Pharmaceutical Research

Trastuzumab`
Generic Form of the Drug: Herceptin

Introduction

The scientists at Genentech believed that monoclonal antibodies, man-made copies of

proteins that the body’s immune system creates to fight off bacteria and viruses, could be

an answer. They were able to build mouse versions of these antibodies that would bind to

the HER2 receptors on breast cancer cells and help block them from transmitting growth

signals. If these antibodies worked in people, they might not only stop tumors from

growing, but possibly even shrink them.

Classification: HER2/neu receptor inhibitor

Purpose: Herceptin is approved for the treatment of early-

stage breast cancer that is Human Epidermal growth factor
Receptor 2-positive (HER2+) and has spread into the lymph
nodes, or is HER2+ and has not spread into the lymph nodes.

Side Effects: Some patients receiving HERCEPTIN for

breast cancer had the following side effects:

● Fever

● Feeling sick to your stomach (nausea)

● Throwing up (vomiting)

● Infusion reactions

● Diarrhea

● Infections

● Increased cough

● Headache

● Feeling tired

● Shortness of breath

● Rash

● Low white and red blood cell counts

● Muscle pain

Some patients receiving HERCEPTIN for metastatic stomach cancer had the

following side effects:

● Low white blood cell counts

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 ● Diarrhea

● Feeling tired

● Low red blood cell counts

● Swelling of the mouth lining

● Weight loss

● Upper respiratory tract infections

● Fever

● Low platelet counts

● Swelling of the mucous membranes

● Swelling of the nose and throat

● Change in taste

Doses: Initial dose of 4 mg/kg over 90 minute IV infusion,

then 2 mg/kg over 30 minute IV infusion weekly for 52 weeks

Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg

over 30−90 minutes IV infusion every three weeks for 52 weeks.

Warnings: Cardiomyopathy, Infusion Reactions, Exacerbation

of Chemotherapy-Induced Neutropenia, Pulmonary Toxicity,
Embryo-fetal Toxicity

Contraindications: Herceptin is contraindicated in

patients with known hypersensitivity to trastuzumab or to any
other component of the product. Herceptin can cause left
ventricular cardiac dysfunction, arrhythmias, hypertension,
disabling cardiac failure, cardiomyopathy, and cardiac death

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How it is given: Herceptin only can be given intravenously,
which means it's dripped into your body through a needle
inserted into a vein. The first dose of Herceptin takes about 90
minutes. After that, it takes about 30 minutes to get the other
doses of Herceptin