MyStelara. For patients who have been prescribed Stelara

MyStelara For patients who have been prescribed Stelara

MyStelara Welcome This Stelara Patient Pack has been given to you because your doctor has prescribed Stelara for the treatment of psoriasis, psoriatic arthritis or Crohn s disease. The pack has been designed to provide you with all the relevant information about your condition and what you can expect from your treatment and the homecare service available to you. Before starting your treatment, carefully read the patient information leaflet relevant to your prescribed dose of Stelara which is included in the Stelara medication package. If you have any questions or concerns about your treatment regime, contact your healthcare professional immediately, as they are the best people to help you with your queries. In this booklet you will find: MyTreatment 3 MyInformation 11 MyQuestions 15 MyHomecare 19 MyContacts 21 1

MyTreatment What is Stelara? 1 Stelara is a type of medicine called a monoclonal antibody. You may hear it referred to as a biologic (or biological treatment) used for the treatment of adult and adolescent psoriasis, psoriatic arthritis and Crohn s disease. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body. Stelara belongs to a group of medicines called immunosuppressants. These medicines work by weakening part of the immune system. These proteins have to be injected into the body and cannot be taken in tablet form. Stelara is administered by subcutaneous injection, this means the injection is given just under the skin. The active substance in Stelara is called Ustekinumab. Who is Stelara used for? 1 Stelara is used to treat psoriasis, psoriatic arthritis and Crohn s disease in the following circumstances: Adult psoriasis: to treat moderate-to-severe plaque psoriasis in adult patients who cannot use, or did not respond to, other medicines used to treat plaque psoriasis, or phototherapy treatment. Adolescent psoriasis: to treat moderate to severe plaque psoriasis in adolescent patients who are from the age of 12 years and over, who are inadequately controlled by other systemic therapies or phototherapies, and who are intolerant to other systemic therapies or phototherapies. 3

MyStelara Patient Pack Adult psoriatic arthritis: to treat active psoriatic arthritis in adult patients when the response to other non-biological medicines has been inadequate. Adult Crohn s disease: to treat adult patients with moderately to severely active Crohn s disease in adult patients who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFalpha antagonist or have medical contraindications to such therapies. Recommended Dosing: Psoriasis and Psoriatic Arthritis Your doctor will decide how much Stelara you need to use and for how long. Always use this medicine exactly as your doctor has told you. Adult Psoriasis: In adults under 100kg, the recommended dose of Stelara is 45mg. In adults weighing more than 100kg the recommended dose of Stelara is 90mg. Adult Psoriatic Arthritis: In adults under 100kg, the recommended dose of Stelara is 45mg. Adults weighing more than 100kg, a dose of either 45mg or 90mg may be given Adolescent Psoriasis: Your doctor will decide how much Stelara you need to use and for how long. Always use this medicine exactly as your doctor has told you. Recommended Dosing: Crohn s Disease Your doctor will decide how much Stelara you need to use and for how long. Always use this medicine exactly as your doctor has told you. Stelara treatment is to be initiated with a single intravenous (IV) dose based on body weight (approximately 6 mg/kg). This is a once-off IV infusion which will take place in the hospital. Your healthcare professional or nurse specialist will discuss this in detail with you and organise a date and time for this to take place. Your first maintenance dose will be a 90mg of Stelara which will be administrated subcutaneously 8 weeks after the intravenous dose. 4

MyTreatment Following this you will be taking Stelara every 12 weeks unless directed otherwise by your healthcare professional. How is Stelara given? Stelara is given by injection under the skin surface (subcutaneously) and comes in a prefilled syringe or a vial. Your healthcare professional will decide which dose of Stelara is necessary for you based on if you are an adult or an adolescent, your weight at the time of injection and also if you have psoriasis, psoriatic arthritis or Crohn s disease. When you first start treatment, your doctor or nurse specialist may inject your Stelara for you. However, you and your doctor or nurse specialist may decide that you can inject your medicine yourself. In this case, you will be trained on how to inject, so that you learn the proper technique and minimise any discomfort from the needle. They will also discuss the MyStelara Homecare Programme with you and they may refer you to this service for your first injection. Should you wish to find out more information on the MyStelara Homecare Nurse Support Programme, refer to the MyHomecare section of this booklet. Injecting yourself with Stelara The following instructions for administration show you how to prepare and inject your Stelara treatment. It is important to refer to this if you are unsure of any of the steps involved in injections your Stelara treatment. Please note that you should never try to inject Stelara yourself until you have been shown the right way to self-administer the injections by your doctor or nurse specialist, or by the MyStelara Homecare Nurse. When you decide you are ready to self-inject your TCP nurse will take you through a simple training programme and sign to confirm that you are now an independent self-injector. It is recommended that you avail of the Sharps Collection service for the safe disposal of your used syringes. 5

