Trastuzumab
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-TRASTUZUMAB |
|---|---|
| Type | Drug |
| Aliases | HerceptinHerceptin Hylecta (SC fixed dose)Herzuma (biosimilar)Kanjinti (biosimilar)Ogivri (biosimilar)Ontruzant (biosimilar)Trazimera (biosimilar)Трастузумаб |
| Status | reviewed 2026-04-26 | pending_clinical_signoff |
| Diseases | DIS-BREAST DIS-CRC DIS-ESOPHAGEAL DIS-GASTRIC |
| Sources | SRC-ESMO-BREAST-EARLY-2024 SRC-NCCN-BREAST-2025 |
Drug Facts
| Class | Anti-HER2 humanized IgG1 monoclonal antibody (subdomain IV) |
|---|---|
| Mechanism | Humanized 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. |
| Typical dosing | IV 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 registered | True |
| NSZU reimbursed | True |
| Ukraine last verified | 2026-04-27 |
Warnings
- Cardiomyopathy (LVEF decline; symptomatic CHF risk; usually reversible on discontinuation; additive with anthracyclines)
- Severe infusion reactions (anaphylaxis, hypersensitivity, ARDS — most occur during or within 24 h of first infusion)
- Pulmonary toxicity (interstitial pneumonitis, pulmonary infiltrates, ARDS — can be fatal)
- Embryo-fetal toxicity (oligohydramnios, fetal renal failure, fatal pulmonary hypoplasia — effective contraception required)
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.
Used By
Regimens
REG-HP-MAINTENANCE- Trastuzumab + Pertuzumab (HP) maintenance, HER2+ metastatic breast post-THP inductionREG-TCHP-NEOADJUVANT- TCHP — docetaxel + carboplatin + trastuzumab + pertuzumab (HER2+ neoadjuvant)REG-THP-METASTATIC- THP — docetaxel + trastuzumab + pertuzumab (HER2+ metastatic 1L)REG-TRASTUZUMAB-CHEMO-TOGA- Trastuzumab + capecitabine + cisplatin (TOGA / KEYNOTE-811)REG-TUCATINIB-TRASTUZUMAB-CAPECITABINE-BREAST- Tucatinib + trastuzumab + capecitabine (HER2+ metastatic ≥3L, especially with brain metas...REG-TUCATINIB-TRASTUZUMAB-CRC- Tucatinib + Trastuzumab (MOUNTAINEER, HER2+ RAS-WT mCRC)