Targeted Therapy / Oncology — Breast Cancer

Kadcyla (ado-trastuzumab emtansine)

Genentech / Roche · HER2-Targeted Antibody-Drug Conjugate (ADC)

FDA Approved 2013 Intravenous (IV) infusion Specialty Medication
Kadcyla ado-trastuzumab emtansine 100mg vial for intravenous infusion, Roche Genentech, HER2 ADC

What is Kadcyla? Kadcyla (ado-trastuzumab emtansine, T-DM1) is an antibody-drug conjugate (ADC) by Genentech combining trastuzumab (HER2 antibody) with emtansine (DM1, a microtubule inhibitor) via a stable linker. It is approved for HER2-positive early and metastatic breast cancer.

About Kadcyla

Brand NameKadcyla
Generic / INNado-trastuzumab emtansine
Drug ClassHER2-Targeted Antibody-Drug Conjugate (ADC)
ManufacturerGenentech / Roche
AdministrationIntravenous (IV) infusion
FDA Approval2013
📦 100 mg and 160 mg vials (lyophilized powder for reconstitution). Do NOT confuse or substitute with trastuzumab (Herceptin), pertuzumab, or trastuzumab deruxtecan (Enhertu).

FDA-Approved Uses for Kadcyla

Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.

  • HER2-positive early breast cancer — adjuvant treatment in patients with residual invasive disease after neoadjuvant taxane-based and HER2-targeted therapy
  • HER2-positive metastatic breast cancer — after prior trastuzumab and a taxane
Biomarker Note: HER2 overexpression (IHC 3+ or FISH-amplified) must be confirmed by an FDA-approved companion diagnostic before using Kadcyla.

How Does Kadcyla Work?

Kadcyla binds HER2 on tumor cells via the trastuzumab component, is internalized, then releases emtansine (DM1) intracellularly. DM1 binds tubulin, inhibiting microtubule polymerization and causing mitotic arrest and apoptosis. The ADC approach targets cytotoxin delivery specifically to HER2-overexpressing cells, reducing systemic toxicity.

Dosage & Administration

3.6 mg/kg IV every 3 weeks. First infusion over 90 minutes; subsequent infusions over 30 minutes if tolerated. Do not substitute Kadcyla for or with trastuzumab (Herceptin) or other HER2 agents — they are not interchangeable.

⚠️ Important

Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.

Warnings, Precautions & Side Effects

General Warning

Hepatotoxicity — monitor LFTs; fatal hepatic failure reported. Cardiac toxicity — evaluate LVEF before and during treatment. Embryo-fetal toxicity. Thrombocytopenia. ILD/pneumonitis. Peripheral neuropathy. Do NOT substitute with trastuzumab (Herceptin).

⛔ Serious Warnings & Precautions
  • Hepatotoxicity (including fatal)
  • Cardiotoxicity / decreased LVEF
  • ILD/pneumonitis
  • Thrombocytopenia
  • Embryo-fetal toxicity
  • Peripheral neuropathy

Common Side Effects

  • Fatigue
  • Nausea
  • Musculoskeletal pain
  • Thrombocytopenia
  • Headache
  • Elevated LFTs
  • Peripheral neuropathy
  • Constipation

This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.

Storage & Handling

Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze. Reconstituted and diluted solutions: refrigerate; use within 4 hours at room temperature.

BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.

Insurance Coverage, Prior Authorization & Patient Assistance

🛡️ Commercial Insurance

Kadcyla is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.

✅ Prior Authorization

Prior authorization is required by virtually all insurance plans for Kadcyla. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.

🏥 Medicare Coverage

Medicare Part B covers this IV medication when administered in a clinical setting. Medicaid coverage varies by state.

🆓 Patient Assistance

Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.

Prior Authorization Patient Assistance Insurance & Savings Medication Costs

Frequently Asked Questions — Kadcyla

Kadcyla (ado-trastuzumab emtansine) is a HER2-targeted antibody-drug conjugate combining trastuzumab and a chemotherapy agent (DM1) linked together. It delivers the cytotoxin directly into HER2-positive tumor cells.

No — Kadcyla (ado-trastuzumab emtansine) must NEVER be substituted for trastuzumab (Herceptin) or other trastuzumab products. They are entirely different drugs despite both targeting HER2.

Kadcyla is used as adjuvant therapy in early HER2+ breast cancer with residual disease after neoadjuvant therapy, and as a later-line option in metastatic HER2+ breast cancer after prior trastuzumab and taxane.

Kadcyla is covered by Medicare Part B and commercial insurance for HER2+ breast cancer with prior authorization and HER2 biomarker documentation.

Related Medications

Trastuzumab (Herceptin)  ·  Enhertu (trastuzumab deruxtecan)  ·  Perjeta (pertuzumab)  ·  Verzenio (abemaciclib)

Related Conditions

HER2-positive breast cancer  ·  Early breast cancer (residual disease)  ·  Metastatic HER2+ breast cancer

Comparisons

Verzenio Lynparza

Authoritative References

Medical Disclaimer: This page is for general educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult your oncologist, hematologist, or licensed healthcare professional before making any treatment decisions. Last reviewed: August 2026 by the BiologicHealthPlus Clinical Team.