Transcription
STELARA Patient Booklet
WelcomeYou have been given this STELARA Patient Packbecause your doctor has prescribed STELARA forthe treatment of your psoriasis, psoriatic arthritis,Crohn’s disease or ulcerative colitis. The pack hasbeen designed to provide you with all the relevantinformation about your condition and what you canexpect from your treatment.Before starting your treatment, carefully read thepatient information leaflet relevant to your prescribeddose of STELARA which is included in the STELARA medication package.If you have any questions or concerns about yourtreatment with STELARA , contact your healthcareprofessional immediately, as they are the best peopleto help you with your queries.
My Treatment with STELARA What is STELARA Who is STELARA used for?1STELARA is a type of medicine called a monoclonalantibody. You may hear it referred to as a biologic (orbiological treatment) used for the treatment of adultand adolescent psoriasis, psoriatic arthritis, Crohn’sdisease and ulcerative colitis. Monoclonal antibodiesare proteins that recognise and bind specifically tocertain proteins in the body.STELARA is used to treat psoriasis, psoriatic arthritis,Crohn’s disease and ulcerative colitis in the followingcircumstances:STELARA belongs to a group of medicines called‘immunosuppressants’. These medicines workby weakening part of the immune system. Theseproteins have to be injected into the body and cannotbe taken in tablet form. STELARA is administeredby subcutaneous injection, this means the injectionis given just under the skin.The active substance in STELARA is calledUstekinumab. Adult psoriasis: to treat moderate-to-severe plaquepsoriasis in adult patients who cannot use, or didnot respond to, other medicines used to treat plaquepsoriasis, or phototherapy treatment. Adolescent psoriasis: to treat moderate to severeplaque psoriasis in adolescent patients whoare from the age of 12 years and over, who areinadequately controlled by other systemic therapiesor phototherapies, and who are intolerant to othersystemic therapies or phototherapies. Adult psoriatic arthritis: to treat active psoriaticarthritis in adult patients when the response to othernon-biological medicines has been inadequate.1
Adult Crohn’s disease: to treat adult patients withmoderately to severely active Crohn’s disease inadult patients who have had an inadequate responsewith, lost response to, or were intolerant to eitherconventional therapy or a TNF-alpha antagonist or havemedical contraindications to such therapies. Adult Ulcerative Colitis: to treat moderately to severelyactive ulcerative colitis in adult patients who have hadan inadequate response with, lost response to, or wereintolerant to either conventional therapy or a biologic orhave medical contraindications to such therapies.Recommended Dosing: Psoriasis andPsoriatic ArthritisYour doctor will decide how much STELARA you need touse and for how long. Always use this medicine exactly asyour doctor has told you.Adult Psoriasis In adults under 100 kg, the recommended dose ofSTELARA is 45 mg. In adults weighing more than 100 kg the recommendeddose of STELARA is 90 mg.Adult Psoriatic Arthritis In adults under 100 kg, the recommended dose ofSTELARA is 45 mg. In adults weighing more than 100 kg the recommendeddose of STELARA is 90 mg.Adolescent Psoriasis Your doctor will decide how much STELARA you needto use and for how long. Always use this medicineexactly as your doctor has told you.2
Recommended Dosing: Crohn’s Diseaseand Ulcerative ColitisYour doctor will decide how much STELARA you needto use and for how long. Always use this medicineexactly as your doctor has told you.STELARA treatment is to be initiated with asingle intravenous (IV) dose based on body weight(approximately 6 mg/kg). This is a once-off IV infusionwhich will take place in the hospital. Your healthcareprofessional or nurse specialist will discuss this indetail with you and organise a date and time for this totake place.Your first maintenance dose will be a 90 mg ofSTELARA which will be administrated subcutaneously8 weeks after the intravenous dose.How is STELARA given?STELARA is given by injection under the skinsurface (subcutaneously) and comes in a pre-filledsyringe or a vial.Your healthcare professional will decide which doseof STELARA is necessary for you based on if you arean adult or an adolescent, your weight at the timeof injection and also if you have psoriasis, psoriaticarthritis, Crohn’s disease or ulcerative colitis.When you first start treatment, your doctor or nursespecialist may inject your STELARA for you.However, you and your doctor or nurse specialist maydecide that you can inject your medicine yourself.In this case, you will be trained on how to inject, sothat you learn the proper technique and minimise anydiscomfort from the needle.Following this you will be taking STELARA every 8 or12 weeks.3
