Trastuzumab
Ado-trastuzumab emtansine is a HER2-targeted antibody-drug conjugate used to treat HER2-positive breast cancer. It combines the targeting ability of trastuzumab (a monoclonal antibody) with a potent chemotherapy agent (DM1, a microtubule inhibitor) to deliver treatment directly to cancer cells while minimizing damage to normal tissues.
A targeted cancer therapy that delivers chemotherapy directly to HER2-positive cancer cells via an antibody-drug conjugate.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01FD01
- RxNorm
- 224905
- Generic
- Trastuzumab
- Class
- atc-l01
- Brands
- Herceptin, KADCYLA, Herzuma, Herceptin Hylecta, Kanjinti, Ogivri, Enhertu, Trazimera, Ontruzant, Phesgo, Hercessi
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection, solution
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 8mg/kg loading dose then 6mg/kg every 3 weeks
- Maximum
- consult physician
- Frequency
- every 3 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 6mg/kg every 3 weeks
- Maximum
- consult physician
- Frequency
- every 3 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 8mg/kg loading dose then 6mg/kg every 3 weeks
- Maximum
- consult physician
- Frequency
- every 3 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the mother
regular fetal monitoring including ultrasound for amniotic fluid levels
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteravoid if possible
discontinue therapy if pregnancy occurs; evaluate fetal well-being
comprehensive fetal ultrasound and amniotic fluid assessment
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid
do not breastfeed during treatment and for at least 6 months after last dose
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyno specific dose adjustment required
monitor cardiac function closely due to increased risk of cardiotoxicity
regular left ventricular ejection fraction monitoring every 3 months
Use with caution and monitor for adverse effects.
pediatric_age
children adolescentsnot established
not approved for use in patients under 18 years of age
not established
renal_impairment
mild moderateno dose adjustment needed
no dose adjustment required for mild to moderate renal impairment
standard monitoring
renal_impairment
severelimited data - use with caution
use with caution in severe renal impairment due to limited clinical data
enhanced monitoring recommended
Use with caution and monitor for adverse effects.
hepatic_impairment
mild moderateno dose adjustment required
no dose adjustment needed for mild to moderate hepatic impairment
standard cardiac monitoring
Statistics and clinical data
FDA approval year
Initial FDA approval for Trastuzumab
Drug class
ATC classification L01XC02
Primary indication
Main therapeutic use
Target
Molecular mechanism of action
Treatment of HER2-positive early or metastatic breast cancer, typically in patients who have previously received trastuzumab and taxane-based chemotherapy. Often used as adjuvant therapy after surgery or for advanced/metastatic disease.
The trastuzumab component binds to the HER2 receptor on cancer cells, allowing the conjugate to be internalized. Once inside the cell, DM1 (a microtubule inhibitor) is released and disrupts microtubule function, leading to cell death. This targeted approach allows for selective delivery of the cytotoxic agent to HER2-overexpressing tumor cells.
Requires HER2 positivity confirmation before treatment. Monitor for hepatotoxicity, cardiotoxicity, and pulmonary toxicity. May cause thrombocytopenia and peripheral neuropathy. Administered as intravenous infusion every 3 weeks. Cannot be interchanged with trastuzumab as they are distinct formulations with different dosing.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy