Orencia 125mg/ml Opl Inf Voorgevulde Pen 4

Combinatie met TNF‑remmers Er is beperkte ervaring met het gebruik van abatacept in combinatie met TNF‑remmers (zie rubriek 5.1). In placebogecontroleerde klinische onderzoeken, waarin de combinatie van TNF‑remmers en placebo is vergeleken met de combinatie van TNF‑remmers en abatacept, ondervonden de patiënten die werden behandeld met de combinatie van TNF‑remmers en abatacept een verhoging van het totale aantal infecties en ernstige infecties (zie rubriek 4.5). Abatacept wordt niet aangeraden voor gebruik in combinatie met TNF‑remmers. Bij de overstap van behandeling met TNF‑remmers naar ORENCIA dienen patiënten te worden gecontroleerd op tekenen van infectie (zie rubriek 5.1 onderzoek VII). <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...> <...> (the text continues as below) <...>

Reumatoïde artritis

• In combinatie met methotrexaat.
• Bij matig-ernstige tot ernstige reumatoïde artritis bij volwassen patiënten met onvoldoende respons op eerdere therapie met één of meer Disease-Modifying Anti-Rheumatic Drugs (DMARDs) inclusief methotrexaat of een tumornecrosefactor (TNF)-alfa-remmer.

1. KWALITATIEVE EN KWANTITATIEVE SAMENSTELLING

Elke injectieflacon bevat 250 mg abatacept. Elke ml bevat na bereiding van het concentraat 25 mg abatacept.

Abatacept is een fusie-eiwit verkregen door recombinant DNA technologie uit ovariumcellen van Chinese hamsters.

Hulpstof met bekend effect

natrium: 0,375 mmol (8,625 mg) per injectieflacon

Voor de volledige lijst van hulpstoffen, zie rubriek 6.1.

De combinatie met TNF‑remmers Er is beperkte ervaring met het gebruik van abatacept in combinatie met TNF‑remmers (zie rubriek 5.1). Hoewel TNF‑remmers de klaring van abatacept niet beïnvloedden, was in placebogecontroleerde klinische onderzoeken de frequentie van infecties en ernstige infecties bij patiënten die gelijktijdig behandeld werden met abatacept en een TNF‑remmer hoger dan bij patiënten die alleen behandeld werden met TNF‑remmers. Daarom wordt gelijktijdig gebruik van abatacept en een TNF‑remmer niet aanbevolen. De combinatie met andere geneesmiddelen Farmacokinetische onderzoeken in populaties toonde geen effecten aan van methotrexaat, NSAID's en corticosteroïden op de klaring van abatacept (zie rubriek 5.2). Er werden geen grote veiligheidsrisico's geïdentificeerd bij het gebruik van abatacept in combinatie met sulfasalazine, hydroxychloroquine of leflunomide. De combinatie met andere geneesmiddelen die het immuunsysteem beïnvloeden en met vaccins Gelijktijdige toediening van abatacept met biologische immunosuppressiva of immunomodulerende middelen kan het effect van abatacept op het immuunsysteem versterken. Er is onvoldoende bewijs om de veiligheid en werkzaamheid van abatacept in combinatie met anakinra of rituximab te beoordelen (zie rubriek 4.4). Levende vaccins mogen niet gelijktijdig of binnen 3 maanden na beëindiging van de behandeling met abatacept gegeven worden. Er zijn geen gegevens beschikbaar over secundaire infectieoverdracht van personen die levende vaccins krijgen op patiënten die abatacept krijgen. Geneesmiddelen die invloed hebben op het immuunsysteem, waaronder abatacept, kunnen de werkzaamheid van sommige immunisaties verlagen (zie rubrieken 4.4 en 4.6). Verkennende studies om het effect van abatacept op de antilichaamrespons bij vaccinatie van gezonde proefpersonen evenals de antilichaamrespons bij griep- en pneumokokkenvaccinatie van RA‑patiënten te beoordelen suggereren dat abatacept de werkzaamheid van de immuunrespons kan verminderen, maar het vermogen om een klinisch significante of positieve immuunreactie te ontwikkelen werd niet significant afgeremd. Abatacept werd geëvalueerd in een open-label studie bij RA‑patiënten die het 23‑valent pneumokokkenvaccin toegediend kregen. Na pneumokokkenvaccinatie, waren 62 van de 112 met abatacept behandelde patiënten in staat om een adequate immuunrespons van ten minste een 2‑voudige toename in de antistoftiters tegen het pneumokokkenpolysaccharidevaccin te ontwikkelen. Abatacept werd ook geëvalueerd in een open‑label studie bij RA‑patiënten die het trivalente virusvaccin tegen seizoensgriep toegediend kregen. Na griepvaccinatie, waren 73 van de 119 met abatacept behandelde patiënten die geen beschermende hoeveelheid antistof hadden bij aanvang, in staat om een adequate immuunrespons van ten minste een 4‑voudige toename van de antistoftiters tegen het trivalente griepvaccin te ontwikkelen.

