30 minute read

The impact of transitioning on juvenile arthritis patients

Transitioning – Part of the JIA Journey

The Irish Childrens Arthritis Network, also known as iCAN, is working to get children in Ireland better access to rheumatological. Currently, Ireland is at the bottom of the EU for paediatric rheumatological care. Over one thousand children and teens in Ireland are diagnosed with JIA, with numbers growing daily. iCAN offers help through our online support network, family days out and information days. Wendy Costello is Chairperson of iCAN. She tells us, “Transition is a part of the JIA journey that is sometimes forgotten as the race to find remission is focused on.

“The young patient needs to be making the decisions in conjunction with their rheumatology team. Self management skills are so important and together as a family and rheumatology team these can start as early as 11yrs of age. By the time transition to your new team comes you are ready for that leap. “We need to put more time, research and education into this vital period of a young patients life. Leaving the paediatric setting of Crumlin or Temple St and heading to local adult services is daunting for a 16yr old. We in iCAN want to help smooth that journey. “iCAN support, advocate for and raise awareness of Juvenile Idiopathic Arthritis. As part of our support to families we run workshops on transitioning from paediatric services to adult. Our focus is to prepare families for this important move. “Our expert speakers include clinicians, nurses, young people and parents. No one size fits all but we can work with each family individually in conjunction with their rheumatology teams. Niamh and Cal have both used our workshops and now are mentors guiding families through this process.” Below, they share their personal journeys. For any more information contact iCAN on 0868289817 or email icanireland@gmail.com

Niamh Costello

My experience of life with Juvenile Idiopathic Arthritis and transitioning from paediatric care to adult services– Niamh Costello, 22

My name is Niamh Costello. I am 22 years old and I was diagnosed with Juvenile Idiopathic Arthritis when I was 3. I sometimes think that being diagnosed at such a young age was a blessing in disguise, as I have grown up with JIA. It has been a part of my life for as long as I can remember and it will always be this crutch that I have to carry. Because of this, I have had to adapt my life to suit my needs and also learn to know my limits. Whereas I know lots of young people who lived a healthy, sporty and energetic lifestyle until they suddenly got diagnosed in their teenage years. This must be hard to accept as their lives have now become completely different. I also count my blessings that I don’t remember much of my diagnosis, as I was so young. My poor parents had to take the brunt of it. They tell me that one morning I crawled into their bedroom on my hands and knees screaming that I couldn’t walk with the pain in my knee. They looked down to see my whole left leg swollen up like a balloon. My knee was red and hot to touch and I was clearly in a lot of pain as they couldn’t stop me crying. They brought me straight to my GP who brushed it off as a virus or growing pains. I soon turned from this happy, energetic 3 year old to a whiney, tiresome one who had to be carried everywhere. This persisted for a number of weeks until my parents brought me back up to the GP as they knew it clearly wasn’t a virus. I was admitted to hospital with a rash and a temperature and this swollen knee that was getting bigger by the day. Lots of tests and scans were done and one day, a doctor who had done some of his training under Paediatric Rheumatology, recognised my symptoms and referred me straight to Our Lady’s Children’s Hospital in Crumlin, Dublin. That is where my lifelong journey of JIA began. I was diagnosed a couple of weeks later and was put on a high course of steroids. At the time there was no paediatric rheumatologist in Ireland so little was known about JIA and its prognosis. It was going to be a case of trial and error with my treatment. The oral steroids didn’t work so I was given a steroid injection directly into the knee joint and the fluid was drained. And believe it or not that was it for 4 years! I went into remission and I thought I would never have to see a hospital again. Unfortunately I was wrong. When I was 7, the trips to hospitals started again and this time I wouldn’t get a 4 year break.

