Kadcyla Ado-trastuzumab Emtansine (T-DM1) 100/160mg | Roche EU Originator | GLT

Generic Information: Kadcyla (European Union)

This listing is the European Union presentation of Kadcyla, Roche's ado-trastuzumab emtansine, supplied as 100 mg and 160 mg single-use vials of lyophilized powder with European Medicines Agency provenance. It is the same originator antibody-drug conjugate approved across the EU for HER2-positive breast cancer, offered here for institutions and importing pharmacies that require the European reference product with its characteristic regulatory and traceability profile.

What Is Ado-trastuzumab Emtansine (Kadcyla) Used For?

The medicine serves two HER2-positive breast cancer indications. As monotherapy it treats metastatic disease in patients previously treated with trastuzumab and a taxane, where the EMILIA trial established both a progression-free and an overall survival benefit over lapatinib plus capecitabine. It is also approved for the adjuvant treatment of early breast cancer with residual invasive disease after neoadjuvant therapy, the setting validated by the KATHERINE trial.

How Does Kadcyla Work?

Kadcyla combines the targeting of trastuzumab with the potency of a maytansinoid. The antibody component binds the HER2 receptor that is over-expressed on cancer cells, and the entire conjugate is internalized. Inside the cell, the non-cleavable linker is broken down to liberate DM1, a microtubule inhibitor that prevents spindle formation during mitosis and pushes the cell into apoptosis. This design delivers a chemotherapy many times more potent than paclitaxel directly into the tumour.

Indications

In the European Union, Kadcyla is indicated as a single agent for the treatment of adults with HER2-positive metastatic breast cancer who have previously received trastuzumab and a taxane, separately or in combination, and for the adjuvant treatment of adults with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane-based and trastuzumab-based therapy. HER2 status must be confirmed by a validated test before treatment begins.

Dosage

The recommended dose is 3.6 mg per kilogram by intravenous infusion every three weeks. The initial infusion runs over 90 minutes; if tolerated, subsequent infusions may be given over 30 minutes. The 100 mg and 160 mg vial sizes support accurate dose rounding for patients of different weights, and dosing continues until disease progression or unacceptable toxicity.

Side Effects

Fatigue, nausea, musculoskeletal pain, headache and thrombocytopenia are the most common adverse events. The product carries boxed warnings for severe liver injury, cardiac toxicity manifesting as reduced left-ventricular function, and embryo-fetal toxicity, so liver and cardiac function are monitored and platelet counts are checked before each dose to manage bleeding risk.

Storage

Kadcyla vials require refrigeration at 2°C to 8°C, protected from light, and are transported as a cold-chain biologic. GLT ships through validated temperature-controlled logistics from a Hong Kong-licensed facility, with batch documentation and a certificate of analysis enclosed.

Why Choose Kadcyla Through GLT?

The European Union presentation offers Roche's originator T-DM1 with EMA provenance and full traceability, suitable for buyers whose procurement or regulatory requirements call for the European reference product. GLT's Hong Kong base provides dependable cold-chain access and documented cross-border supply to overseas institutions.

How to Order

To order Kadcyla (ado-trastuzumab emtansine) from GLT, contact us on WhatsApp at +86 15234153837 or by email at [email protected]. We confirm stock, vial size and cold-chain delivery timelines to your country, and dispatch from a Hong Kong-licensed facility.

FAQ

Is the EU Kadcyla the same molecule? Yes — it is Roche's originator ado-trastuzumab emtansine, identical to the US and China presentations in active ingredient and strength.

Why choose the EU presentation? Some importers and hospitals require European Medicines Agency provenance for their own regulatory or tendering reasons.

Is it refrigerated? Yes — cold-chain at 2°C to 8°C, protected from light.