Trastuzumab


Other name

-

International/Other brands

Herceptin

Groups

Approved

Structure

Prescription products

NameDosageStrengthRouteLabeller
HerceptinPowder, for solution440 mgIntravenousHoffmann La Roche
HerceptinInjection, powder, lyophilized, for solution150 mg/7.4mLIntravenousGenentech, Inc.
HerceptinInjection, powder, for solution150 mgIntravenousRoche Registration Limited
HerceptinInjection, solution600 mgSubcutaneousRoche Registration Limited
HerceptinKit--Genentech, Inc.

Target

EGFR

Description

A recombinant IgG1 kappa, humanized monoclonal antibody that selectively binds with high affinity in a cell-based assay (Kd = 5 nM) to the extracellular domain of the human epidermal growth factor receptor protein. Produced in CHO cell culture. In December 2017, FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). It displays biosimilar properties as Herceptin according to clinical data. While Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer, it is the second biosimilar approved in the U.S. for the treatment of cancer.

Indications

Cancer, Breast; Metastatic Breast Cancer (MBC); Metastatic Gastroesophageal Junction Adenocarcinoma

Other indications

-

Mechaism of action

-

Absorption

Peak and trough plasma concentrations at steady state (between weeks 16 and 32) approximately 123 and 79 mcg/mL, respectively.

Metabolism

Most likely removed by opsonization via the reticuloendothelial system.

Toxicity

Administration of trastuzumab can result in ventricular dysfunction and congestive heart failure. Risk of cardiotocity is especially elevated in patients recieving concurrent anthracycline or cyclophosphamide therapy.