RActemra (tcilizumab) fr Giant Cell Arteritis (GCA) subcutaneus (SC) frmulatin What yu shuld knw abut RActemra This brchure prvides key infrmatin t assist in the patient s understanding f the benefits and risks assciated with RActemra therapy
This educatinal material is prvided by Rche Prducts Limited and Chugai Pharma UK Ltd and is mandatry as a cnditin f the marketing authrisatin f RActemra 162mg slutin fr injectin in pre-filled syringe fr the treatment f GCA in adult patients in rder t further minimise imprtant selected risks. Fr mre infrmatin n RActemra, please see the Patient Infrmatin Leaflet (PIL) that cmes with yur medicine. If yu have any further questins, please ask yur dctr, nurse r pharmacist. 2
What yu shuld knw abut RActemra All medicatins carry bth ptential benefits and ptential risks t ur health and it is imprtant t understand these. Finding the balance between the tw will lead yu t a treatment fr giant cell arteritis (GCA) treatment that wrks best fr yu. RActemra might be that treatment. RActemra initially in cmbinatin with sterids, can be used t treat GCA in adult patients. This brchure will answer sme questins yu may have abut the side effects and ptential risks f RActemra. Talk t yur dctr, nurse r pharmacist if yu have any questins r prblems. This brchure des nt take the place f speaking t yur dctr, nurse r pharmacist. Medicines are smetimes prescribed fr purpses ther than thse listed. Only take RActemra as directed fr the cnditin fr which it was prescribed. 3
What yu shuld knw abut GCA and RActemra What causes GCA? N ne knws fr sure. In GCA, the bdy s immune system desn t wrk the way it shuld. The immune system is suppsed t attack nly freign substances like germs. But when it desn t wrk right, it can als attack the bdy itself. Diseases in which this happens, like GCA, are called autimmune diseases. When the immune system attacks the bdy, it can lead t the symptms peple with GCA have. In GCA these may include headaches and visin lss. What is IL-6? Interleukin-6 (IL-6) is a prtein that is made by the immune system. The bdy uses IL-6 t manage inflammatin and infectins. What is RActemra? RActemra is a bilgic drug (a type f therapy made frm living cells) that blcks the actins f IL-6 in the bdy. It is used in adults t treat GCA. Hw has RActemra been studied in GCA? RActemra has been studied in adults with GCA in cmbinatin with a gradual reductin f sterids. Hw is RActemra used in GCA? RActemra can be used in cmbinatin with a gradual reductin f sterids; RActemra can als be used alne fllwing discntinuatin f sterids. Hw is RActemra given in GCA? RActemra is administered as a subcutaneus (under the skin) (SC) injectin using a pre-filled syringe. Please refer t the relevant sectin belw fr mre specific infrmatin n hw RActemra is administered. 4
Receiving RActemra by subcutaneus injectin by pre-filled syringe Yu and yur dctr r nurse will decide if yu (r yur caregiver) are suitable fr RActemra SC use at hme - In this case yu will receive prper training n hw t inject RActemra SC using a pre-filled syringe Yur dctr r nurse will give yu yur first RActemra SC injectin Injectin is int yur abdmen r thigh Dsing is set at 162 mg RActemra, regardless f bdy weight RActemra is given nce per week It is very imprtant t use RActemra exactly as prescribed by yur dctr and t keep track f yur dses. If yu miss yur weekly injectin f RActemra but are within 7 days f when yur dse was due, just take yur nrmal dse as usual n the next scheduled day If yu miss yur weekly dse by mre than 7 days r are nt sure when t inject RActemra, call yur dctr, nurse r pharmacist General cnsideratins fr administratin (pre-filled syringe) RActemra 162 mg is supplied in 0.9 ml f slutin fr injectin as a pack f 4 single use pre-filled syringes. The fllwing shuld be cnsidered befre administratin: The pre-filled syringes shuld be stred at 2 C 8 C and shuld nt be frzen The pre-filled syringes shuld be kept in the uter cartn t prtect them frm light and shuld be kept dry. The pre-filled syringes shuld be kept ut f sight and reach f children Inspect the pre-filled syringe visually fr particulate matter and discluratin prir t administratin. D nt use if the medicine is cludy r cntains particles, is any clur besides clurless t slightly yellwish, r if any part f the pre-filled syringe appears t be damaged 5