My JIA resurfaced and soon spread to other joints which made my day to day life that bit harder. Getting up for school every morning was a struggle. I needed help with things like brushing my hair and teeth, getting in and out of bed, showering etc. I had little independence and always wanted to be near my Mum for reassurance. I had to miss out on lots of things growing up as some days I physically couldn’t get out of bed due to the pain, swelling and stiffness of my joints. I felt like I missed out on a normal childhood. Instead of birthday parties, sleepovers, school trips and running around with my friends my childhood consisted of weekly injections, trips to hospitals, blood tests, scans, needles, fatigue, side effects and a whole lot of pain. I was always told when I was younger that I could possibly grow out of JIA, so my family lived in hope. We did everything we could to try and keep my JIA at bay but when I was 12 I remember my consultant telling me that I will probably have this for the rest of my life. When you are 12 that is a shock to the system. All these thoughts were running through my head, how can I deal with this pain for the rest of my life, will I have to take injections forever, will I be able to have children?! I hit a slump and I was very down in myself for a couple of years after that. I worked my way through various biologic injections until the options started to get less and less and they soon stopped working for me. I had to start on infusions in my teenage years which meant I had to travel to hospital once a week to be hooked up to an IV drip. The infusions made me quite sick and extremely tired. I missed a lot of school throughout this time which was hard academically and socially. When I was around 13/14, I started to go to Teen Clinics in Crumlin children’s hospital. I would go in to clinic and see my nurse and consultant first on my own. This was daunting at first because my parents would do all the talking for me at my appointments and tell my doctors my issues and worries, I would just smile and nod. So the thoughts of having to speak to doctors on my own scared me. It turned out to be a good thing though because if I had any worries or concerns that I didn’t want to discuss in front of my parents I could discuss it with my consultant during this time. It also gave me more independence and a chance to start learning to selfmanage my illness. My parents would then come in at the end of the appointment and say anything that I might have forgotten to say. When I hit 16 I was asked by my paediatric consultant to start thinking about what hospital I would like to transition to. I had to think about some factors such as where I live, what facilities might be available to me at this hospital – Occupational Therapy, Physio etc, where I might be going to third level education – would the hospital be far from here? All of these things had to come into consideration when I was picking an adult hospital. I transitioned from paediatric care to adult services when I was 17. I was quite scared to go to an adult hospital as I had spent my whole life under the care of paediatric doctors. One of the challenges that I found when I transitioned was that I had to speak up for myself a lot more and tell the doctors what I wanted for my care. This was new to me as I was used to going into teen clinic appointments and having my consultant telling me what drug I was going onto next or saying that I needed a steroid injection straight away. I remember my adult doctor saying to me ‘do you think you need a steroid injection?’ I remember thinking well you’re the doctor! You tell me if you think I need one! It taught me that I am the only person who knows my body and illness the best. I have to start making the decisions now such as realising when I need a steroid injection or when I need to start a course of steroids/change in biologic etc. I was also used to going into paediatric consultants and them lying me on the bed and checking my joints and then discovering that actually I had quite a few joints flaring. Sometimes I didn’t even know myself that I was flaring. In adult care they rarely do a full body check of your joints so you have to tell them which joints you feel are flaring. I also have to now organise all my own blood tests and keep track of my own markers in my bloods. Something that my mam and my paediatric consultant did for me when I was younger. For me personally, at 17 I found the time of transition hard as I was in an exam year in school which was another added stress. I think transition should not be carried out until you are either finished exams or the year before you go into final year. It just gives you a chance to get settled. I am now 22 and on a drug that is doing wonders for me. I have graduated from university and have started my first full time job as a primary school teacher. The daily demands in my job have its own challenges but I try to balance my work and downtime as I know this balance is important to stop me from having flare ups due to stress. I have become much more aware of my illness and know when I need something to be done with regards to my care and wellbeing. Don’t let your illness define you, you can still lead the life you want to live just maybe with a few adaptions. I always say that I have JIA, but it doesn’t have me.

Cal’s Experience

My name is Cal I am 18 years old and I have been living with Ankylosing spondylitis arthritis since I was 11 years old. I transitioned from Crumlin children’s Hospital to St James’s Hospital when I was 16 years old. I was in two frames of mind; not knowing what was to come but yet excited for a new beginning. A lot of people helped through my transitioning, including my family (especially my mom and dad), the two mentors Niamh and Aine and my second family as I say - iCAN. Transitioning is different as you have to ask the questions and tell them everything where a lot of the time I would have to ask my mom. I would prefer adult services than child services due to how well the team works. It helps when the Consultant specialises in AS. If I had to give advice on transitioning from child services to adults, it would be that it’s a new beginning. Speak up and ask question about everything around your condition.

