Product Description

1. Technical Specifications

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2. Product Description

Kadcyla 100mg Injection contains Ado-Trastuzumab Emtansine (T-DM1), an antibodydrug conjugate (ADC).
It combines:

• Trastuzumab (a monoclonal antibody targeting HER2 receptors on cancer cells)

• DM1 (emtansine), a cytotoxic microtubule inhibitor (derivative of maytansine)

The conjugate binds to HER2-positive cancer cells, is internalized, and releases DM1 inside the cell leading to microtubule inhibition, cell cycle arrest, and apoptosis.

Kadcyla is indicated in HER2-positive breast cancer patients previously treated with trastuzumab and a taxane.

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3. Product Highlights

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4. Therapeutic Uses

• Early Breast Cancer (EBC): Adjuvant treatment for patients with residual invasive disease after neoadjuvant trastuzumab-based therapy.

• Metastatic Breast Cancer (MBC): For HER2-positive metastatic cases previously treated with trastuzumab and a taxane.

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5. Side Effects

Common:

• Fatigue, headache

• Nausea, vomiting, constipation

• Myalgia, arthralgia

• Low platelet count (thrombocytopenia)

• Increased liver enzymes

• Epistaxis (nosebleeds)

Serious / Severe:

• Hepatotoxicity: liver failure, nodular regenerative hyperplasia

• Cardiotoxicity: left ventricular dysfunction (similar to trastuzumab)

• Thrombocytopenia: severe cases with bleeding risk

• Interstitial lung disease / pneumonitis

• Infusion-related reactions (fever, chills, dyspnea, hypotension)

• Embryo-fetal toxicity

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6. Precautions

• HER2 Testing: Therapy should only be initiated in confirmed HER2-positive patients.

• Liver Function Monitoring: LFTs before each cycle; avoid use in severe hepatic impairment.

• Cardiac Monitoring: Baseline & periodic echocardiograms (risk of cardiomyopathy).

• CBC Monitoring: Regularly check platelets & WBC counts.

• Pregnancy & Breastfeeding: Contraindicated; effective contraception required during and for 7 months post-therapy.

• Drug Interactions: Avoid strong CYP3A4 inhibitors/inducers (clarithromycin, ketoconazole, rifampicin) may alter DM1 metabolism.

• Infusion Reaction Management: Premedication not usually required, but monitor closely during infusion.

Powerful Treatment for HER2-Positive Breast Cancer

Ado-Trastuzumab Emtansine 100mg injection combines targeted therapy with chemotherapy to effectively combat HER2-positive breast cancer in adults. This medicine works by delivering cytotoxic agents directly to cancer cells while minimizing damage to healthy tissue. It is typically administered in a hospital setting under a doctors supervision for optimal safety and effectiveness.


Professional Handling and Storage Requirements

This injection is specifically intended for use by healthcare professionals or under their direct guidance. It must be stored in a cool and dry place to maintain its therapeutic properties. As a sensitive, high-value medication, appropriate handling and compliance with storage instructions are pivotal for ensuring product quality until the point of administration.