Once remved frm the refrigeratr, RActemra 162 mg/0.9 ml must be administered within 8 hurs and shuld nt be kept abve 30 C After remving the pre-filled syringe frm the refrigeratr: - The pre-filled syringe shuld be allwed t reach rm temperature (18 C t 28 C) by waiting fr 25 t 30 minutes, befre injecting RActemra 162 mg/0.9 ml. D nt warm up the pre-filled syringe in any ther way - After remving the needle-cap, the injectin must be started within 5 minutes t prevent the medicine frm drying ut and blcking the needle. If the pre-filled syringe is nt used within 5 minutes f remving the cap, yu must dispse f it in a puncture-resistant cntainer and use a new pre-filled syringe. Never re-attach the needle-cap after remval - The pre-filled syringe shuld nt be shaken - If fllwing insertin f the needle yu cannt depress the plunger, yu must dispse f the pre-filled syringe in a puncture-resistant cntainer and use a new pre-filled syringe. The first dse shuld be administered by a healthcare prfessinal and after prper training in injectin technique, patients may self-inject with RActemra if it is deemed apprpriate Any unused prduct r waste material shuld be dispsed f in a puncture-resistant cntainer. Fr further infrmatin, please cnsult the infrmatin given in the package leaflet. What tests will be dne when I am receiving treatment with RActemra? At each visit t see yur dctr r nurse, they may test yur bld t help guide yur treatment. Here are sme things they may lk at: Neutrphils Having enugh neutrphils is imprtant t help ur bdies fight infectins. RActemra wrks n the immune system and can cause the number f neutrphils, a frm f white bld cells, t drp. Fr this reasn, yur dctr may test t make sure yu have enugh neutrphils and mnitr fr signs and symptms f infectin. 6
Platelets Platelets are small bld cmpnents that help stp bleeding by frming clts. Sme peple taking RActemra had a drp in the number f platelets in their bld. In clinical trials, the drp in platelets was nt assciated with any serius bleeding. Liver enzymes Liver enzymes are prteins prduced by yur liver which may be released int yur bld, smetimes indicating liver damage r disease. Sme peple wh have taken RActemra have had a rise in liver enzymes, which culd be a sign f liver damage. Rises in liver enzymes were seen mre ften when medicatins that culd be harmful t the liver were used with RActemra. If this happens t yu, yur dctr shuld take care f this right away. Yur dctr may decide t change yur dse f RActemra, r f ther medicatin, r ptentially stp treatment with RActemra altgether. Chlesterl Sme peple wh have taken RActemra have had a rise in bld chlesterl, which is a type f lipid (fat). If this happens, yur dctr may prescribe a chlesterl-lwering medicatin. Can patients have vaccinatins during treatment with RActemra? RActemra is a medicatin that affects the immune system and may lwer the bdy s ability t fight infectin. Immunisatin with live r live-attenuated vaccines (which cntain very small amunts f the actual germ r weakened germs), shuld nt be given during treatment with RActemra. Patients shuld be brught up t date with all immunisatins befre starting RActemra. What are the mst cmmn side effects f RActemra? Mst cmmn side effects reprted by patients in clinical trials were usually mild and usually did nt result in the patient having t stp using the medicatin. These cmmn side effects were: Upper respiratry tract infectins (cmmn cld, sinus infectins) Headache Temprary rise in bld pressure Rash Dizziness if yu experience dizziness, yu shuld nt drive r use machines until it has reslved Injectin site reactins (including erythema, pruritus, pain and hematma) 7
What are the serius side effects f RActemra? Infectins RActemra is a medicatin that affects yur immune system. Yur immune system is imprtant because it helps yu fight infectins. Yur ability t fight infectins may be lwered with RActemra. Sme infectins may becme serius while n RActemra. Serius infectins may require treatment and hspitalisatin and in sme cases may lead t death. It is very imprtant t reprt any signs f infectin t yur dctr r nurse right away Seek immediate medical attentin if yu develp signs/symptms f infectin such as: Fever Persistent cugh Weight lss Thrat pain r sreness Wheezing Red r swllen skin blisters, skin tears r wunds Severe weakness r tiredness Allergic reactins Mst allergic reactins ccur during injectin r within 24 hurs f RActemra administratin, althugh allergic reactins can ccur at any time. Serius allergic reactins including anaphylaxis have been reprted in assciatin with RActemra. Such reactins may be mre severe, and ptentially fatal in patients wh have experienced allergic reactins during previus treatment with RActemra. Fatal anaphylaxis has been reprted after marketing authrisatin during treatment with intravenus RActemra. If an anaphylactic reactin r ther serius allergic reactin ccurs, administratin f RActemra shuld be stpped immediately, apprpriate medical treatment initiated and RActemra shuld be permanently discntinued. Yur dctr will assess yu (r yur caregiver) fr yur suitability t use RActemra injectins at hme. D nt take the next dse until yu have infrmed yur dctr AND yur dctr has tld yu t take the next dse if yu have experienced any allergic reactin symptms after receiving RActemra, if yu are administering at hme and yu experience any symptms suggestive f an allergic reactin. 8