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®Amgevita®

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AMGEVITA® (adalimumab) Brief Prescribing Information Please refer to the Summary of Product Characteristics (SmPC) before prescribing Pharmaceutical Form: Single dose pre-fi lled syringe contains 20 mg adalimumab in 0.4 mL (50 mg/mL) solution, 40 mg adalimumab in 0.8 mL (50 mg/mL) solution or single dose pre-fi lled pen (SureClick®) contains 40 mg adalimumab in 0.8 mL (50 mg/mL) solution. Indications and Dosage: please refer to SmPC for full information. For subcutaneous injection. Treatment should be initiated and supervised by specialist physicians experienced in conditions for which AMGEVITA® is indicated. Ophthalmologists should consult with an appropriate specialist before starting treatment. Give patients a Patient Reminder Card. After training in injection technique, patients may self-inject with medical follow-up as necessary. Optimise other concomitant therapies (e.g. corticosteroids and or/immunomodulatory agents). Rheumatoid arthritis (RA), adults: In combination with methotrexate (MTX) for: 1. Moderate to severe, active RA with inadequate response to disease-modifying antirheumatic drugs (DMARDs) including MTX; 2. Severe, active and progressive RA not previously treated with MTX. Can be given as monotherapy if intolerance to or when continued treatment with MTX is inappropriate. Dosage: 40 mg every other week (EOW). Continue concomitant MTX. In monotherapy, patients may require 40 mg every week or 80 mg EOW if there is a decrease in clinical response. Reconsider treatment beyond 12 weeks if no clinical response. Consider need for dose interruption, e.g. before surgery or if serious infection occurs. Polyarticular juvenile idiopathic arthritis (pJIA), paediatrics ≥ 2 years: In combination with MTX for active pJIA with inadequate response to one or more DMARDs. Can be given as monotherapy if intolerance to or when continued treatment with MTX is inappropriate. Dosage: 10 kg to < 30 kg: 20 mg EOW. ≥ 30 kg: 40 mg EOW. Reconsider treatment beyond 12 weeks if no clinical response. Enthesitis-related arthritis (ERA), paediatrics, ≥ 6 years: Active ERA with inadequate response to or intolerance to conventional therapy. Dosage: 15 kg to < 30 kg: 20 mg EOW. ≥ 30 kg: 40 mg EOW. Ankylosing spondylitis (AS), adults: Severe active AS with inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), adults: Severe nr-axSpA with objective signs of infl ammation (elevated CRP and/or MRI), and an inadequate response to or intolerance to nonsteroidal anti-infl ammatory drugs. Psoriatic arthritis (PsA), adults: Active and progressive PsA with inadequate response to DMARDs. Dosage (AS, nr-axSpA, PsA): 40 mg EOW. Reconsider treatment beyond 12 weeks if no clinical response. Psoriasis, adults: Moderate to severe chronic plaque psoriasis in candidates for systemic therapy. Dosage: 80 mg at Week 0, followed by 40 mg EOW from Week 1. Reconsider treatment beyond 16 weeks if no clinical response. Refer to SmPC. Paediatric Plaque Psoriasis, ≥ 4 years: Severe chronic plaque psoriasis with inadequate response to or if topical therapy and phototherapies are inappropriate. Dosage: 15 kg to < 30 kg: 20 mg followed by 20 mg EOW starting one week after initial dose. ≥ 30 kg: 40 mg then 40 mg EOW starting one week after initial dose. Reconsider treatment beyond 16 weeks if no clinical response. Safety has been assessed in paediatric patients with plaque psoriasis for a mean of 13 months. Hidradenitis suppurativa (HS), adults and adolescents ≥ 12 years: Active moderate to severe HS (acne inversa) with inadequate response to conventional systemic therapy. Dosage, adult: 160 mg at Day 1, followed by 80 mg at Day 15. At day 29 continue with 40 mg every week or 80 mg EOW. Reintroduction after treatment interruption: 40 mg every week or 80 mg EOW. Dosage: adolescent (≥ 30 kg): 80 mg at week 0 then 40 mg EOW starting at week 1. If response is inadequate, consider increasing to 40 mg every week or 80 mg EOW. Dosage, adult and adolescent: Antibiotics may be continued if necessary. Use concomitant topical antiseptic wash on a daily basis. Reconsider treatment beyond 12 weeks if no improvement. Periodically evaluate the benefi t and risk of continued treatment. Crohn’s disease (CD), adults: Moderately to severely active CD with no response despite a full and adequate course of, intolerance to or contraindication for a corticosteroid and/ or an immunosuppressant therapy. Dosage: Induction: 80 mg at Week 0, then 40 mg at Week 2. For a more rapid response: 160 mg at Week 0, then 80 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance: 