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Trastuzumab

Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.

IDDRUG-TRASTUZUMAB
TypeMédicament
Alias
- HéréceptineHerceptin Hylecta (dose fixe SC)Herzuma (biosimilaire)Kanjinti (biosimilaire)Ogivri (biosimilaire)Ontruzant (biosimilaire)Trazimères (biosimilaires)Трастузумаб
Étatreviewed 2026-04-26 | pending_clinical_signoff
MaladiesDIS-BREAST DIS-CRC DIS-ESOPHAGEAL DIS-GASTRIC
SourcesSRC-ESMO-BREAST-EARLY-2024 SRC-NCCN-BREAST-2025

Faits sur les drogues

CatégorieAnticorps monoclonal IgG1 humanisé anti-HER2 (sous-domaine IV)
MécanismeHumanized IgG1 monoclonal antibody binding the extracellular subdomain IV of the HER2 (ERBB2) receptor tyrosine kinase. Mechanisms: (1) ADCC mediated by NK cells via Fc-FcγRIIIa interaction; (2) inhibition of ligand-independent HER2 homo- and heterodimerization and downstream PI3K/AKT and MAPK signaling; (3) prevention of HER2 ectodomain shedding (which otherwise yields constitutively active p95-HER2); (4) interference with HER2-driven angiogenesis. Synergizes with chemotherapy and pertuzumab (binds subdomain II, blocking heterodimerization). Activity requires HER2 IHC 3+ or ISH-amplified (HER2:CEP17 ≥2 or HER2 copy number ≥6) per ASCO/CAP 2018 criteria.
Dose typiqueIV q3-week schedule (most common): 8 mg/kg loading dose IV over 90 min, then 6 mg/kg IV over 30-90 min q3 weeks. IV weekly schedule (alternative): 4 mg/kg loading, then 2 mg/kg weekly. SC (Herceptin Hylecta with hyaluronidase): 600 mg fixed dose SC q3w over ~2-5 min — non-inferior to IV (HannaH study). Combined with chemo + pertuzumab for early HER2+ (TCHP) and metastatic 1L (THP, CLEOPATRA). Continued for 1 year total in adjuvant; until progression in metastatic. Cardiac monitoring: baseline LVEF (echo or MUGA) before initiation, then q3 months during therapy and 6 months after completion.
Ukraine enregistréeVrai
NSZU rembourséVrai
Ukraine vérifiée pour la dernière fois2026-04-27

Avertissements

Notes

Cross-disease entity. HER2+ breast (early + metastatic), HER2+ gastric/GEJ (1L per ToGA), occasional uterine / biliary / lung HER2-amplified use (off-label / clinical trial). Cardiac surveillance: baseline LVEF + q3 months on therapy + 6 months post; hold for asymptomatic decline ≥10% absolute or below institutional threshold (commonly <50%); discontinue for symptomatic CHF or persistent decline. Sequence with anthracyclines (AC → T+H, or non-anthracycline TCHP) preferred to minimize cardiac risk. SC formulation: shorter administration, fixed-dose, no loading dose required, non-inferior efficacy. Biosimilars (Ogivri, Kanjinti, Herzuma, Trazimera, Ontruzant) clinically interchangeable per FDA / EMA. For HER2+ gastric: ToGA trial established 1L cis/cape/5-FU + trastuzumab; later lines move to T-DXd (DESTINY-Gastric) and other HER2-targeted agents.

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