In DMARD-IR AnD TnF-IR RA PATIenTs, In DMARD-IR AnD TnF-IR RA PATIenTs, WHEN COMBINATION WITH MTX IS NOT AN OPTION... WHEN COMBINATION WITH MTX IS NOT AN OPTION... ROACTEMRA ROACTEMRA STANDS OUT1 STANDS OUT1 RoActemRA, in combination with methotrexate (mtX), is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying RoActemRA, in combination with methotrexate (mtX),factor is indicated for the treatment of patients, moderate to severe active rheumatoid arthritis (RA) anti-rheumatic drugs (DmARDs) or tumour necrosis (tNF) antagonists. In these RoActemRA can be given as monotherapy in adult patients who have to either inadequately to, orwith whomtX wereisintolerant to, previous therapy with one or more disease-modifying in case of intolerance mtXresponded or where continued treatment inappropriate. RoActemRA has been shown to reduce the rate of 2 anti-rheumatic drugs (DmARDs) necrosis factor antagonists. In function these patients, RoActemRA can be given as monotherapy progression of joint damageorastumour measured by X-ray and(tNF) to improve physical when given in combination with methotrexate. in case of intolerance to mtX or where continued treatment with mtX is inappropriate. RoActemRA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.2 ABRIDGED PRESCRIBING INFORMATION (For full prescribing information, refer to the Summary of Product Characteristics [SmPC]) RoActemra® (Tocilizumab) 20mg/ml Concentrate for Solution for Infusion Indications: (i) In combination with methotrexate (MTX), for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more DMARDs or TNF antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. (ii) As monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX, for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients ≥ 2 years ® ABRIDGED PRESCRIBING INFORMATION (For fulltoprescribing information, refer and to the Summary of Product Dosage Characteristics [SmPC]) RoActemra (Tocilizumab) 20mg/ml Concentrate for Solution for Infusion of age, who have responded inadequately previous therapy with NSAIDs systemic corticosteroids. and Administration: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA or sJIA and all patients should be given Patient Alert Card. Recommended posology is 8mg/kgtodiluted a final volume ofarthritis 100ml, (RA) givenwho once every weeks by iv infusion over hour. For patients > 100kg, dosesantagonists. > 800mg per infusion are not Indications: (i) In combination with the methotrexate (MTX), forRA thePatients: treatment of adult patients with moderate severeto active rheumatoid have had4an inadequate response or 1intolerance to one orweighing more DMARDs or TNF In these patients, recommended. data on dosesinabove 1.2g. Dose adjustments: interruption orMTX in some cases discontinuation of RoActemra recommended therate event raised liverofenzymes, low absolute neutrophil count (ANC) or low physical platelet count (see RoActemra can be given No as monotherapy case of intolerance to MTX or Dose wheremodification, continued treatment with is inappropriate. RoActemra has been shown to reduceinthe of of progression joint damage as measured by X-ray and to improve function 9 SmPC for details). In patients not previously with RoActemra, not to recommended in treatment patients with anMTX ANCisbelow 2 x 10 /l. Closely monitor renal in patients with moderate severe juvenile renal impairment RoActemra not been≥studied when given in combination with methotrexate. (ii) As treated monotherapy (in case ofinitiation intolerance MTX or where with inappropriate) or in combination withfunction MTX, for the treatment of active to systemic idiopathicasarthritis (sJIA)has in patients 2 yearsin these patients. No data in patients to with hepatictherapy impairment. Patients: No data in patients < 2 years of age. 8mg/kg for patientsshould ≥ 30kgbe or initiated 12mg/kgby forhealthcare patients < professionals 30kg once every 2 weeks byinivthe infusion over and 1 hour. Check patient’s at each of age, who have responded inadequately previous with sJIA NSAIDs and systemic corticosteroids. Dosage andPosology: Administration: Treatment experienced diagnosis treatment of RA orweight sJIA and all visit – refer to SmPC. In the event raised enzymes, low ANC or low plateletiscount, interrupt/discontinue RoActemra dose orgiven modify/stop concomitant other over medications appropriate. – see>SmPC details. Reduction RoActemra dose patients should be given the Patient AlertofCard. RAliver Patients: Recommended posology 8mg/kg diluted to a final volume of 100ml, once every 4 weeksMTX by ivand infusion 1 hour. where For patients weighing 100kg,fordoses > 800mg perofinfusion are not due to No laboratory studied sJIA patients.Dose Clinical improvement is generallyorseen withincases 6 weeks of starting RoActemra, reconsider continuedintherapy if noof improvement seen in thislow timeframe. Hypersensitivity to anycount component recommended. data onabnormalities doses abovenot 1.2g. Doseinadjustments: modification, interruption in some discontinuation of RoActemra recommended the event raised liver enzymes, absoluteContraindications: neutrophil count (ANC) or low platelet (see the product; active, severe infections. Warnings and Precautions: Serious (sometimes fatal) infections reported inbelow patients immunosuppressive agents including RoActemra. Do nottoinitiate patients with active infection. If serious develops SmPC forof details). In patients not previously treated with RoActemra, initiation not recommended in patients with an ANC 2 xreceiving 109/l. Closely monitor renal function in patients with moderate severeinrenal impairment as RoActemra has notinfection been studied in interrupt infection controlled. Caution insJIA patients with No history infections, or other underlying conditions may patients to < infection. Vigilance forweeks the timely of serious recommended. these patients. Notherapy data in until patients with hepatic impairment. Patients: dataofinrecurring/chronic patients < 2 years of age. Posology: 8mg/kg for patientswhich ≥ 30kg or predispose 12mg/kg for patients 30kg