40 mg dose EOW. Corticosteroids may be tapered in accordance with clinical guidelines. If decrease in clinical response, can increase to 40 mg every week or 80 mg EOW. If no response by Week 4 there may be benefi t from continued therapy to week 12. Reconsider treatment beyond 12 weeks if no clinical response. Paediatric CD, ≥ 6 years: Moderately to severely active CD with inadequate response to, intolerance to or contraindication to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator. Dosage: < 40 kg: Induction: 40 mg at week 0 then 20 mg at week 2. For a more rapid response: 80 mg at week 0 then 40 mg at week 2; risk of adverse events higher during rapid induction. Maintenance starting at week 4: 20 mg dose EOW. If insuffi cient response, consider 20 mg every week. Dosage: ≥ 40 kg: Induction: 80 mg at Week 0 then 40 mg at Week 2. For a more rapid response: 160 mg at Week 0, then 80 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance starting at week 4: 40 mg dose EOW. If insuffi cient response, consider 40 mg every week or 80 mg EOW. Reconsider treatment beyond 12 weeks if no clinical response. Ulcerative colitis (UC), adults: Moderately to severely active UC with inadequate response to, intolerance to or contraindication for conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA). Dosage: Induction: 160 mg at week 0 and 80 mg at week 2. Maintenance: 40 mg EOW. Corticosteroids may be tapered in accordance with clinical guidelines. If insuffi cient response, consider increasing to 40 mg every week or 80 mg EOW. Do not continue treatment beyond 8 weeks if no clinical response. Paediatric UC, ≥6 years: Moderately to severely active UC with an inadequate response to conventional therapy including corticosteroids and/or 6-MP or AZA, or who are intolerant to or have contraindications. Dosage: < 40 kg: Induction: 80 mg at Week 0 and 40 mg at Week 2. Maintenance starting at week 4: 40mg EOW. Dosage: ≥ 40 kg: Induction: 160 mg Week 0 and 80 mg Week 2. Maintenance starting at week 4: 80mg EOW. Patients reaching 18 years should continue their prescribed maintenance dose. Reconsider treatment beyond 8 weeks if no clinical response. No relevant use in children <6 years. Uveitis, adults: Non-infectious intermediate, posterior and panuveitis with inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Dosage: 80 mg at Week 0 and 40 mg EOW from Week 1. There is limited experience in initiation of treatment with adalimumab alone. Treatment can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be tapered starting two weeks after initiating treatment with AMGEVITA® . Evaluate on a yearly basis the benefi t and risk of continued treatment. Paediatric uveitis, ≥ 2years: Chronic non-infectious anterior uveitis with inadequate response or intolerance to conventional therapy, or in whom conventional therapy is inappropriate. In paediatric uveitis, there is no experience in the treatment with AMGEVITA® without concomitant treatment with methotrexate. Dosage: < 30 kg: 20 mg EOW in combination with MTX. Dosage: ≥ 30 kg: 40 mg EOW in combination with MTX. A loading dose of 40 mg (< 30 kg) or 80 mg (≥ 30 kg) may be administered 1 week in advance of maintenance therapy. No clinical data on use of loading dose in patients < 6 years. Evaluate benefi t and risk of continued treatment on a yearly basis. Contraindications: Hypersensitivity to the active substance or to any excipients; Active tuberculosis (TB) or other severe infections such as sepsis and opportunistic infections; Moderate to severe heart failure (NYHA class III/ IV). Warnings and Precautions: Clearly record the name and batch number. Infections: Patients taking TNF-antagonists are more susceptible to serious infections, especially if impaired lung function. Monitor for infections, before, during and for 4 months after treatment. Do not initiate treatment during an active infection, until infection is controlled. Consider risk/benefi t prior to treatment in patients exposed to TB or who have travelled in areas of high risk of TB or endemic mycoses. Evaluate new infections and monitor closely. Stop treatment if new serious infection or sepsis and treat. Exercise caution in patients with a history of recurring infections or who are predisposed to infections, including the use of concomitant immunosuppressive medications. Serious Infections: Consult SmPC for details. Serious infections, including those associated with hospitalisation or death, were reported in patients receiving treatment. TB: Reactivation and new onset TB, both pulmonary and extra-pulmonary (disseminated). Screen all patients before therapy initiation

