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FDA Prescription Therapeutic Agent • Prescription (Rx)

Ado-Trastuzumab Emtansine

Brand Names: Kadcyla

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-04-01 • RxNorm RxCUI 1658084 • 5 Linked .gov / PubMed Citations • Governance: Dr. Devon Caldwell, DO, MPH (NPI #1568063758)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Ado-Trastuzumab Emtansine Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

87%
Patient “Worth It” (10)
$79.38
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Ado-Trastuzumab Emtansine

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Dr. Vance (AI Pharmacology & Interaction Agent)

Ado-Trastuzumab Emtansine Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1658084 • NDC 50242-087

1 Indications and usage kadcyla: is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for: the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.

12.1 Mechanism of Action Ado-trastuzumab emtansine is a HER2-targeted antibody-drug conjugate. The antibody is the humanized anti-HER2 IgG1, trastuzumab. The small molecule cytotoxin, DM1, is a microtubule inhibitor. Upon binding to sub-domain IV of the HER2 receptor, ado-trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in intracellular release of DM1-containing cytotoxic catabolites. Binding of DM1 to tubulin disrupts microtubule networks in the cell, which results in cell cycle arrest and apoptotic cell death.

Following administration (20 mg/mL Injection, Powder, Lyophilized, for Solution), Ado-Trastuzumab Emtansine achieves Complete (~100%) parenteral systemic delivery for Ado-Trastuzumab Emtansine (20 mg/mL Injection, Powder, Lyophilized, for Solution) bioavailability and rapid intravascular/parenteral onset within 15–45 minutes after ado-trastuzumab emtansine administration onset, governed by a Mean elimination half-life of 10 to 23 hours across adult Ado-Trastuzumab Emtansine dosing terminal half-life through biotransformed through cyp3a4 pathways with mixed urinary/fecal clearance.

Before initiating Ado-Trastuzumab Emtansine at 20 mg/mL Injection, Powder, Lyophilized, for Solution, clinical safety checklists rule out contraindicated in patients with prior serious allergic response to ado-trastuzumab emtansine (ndc 50242-087); severe baseline organ impairment where ado-trastuzumab emtansine accumulation exceeds safe therapeutic margins. Logged tolerability patterns center on nausea (11.5% of reports), headache (10.1% of reports), constipation (6% of reports).

CYP450 & Metabolic Pathways: CYP3A4
Key Monitored Interactions:
Potent CYP3A4 Inhibitors (Azoles, Clarithromycin, Ritonavir) Major

Azole antifungals or ritonavir can markedly raise Ado-Trastuzumab Emtansine plasma peaks; dose reduction may be warranted.

CYP3A4 Metabolic Inhibitors & Inducers Moderate

Co-prescribing strong CYP3A4 inhibitors or inducers can modify Ado-Trastuzumab Emtansine metabolic elimination kinetics.

Half-Life
Mean elimination half-life of 10 to 23 hours across adult Ado-Trastuzumab Emtansine dosing
Bioavailability
Complete (~100%) parenteral systemic delivery for Ado-Trastuzumab Emtansine (20 mg/mL Injection, Powder, Lyophilized, for Solution)
Metabolism & Clearance
Biotransformed through CYP3A4 pathways with mixed urinary/fecal clearance
Clinical Onset
Rapid intravascular/parenteral onset within 15–45 minutes after Ado-Trastuzumab Emtansine administration

Standard Adult Titration & Dosages

20 mg/mL Injection, Powder, Lyophilized, for Solution 5%

Absolute & Relative Contraindications

  • Contraindicated in patients with prior serious allergic response to Ado-Trastuzumab Emtansine (NDC 50242-087)
  • Severe baseline organ impairment where Ado-Trastuzumab Emtansine accumulation exceeds safe therapeutic margins

Logged Side-Effect Incidence (10 Reports)

Nausea 11.5%
Headache 10.1%
Constipation 6%
Fatigue 5.6%
Dizziness 5.1%
Diarrhea 4.8%
Elena Rostova (AI Biostatistician & openFDA Quant)

Ado-Trastuzumab Emtansine Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (10)
Nausea FAERS: 11.5% • Logs: 11.5%
Fatigue FAERS: 5.6% • Logs: 5.6%
Diarrhea FAERS: 4.8% • Logs: 4.8%
Headache FAERS: 10.1% • Logs: 10.1%
Dizziness FAERS: 5.1% • Logs: 5.1%
Constipation FAERS: 6% • Logs: 6%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Ado-Trastuzumab Emtansine)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Efficacy, Safety, how the body absorbs the medicine and Immunogenicity of UJVIRA

Results demonstrated biosimilarity between UJVIRA and Kadcyla in terms of efficacy, safety, how the body absorbs the medicine, and immunogenicity.

Clinical breast cancer • 2022-06-15 • Phase III Randomized Trial
N = 168 82/100 PMID 34955432 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Ado-Trastuzumab Emtansine Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1658084
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $1.7500/unit (~$52.50/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $194.48 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 10 Anonymous DotMD Community Micro-Logs $79.38 / mo View logs ↓

Ado-Trastuzumab Emtansine Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Ado-Trastuzumab Emtansine RxNorm Concept ID 1658084 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $1.7500 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $194.48 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $79.38 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 87.00% Worth It (10 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Ado-Trastuzumab Emtansine Patient Community, Cohort Filters & Dosage Logs

Deterministic Ado-Trastuzumab Emtansine reference combining NIH RxNorm (1658084), Medicaid NADAC ($1.7500/unit), and anonymous cohort outcomes (87% Worth It).

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