MyStelara Patient Pack STEP 1: ALLOW THE PRODUCT TO WARM TO ROOM TEMPERATURE mins Take the carton containing your Stelara pre-filled syringe out of the refrigerator and allow the syringe to sit outside the carton for 30 minutes. This will let it come to room temperature. If you inject yourself with cold Stelara it will be uncomfortable. Check to make sure that the number of syringes and dosage are correct. TIP: Take the pre-filled syringe out of the carton and wait 30 minutes. STEP 2: CHECK THE PRE-FILLED SYRINGE Hold your Stelara pre-filled syringe by the body with the covered needle pointing upward. Make sure not to touch the needle guard activation clips. Check the syringe to make sure that it has not been damaged and that the expiration date has not passed. Make sure that the liquid is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow. Do not inject the liquid if it is cloudy or discoloured, or has any foreign particles in it. TIP: You may notice an air bubble this is normal. 6

MyTreatment STEP 3: GATHER THE SUPPLIES FOR YOUR INJECTION AND WASH YOUR HANDS Make sure you have all your injection supplies available including your Stelara pre-filled syringe, an antiseptic wipe, cotton ball or gauze and your sharps container for disposal of the used syringe. Wash your hands well with soap and warm water. TIP: Make sure everything is ready BEFORE you wash your hands and that you are able to sit down comfortably. STEP 4: PREPARE THE INFUSION SITE Good places for the injection are the upper thigh or around the stomach, but at least 5cm away from the belly button. Don t inject into an area of skin affected by psoriasis, if possible. Wipe the area you will inject with the antiseptic wipe. Do not touch this area again before giving the injection. TIP: If possible, choose an area of skin not affected by psoriasis. 7

MyStelara Patient Pack STEP 5: REMOVE THE NEEDLE COVER Hold the body of the pre-filled syringe with one hand and pull the needle cover straight off. Take care not to touch the needle or touch the plunger while removing the needle cover. You need to inject Stelara promptly after the needle cover has been removed. Do not remove the needle cover until you are ready to inject Stelara. TIP: You may notice a drop of liquid at the end of the needle - this is normal. STEP 6: POSITION THE SYRINGE Hold the body of your Stelara pre-filled syringe in one hand between your middle and index fingers and place your thumb on top of the plunger head. Make sure you don t pull back on the plunger at any time. Use your other hand to gently pinch the area of skin that you previously cleaned. TIP: Gently pinch the area of skin where you will inject Stelara and hold firmly. 8

MyTreatment STEP 7: INJECT THE PRODUCT Use a quick, dart-like motion to insert the needle into the pinched skin as far as it will go. Inject all of the medicine by using your thumb to push in the plunger until the plunger head is completely between the needle guard wings. When the plunger is pushed in as far as it will go, keep pressure on the plunger head. TIP: Count to 5 to ensure that the product is injected slowly. STEP 8: WITHDRAW THE NEEDLE AND SYRINGE Pull the needle and syringe out and let go of your skin. Slowly take your thumb off the plunger head. This will let the empty syringe move up until the entire needle is covered by the needle guard. TIP: Withdraw the needle and syringe carefully then let go of your skin. 9

