WHAT YOU SHOULD KNOW ABOUT RoACTEMRA

Transcription

1 RoACTEMRA for Giat Cell Arteritis WHAT YOU SHOULD KNOW ABOUT RoACTEMRA This brochure provides key iformatio to assist i the patiet s uderstadig of the beefits ad risks associated with RoACTEMRA therapy Refer to the Package Leaflet available o for further iformatio IE Versio Date of Preparatio: August 2017 Date of HPRA approval: October 2017

2 This educatioal material is madatory as a coditio of the marketig authorisatio of subcutaeous RoACTEMRA 162 mg solutio i the treatmet of adult patiets with giat cell arteritis i order to further miimise importat selected risks. Call Roche Medical Iformatio Departmet o 01 ( ). 2 IE Versio 1.0.0

3 What you should kow about RoACTEMRA All medicatios carry both potetial beefits ad potetial risks to our health ad it is importat to uderstad these. Fidig the balace betwee the two will lead you to a giat cell arteritis (GCA) treatmet that works best for you. RoACTEMRA is idicated for the treatmet of Giat Cell Arteritis (GCA) i adult patiets. RoACTEMRA mootherapy should ot be used for the treatmet of acute relapses. This brochure will aswer some questios you may have about the side effects ad potetial risks of RoACTEMRA. Talk to your doctor, urse or pharmacist if you have ay questios or problem. This brochure does ot take the place of speakig to your doctor, urse or pharmacist. Medicatios are sometimes prescribed for purposes other tha those listed. Oly take RoACTEMRA as directed for the coditio for which it was prescribed. What you should kow about GCA ad RoACTEMRA What causes GCA? No oe kows for sure. I GCA, the body s immue system does t work the way it should. The immue system is supposed to attack oly foreig substaces like germs. But whe it does t work right, it ca also attack the body itself. Diseases i which this happes, like GCA, are called autoimmue diseases. Whe the immue system attacks the body, it ca lead to the symptoms people with GCA have. I GCA these may iclude headaches ad visio loss. What is IL-6? Iterleuki-6 (IL-6) is a protei that is made by the immue system. The body uses IL-6 to maage iflammatio ad ifectios. What is RoACTEMRA? RoACTEMRA is a biologic drug (a type of therapy made from livig cells) that blocks the actios of IL-6 i the body. It is used i adults to treat GCA. How has RoACTEMRA bee studied i GCA? RoACTEMRA has bee studied i adults with GCA i combiatio with a gradual reductio of steroids. How is RoACTEMRA used i GCA? GCA is ofte treated with medicies called steroids. They are usually effective, but ca have side effects if used at high doses for a log time. Reducig the steroid dose ca also lead to a flare-up of the GCA. Addig RoACTEMRA to the treatmet meas that steroids ca be used for a shorter time, while still cotrollig GCA. IE Versio

4 How is RoACTEMRA give i GCA? RoACTEMRA is admiistered as a subcutaeous (uder the ski) (SC) ijectio usig a pre-filled syrige. Please refer to the relevat sectio below for more specific iformatio o how RoACTEMRA is admiistered. Receivig RoACTEMRA by subcutaeous ijectio by pre-filled syrige You ad your doctor or urse will decide if you (or your caregiver) are suitable for RoACTEMRA SC use at home I this case you will receive proper traiig o how to iject RoACTEMRA SC usig a pre-filled syrige Your doctor or urse will give you your first RoACTEMRA SC ijectio Ijectio is ito your abdome or thigh Dosig is set at 162 mg RoACTEMRA, regardless of body weight RoACTEMRA is give oce per week (uless istructed otherwise by your healthcare professioal) It is very importat to use RoACTEMRA exactly as prescribed by your doctor ad to keep track of your doses. If you miss your weekly ijectio of RoACTEMRA but are withi 7 days of whe your dose was due, just take your ormal dose as usual o the ext scheduled day If you miss your oce-every-other-weekly ijectio of RoACTEMRA ad are withi 7 days of whe the missed dose was due, you should take the missed dose immediately ad take your ext dose as usual o the ext scheduled day If you miss your weekly or every-other-weekly dose by more tha 7 days or are ot sure whe to iject RoACTEMRA, call your doctor, urse or pharmacist 2 IE Versio 1.0.0

