A guide for patients who have been prescribed Stelara

Transcription

1 guide for patients who have been prescribed Stelara

2 Getting to know your ne w treatment This guide aims to provide you with useful information about your new treatment, Stelara. To help you understand your new therapy including how to take it and things to look out for we recommend you take the time to read through each of the topics. If you have any questions about treatment not covered in this guide, please speak with your healthcare professional or visit

3 Why Stelara? Stelara can be used to treat: oderate to severe plaque psoriasis in adults M who cannot use, or did not respond to, other medicines or phototherapy treatment. oderate to severe plaque psoriasis in M adolescent patients from the age of 12, who are unable to tolerate or did not respond to other medicines or phototherapy treatment. ctive psoriatic arthritis in adult patients when the response to other non-biologic medicines has been inadequate. oderate to severe Crohn s disease in adults M who are unable to tolerate or did not respond to, or stopped responding to other medicines.

4 How does Stelara work? Stelara contains the active substance ustekinumab, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body. Stelara targets and blocks the action of two cytokines (chemicals involved in the body) called IL-12 and IL-23, which are important in the development of psoriasis, psoriatic arthritis and Crohn s disease. In this way, Stelara works to weaken part of your immune system to reduce inflammation and other signs of psoriasis and/or psoriatic arthritis and/or Crohn s disease. This means Stelara belongs to a group of medicines called immunosuppressants. What does Stelara contain? Each pre-filled syringe contains either 45 mg ustekinumab in 0.5 ml or 90 mg in 1 ml. For children with psoriasis who need to receive less than the full 45 mg dose, a 45 mg vial is available. For Crohn s disease patients, your first dose will be administrated through a drip in the vein of your arm (intravenous infusion) in a hospital setting. Other ingredients contained in the syringe are sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 and water for injections.

5 What you need to know before starting treatment Before you use Stelara, please read the enclosed Package Leaflet carefully. It includes important information on Stelara such as possible side effects, and when you shouldn t use this treatment. If you have any questions or concerns about your treatment, it s important that you speak with your nurse or doctor. Before you use Stelara Tell your doctor if you: Have ever had any type of cancer. This is because immunosuppressants like Stelara weaken part of the immune system. This may increase the risk of cancer. Have or have had tuberculosis, or have been in close contact with someone who has tuberculosis. Your doctor will examine you for tuberculosis and perform a test to see if you have tuberculosis, before you start treatment. If your doctor thinks that you are at risk of tuberculosis, you may be given a medicine for tuberculosis. This will be before you begin treatment with Stelara, and may continue during treatment. Have or have had a recent infection. This is because Stelara may make you less able to fight infections. Some infections could become serious. This could mean that you may require additional treatment or need to go to hospital. Tell your doctor even if it is a minor infection, or if you have any signs that 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, warm, red and painful skin rash with blisters, burning when passing water and diarrhoea. Signs of chest infection (lower respiratory tract infection) include cough, mucus discharges, high temperature, dizziness, pressure or heaviness in your chest, shortness of breath or rapid breathing. Other symptoms include a blocked or watery nose, and increased heartrate.

6 If you are not sure, talk to your doctor straight away. It is particularly important to tell your doctor if you have an infection that will not go away or keeps coming back. lso, tell your doctor if you have any open cuts or sores as they might become infected. re 65 years of age or over. You may be more likely to get infections. re 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 use a reliable form of contraception whilst receiving Stelara, and for at least 15 weeks after their last injection. re breast-feeding or if you plan to breast-feed while using Stelara. Your doctor will decide whether you should start treatment. Have ever had an allergic reaction to Stelara or to latex 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. re having any other treatment for psoriasis, psoriatic arthritis and/or Crohn s disease. Have recently had, or are going to have, a vaccine. Have any new or changing skin lesions within psoriasis areas or on normal skin. What side effects should you look out for? Like all medicines, Stelara may cause side effects, although not everybody gets them. Most are mild to moderate, however some people may experience more serious side effects. Tell your doctor straight away if you notice any of the following serious side effects as you may need urgent 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, warm, red and painful skin, or a painful skin rash with blisters, burning when passing water and diarrhoea. Signs of chest infections (lower respiratory tract infection) include cough, mucus discharges, high temperature, dizziness, pressure or heaviness in your chest, shortness of breath or rapid breathing. Other symptoms include a blocked or watery nose, and increased heartrate. Shedding of skin increase in redness and shedding of skin over a larger area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. You can find a full list of side effects in your Package Leaflet. When should you not use Stelara? You should not use Stelara if you are allergic to any of its ingredients or if you have an active infection. If you think either of these apply to you, it s important that you let your health care team know. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects that are not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at: /yellowcard and to Janssen-Cilag Ltd on By reporting side effects, you can help provide more information on the safety of this medicine.

7 Taking your treatment correctly Psoriasis or Psoriatic rthritis Stelara is administered by subcutaneous injection an injection just under the skin. In adults and the elderly, the recommended dose is 45mg. For psoriasis patients the recommended dose is 90mg if you weigh more than 100kg. For psoriatic arthritis patients, if you weigh more than 100kg, a dose of either 45mg or 90mg may be given. In children aged 12 years or older, the recommended dose is 0.75mg/kg if they weigh less than 60kg, 45mg if they weigh from 60kg to 100kg, and 90mg if they weigh more than 100kg. The Stelara dosing schedule looks like this: Week 0 1st Starter Dose Week 4 2nd Starter Dose Week 16 1st Maintenance Dose Every 12 Weeks Subsequent Maintenance Doses fter your two starter doses, you will only need to take Stelara four times a year. In taking your treatment, you have the choice of: visiting the hospital or clinic for your injections signing up for the Homecare Service, or administering the injections yourself at home.