MAKES THE DIFFERENCE

AMGEVITA® 40mg SureClick® Pre-fi lled pen

AMGEVITA® 20mg Pre-fi lled syringe AMGEVITA® 40mg Pre-fi lled syringe

Information for Healthcare Professionals

The Medicine Management Programme recommends AMGEVITA® as a citrate-free formulation of adalimumab. Prescribing AMGEVITA® has lead to signifi cant savings for the health service, in the order of millions of euros1,2,3

for active or inactive (latent) TB. Perform detailed medical assessment and appropriate screening tests for TB in all patients and results recorded on patient reminder card. If latent TB is suspected, consult physician with appropriate expertise Despite prophylaxis, TB reactivation has occurred on adalimumab. If active TB is diagnosed, do not initiate AMGEVITA® treatment. Other opportunistic infections: Opportunistic infections were observed in patients receiving adalimumab. Stop AMGEVITA® in patients with signs and symptoms of such infections. Consult with physician with appropriate expertise for diagnosis and administration of empiric antifungal therapy. Hepatitis B reactivation: Reactivation of HBV has occurred in chronic carriers; some cases were fatal. Test patients for HBV infection before initiating treatment. HBV carriers should consult a specialist physician and be closely monitored for reactivation of HBV infection throughout therapy and for several months after treatment. If reactivation occurs, stop treatment and initiate appropriate antiviral and supportive treatment. Neurological events: Caution in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders. Consider discontinuation if any of these develop. Perform neurologic evaluation in patients with non-infectious intermediate uveitis prior to initiation of treatment and regularly during treatment. Allergic reactions: Reports of serious allergic reactions including anaphylaxis. For serious allergic or anaphylactic reaction, stop AMGEVITA® immediately and initiate appropriate therapy. Dry natural rubber: The needle cover of the pen (SureClick®) is made from dry natural rubber (a derivative of latex), which may cause allergic reactions. Malignancies and lymphoproliferative disorders: A possible risk of malignancy, some fatal, including lymphomas and leukaemia, cannot be excluded (see SmPC). Examine all patients, especially those with a medical history of extensive immuno-suppressant therapy or psoriasis patients with a history of PUVA treatment, for non-melanoma skin cancer prior to and during treatment. Melanoma and Merkel cell carcinoma have also been reported. Caution in COPD patients, and in patients with increased risk for malignancy due to heavy smoking. Consider the potential risk with the combination of AZA or 6-MP and AMGEVITA® (hepatosplenic T-cell lymphoma has occurred). Caution in patients with a history of malignancy. Risk of developing dysplasia or colon cancer unknown. Screen patients with UC, history of dysplasia or colon carcinoma, for dysplasia before and during treatment. Haematologic reactions: Adverse events of the haematologic system, including medically signifi cant cytopenia, have been reported. Advise patients to seek immediate medical attention if signs and symptoms of blood dyscrasias develop. Vaccinations: Patients may receive concurrent vaccinations, except for live vaccines. Bring paediatric patients up to date with all immunisations prior to initiating treatment. Congestive heart failure: See contraindications. Caution in mild heart failure (NYHA class I/II). Discontinue treatment if new or worsening symptoms of congestive heart failure. Autoimmune processes: Autoimmune antibodies may form. Stop treatment if development of a lupus-like syndrome with positive antibodies against doublestranded DNA. Surgery: Consider the long half-life of AMGEVITA® for planned surgical procedures. Monitor closely for infections. There is limited safety experience in patients undergoing arthroplasty or surgical procedures. Elderly patients: Serious infections were higher in patients over 65, some of which were fatal. Consider risk of infections in these patients. Interactions: Antibody formation was lower when AMGEVITA® was given together with MTX rather than as monotherapy. Combination of AMGEVITA® with other biologic DMARDs (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended. Fertility, pregnancy and lactation Only use during pregnancy if clearly needed. Women of childbearing age to consider use of adequate contraception during and for at least 5 months after the last treatment. Administration of live vaccines (e.g. BCG) to infants exposed to AMGEVITA ® in utero is not recommended for 5 months following the mother’s last injection during pregnancy. AMGEVITA ® can be used during breastfeeding. Effects on ability to drive and use machines: AMGEVITA® may have a minor infl uence on the ability to drive and use machines. Adverse Reactions: Very common ≥ 1/10: Respiratory tract infections, leukopenia, anaemia, lipids increased, headache, abdominal pain, nausea and vomiting, elevated liver enzymes, rash, musculoskeletal pain, injection site reaction. Common ≥ 1/100 to < 1/10: Systemic infections, intestinal infections, skin and soft tissue infections, ear infections, oral infections , reproductive tract infections , urinary tract infections, fungal infections, joint infections, skin cancer excluding melanoma, benign neoplasm, leucocytosis, thrombocytopenia, hypersensitivity, allergies, hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration, mood alterations , anxiety, insomnia, paraesthesia, migraine, nerve root compression, visual impairment, conjunctivitis, blepharitis, eye swelling, vertigo, tachycardia, hypertension, fl ushing, haematoma, asthma, dyspnoea, cough, GI haemorrhage, dyspepsia, gastroesophageal refl ux disease, Sicca syndrome, worsening or new onset of psoriasis , urticaria, bruising , dermatitis, onychoclasis, hyperhidrosis, alopecia, pruritus, muscle spasms , renal impairment, haematuria, chest pain, oedema, pyrexia, coagulation and bleeding disorders, autoantibody test positive , blood lactate dehydrogenase increased, impaired healing. Serious, including fatal, adverse reactions have been reported including infections/sepsis, TB, opportunistic infections, allergic reactions, HBV reactivation and malignancies. Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupusrelated conditions and Stevens-Johnson syndrome. Other less common and rarely reported adverse reactions are listed in the SmPC. Pharmaceutical Precautions: Store in a refrigerator (2°C – 8°C). Do not freeze. Keep in the outer carton in order to protect from light. Out of the refrigerator, may be stored up to 25°C for up to 14 days. Legal Category: POM. Presentation and Marketing Authorisation Number. AMGEVITA® 20 mg solution for injection in pre-fi lled syringe: EU/1/16/1164/001 – 1 pack: cost AMGEVITA® 40 mg solution for injection in pre-fi lled syringe: EU/1/16/1164/003 – 2 pack AMGEVITA® 40 mg solution for injection in pre-fi lled pen: EU/1/16/1164/007 – 2 pack. Marketing Authorisation Holder: Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands. Further information is available from Amgen Ireland Limited, 21 Northwood Court, Santry, Dublin D09 TX31. AMGEVITA® is a registered trademark of Amgen Inc. Date of PI preparatio n: December 2021 (Ref:IE-AMB-1121-00005)