once every 2 by iv detection infusion over 1 hour.infection Check patient’s weight Advise at eachall patients and In parents/guardians of sJIA to contact their healthcare immediately when RoActemra symptoms suggestive of an infection appear. Screen for latent prior to starting Treat latent withfor standard therapy dose before visit – refer to SmPC. the event of raised liverpatients enzymes, low ANC or low plateletprofessional count, interrupt/discontinue dose or modify/stop concomitant MTX and otherTB medications wheretherapy. appropriate. – see TB SmPC details.anti-mycobacterial Reduction of RoActemra initiating RoActemra. Viral reactivation (e.g. hepatitis B) reported with biologic therapies for RA. Patients screening positive for hepatitis excluded from clinical trials. Events of diverticular perforations as complications of diverticulitis reported uncommonly with due to laboratory abnormalities not studied in sJIA patients. Clinical improvement is generally seen within 6 weeks of starting RoActemra, reconsider continued therapy if no improvement seen in this timeframe. Contraindications: Hypersensitivity to any component RoActemra in severe RA patients. Exercise cautionand in patients with a Serious history of intestinal ulceration or diverticulitis. patients withimmunosuppressive symptoms of complicated promptly. Serious reactions reported - may be more severe and develops potentially of the product; active, infections. Warnings Precautions: (sometimes fatal) infections reported Evaluate in patients receiving agentsdiverticulitis including RoActemra. Do nothypersensitivity initiate in patients with active infection. If serious infection in patients who have experienced hypersensitivity reactions during previous infusions even if they have received premedication with steroids and anti-histamines. Appropriate treatment be available use in the event of an anaphylactic interrupt fatal therapy until infection controlled. Caution in patients with history of recurring/chronic infections, or other underlying conditions which may predispose patients to infection. Vigilance for should the timely detectionfor ofimmediate serious infection recommended. Advise all reaction with RoActemra. If an patients anaphylactic reaction or other serious hypersensitivity/serious related reaction occurs, stop administration of RoActemra immediately and discontinue therapy with caution in patients with activebefore hepatic patients and parents/guardians of sJIA to contact their healthcare professional immediately infusion when symptoms suggestive of an infection appear. Screen for latent TB prior to starting therapy. Treat permanently. latent TB withUse standard anti-mycobacterial therapy disease or hepatic impairment. Not recommended in patients with baseline ALT or AST > 5 x ULN; use with caution in patients with ALT or AST > 1.5 x ULN. Monitor ALT and AST levels for RA and sJIA patients according to SmPC – other liver function tests including initiating RoActemra. Viral reactivation (e.g. hepatitis B) reported with biologic therapies for RA. Patients screening positive for hepatitis excluded from clinical trials. Events of diverticular perforations as complications of diverticulitis reported uncommonly with bilirubin beExercise considered whereinindicated. If raised, followofdosage recommendations in SmPC for RA and sJIA patients. Risk of neutropenia may be increased in patients previously treated with a TNF antagonist. Continued therapy not recommended in patients RoActemra in RA should patients. caution patients with a history intestinal ulceration or diverticulitis. Evaluate patients with symptoms of complicated diverticulitis promptly. Serious hypersensitivity reactions reported - may be more severe and potentially 9 3 9 who develop an ANC < 0.5 x 10 /l or platelet count < 50 x 10 /μl. In patients not previously treated with RoActemra, initiation not recommended where ANC is below 2 x 10 l. Caution in patients with low platelet count; monitor neutrophils and platelets in RA and fatal in patients who have experienced hypersensitivity reactions during previous infusions even if they have received premedication with steroids and anti-histamines. Appropriate treatment should be available for immediate use in the event of an anaphylactic sJIA patients according to SmPC. If reduced, follow dosage recommendations in SmPC for RA and sJIA patients. Elevations in lipid parameters seen - refer to SmPC. Assess lipid parameters according to SmPC, if elevated, manage patients according to local reaction with RoActemra. If an anaphylactic reaction or other serious hypersensitivity/serious infusion related reaction occurs, stop administration of RoActemra immediately and discontinue therapy permanently. Use with caution in patients with active hepatic guidelines for hyperlipidaemia. Potential for central demyelination with RoActemra currently unknown; physicians should be vigilant for symptoms of new onset disease. Immunomodulatory medicines may increase malignancy risk in RA patients. Do not give live disease or hepatic impairment. Not recommended in patients with baseline ALT or AST > 5 x ULN; use with caution in patients with ALT or AST > 1.5 x ULN. Monitor ALT and AST levels for RA and sJIA patients according to SmPC – other liver function tests including and live attenuated vaccines concurrently with RoActemra as safety not established – refer to SmPC for further details on immunisations. RA patients should have CV risk factors managed as part of usual standard of care. Not recommended for use with other bilirubin should be considered where indicated. If raised, follow dosage recommendations in SmPC for RA sJIA patients. Riskpatients of neutropenia may be increased patients treated a TNF Continued therapy not recommended into patients biological agents. Macrophage activation syndrome (MAS) is a serious life-threatening disorder thatand may develop in sJIA – RoActemra has not beeninstudied in previously patients during an with active MASantagonist. episode. Advise patients experiencing dizziness not drive or who develop an ANC