8 Taking your treatment correctly Crohn s disease The first dose of Stelara treatment for Crohn s disease is given in a hospital by a healthcare professional as a drip in a vein of your arm (intravenous infusion). fter the starting intravenous dose you will have the next dose of 90mg by injection under your skin (subcutaneous injection) 8 weeks later, and then every 8 or 12 weeks thereafter. Your doctor will decide how often you will need to receive Stelara and for how long. The Stelara dosing schedule looks like this: Week 0 Intravenous Infusion Week 8 1st Maintenance Injection Week 16 or 20 2nd Maintenance Injection Subsequent Maintenance Doses In taking your injection, you have the choice of: visiting the hospital or clinic for your injections signing up for the Homecare Service, or administering the injections yourself at home.

9 Homecare Service This is a personalised delivery and care service that can make taking your treatment easy and convenient. The Homecare Service provides users with: Home delivery Delivery of your new medicine directly to your home (or other address of your choice). Keep your syringes or vials in the fridge (2-8 C). Do not freeze them. Home visits Visits from a fully-qualified nurse to administer your injection to you at home or to train you to self-inject, depending on what you and your doctor have agreed. If you haven t been signed up for Homecare yet, ask your doctor about this service. Self injection Your health care team could help you determine if self-injection is a good option for you. If you do decide to self-inject, you will be trained by a nurse or other healthcare professional on the proper administration of Stelara. You can choose to receive this training at the clinic or hospital, or have a Homecare nurse visit you at home to teach you how to self-inject. Instructions for self-injection You can find full instructions for self-injection in the Instructions for administration section in the Package Leaflet contained within this guide. Once you have been registered with the service by your doctor, you will be assigned your very own Homecare co-ordinator. This person will contact you, explain the service, answer any questions you may have, and book a time for your medicine delivery and nurse visit.

10 Common questions about Stelara treatment How do I store Stelara? You must store Stelara in the following ways: Keep Stelara out of the sight and reach of children. Keep your syringes or vials in a fridge (2 8 C). Do not keep them 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. 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.

11 How do I take Stelara with me when I travel? How do I dispose of my used Stelara syringe or vial? Your doctor will tell you how often to take your Stelara. Typically this is once every 12 weeks for psoriasis and psoriatic arthritis patients, or every 8 or 12 for Crohn s disease patients. If you are travelling between your scheduled doses you will not need to bring your medication with you. Check your calendar to see when your next dose is due and when you are travelling If you need to travel when your Stelara dose is due, speak to your doctor and follow their recommendations. They are likely to give you a letter permitting you to travel with prescription medications. Show the letter to airport security to let them know what you are carrying. What if my Stelara is left outside the fridge? You should not use your dose of Stelara if it is left outside 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. ccording to Department of Health guidelines, used syringes or vials should be placed in a puncture-resistant container, like a sharps container and returned to your pharmacist. You may be able to get a sharps container from your doctor or nurse. They will be able to advise you on how to use it and how to properly dispose of your used needles and vials. You may even be able to return your healthcare waste to your local clinic. If neither of the methods suggested above are possible, you can contact your local council, who then have the duty to collect your healthcare waste from your home. For more information, call your local council or visit NEVER re-use a syringe, for your safety and the health and safety of others. ntiseptic wipes and other supplies can be disposed of in your household waste. ny 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. Medicines should not be disposed of via wastewater or household waste. sk your pharmacist how to dispose of medicines if you are unsure.

12 What do I need to check before taking my injection? What if I use more Stelara than recommended? 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. 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. The product hasn t been shaken vigorously. If it has, do not use the dose. Can I stop using Stelara? Its appearance is intact. 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 if the liquid is discoloured, cloudy or you can see other foreign particles floating in it. If you would like to stop taking Stelara you should discuss this with your doctor first. He/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. What do I do if I have side effects? What if I want a break from taking Stelara? Speak to your doctor, pharmacist or nurse. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects that are not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at: /yellowcard and to Janssen-Cilag Ltd on By reporting side effects, you can help provide more information on the safety of this medicine. You should talk to your doctor if you want to take a break from your medication, as he/she is the only one who can say whether stopping treatment for some time is appropriate for you. Where can I get additional information on Stelara? If you have a question about your treatment, please read the Package Leaflet, speak to your healthcare professional or visit

13 Where can I find additional information about biologic treatments, psoriasis, psoriatic arthritis or Crohn s disease? Here s a list of useful organisations and websites for psoriasis, psoriatic arthritis, Crohn s disease and their treatment: Psoriasis The Psoriasis ssociation Psoriasis Scotland, PSLV Psoriatic arthritis rthritis Research UK psoriatic-arthritis Psoriatic rthritis Online The Psoriasis and Psoriatic rthritis lliance Crohn s disease Crohn s & Colitis UK NHS Choices Patient Notes If you have any feedback on this guide or on your Stelara treatment, please contact Janssen medical information on or , visit our website or us on medinfo@its.jnj.com

14 Notes

15 Date of preparation: December 2017 PHGB/STE/0915/0017a(1)a