5 Geeral cosideratios for admiistratio (pre-filled syrige) RoACTEMRA 162 mg is supplied i 0.9 ml of solutio for ijectio as a pack of 4 sigle use pre-filled syriges. The followig should be cosidered before admiistratio: The pre-filled syriges should be stored at 2 C-8 C ad should ot be froze The pre-filled syriges should be kept i the outer carto to protect them from light ad should be kept dry. The pre-filled syriges should be kept out of sight ad reach of childre Ispect the pre-filled syrige visually for particulate matter ad discolouratio prior to admiistratio. Do ot use if the medicie is cloudy or cotais particles, is ay colour besides colourless to slightly yellowish, or if ay part of the pre-filled syrige appears to be damaged Oce removed from the refrigerator, RoACTEMRA 162 mg/0.9 ml must be admiistered withi 8 hours ad should ot be kept above 30 C After removig the pre-filled syrige from the refrigerator: The pre-filled syrige should be allowed to reach room temperature (18 C to 28 C) by waitig for 25 to 30 miutes, before ijectig RoACTEMRA 162 mg/0.9 ml. Do ot warm up the pre-filled syrige i ay other way After removig the eedle-cap, the ijectio must be started withi 5 miutes to prevet the medicie from dryig out ad blockig the eedle. If the pre-filled syrige is ot used withi 5 miutes of removig the cap, you must dispose of it i a pucture-resistat cotaier ad use a ew pre-filled syrige. Never re-attach the eedle-cap after removal The pre-filled syrige should ot be shake If followig isertio of the eedle you caot depress the pluger, you must dispose of the pre-filled syrige i a pucture-resistat cotaier ad use a ew pre-filled syrige The first dose should be admiistered by a healthcare professioal ad after proper traiig i ijectio techique, patiets may self-iject with RoACTEMRA if it is deemed appropriate Ay uused product or waste material should be disposed of i a pucture-resistat cotaier For further iformatio, please cosult the Step-by-Step Dosig ad Admiistratio Guide for RoACTEMRA ad iformatio give i the Package Leaflet. IE Versio

6 What tests will be doe whe I am receivig treatmet with RoACTEMRA? At each visit to see your doctor or urse, they may test your blood to help guide your treatmet. Here are some thigs they may look at: Neutrophils. Havig eough eutrophils is importat to help our bodies fight ifectios. RoACTEMRA works o the immue system ad ca cause the umber of eutrophils, a form of white blood cells, to drop. For this reaso, your doctor may test to make sure you have eough eutrophils ad moitor for sigs ad symptoms of ifectio. Platelets. Platelets are small blood compoets that help stop bleedig by formig clots. Some people takig RoACTEMRA had a drop i the umber of platelets i their blood. I cliical trials, the drop i platelets was ot associated with ay serious bleedig. Liver ezymes. Liver ezymes are proteis produced by your liver which may be released ito your blood, sometimes idicatig liver damage or disease. Some people who have take RoACTEMRA have had a rise i liver ezymes, which could be a sig of liver damage. Rises i liver ezymes were see more ofte whe medicatios that could be harmful to the liver were used with RoACTEMRA. If this happes to you, your doctor should take care of this right away. Your doctor may decide to chage your dose of RoACTEMRA, or of other medicatio, or potetially stop treatmet with RoACTEMRA altogether. Cholesterol. Some people who have take RoACTEMRA have had a rise i blood cholesterol, which is a type of lipid (fat). If this happes, your doctor may prescribe a cholesterol-lowerig medicatio. Ca patiets have vacciatios durig treatmet with RoACTEMRA? RoACTEMRA is a medicatio that affects the immue system ad may lower the body s ability to fight ifectio. Immuisatio with live or live-atteuated vaccies (which cotai very small amouts of the actual germ or weakeed germs), such as a flu shot, should ot be give durig treatmet with RoACTEMRA. Patiets should be brought up to date with all immuisatios before startig RoACTEMRA. What are the most commo side effects of RoACTEMRA? Most commo side effects reported by patiets i cliical trials were usually mild ad usually did ot result i the patiet havig to stop usig the medicatio. These commo side effects were: Upper respiratory tract ifectios (commo cold, sius ifectios) Headache Temporary rise i blood pressure Rash Dizziess if you experiece dizziess, you should ot drive or use machies util it has resolved Ijectio site reactios (icludig erythema, pruritus, pai ad hematoma) 4 IE Versio 1.0.0