4.8 Bijwerkingen

Samenvatting van het veiligheidsprofiel bij reumatoïde artritis

Abatacept is onderzocht bij patiënten met actieve reumatoïde artritis in placebogecontroleerde klinische onderzoeken (2.653 patiënten met abatacept, 1.485 met placebo).

In placebogecontroleerde klinische onderzoeken met abatacept werden bijwerkingen gemeld bij 49,4% van de met abatacept behandelde patiënten en bij 45,8% in de placebogroep. De frequentst gemelde bijwerkingen (≥ 5%) bij de met abatacept behandelde patiënten waren hoofdpijn, misselijkheid en bovenste luchtweginfecties (inclusief sinusitis). Het deel van de patiënten dat stopte met de behandeling in verband met bijwerkingen was 3,0% voor de met abatacept behandelde patiënten en 2,0% voor de placebogroep.

Lijst met bijwerkingen in tabelvorm

In tabel 2 zijn de bijwerkingen, waargenomen in klinische studies en postmarketingervaring, weergegeven per systeem/orgaanklasse en frequentie waarbij de volgende categorieën zijn gebruikt: zeer vaak (≥ 1/10), vaak (≥ 1/100, < 1/10), soms (≥ 1/1.000, < 1/100), zelden (≥ 1/10.000, < 1/1.000), zeer zelden (< 1/10.000). Binnen iedere frequentiegroep worden bijwerkingen gerangschikt naar afnemende ernst.

Tabel 2: Bijwerkingen

Infecties en parasitaire aandoeningen

Zeer Vaak Bovenste luchtweginfectie (waaronder tracheïtis, nasopharyngitis en sinusitis)

Vaak Infectie van de onderste luchtwegen (waaronder bronchitis), urineweginfectie, herpes infecties (waaronder herpes simplex, orale herpes en herpes zoster), pneumonie, influenza

Soms Tandinfectie, onychomycose, sepsis, skeletspierstelselinfecties, huidabces, pyelonefritis, rhinitis, oorinfectie

U bent allergisch voor één van de stoffen in dit geneesmiddel. Deze stoffen kunt u vinden in rubriek 6. U heeft een ernstige of niet onder controle gebrachte infectie. De behandeling met ORENCIA mag niet worden gestart. Indien u een infectie heeft, bestaat de kans op ernstige bijwerkingen van ORENCIA.

De gevolgen van ORENCIA voor de zwangerschap zijn niet bekend, u mag ORENCIA daarom niet gebruiken wanneer u zwanger bent, tenzij uw arts dit specifiek aangeeft.

• Als u een vrouw in de vruchtbare leeftijd bent, moet u geschikte anticonceptie (middelen voor geboortebeperking) gebruiken tijdens het gebruik van ORENCIA en tot en met 14 weken na de laatste dosis. Uw arts zal u adviseren over geschikte methoden van anticonceptie.
• Als u zwanger wordt tijdens de behandeling met ORENCIA, waarschuw dan uw arts.

Volwassenen

• Subcutane injectie van 125 mg eenmaal per week.
• Kan zowel met als zonder een intraveneuze oplaaddosis (IV) worden gestart.
• Eerste dosis binnen 24 u na oplaaddosis via een intraveneuze infusie.

Toedieningswijze

• Subcutane injectie.
• Injectieplaatsen moeten afgewisseld worden.
• Injecties mogen nooit toegediend worden op plaatsen waar de huid gevoelig, gekneusd, rood of hard is.
• Als een zorgverstrekker heeft bepaald dat dit kan, kan een patiënt na de benodigde training in de subcutane toedieningstechniek zichzelf injecteren.