Seek immediate medical attentin if yu ntice any f the fllwing signs r symptms f allergic reactins after receiving RActemra: Rash, itching r hives Shrtness f breath r truble breathing Swelling f the lips, tngue r face Chest pain Feeling dizzy r faint Severe stmach pain r vmiting Very lw bld pressure Abdminal pain Patients taking RActemra have n rare ccasins experienced serius side effects in their stmach and intestines. Symptms may include fever and persistent abdminal pain with change in bwel habits. Seek immediate medical attentin if yu develp stmach pain r clic, r ntice bld in yur stl. Malignancies Medicines which act n the immune system, like RActemra, may increase the risk f malignancy. Summary and cntact infrmatin This GCA patient brchure reviews sme f the mst imprtant infrmatin abut RActemra. Medicines are smetimes prescribed fr purpses ther than thse listed. D nt use RActemra fr a cnditin fr which it was nt prescribed. Tell yur dctr, nurse r pharmacist abut any side effect yu experience, bthers yu r that des nt g away. These side effects listed in this brchure are nt all f the pssible side effects that yu culd experience with RActemra. Ask yur dctr, nurse r pharmacist fr mre infrmatin. Talk t yur dctr, nurse r pharmacist if yu have any questins r prblems. Reprting f side effects If yu get any side effects, talk t yur dctr, pharmacist r nurse. This includes any pssible side effects nt listed in the package leaflet. Yu can als reprt side effects directly via the Yellw Card Scheme at www.mhra.gv.uk/yellwcard r search fr MHRA Yellw Card in the Ggle Play r Apple App Stre, r t Rche Prducts Limited. Please cntact Rche Drug Safety Centre by emailing welwyn.uk_dsc@rche.cm r calling +44 (0)1707 367554. By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. Detailed infrmatin n this medicine is available n the Eurpean Medicines Agency website (www.ema.eurpa.eu). 9
Pre-Administratin Checklist fr GCA - Befre each administratin f RActemra, please review the pints belw RActemra may nt be right fr yu. Befre starting RActemra, and befre each administratin f RActemra, please review the pints belw, and tell yur dctr r nurse if yu checked yes fr any f the fllwing: Infectins D yu have an infectin r feel unwell? (Signs f an infectin may include: fever, cugh, headache, pen wunds r sres (as in chicken px r shingles) Are yu being treated fr an infectin r get a lt f infectins? D yu have tuberculsis (TB) r have yu been in clse cntact with smene wh has had TB? (Yur dctr shuld test yu fr TB befre starting RActemra.) Have yu had r currently have viral hepatitis r any disease f the liver? D yu have diabetes r ther cnditins that increase the chance f infectins? Allergic Reactins Have yu had any allergic reactins t previus medicatins, including RActemra? Gastrintestinal Cmplicatins YES NO Have yu had r currently have gastrintestinal ulcers r diverticulitis (inflammatin in parts f yur large intestine)? (Symptms my include abdminal pain and unexplained changes in bwel habits, with fever) Medical Histry Have yu had r d yu nw have impaired lung functin? (Fr example, interstitial lung disease, where inflammatin and scarring in the lungs make it difficult t get enugh xygen) Have yu ever had cancer? D yu have heart r circulatry disease? (Examples include raised bld pressure r chlesterl levels) D yu have kidney prblems? D yu have persistent headaches? 10
YES NO Pregnancy Are yu pregnant, pssibly pregnant r d yu intend t becme pregnant? (Wmen f childbearing ptential must use effective cntraceptin during (and up t 3 mnths after)) treatment. RActemra shuld nt be used during pregnancy unless abslutely necessary). Are yu breast-feeding r d yu intend t breast-feed? Medicatins Have yu recently had a vaccinatin (immunisatin), r are scheduled t have ne? Are yu taking ther medicatins? Tell yur dctr r nurse abut all the medicines yu take. This includes prescriptin (such as sterids) and nnprescriptin medicatins, vitamins and herbal medicines Yu can take ther medicatins if yur dctr has tld yu it is kay t take them while yu are taking RActemra. RActemra may interact with sme medicatins. This may affect the dse yu need f that medicatin. N effect f cumulative crticsterid dse n RActemra expsure was bserved In GCA patients. Tell yur dctr if yu are taking the fllwing medicines: atrvastatin, used t reduce chlesterl levels calcium channel blckers (e.g. amldipine), used t treat raised bld pressure thephylline, used t treat asthma warfarin, used as a bld-thinning agent phenytin, used t treat cnvulsins ciclsprin, used t suppress the immune system during rgan transplants benzdiazepines (e.g. temazepam), used t relieve anxiety 11
12 RCUKACTE01604e March 2018