Adverse reactions/events should be reported to the Health Products Regulatory Authority (HPRA) using the available methods via www.hpra.ie. Adverse reactions/events should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160.

1. BVBM Amgevita Product Information Sheet. https://www.hse. ie/eng/about/who/cspd/ncps/medicines-management/bestvalue-medicines/best-value-biological-medicines/bvb-medicineamgevita-product-information-sheet.pdf. Accessed January 2022. 2. Oireachtas.ie, Debates, December 2020, Written Answer by Minister for Health. https://www.oireachtas.ie/en/debates/ question/2020-12-10/373/. Accessed January 2022. 3. Medicines Management Programme Best-Value Biological Medicines: Adalimumab 20 mg solution for injection. https://www.hse.ie/eng/ about/who/cspd/ncps/medicines-management/best-value-medicines/ best-value-biological-medicines/mmp-report-bvb-medicineadalimumab-20mg-march-2021.pdf. January 2022. 4. AMGEVITA® (adalimumab) summary of product characteristics.

IE-AMB-0122-00003 Date of preparation: January 2022

Strength of Balance

JYSELECA – a preferential JAK1 inhibitor for moderate to severe RA1

Indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs.1 May be used as monotherapy or in combination with methotrexate.1

Learn more at strengthofbalance.co.uk

Refer to Summary of Product Characteristics (SmPC) before prescribing, and for full prescribing information.