MyStelara Patient Pack STEP 9: AFTER THE INJECTION Press an antiseptic wipe over the injection site for a few seconds after the injection. There may be a small amount of blood or liquid at the injection site, which is normal. Press a cotton ball or gauze over the injection site for about 10 seconds. Do not rub your skin. Put your used syringe in your sharps container. TIP: If needed, you can cover the injection site with a small adhesive bandage. STEP 10: YOU HAVE SUCCESSFULLY FINISHED YOUR INJECTION mins If your dose is 90 mg and you received two 45 mg syringes, you will need to give yourself a second injection within 5 minutes of the first one. Always choose a different body area if administering a second injection. 10

MyInformation Before starting Stelara Check with your doctor before starting treatment with Stelara if you have any of the following: LATEX SENSITIVITY/ALLERGY The needle cover of the pre-filled syringe contains latex rubber. This may cause severe allergic reactions in people who are sensitive to latex. Tell your doctor if you have ever had an allergic reaction to latex or developed any allergic reaction to the Stelara injection. INFECTIONS You must tell your doctor if you have any kind of infection, open cuts or sores, or if you have signs you might be getting an infection, as Stelara may make you less able to fight infections. Tell your doctor even if it is a very minor infection, or if you have any signs or symptoms that might make you think you might be getting an infection. Signs of infection (including tuberculosis) include fever, flu-like symptoms, night sweats, feeling tired or short of breath, cough which will not go away, blood tinged sputum, warm, red and painful skin, or a painful skin rash with blisters, burning when passing water, diarrhoea, vomiting. Signs of infections of the chest (lower respiratory tract infections) such as cough, mucus discharges, high temperature, dizziness, feeling a pressure or heaviness in your chest, shortness of breathing or breathing at an increased rate. Also blocking of nose, watering of nose and increased heartbeat can be the symptoms of lower respiratory tract infection. 11

MyStelara Patient Pack It is particularly important to tell your doctor or nurse specialist if you have an infection that will not go away or that keeps coming back. TUBERCULOSIS (TB) It is important to tell your doctor if you ever had TB or if you have recently been near anyone who might have TB or if you have visited any country where TB is common. Your doctor will examine will examine you for TB according to local regulations 3, to see if you have TB before you start your treatment. If your doctor thinks you are at risk of TB, you will be given medicine before you start your treatment with Stelara, and this TB treatment may continue during your treatment with Stelara. CANCER Please inform your doctor if you have ever had any type of cancer. Medicines like Stelara weaken part of the immune system. This may increase your risk of cancer. If you have any queries about this please discuss these with your doctor. OTHER THERAPIES Tell your doctor or nurse specialist if you are taking or have been prescribed an immunosuppressive medicine (a medicine that reduces your body s ability to fight infection) or phototherapy (when your body is treated with special types of ultraviolet (UV) light) while using Stelara. Stelara has an effect on your immune system and the combination of these therapies may increase the risk of diseases related to a weakened immune system. However, the combination of these therapies has not been studied in clinical trials. If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse specialist before starting treatment with Stelara. USING OTHER MEDICINES Stelara may affect other medicines and other medicines may affect Stelara. 12

MyInformation Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. Do not take any new medicines, herbal remedies, vitamins or other over the counter medicines without contacting your healthcare professional to discuss first. PREGNANCY AND BREAST-FEEDING Talk to your doctor if you are pregnant or are planning to become pregnant while using Stelara. The effects of this medicine on pregnant women and unborn babies are not known. Women who are able to have children are advised to avoid becoming pregnant and must use an effective method of contraception during treatment and for 15 weeks after your last injection with Stelara. Talk to your doctor if you are breast-feeding or if you plan to breast-feed while using Stelara. Your doctor will decide whether you should start treatment. DRIVING AND USING MACHINES Stelara should not affect your ability to drive or operate machines VACCINATIONS Tell your doctor if you have recently had or are going to have a vaccination. When should I not use Stelara? Do not use Stelara if any of the following apply: The expiry date has passed. You can find the expiry date on the label and the carton after EXP. The expiry date refers to the last day of that month. You know, or think, it may have been exposed to extreme temperatures (such as accidentally frozen or heated). The product has been shaken vigorously. Stelara is a clear to slightly opalescent (have a pearl-like shine), colourless to light yellow solution. The solution may contain a few small translucent or white particles of protein. Do not use if the liquid is discoloured, cloudy or you can see other foreign particles floating in it. 13

MyStelara Patient Pack Possible Side Effects WHAT POTENTIAL SIDE EFFECTS SHOULD I BE AWARE OF? 2 Like all medicines, Stelara may cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some people may experience more serious side effects that could require urgent treatment. Tell your doctor straight away if you notice any of the following serious side effects as you may need urgent medical treatment: Signs of an allergic reaction such as difficulty breathing or swallowing, low blood pressure, which can cause dizziness or light-headedness, swelling of the face, lips, mouth or throat, skin rash and hives. Signs of infection (including tuberculosis) such as fever, flu-like symptoms, night sweats, feeling tired or short of breath, cough which will not go away, blood tinged sputum, warm, red and painful skin, or a painful skin rash with blisters, burning when passing water, diarrhoea, vomiting. Signs of infections of the chest (lower respiratory tract infections) such as cough, mucus discharges, high temperature, dizziness, feeling a pressure or heaviness in your chest, shortness of breathing or breathing at an increased rate. Also blocking of nose, watering of nose and increased heartbeat can be the symptoms of lower respiratory tract infection. Shedding of skin, as an increase in redness and shedding of skin over a larger area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis. Reporting of Side Effects If you get any side effects, talk to your doctor, pharmacists or nurse. This includes any possible side effect not listed on the package leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2. Tel: +3536764971; Fax: +35316762517; website: www.hpra. ie; email: medsafety@hpra.ie and to Janssen-Cilag Ltd on +441494567447. 14

MyQuestions HOW DO I STORE STELARA? Keep Stelara out of the sight and reach of children. Keep your pre-filled Stelara syringes or vials in a fridge (2 8 C). Do not keep Stelara in the freezer. Keep the pre-filled syringes or vials in the outer carton to protect them from light. Do not shake the pre-filled syringes or vials as this may damage the medicine. Remove your treatment from the fridge 30 minutes before your injection so it can reach room temperature. WHAT IF I LEFT MY STELARA OUT OF THE FRIDGE? You should not use your dose of Stelara if it is left out of the fridge for more than 30 minutes. If you think you ve left your medicine out of the fridge longer than you should, place the vial or pre-filled syringe back in the fridge and contact your healthcare professional as soon as possible for advice. HOW DO I DISPOSE OF MY USED STELARA SYRINGE OR VIAL? Stelara is for single use only. Any unused product remaining in the syringe or vial should not be used and should be disposed of with the syringe and/or vial. Stelara pre-filled or empty vials should be placed in a puncture-resistant container, like a sharps container. Sharps bin waste collection service is available to everyone who has been prescribed Stelara. Please talk to your doctor for more information on the service. Sharps bins are delivered and collected every 12 months as part of the MyStelara Homecare Service. 15

MyStelara Patient Pack Antiseptic wipes and other supplies can be disposed of in your household waste. Any unused Stelara (e.g. pre-filled syringes that are unusable or past their expiry date, or any vials with some medicine left in them) should be disposed of with the syringe intact in a sharps container. HOW DO I TAKE STELARA WITH ME WHEN I TRAVEL? Your doctor will tell you how often to take your Stelara. When you are planning your trip, check your calendar to see when your next dose is due. You may find that you will be travelling during some of your dose-free days. This means you can leave your Stelara at home. Check your calendar or use the dosing wheel at the end of this booklet to see when your next dose is due to ensure you are fully prepared. If you need to travel when your Stelara dose is due, speak to your doctor and follow their recommendations. Air travel restrictions may mean that you need a doctor s letter before you can travel with your prescription medicines. Keep your doctor s letter and your Stelara in your handbag or carry-on luggage, and show the letter to airport security to let them know what you are carrying. Stelara will need to be kept at 2-8 C during your journey. You can use the free travel pack that you received from your pharmacist with your first dose. Speak to your pharmacist or prescriber about the best way to do this. Always store Stelara in a fridge when you get to your destination. 16