7 What are the serious side effects of RoACTEMRA? Ifectios. RoACTEMRA is a medicatio that affects your immue system. Your immue system is importat because it helps you fight ifectios. Your ability to fight ifectios may be lowered with RoACTEMRA. Some ifectios may become serious while o RoACTEMRA. Serious ifectios may require treatmet ad hospitalisatio ad i some cases may lead to death. It is very importat to report ay sigs of ifectio to your doctor or urse right away. Seek immediate medical attetio if you develop sigs/symptoms of ifectio such as: Fever Wheezig Persistet cough Red or swolle ski blisters, ski tears or wouds Weight loss Severe weakess or tiredess Throat pai or soreess Allergic reactios. Most allergic reactios occur durig ijectio or withi 24 hours of RoACTEMRA admiistratio, although allergic reactios ca occur at ay time. Serious allergic reactios icludig aaphylaxis have bee reported i associatio with RoACTEMRA. Such reactios may be more severe, ad potetially fatal i patiets who have experieced allergic reactios durig previous treatmet with RoACTEMRA. Fatal aaphylaxis has bee reported after marketig authorisatio durig treatmet with itraveous RoACTEMRA. If a aaphylactic reactio or other serious allergic reactio occurs, admiistratio of RoACTEMRA should be stopped immediately, appropriate medical treatmet iitiated ad RoACTEMRA should be permaetly discotiued Your doctor will assess you (or your caregiver) for your suitability to use RoACTEMRA ijectios at home Do ot take the ext dose util you have iformed your doctor AND your doctor has told you to take the ext dose if you have experieced ay allergic reactio symptoms after receivig RoACTEMRA, if you are admiisterig at home ad you experiece ay symptoms suggestive of a allergic reactio Seek immediate medical attetio if you otice ay of the followig sigs or symptoms of allergic reactios after receivig RoACTEMRA: Rash, itchig or hives Shortess of breath or trouble breathig Swellig of the lips, togue or face Chest pai Feelig dizzy or fait Severe stomach pai or vomitig Very low blood pressure IE Versio

8 Abdomial pai. Patiets takig RoACTEMRA have o rare occasios experieced serious side effects i their stomach ad itesties. Symptoms may iclude fever ad persistet abdomial pai with chage i bowel habits. Seek immediate medical attetio if you develop stomach pai or colic, or otice blood i your stool. Maligacies. Medicial products which act o the immue system, like RoACTEMRA, may icrease the risk of maligacy. Summary ad cotact iformatio This GCA patiet brochure reviews some of the most importat iformatio about RoACTEMRA. Medicatios are sometimes prescribed for purposes other tha those listed. Do ot use RoACTEMRA for a coditio for which it was ot prescribed. Tell your doctor, urse or pharmacist about ay side effect you experiece, bothers you or that does ot go away. These side effects listed i this brochure are ot all of the possible side effects that you could experiece with RoACTEMRA. Ask your doctor, urse or pharmacist for more iformatio. Talk to your doctor, urse or pharmacist if you have ay questios or problems. Reportig of suspected adverse evets or reactios If you get ay side effects, talk to your doctor, pharmacist or urse. This icludes ay possible side effects ot listed i the Package Leaflet. You ca also report side effects directly (see details below). By reportig side effects you ca help provide more iformatio o the safety of this medicie. I the evet of a suspected adverse evet, please report it to: The Drug Surveillace Cetre Roche Products (Irelad) Limited 3004 Lake Drive, Citywest, Naas Road, Dubli 24 Telephoe: (01) Fax: (01) irelad.drug_surveillace_cetre@roche.com Alteratively, suspected adverse reactios should be reported to: HPRA Pharmacovigilace The Health Products Regulatory Authority Kevi O Malley House, Earlsfort Cetre, Earlsfort Terrace, Dubli 2 Telephoe: (01) Fax: (01) medsafety@hpra.ie Website: 6 IE Versio 1.0.0

9 For full iformatio o all possible adverse evets please see the Patiet Leaflet which is available i all EU/EEA laguages o the Europea Medicies Agecy website ( europa.eu) or For further iformatio about RoACTEMRA, please cotact Medical Iformatio at Roche Products (Irelad) Limited by telephoe ( ), fax ( ) or (Irelad.drugifo@roche.com). IE Versio

10 Pre-Admiistratio Checklist for GCA Before each admiistratio of RoACTEMRA, please review the poits below RoACTEMRA may ot be right for you. Before startig RoACTEMRA, ad before each admiistratio of RoACTEMRA, please review the poits below, ad tell your doctor or urse if you checked yes for ay of the followig: YES NO Ifectios Do you have a ifectio or feel uwell? (Sigs of a ifectio may iclude: fever, cough, headache, ope wouds or sores (as i chicke pox or shigles)) Are you beig treated for a ifectio or get a lot of ifectios? Do you have tuberculosis (TB) or have you bee i close cotact with someoe who has had TB? (Your doctor should test you for TB before startig RoACTEMRA) Have you had or curretly have viral hepatitis or ay disease of the liver? Do you have diabetes or other coditios that icrease the chace of ifectios? Allergic Reactios Have you had ay allergic reactios to previous medicatios, icludig RoACTEMRA? Gastroitestial Complicatios Have you had or curretly have gastroitestial ulcers or diverticulitis (iflammatio i parts of your large itestie)? (Symptoms may iclude abdomial pai ad uexplaied chages i bowel habits, with fever) Medical History Have you had or do you ow have impaired lug fuctio? (For example, iterstitial lug disease, where iflammatio ad scarrig i the lugs make it difficult to get eough oxyge) Have you ever had cacer? Do you have heart or circulatory disease? (Examples iclude raised blood pressure or cholesterol levels) Do you have kidey problems? Do you have persistet headaches? 8 IE Versio 1.0.0

11 YES NO Pregacy Are you pregat, possibly pregat or do you ited to become pregat? (Wome of childbearig potetial must use effective cotraceptio durig (ad up to 3 moths after) treatmet. RoACTEMRA should ot be used durig pregacy uless absolutely ecessary) Are you breast-feedig or do you ited to breast-feed? Medicatios Have you recetly had a vacciatio (immuisatio), such as a flu shot, or are scheduled to have oe? Are you takig other medicatios? Tell your doctor or urse about all the medicies you take. This icludes prescriptio (such as steroids) ad o-prescriptio medicatios, vitamis ad herbal medicies. You ca take other medicatios if your doctor has told you it is okay to take them while you are takig RoACTEMRA. RoACTEMRA may iteract with some medicatios. This may affect the dose you eed of that medicatio. No effect of cumulative corticosteroid dose o RoACTEMRA exposure was observed i GCA patiets Tell your doctor if you are takig the followig medicies: atorvastati, used to reduce cholesterol levels methylpredisoloe, dexamethasoe, used to reduce iflammatio calcium chael blockers (e.g. amlodipie), used to treat raised blood pressure theophyllie, used to treat asthma warfari, used as a blood-thiig aget pheytoi, used to treat covulsios ciclospori, used to suppress the immue system durig orga trasplats bezodiazepies (e.g. temazepam), used to relieve axiety

12 IE Versio Date of Preparatio: August 2017 Copyright 2017 by Roche Products (Irelad) Limited. All rights reserved.