JYSELECA® filgotinib 100 mg or 200 mg film-coated tablets. Indication: Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Dosage: Adults: 200 mg once daily. Taken orally with/without food. It is recommended that tablets are swallowed whole. Laboratory Monitoring: Refer to the SmPC for information regarding laboratory monitoring and dose initiation or interruption. Elderly: A starting dose of 100 mg once daily is recommended for patients aged 75 years and older as clinical experience is limited. Renal impairment: No dose adjustment required in patients with estimated creatinine clearance (CrCl) ≥ 60 mL/min. A dose of 100 mg of filgotinib once daily is recommended for patients with moderate or severe renal impairment (CrCl 15 to < 60 mL/min). Not recommended in patients with CrCl < 15 mL/min. Hepatic impairment: Mild/moderate hepatic impairment: no dose adjustment required. Severe hepatic impairment: not recommended. Children (< 18years): Safety and efficacy not yet established. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active tuberculosis (TB) or active serious infections. Pregnancy. Warnings/Precautions: See SmPC for full information. Immunosuppression: Combination use, with immunosuppressants e.g. azathioprine, ciclosporin, tacrolimus, or biologic DMARDs (bDMARDs) or other Janus kinase (JAK) inhibitors is not recommended as a risk of additive immunosuppression cannot be excluded. Infections: Infections, including serious infections such as pneumonia and opportunistic infections e.g. tuberculosis (TB), oesophageal candidiasis, and cryptococcosis have been reported. Risk benefit should be assessed prior to initiating in patients with risk factors for infections (see SmPC). Patients should be closely monitored for the development of signs and symptoms of infections during and after filgotinib treatment. Treatment should be interrupted if the patient is not responding to antimicrobial therapy, until infection is controlled. There is a higher incidence of serious infections in the elderly aged 75 years and older, caution should be used when treating this population. Tuberculosis: Patients should be screened for TB before initiating filgotinib, and filgotinib should not be administered to patients with active TB. Viral reactivation: Cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies (see SmPC). If a patient develops herpes zoster, filgotinib treatment should be temporarily interrupted until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed. Malignancy: Immunomodulatory medicinal products may increase the risk of malignancies. Malignancies were observed in clinical studies (see SmPC). Fertility: In animal studies, decreased fertility, impaired spermatogenesis, and histopathological effects on male reproductive organs were observed (see SmPC). The potential effect of filgotinib on sperm production and male fertility in humans is currently unknown. Haematological abnormalities: Do not start therapy, or temporarily stop, if Absolute Neutrophil Count (ANC) <1 × 109 cells/L, ALC <0.5 × 109 cells/L or haemoglobin <8 g/dL. Temporarily stop therapy if these values are observed during routine patient management. Vaccinations: Use of live vaccines during, or immediately prior to, filgotinib treatment is not recommended. Lipids: Treatment with filgotinib was associated with dose dependent increases in lipid parameters, including total cholesterol, and high-density lipoprotein (HDL) levels, while low density lipoprotein (LDL) levels were slightly increased (see SmPC). Cardiovascular risk: Rheumatoid arthritis patients have an increased risk for cardiovascular disorders. Patients should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care. Venous thromboembolism: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including filgotinib. Caution should be used in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery, and prolonged immobilisation. Lactose content: Contains lactose; patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take filgotinib. Pregnancy/Lactation: Filgotinib is contraindicated in pregnancy. Filgotinib should not be used during breast-feeding. Women of childbearing potential must use effective contraception during and for at least 1 week after cessation of treatment. Driving/Using machinery: No or negligible influence, however dizziness has been reported. Side effects: See SmPC for full information. Common (≥1/100 to <1/10): nausea, upper respiratory tract infection, urinary tract infection and dizziness. Uncommon (≥1/1000 to <1/100): herpes zoster, pneumonia, neutropenia, hypercholesterolaemia and blood creatine phosphokinase increase. Serious side effects: See SmPC for full information Legal category: POM Pack: 30 film-coated tablets/bottle Price: UK Basic NHS cost: £863.10; Ireland: POA Marketing authorisation number(s): Jyseleca 100mg film-coated tablets EU/1/20/1480/001 EU/1/20/1480/002 Jyseleca 200mg film-coated tablets EU/1/20/1480/003 EU/1/20/1480/004 Further information: Galapagos UK, Belmont House, 148 Belmont Road, Uxbridge UB8 1QS, United Kingdom 00800 7878 1345 medicalinfo@glpg.com Jyseleca® is a trademark. Date of Preparation: January 2022 IE-RA-FIL-202112-00003

Additional monitoring required

Adverse events should be reported. For Northern Ireland, reporting forms and information can be found at yellowcard.mhra.gov.uk or via the Yellow Card app (download from the Apple App Store or Google Play Store). Adverse events should also be reported to Galapagos via email to Drug.safety.UK.Ireland@glpg.com or 00800 7878 1345

Adverse events should be reported. For Ireland, reporting forms and information can be found at www.hpra.ie and can be reported to HPRA on +353 1 6764971. Adverse events should also be reported to Galapagos via email to Drug.safety.UK.Ireland@glpg.com or 00800 7878 1345

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