Vrije Universiteit Brussel Supportieve zorg bij de behandeling met immuuncheckpointinhibitoren Awada, Gil; Rogiers, Anne Irène; Neyns, Bart Published in: OncoHemato Publication date: 2019 Link to publication Citation for published version (APA): Awada, G., Rogiers, A. I., & Neyns, B. (2019). Supportieve zorg bij de behandeling met immuuncheckpointinhibitoren. OncoHemato, 12(7), 39-50. 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Oct. 2021 VOL 12 Nr 7 DECEMBER 2018- JANUARI 2019 - 6x/jaar Afgiftekantoor - Charleroi X - P801027 Onco hemato MULTID ISC IPL INAIR T IJDSCHRIFT VOOR ONCOLO GIE EN HEMATOLOGIE www.oncohemato.be Burn-out bij Belgische arts-specialisten in opleiding Ruben Willems, Chris Monten, Gwendolyn Portzky Supportieve zorg bij de behandeling met immuuncheckpointinhibitoren Gil Awada, Anne Rogiers, Bart Neyns Late Breaking Abstracts op het ASH-congres Dominique-Jean Bouilliez ONCO_12_7_N_2018 REGIMEN Leading the Way in Immuno-Oncology Verantwoordelijke uitgever: V. Leclercq - Varenslaan 6 - 1950 Kraainem - Varenslaan Leclercq uitgever: V. Verantwoordelijke 1506BE18PR01355 03/2018 ISSN 2030-2738 ISSN 2030-272X OPDI 6685 Pavé_80x80 1.3.indd 2 13/03/18 14:57 This product is not yet marketed BEHIND KANJINTI® AMGEN’S EXPERTISE DELIVERS CONFIDENCE AND RELIABILITY KANJINTI® The trastuzumab biosimilar by Amgen Discover Amgen Biosimilars via https://www.amgenbiosimilars.be KANJINTI® is the trastuzumab biosimilar by Amgen indicated for the treatment of HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction, all in adult patients.1 HER2 = human epidermal growth factor receptor 2. 1. KANJINTI Summary of Product Characteristics. Latest version. R.E. Amgen nv, Telecomlaan 5-7, 1831 Diegem - BL-P-BIO-0718-066071(1) - Creation date: November, 2018 KANJINTI® powder for concentrate for solution for infusion ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT: KANJINTI whom an anthracycline is not suitable. In combination initiation of therapy (see sections 4.4 and 5.1). KANJINTI 150 mg and 420 mg powder for concentrate for with docetaxel for the treatment of those patients who treatment should only be initiated by a physician solution for infusion. 2. QUALITATIVE AND have not received chemotherapy for their metastatic experienced in the administration of cytotoxic QUANTITATIVE COMPOSITION: KANJINTI 150 mg disease. In combination with an aromatase inhibitor for chemotherapy (see section 4.4), and should be powder for concentrate for solution for infusion: One the treatment of postmenopausal patients with administered by a healthcare professional only. vial contains 150 mg of trastuzumab, a humanised IgG1 hormone-receptor positive MBC, not previously treated KANJINTI intravenous formulation is not intended for monoclonal antibody produced by mammalian with trastuzumab. Early breast cancer: KANJINTI is subcutaneous administration and should be (Chinese hamster ovary) cell suspension culture and indicated for the treatment of adult patients with HER2 administered via an intravenous infusion only. In order purifi ed by affi nity and ion exchange chromatography positive early breast cancer (EBC): Following surgery, to prevent medication errors it is important to check the including specifi c viral inactivation and removal chemotherapy (neoadjuvant or adjuvant) and vial labels to ensure that the medicinal product being procedures. KANJINTI 420 mg powder for concentrate radiotherapy (if applicable) (see section 5.1). Following prepared and administered is KANJINTI (trastuzumab) for solution for infusion: One vial contains 420 mg of adjuvant chemotherapy with doxorubicin and and not trastuzumab emtansine. Posology: Metastatic trastuzumab, a humanised IgG1 monoclonal antibody cyclophosphamide, in combination with paclitaxel or breast cancer: Three-weekly schedule: The produced by mammalian (Chinese hamster ovary) cell docetaxel. In combination with adjuvant chemotherapy recommended initial loading dose is 8 mg/kg body suspension culture and purifi ed by affi nity and ion consisting of docetaxel and carboplatin. In combination weight. The recommended maintenance dose at exchange chromatography including specifi c viral with neoadjuvant chemotherapy followed by adjuvant threeweekly intervals is 6 mg/kg body weight, inactivation and removal procedures. The reconstituted KANJINTI therapy, for locally advanced (including beginning three weeks after the loading dose. Weekly KANJINTI solution contains 21 mg/mL of trastuzumab. infl ammatory) disease or tumours > 2 cm in diameter schedule: The recommended initial loading dose of For the full list of excipients, see section 6.1. 