Injecting yourself with STELARA The following instructions for administration showyou how to prepare and inject your STELARA treatment. It is important to refer to this if you areunsure of any of the steps involved in injectionsyour STELARA treatment.Please note that you should never try to injectSTELARA yourself until you have been shown theright way to self-administer the injections by yourdoctor or nurse specialist.Step 1: Allow the product to warm toroom temperatureminsTake the carton containing your STELARA pre-filledsyringe out of the refrigerator and allow the syringe to sitoutside the carton for 30 minutes. This will let it cometo room temperature. If you inject yourself with coldSTELARA it will be uncomfortable.Check to make sure that the number of syringes anddosage are correct.TIP: Take the pre-filled syringe out of the carton and wait30 minutes.4
insStep 2: Check the pre-filled syringeStep 3: Gather the supplies for yourinjection and wash your handsminsHold your STELARA pre-filled syringe by the body withthe covered needle pointing upward. Make sure not totouch the needle guard activation clips.Check the syringe to make sure that it has not beendamaged 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, orhas any foreign particles in it.Make sure you have all your injection supplies availableincluding your STELARA pre-filled syringe, an antisepticwipe, cotton ball or gauze and your sharps container fordisposal of the used syringe.Wash your hands well with soap and warm water.TIP: Make sure everything is ready BEFORE you wash yourhands and that you are able to sit down comfortably.TIP: You may notice an air bubble – this is normal.5
minsStep 4: Prepare the injection siteStep 5: Remove the needle coverGood places for the injection are the upper thigh oraround the stomach, but at least 5cm away from thebelly button. If possible, do not inject into an area of skinaffected by psoriasis.Hold the body of the pre-filled syringe with one hand andpull the needle cover straight off. Take care not to touchthe needle or touch the plunger while removing the needlecover. You need to inject STELARA promptly after theneedle cover has been removed.Wipe the area you will inject with the antiseptic wipe. Donot touch this area again before giving the injection.TIP: If possible, choose an area of skin not affected by psoriasis.Do not remove the needle cover until you are ready toinject STELARA .TIP: You may notice a drop of liquid at the end of the needle this is normal.mins6mins
Step 6: Position the syringeStep 7: Inject the productHold the body of your STELARA pre-filled syringe in onehand between your middle and index fingers and placeyour thumb on top of the plunger head. Make sure youdon’t pull back on the plunger at any time.Use a quick, dart-like motion to insert the needle into thepinched skin as far as it will go.Use your other hand to gently pinch the area of skin thatyou previously cleaned.TIP: Gently pinch the area of skin where you will injectSTELARA and hold firmly.Inject all of the medicine by using your thumb to push inthe plunger until the plunger head is completely betweenthe needle guard wings. When the plunger is pushed in asfar as it will go, keep pressure on the plunger head.TIP: Count to 5 to ensure that the product is injected slowly.7
Step 8: Withdraw the needle and syringeStep 9: After the injectionPull the needle and syringe out and let go of your skin.Press an antiseptic wipe over the injection site for a fewseconds after the injection. There may be a small amountof blood or liquid at the injection site, which is normal.Slowly take your thumb off the plunger head. This willlet the empty syringe move up until the entire needle isminscovered by the needle guard.TIP: Withdraw the needle and syringe carefully then let go ofyour skin.8Press a cotton ball or gauze over the injection site forabout 10 seconds. Do not rub your skin.TIP: If needed, you can cover the injection site with a smalladhesive bandage.
