELARA injections are for STELARA should not be used: Check Solution in Syringe single use in one patient only. • after the expiry date on the Hold the pre-filled syringe with STELARA is intended for use label; the covered needle pointing under the guidance and upward. Make sure the syringe is • if the seal is broken; supervision of your doctor. When not damaged. Look at the solution you start treatment, STELARA • if the liquid is discoloured, or liquid in the vial to make sure may be injected by your healthcare cloudy or you can see other that it is not cloudy and not frozen. particulate matter floating in provider. If your doctor Assemble Additional Supplies determines that it is appropriate, it;

STELARA (200603) ACMI NZ 2 CCDS191010 Assemble the additional supplies You may also see a drop of liquid Immediately dispose of the empty you will need for your injection. at the end of the needle – this is syringe into the sharps container. These include an antiseptic wipe, a normal. Do not touch the needle For your safety and health and for cotton ball or gauze, and a sharps or allow it to touch any surface. the safety of others, needles and container for syringe disposal. Note: The needle cover should syringes must NEVER be re-used. DO NOT remove the needle cover NOT be removed until you are Dispose of sharps container from the pre-filled syringe. ready to inject the dose. Do not according to your local DO NOT pull back on the plunger use the syringe if it is dropped regulations. See ‘After using head at any time. without the needle cover in place. STELARA - Disposal’. If you drop the syringe without the Use a Cotton Ball or Gauze 2. CHOOSING AND needle cover in place, please There may be a small amount of PREPARING THE contact your healthcare provider blood or liquid at the injection site, INJECTION SITE for assistance. which is normal. You can press a cotton ball or gauze over the Choose the Injection Site* injection site and hold for 10 Good sites are the top of the thigh 4. INJECT THE MEDICATION seconds. Do not rub the injection site. You may cover the injection Gently pinch the cleaned skin site with a small adhesive between your thumb and index bandage, if necessary. finger. Don’t squeeze it. If your dose amount is 90 mg, and Push the syringe needle into the you receive two 45 mg syringes pinched skin. you may need to give a second and around the tummy (abdomen) injection right after the first. but about 2 inches away from the Choose a different site for the belly button (navel). Avoid, if second injection. possible, skin involved with If you do not understand the psoriasis. If your caregiver is instructions provided with this giving you the injection, they may medicine, ask your doctor or use the upper arms or buttocks as pharmacist for help. well. Push the plunger with your thumb Prepare the Injection Site as far as it will go to inject all of If you forget to use it Thoroughly wash your hands with • Make the next injection as soap and warm water. Wipe the soon as you remember, and injection site with an antiseptic then continue to use it as you wipe. DO NOT touch this area would normally. again before giving the injection. • Do not administer a double dose to make up for the dose 3. INJECTING THE you missed. MEDICATION If you have missed more than one Remove the Needle Cover the liquid. Push it slowly and dose, or are not sure what to do, evenly, keeping the skin gently check with your doctor or pinched. pharmacist. When the plunger meets the end of If you have trouble remembering the syringe barrel, and all of the when to use your medicine, ask medication has been injected, your pharmacist for some hints. release the pinched skin and gently When you are ready to inject, pick remove the needle. Following If you have used too much up the pre-filled syringe with one complete injection, the needle (overdose) hand and pull the needle cover guard will automatically extend Immediately telephone your straight off. over the needle and lock as you doctor or the Poisons Information Throw the needle cover into the take your hand off the plunger. Centre for advice, or go to rubbish. Accident and Emergency at your nearest hospital. You may notice a small air bubble 5. AFTER THE INJECTION in the pre-filled syringe. You do Do this even if there are no signs Dispose of the Empty Syringe not need to remove the air bubble. of discomfort or poisoning. You

