TRASTUZUMAB

HER2-Targeted Therapy

Brand names: Herceptin

Intravenous

Mechanism of Action

12.1 Mechanism of Action The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Herceptin has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Herceptin is a mediator of antibody-dependent cellular cytotoxicity (ADCC). In vitro , Herceptin-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.

Indications

1 INDICATIONS AND USAGE Herceptin is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1

cyclophosphamide

in combination with cisplatin and capecitabine or 5-fluorouracil

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Exacerbation of Chemotherapy-Induced Neutropenia
1 Cardiomyopathy Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death [see Boxed Warning: Cardiomyopathy ]
Patients who receive anthracycline after stopping Herceptin may also be at increased risk of cardiac dysfunction [see Drug Interactions (7) and Clinical Pharmacology (12
2% (64/2000) Includes 1 patient with fatal cardiomyopathy and 1 patient with sudden death without documented etiology

Known Side Effects

8 documented side effects by frequency

Diarrhea

>10%

Nausea

1-10%

Hair Loss

1-10%

Fatigue

1-10%

Vomiting

1-10%

Shortness of Breath

1-10%

Fever

0.1-1%

Weakness

0.1-1%

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Compare With

6 available comparisons

Formulations

Dosage Forms

Tablet

Route

Intravenous