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Trastuzumab Emtansine

Kadcyla · ATC code L01FD03

Also known as: Trastuzumab emtansin

Key facts
Active substance
Trastuzumab Emtansine
ATC code
L01FD03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Kadcyla 100 mg powder for concentrate for solution for infusion / Kadcyla 160 mg powder for concentrate for solution for infusion
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-28

Key facts

Trastuzumab emtansine (Kadcyla) is a HER2-directed antibody-drug conjugate used to treat HER2-positive early and metastatic breast cancer.

What it is used for

  • Early breast cancer: single-agent adjuvant treatment of HER2-positive early breast cancer with residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy.
  • Metastatic breast cancer: single agent for HER2-positive unresectable locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane (prior therapy for advanced disease, or recurrence during or within six months of adjuvant therapy).
  • Requires HER2-positive tumour status (IHC 3 + or ISH ratio ≥ 2.0).

Dosing

  • 3.6 mg/kg bodyweight as an intravenous infusion every 3 weeks (21-day cycle); first infusion over 90 minutes, later infusions over 30 minutes if well tolerated.
  • Early breast cancer: a total of 14 cycles; metastatic breast cancer: until progression or unmanageable toxicity.
  • Dose reductions for adverse reactions: 3 mg/kg, then 2.4 mg/kg, then discontinue; do not re-escalate.
  • Avoid confusion with other trastuzumab-containing products (e.g. trastuzumab deruxtecan).

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Thrombocytopenia, the most common reason for interruption, reduction or discontinuation; check platelets before each dose, with close monitoring on anticoagulants.
  • Haemorrhage, including serious events.
  • Hepatotoxicity, left ventricular dysfunction, pulmonary toxicity and peripheral neuropathy – see the full text.
  • Infusion-related reactions and delayed skin injury after extravasation.

Side effects

  • Most common (≥ 25%): nausea, fatigue, musculoskeletal pain, haemorrhage, headache, transaminases increased, thrombocytopenia and peripheral neuropathy; mostly Grade 1 or 2.
  • Most common Grade ≥ 3 reactions: thrombocytopenia, increased transaminases, anaemia, neutropenia, fatigue and hypokalaemia.
  • Most common serious reactions: haemorrhage, pyrexia, thrombocytopenia, dyspnoea, abdominal pain, musculoskeletal pain and vomiting.

Interactions

  • Avoid strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir, voriconazole), which may increase DM1 exposure and toxicity.

Pregnancy and breastfeeding

  • Women: effective contraception during and for at least 7 months after the last dose; men with partners of childbearing potential: at least 4 months.
  • Pregnancy: see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • KadcylaRoche Registration GmbH · EMEA/H/C/002389

Source: European Medicines Agency (EMA), product information

Turkey

  • KadcylaROCHE MÜSTAHZARLARI SAN.A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Kadcyla
Liechtenstein
Kadcyla
Norway
Kadcyla

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Kadcyla – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.