Step 10: You have successfully finishedyour injectionminsIf your dose is 90 mg and you received two 45 mgsyringes, you will need to give yourself a second injectionwithin 5 minutes of the first one.Always choose a different body area if administering asecond injection.9
Before starting STELARA Check with your doctor before starting treatment withSTELARA if you have any of the following:Latex sensitivity/allergyThe needle cover of the pre-filled syringe contains latexrubber. This may cause severe allergic reactions in peoplewho are sensitive to latex. Tell your doctor if you have everhad an allergic reaction to latex or developed any allergicreaction to the STELARA injection.InfectionsYou must tell your doctor if you have any kind of infection,open cuts or sores, or if you have signs you might begetting an infection, as STELARA may make you lessable to fight infections.Tell your doctor even if it is a very minor infection, or ifyou have any signs or symptoms that might make youthink you might be getting an infection. Signs of infection10(including tuberculosis) include fever, flu-like symptoms,night sweats, feeling tired or short of breath, cough whichwill not go away, blood tinged sputum, warm, red andpainful skin, or a painful skin rash with blisters, burningwhen passing water, diarrhoea, vomiting.Signs of infections of the chest (lower respiratory tractinfections) such as cough, mucus discharges, hightemperature, dizziness, feeling a pressure or heavinessin your chest, shortness of breathing or breathing at anincreased rate. Also blocking of nose, watering of noseand increased heartbeat can be the symptoms of lowerrespiratory tract infection.It is particularly important to tell your doctor or nursespecialist if you have an infection that will not go away orthat keeps coming back.Tuberculosis (TB)It is important to tell your doctor if you ever had TB or ifyou have recently been near anyone who might have TB or
if you have visited any country where TB is common. Yourdoctor will examine you according to local regulations3, tosee if you have TB before you start your treatment.If your doctor thinks you are at risk of TB, you will begiven medicine before you start your treatment withSTELARA , and this TB treatment may continue duringyour treatment with STELARA .Cancer(a medicine that reduces your body’s ability tofight infection) or phototherapy (when your body istreated with special types of ultraviolet (UV) light)while using STELARA .STELARA has an effect on your immune systemand the combination of these therapies mayincrease the risk of diseases related to a weakenedimmune system. However, the combination of thesetherapies has not been studied in clinical trials.Please inform your doctor if you have ever had any typeof cancer. Medicines like STELARA weaken part of theimmune system. This may increase your risk of cancer. Ifyou have any queries about this please discuss these withyour doctor.If you are not sure if any of the above appliesto you, talk to your doctor, pharmacist or nursespecialist before starting treatment with STELARA .Other therapiesSTELARA may affect other medicines and othermedicines may affect STELARA . Please tell yourdoctor or pharmacist if you are taking or haverecently taken any other medicines.Tell your doctor or nurse specialist if you are taking orhave been prescribed an ‘immunosuppressive medicine’Using other medicines11
Do not take any new medicines, herbal remedies,vitamins or other over the counter medicines withoutcontacting your healthcare professional to discuss first.Pregnancy and breast-feedingTalk to your doctor if you are pregnant or are planningto become pregnant while using STELARA . Theeffects of this medicine on pregnant women andunborn babies are not known.Women who are able to have children are advised toavoid becoming pregnant and must use an effectivemethod of contraception during treatment and for 15weeks after your last injection with STELARA .Talk to your doctor if you are breast-feeding or if youplan to breast-feed while using STELARA . Your doctorwill decide whether you should start treatment.Driving and using machinesSTELARA should not affect your ability to drive oroperate machines’12VaccinationsTell your doctor if you have recently had or are goingto 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 expirydate on the label and the carton after ‘EXP’. Theexpiry date refers to the last day of that month. You know, or think, it may have been exposed toextreme temperatures (such as accidentally frozenor heated). The product has been shaken vigorously. STELARA is a clear to slightly opalescent (have apearl-like shine), colourless to light yellow solution.The solution may contain a few small translucentor white particles of protein. Do not use if theliquid is discoloured, cloudy or you can see otherforeign particles floating in it.
Possible Side EffectsWhat potential side effects shouldI be aware of?2Like all medicines, STELARA may cause side effects,although not everybody gets them. Most side effectsare mild to moderate. However, some people mayexperience more serious side effects that could requireurgent treatment.Tell your doctor straight away if you notice any of thefollowing serious side effects as you may need urgentmedical treatment: Signs of an allergic reaction such as difficultybreathing or swallowing, low blood pressure, whichcan cause dizziness or light-headedness, swelling ofthe face, lips, mouth or throat, skin rash and hives. Signs of infection (including tuberculosis) such asfever, flu-like symptoms, night sweats, feeling tiredor 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 whenpassing water, diarrhoea, vomiting. Signs of infections of the chest (lower respiratory tractinfections) such as cough, mucus discharges, hightemperature, dizziness, feeling a pressure or heavinessin your chest, shortness of breathing or breathing at anincreased rate. Also blocking of nose, watering of noseand increased heartbeat can be the symptoms of lowerrespiratory tract infection. Shedding of skin, as an increase in redness andshedding of skin over a larger area of the body maybe symptoms of erythrodermic psoriasis or exfoliativedermatitis.Reporting of Side EffectsAdverse events should be reported. Healthcareprofessionals are asked to report any suspected adverseevents via: HPRA Pharmacovigilance, Earlsfort Centre,Block A, Earlsfort Terrace, Dublin 2, Tel: 353 16764971, Fax: 353 1 6762517, Website: www.hpra.ie,E-mail: medsafety@hpra.ie. Adverse events should alsobe reported to Janssen Sciences Ireland UC on 1800 709122 or at dsafety@its.jnj.com.13
