TRASTUZUMAB (Vivitra™ 440mg)

Product Information

Generic Name: Trastuzumab
Brand: Vivitra™
Manufacturer: Zydus
Strength: 440mg Multi-Dose Vial
Dosage Form: Lyophilized Powder for Concentrate for Solution for Infusion
Administration: IV Infusion Only
Pack Contents: 1 vial Trastuzumab + 1 vial 20ml Sterile Bacteriostatic Water for Injection + Package Insert
Rx Status: Prescription Only Medicine

Overview

Vivitra™ contains Trastuzumab, a recombinant humanized monoclonal antibody that specifically targets the HER2 receptor. Trastuzumab revolutionized the treatment of HER2-positive cancers and remains one of the most important targeted therapies in oncology.

For more than 25 years, oncologists worldwide have relied on Trastuzumab to improve treatment outcomes in HER2-positive breast and gastric cancers. Furthermore, extensive clinical research continues to support its effectiveness and safety.

Clinical Indications

HER2-Positive Early Breast Cancer

Doctors use Trastuzumab as a standard treatment in both adjuvant and neoadjuvant settings for HER2-positive early breast cancer. Additionally, combining Trastuzumab with chemotherapy significantly increases pathological complete response rates.

Clinical studies have demonstrated that Trastuzumab reduces disease recurrence and improves long-term survival.

HER2-Positive Metastatic Breast Cancer

Oncologists commonly prescribe Trastuzumab as a first-line treatment for HER2-positive metastatic breast cancer. Moreover, physicians often combine it with Pertuzumab and Taxane-based chemotherapy as part of the CLEOPATRA regimen.

As a result, patients may achieve improved progression-free and overall survival.

HER2-Positive Metastatic Gastric Cancer

Healthcare professionals use Trastuzumab together with Cisplatin and Fluoropyrimidine chemotherapy for HER2-positive metastatic gastric cancer and gastroesophageal junction adenocarcinoma.

Furthermore, clinical evidence from the ToGA trial demonstrated significant survival benefits in eligible patients.

Mechanism of Action

HER2 is a transmembrane receptor that regulates cell growth and survival. In HER2-positive cancers, cancer cells produce excessive HER2 proteins, which promote uncontrolled cell division.

Trastuzumab works through multiple mechanisms:

HER2 Receptor Blockade

Trastuzumab binds to the HER2 receptor and blocks signaling pathways responsible for tumor growth and survival.

Antibody-Dependent Cellular Cytotoxicity (ADCC)

The antibody recruits immune cells, including natural killer cells, to identify and destroy HER2-positive cancer cells.

Inhibition of HER2 Shedding

Trastuzumab helps prevent the formation of abnormal HER2 receptor fragments that may contribute to cancer progression.

Anti-Angiogenic Activity

Additionally, Trastuzumab may reduce tumor-associated blood vessel formation, limiting tumor growth.

Key Clinical Benefits

• More than 25 years of global clinical experience

• Reduces recurrence risk in early HER2-positive breast cancer

• Improves survival outcomes in metastatic breast cancer

• Effective treatment option for HER2-positive gastric cancer

• Multiple mechanisms of action

• Compatible with established HER2-targeted treatment regimens

• Supported by extensive clinical evidence

• Included in major international oncology guidelines

Product Details

• Generic Name: Trastuzumab

• Brand: Vivitra™

• Strength: 440mg Multi-Dose Vial

• Route: IV Infusion Only

• Reconstitution: 20ml Sterile Bacteriostatic Water for Injection

• Manufacturer: Zydus

Regulatory Recognition

• UK MHRA Approved

• US FDA Approved

• Health Canada Approved

• Included in the WHO Essential Medicines List

• Referenced by NCCN, ESMO, and NICE Guidelines

• Widely used in oncology treatment centers worldwide

Important Safety Information

Trastuzumab is a prescription-only medicine and should be administered only by trained healthcare professionals under the supervision of a qualified oncologist.

Healthcare providers should monitor patients according to approved treatment protocols. Use this medicine only with a valid prescription and appropriate medical guidance.

For healthcare professionals and licensed pharmaceutical buyers only.