{"id":99174,"date":"2024-08-13T13:09:31","date_gmt":"2024-08-13T13:09:31","guid":{"rendered":"https:\/\/www.mymsd.ch\/it\/?page_id=99174"},"modified":"2026-04-10T14:13:59","modified_gmt":"2026-04-10T14:13:59","slug":"keytruda","status":"publish","type":"page","link":"https:\/\/www.mymsd.ch\/it\/succinctstatement\/keytruda\/","title":{"rendered":"Informazione professionale KEYTRUDA\u00ae"},"content":{"rendered":"\n<h1 class=\"wp-block-heading  has-border-color has-has-red-border-color-border-color has-teal-500-color has-text-color mhh-mcn-v1-heading--left mhh-mcn-v1-heading mhh-mcn-v1-heading--428d1778678f87884a95fd422f075610\">Informazione professionale breve di KEYTRUDA\u00ae (pembrolizumab)<\/h1>\n\n\n\n<p class=\"has-border-color has-has-red-border-color-border-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--07bade83b4956aa53c320ba02450c379\"><br><strong>KEYTRUDA<sup>\u00ae<\/sup>:<\/strong> <strong>PA: <\/strong>pembrolizumab. <strong>I: <\/strong><em>Adulti:<\/em>monoterapiamelanoma non resecabile o metastatico e trattamento adiuvante del melanoma in stadio III completamente resecato. Autorizzazione temporanea: monoterapia \u00e8 indicato nel trattamento adiuvante con melanoma allo stadio IIB o IIC completamente rimosso. <strong>P: <\/strong><em>Adulti: <\/em>200 mg e.v. 30 min. ogni 3 settimane o400 mg e.v. 30 min. ogni 6 settimane; trattamento fino a progressione della malattia o alla comparsa di recidiva, o fino a una tossicit\u00e0 inaccettabili; per la durata massima del trattamento in caso di adiuvante per melanoma 12 mesi. <strong><em>Per ulteriori indicazioni e i corrispondenti dosaggi per adulti e pazienti pediatrici, si prega di fare riferimento alle informazione professionale.<\/em><\/strong> <strong>CI: <\/strong>ipersensibilit\u00e0 a principio attivo\/sostanze ausiliarie. <strong>AP: <\/strong>reazioni avverse immuno-mediate: tra cui polmonite, colite, epatite, nefrite, endocrinopatie (incl. ipofisite, diabete di tipo 1, disfunzioni tiroidee; nel TNBC monitorare il livello di cortisolo), linfoistiocitosi emofagocitica (HLH), reazioni cutanee gravi (sindrome di Stevens-Johnson, necrolisi epidermica tossica, sindrome DRESS), altre reazioni avverse immuno-mediate; pazienti con malattia autoimmune preesistente; trapianto \/ trapianto di cellule staminali (HSCT): malattia del trapianto contro l\u2019ospite (GvHD) e malattia veno-occlusiva epatica (VOD); terapia adiuvante per melanoma IIB\/IIC e NSCLC IB\/II\/IIIA: analisi dell\u2019OS in attesa; trattamento adiuvante dopo una terapia neoadiuvante associato a tossicit\u00e0 aggiuntiva; l\u2019effetto sulla successiva risomministrazione di terapie sistemiche a base di anti-PD-(L)1, comprese le resistenze in caso di recidiva, non \u00e8 stato studiato; enzimi epatici elevati se KEYTRUDA\u00ae viene associato ad axitinib (monitorare gli enzimi epatici prima dell\u2019inizio e durante il trattamento); infarto miocardico con l&#8217;associazione KEYTRUDA\u00ae + lenvatinib nell&#8217;RCC; mieloma multiplo: elevata mortalit\u00e0 nell&#8217;associazione di KEYTRUDA\u00ae con talidomide analogo e desametasone; associazione con trastuzumab nel carcinoma gastrico, consultare l&#8217;informazione professionale del trastuzumab; dati sulle terapie precedenti con immunoterapia per indicazioni individuali non disponibili, o tali pazienti esclusi dagli studi; reazioni correlate all&#8217;infusione (comprese ipersensibilit\u00e0 e anafilassi); pazienti sono stati esclusi dagli studi clinici (consultare l\u2019informazione professionale per dettagli). <strong>IA: <\/strong>non note \/ non esaminato. <strong>G\/A:<\/strong> non raccomandato, contraccezione. <strong>EI (molto comune):<\/strong> infezioni delle vie respiratorie, infezione urinaria, anemia, conta dei neutrofili diminuita, neutropenia, trombocitopenia, ipotiroidismo, appetito ridotto, ipokaliemia, peso diminuito, ipomagnesiemia, insomnia, cefalea, neuropatia periferica, dysgeusia, ipertensione, emorragie, dispnea, tosse, disfonia, diarrea, dolore addominale, nausea, vomito, stipsi, lipasi aumentata, infiammazioni orali, stomatite, ALT aumentata, AST aumentata, eruzione cutanea, eruzione maculo-papulare, prurito, alopecia, Sindrome da eritrodisestesia palmo-plantare, dolore muscolo-scheletrico, artralgia, miosite, dolore alle estremit\u00e0, proteinuria, creatinina ematica aumentata, stanchezza\/spossatezza, astenia, edema, febbre. <strong>Conf: <\/strong>2 flaconcini perforabili da 100 mg \/ 4 ml. <strong>CD: <\/strong>A. <strong>TO:<\/strong> MSD Merck Sharp &amp; Dohme AG, B\u00fcrgenstrasse 8, 6005 Lucerna, Svizzera. (V29.0); CH-KEY-00084.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-text-color has-gray-300-color has-alpha-channel-opacity has-gray-300-background-color has-background\" \/>\n\n\n\n<p dir=\"ltr\" lang=\"it-IT\" class=\"has-border-color has-has-red-border-color-border-color has-object-object-font-size   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--dd4310fe6031a5bbabe8114ed9028142\"><em>Prima della prescrizione, consultare l\u2019informazione professionale completa, pubblicata sul sito web di Swissmedic&nbsp;<a href=\"https:\/\/www.swissmedicinfo-pro.ch\/ShowText.aspx?textType=FI&amp;lang=IT&amp;authNr=66231\" target=\"_blank\" rel=\"noreferrer noopener\">www.swissmedicinfo-pro.ch<\/a>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Informazione professionale breve di KEYTRUDA\u00ae (pembrolizumab) KEYTRUDA\u00ae: PA: pembrolizumab. 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