MyQuestions WHAT DO I NEED TO CHECK BEFORE TAKING MY INJECTION? Before you use your Stelara, you should check that: It hasn t passed its expiry date. You can find this on the label and the carton after EXP. The expiry date refers to the last day of that month. Do not use Stelara if the expiry date has passed. It hasn t been exposed to extreme temperatures. Do not use Stelara if you know, or think that it may have been accidentally frozen or heated. The product hasn t been shaken vigorously. If it has, do not use the dose. Ensure it looks as expected. Stelara is a clear to slightly opalescent (having a pearl-like shine), colourless to light yellow solution for injection. The solution may contain a few small translucent or white particles of protein. Do not use Stelara if the liquid is discoloured, cloudy or you can see other foreign particles floating in it. WHAT IF I USE MORE STELARA THAN RECOMMENDED? If you think you have used more Stelara than you should have, talk to a doctor or pharmacist straight away. If you can, take the outer carton of the medicine with you, even if it s empty. WHAT IF I FORGET TO USE STELARA? If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose. CAN I STOP USING STELARA? If you would like to stop taking Stelara you should discuss this with your doctor first. He or she will advise you on the best way to do this. If you stop taking it, your symptoms may come back. If you have any questions on the use of this medicine, ask your doctor or pharmacist. 17

WHERE CAN I GET ADDITIONAL INFORMATION ON STELARA? If you have a question about your treatment, please read the Patient Information Leaflet or speak to your healthcare professional. WHAT DO I DO IF I HAVE SIDE EFFECTS? Speak to your doctor, pharmacist or nurse. Reporting of Side Effects If you get any side effects, talk to your doctor, pharmacists or nurse. This includes any possible side effect not listed on the package leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2. Tel: +3536764971; Fax: +35316762517; website: www.hpra. ie; email: medsafety@hpra.ie and to Janssen-Cilag Ltd on +441494567447.

MyHomecare The MyStelara Homecare Service has been developed to support individuals who have been prescribed Stelara for their psoriasis, psoriatic arthritis or Crohn s disease. The aim of the Stelara homecare service is to support you with your treatment on Stelara and to work with you to ensure that you become confident to self inject. A PERSONALISED HOMECARE SERVICE This personalised homecare service is designed to support you by making your treatment easy and convenient. Homecare Co-ordinator Once you have been registered with the MyStelara Homecare service by your doctor you will be assigned your own Homecare Co-ordinator. This person will contact you to explain the service, answer any questions you may have and book a time for your first nurse visit. Home Visits A fully qualified nurse will visit your home or workplace (if required) to talk you through your treatment with Stelara and to teach you how to self-inject with confidence. If you have any questions or concerns about your next scheduled visit, administration of Stelara or sharps waste bin collection please contact TCP on 1800 936 805 19

Sharps Collection Once you have been trained to self-inject by a fully qualified TCP nurse you can avail of the sharps bin service. Please contact your TCP Homecare Co-ordinator to request delivery of a new sharps bin or collection of a full sharps bin on 1800 936 805. The MyStelara Homecare Service is free to all patients who have been prescribed Stelara. The service is offered by TCP Homecare (an independent Irish company) working in partnership with Janssen (the manufacturers of Stelara ).

MyContacts There are many support services available who offer advice, support and networking opportunities to meet other people with your condition: The Irish Skin Foundation www.irishskin.ie Arthritis Ireland www.arthritisireland.ie The Irish Society of Crohns & Colitis www.iscc.ie The Psoriasis Association www.psoriasis-association.org.uk The Psoriasis and Psoriatic Arthritis Alliance www.papa.org The British Association of Dermatologists www.bad.org.uk International Federation of Psoriasis Associations www.ifpa-pso.org European Federation of Psoriasis Associations www.europso.eu European Academy of Dermatology and Venereology www.eadv.org Psonet: European Registry of Psoriasis www.psonet.eu 21

References: 1. Stelara Summary of Product Characteristics. Available from www.medicines.ie. 2. Stelara Patient Information Leaflet. Available from www.medicines.ie. 3. Guidelines on the Prevention and Control of Tuberculosis in Ireland 2010. Available from http://www.hpsc.ie/a-z/vaccinepreventable/tuberculosistbguidance/file,4349,en.pdf. For further information on Stelara contact Janssen Medical Information on 1800 709122. October 2017 PHIR/STE/0916/0005a(2)