3. (see sections 4.4 and 5.1). KANJINTI should only be KANJINTI is 4 mg/kg body weight. The recommended PHARMACEUTICAL FORM: Powder for concentrate used in patients with metastatic or early breast cancer weekly maintenance dose of KANJINTI is 2 mg/kg for solution for infusion. White to pale yellow lyophilised whose tumours have either HER2 overexpression or body weight, beginning one week after the loading powder. 4. CLINICAL PARTICULARS: 4.1 Therapeutic HER2 gene amplifi cation as determined by an accurate dose. Administration in combination with paclitaxel or indications: Breast cancer: Metastatic breast cancer: and validated assay (see sections 4.4 and 5.1). Metastatic docetaxel: In the pivotal trials (H0648g, M77001), KANJINTI is indicated for the treatment of adult gastric cancer: KANJINTI in combination with paclitaxel or docetaxel was administered the day patients with HER2 positive metastatic breast cancer capecitabine or 5-fl uorouracil and cisplatin is indicated following the fi rst dose of trastuzumab (for dose, see (MBC): As monotherapy for the treatment of those for the treatment of adult patients with HER2 positive the Summary of Product Characteristics (SmPC) for patients who have received at least two chemotherapy metastatic adenocarcinoma of the stomach or paclitaxel or docetaxel) and immediately after the regimens for their metastatic disease. Prior gastroesophageal junction who have not received prior subsequent doses of trastuzumab if the preceding chemotherapy must have included at least an anti-cancer treatment for their metastatic disease. dose of trastuzumab was well tolerated. Administration anthracycline and a taxane unless patients are KANJINTI should only be used in patients with in combination with an aromatase inhibitor: In the unsuitable for these treatments. Hormone-receptor metastatic gastric cancer (MGC) whose tumours have pivotal trial (BO16216) trastuzumab and anastrozole positive patients must also have failed hormonal HER2 overexpression as defi ned by IHC 2+ and a were administered from day 1. There were no restrictions therapy, unless patients are unsuitable for these confi rmatory SISH or FISH result, or by an IHC 3+ result. on the relative timing of trastuzumab and anastrozole treatments. In combination with paclitaxel for the Accurate and validated assay methods should be used at administration (for dose, see the SmPC for treatment of those patients who have not received (see sections 4.4 and 5.1). 4.2 Posology and method of anastrozole or other aromatase inhibitors). Early breast chemotherapy for their metastatic disease and for administration: HER2 testing is mandatory prior to cancer: Threeweekly and weekly schedule: As a AMG-Kanjinti-Journal Ad (SH 100102).indd 1 23/11/18 09:41 threeweekly regimen the recommended initial loading infestations: Very common: Infection, Nasopharyngitis; symptomatic and asymptomatic left ventricular dose of KANJINTI is 8 mg/kg body weight. The Common: Neutropenic sepsis, Cystitis, Herpes zoster, dysfunction was 4.6%. Reversibility of severe CHF recommended maintenance dose of KANJINTI at Influenza, Sinusitis, Skin infection, Rhinitis, Upper (defined as a sequence of at least two consecutive three-weekly intervals is 6 mg/kg body weight, respiratory tract infection, Urinary tract infection, LVEF values ≥ 50% after the event) was evident for beginning three weeks after the loading dose. As a Erysipelas, Cellulitis, Pharyngitis; Uncommon: Sepsis. 71.4% of trastuzumab-treated patients. Reversibility of weekly regimen (initial loading dose of 4 mg/kg Neoplasms benign, malignant and unspecified (incl. mild symptomatic and asymptomatic left ventricular followed by 2 mg/kg every week) concomitantly with Cysts and polyps): Not known: Malignant neoplasm dysfunction was demonstrated for 79.5% of patients. paclitaxel