Questions about STELARA How do I store STELARA ? Keep STELARA out of the sight and reach of children. Keep your pre-filled STELARA syringes or vials in afridge (2–8 C). Do not keep STELARA in the freezer. Keep the pre-filled syringes or vials in the outer cartonto protect them from light. Do not shake the pre-filled syringes or vials as this maydamage the medicine. Remove your treatment from the fridge 30 minutesbefore 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 leftout of the fridge for more than 30 minutes. If you thinkyou’ve left your medicine out of the fridge longer than14you should, place the vial or pre-filled syringe back in thefridge and contact your healthcare professional as soon aspossible for advice.How do I take STELARA with mewhen I travel?Your doctor will tell you how often to take your STELARA .When you are planning your trip, check your calendar tosee when your next dose is due. You may find that youwill be travelling during some of your dose-free days. Thismeans you can leave your STELARA at home.Check your calendar or use the dosing wheel at the end ofthis booklet to see when your next dose is due to ensureyou 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’sletter 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 letterto airport security to let them know what you are carrying.STELARA will need to be kept at 2-8 C during yourjourney. You can use the free travel pack that you receivedfrom your pharmacist with your first dose. Speak to yourpharmacist or prescriber about the best way to do this.Always store STELARA in a fridge when you get to yourdestination.What do I need to check beforetaking my injection? It hasn’t been exposed to extreme temperatures. Do notuse STELARA if you know, or think that it may havebeen accidentally frozen or heated. The product hasn’t been shaken vigorously. If it has, donot use the dose. Ensure it looks as expected. STELARA is a clearto slightly opalescent (having a pearl-like shine),colourless to light yellow solution for injection. Thesolution may contain a few small translucent or whiteparticles of protein. Do not use STELARA if the liquidis discoloured, cloudy or you can see other foreignparticles floating in it.Before you use your STELARA , you should check that:What if I use more STELARA than recommended? It hasn’t passed its expiry date. You can find this on thelabel and the carton after ‘EXP’. The expiry date refersto the last day of that month. Do not use STELARA ifthe expiry date has passed.If you think you have used more STELARA than youshould 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.15
What if I forget to use STELARA ?What do I do if I have side effects?If you forget a dose, contact your doctor or pharmacist. Donot take a double dose to make up for a forgotten dose.Speak to your doctor, pharmacist or nurse.Can I stop using STELARA ?If you would like to stop taking STELARA you shoulddiscuss this with your doctor first. He or she will adviseyou on the best way to do this. If you stop taking it, yoursymptoms may come back.If you have any questions on the use of this medicine, askyour doctor or pharmacist.Where can I get additional informationon STELARA ?If you have a question about your treatment, please readthe Patient Information Leaflet or speak to your healthcareprofessional.16Reporting of Side EffectsAdverse events should be reported. Healthcareprofessionals are asked to report any suspected adverseevents via: HPRA Pharmacovigilance, Earlsfort Centre,Block A, Earlsfort Terrace, Dublin 2, Tel: 353 16764971, Fax: 353 1 6762517, Website: www.hpra.ie,E-mail: medsafety@hpra.ie. Adverse events should alsobe reported to Janssen Sciences Ireland UC on 1800 709122 or at dsafety@its.jnj.com.
Useful ContactsThere are many support services available who offer advice, support and networking opportunities to meetother people with your condition: The Irish Skin Foundationwww.irishskin.ie Arthritis Irelandwww.arthritisireland.ie The Irish Society for Colitis and Crohn’s Diseasewww.iscc.ie The Psoriasis Associationwww.psoriasis-association.org.uk Group for Research and assessment ofPsoriasis and Psoriatic Arthritiswww.grappanetwork.org The British Association of Dermatologistswww.bad.org.uk International Federation of Psoriasis Associationswww.ifpa-pso.org European Federation of Psoriasis Associationswww.europso.eu European Academy of Dermatology and Venereologywww.eadv.org Psonet: European Registry of Psoriasiswww.psonet.eu17
References: 1. STELARA Summary of Product Characteristics. Available fromwww.medicines.ie. 2. STELARA Patient Information Leaflet. Available fromwww.medicines.ie. 3. Guidelines on the Prevention and Control of Tuberculosisin Ireland 2010. Available from osisTBGuidance/File,4349,en.pdf.For further information on STELARA contact Janssen Medical Information on1800 709122.November 2019 EM-18836
dose of STELARA is 90 mg. Adult Psoriatic Arthritis In adults under 100 kg, the recommended dose of STELARA is 45 mg. In adults weighing more than 100 kg the recommended dose of STELARA is 90 mg. Adolescent Psoriasis Your doctor will decide how much STELARA you need to use and for how long. Always use this medicine