STELARA (200603) ACMI NZ 3 CCDS191010 may need urgent medical Ask your doctor or pharmacist to dizziness, cough, fever, attention. answer any questions you may trouble swallowing or Poisons Information Centre have. breathing. telephone numbers: Tell your doctor if you STELARA is a medicine that may decrease the activity of • New Zealand: 0800 POISON experience any of the following your immune system. It can or 0800 764 766 common side effects: increase your chances of getting • Upper respiratory tract • Australia 13 11 26 serious side effects. Tell your infections such as sinus Keep these telephone numbers doctor immediately if you notice infection and colds handy. any of the following, as you may • Dizziness, headache need urgent medical care: • Sore throat • Serious Infections. STELARA • Diarrhoea may lower your ability to fight While you are using • Nausea, vomiting infections. Some infections STELARA • Pruritis (itching) could become serious and lead • Back or muscle pain to hospitalization. If you have an infection, tell your Things you must do • Joint Pain healthcare provider before you • Always follow your doctor’s • Injection site pain or redness start using STELARA. If you instructions carefully. • Fatigue (tiredness) get an infection, have any sign • Tell your doctor about your • Sinus infection of an infection such as fever, feel very tired, cough, flu-like medical conditions before symptoms, or have any open each treatment (see Before Other uncommonly reported you use STELARA). cuts or sores, tell your side effects include: healthcare provider right • Tell your doctor if you • Painful skin rash (Herpes away. become pregnant while using Zoster infection) STELARA. • Cancer. Many drugs such as • Cellulitis STELARA that may decrease • If you are about to start taking • the activity of the immune a new medicine, tell your Dental infections system may increase the risk doctor and pharmacist that you • Viral upper respiratory tract of cancer. Tell your doctor if are using STELARA. infection you have ever had any type of • Vaginal yeast (fungal) Things you must not do cancer. infection • You should not receive a live • Depression vaccine while taking Other side effects not listed above • STELARA. Blocked or stuffy nose may also occur in some people. • Do not use STELARA to treat • Acne Tell your doctor if you notice any any other complaint unless • Injection site reactions other side effects, particularly if your doctor says so. (including bleeding, bruising, they bother you or do not go away. • Do not give this medicine to hardness, swelling and itch) anyone else, even if their • Feeling weak symptoms seem similar to • A change in psoriasis with yours. redness and new, tiny, yellow After using STELARA or white skin blisters, sometimes accompanied by Storage fever (pustular psoriasis) Store STELARA between 2ºC and • Side Effects Worsening reddening or 8ºC in the refrigerator. Do not shedding/peeling of the skin freeze. Keep the product in the All medicines can have side Tell your doctor immediately or original carton to protect from effects. Sometimes they are go to hospital as you need urgent light until the time of use. Do not serious, most of the time they are medical attention: shake. not. You may need medical • treatment if you get some side A serious allergic reaction. Keep your medicines out of effects. Do not be alarmed by this Signs of a serious allergic reach of children. reaction may include a skin list of possible side effects. You Do not store STELARA, or any rash, a swollen face, lips, may not experience any of them. other medicine, in the bathroom or mouth or throat, or wheezing,

STELARA (200603) ACMI NZ 4 CCDS191010 near a sink. Do not leave containing 45 mg ustekinumab in medicines in the car or on 0.5 mL or 90 mg ustekinumab in windowsills. Heat and dampness 1.0mL. Each box contains 1 can destroy some medicines. syringe. If needed, you may store STELARA for intravenous use is STELARA pre-filled syringes at available in glass vials containing room temperature up to 30°C for 130 mg ustekinumab in 26 mL. one period of up to 30 days. • Write the date on the carton, Ingredients when removed from the STELARA 45 mg or 90 mg refrigerator. solution for injection for • If pre-filled syringe has subcutaneous administration reached room temperature, do Each mL of STELARA contains not put it back in the 90 mg of ustekinumab. refrigerator. Inactive ingredients: • Throw away pre-filled histidine/histidine hydrochloride syringe if it has been kept at monohydrate, sucrose, polysorbate room temperature for 30 days 80, and water for injections. and has not been used or No preservatives are present. reached its original expiry. STELARA 130 mg solution for Disposal intravenous infusion After injection, used syringes Each mL of STELARA contains 5 should be placed in a puncture- mg of ustekinumab. resistant container, like a sharps Inactive ingredients: L-histidine, container. Dispose of your sharps L-histidine hydrochloride container according to your local monohydrate, sucrose, polysorbate regulations. Antiseptic wipes and 80, L-methionine, disodium other supplies can be placed in edetate, and water for injection. regular rubbish. No preservatives are present. If your doctor tells you to stop using STELARA, or your Sponsor medicine has passed its expiry Janssen-Cilag (New Zealand) Ltd date, ask your pharmacist what to 507 Mt Wellington Highway do with any medicine that may be left over. AUCKLAND 1060 Telephone: 0800 800 806

This leaflet was prepared in June Product Description 2020.

What it looks like

STELARA injection for subcutaneous use is a colourless to light yellow solution and may contain a few small translucent or white particles of protein. This appearance is not unusual for solutions containing protein. STELARA solution for intravenous use is a clear, colourless to light yellow product. STELARA for subcutaneous use is available in pre-filled syringes

STELARA (200603) ACMI NZ 5 CCDS191010