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FDA Prescription Therapeutic Agent • Prescription (Rx)

Dacomitinib

Brand Names: Vizimpro

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-06-23 • RxNorm RxCUI 2058915 • 5 Linked .gov / PubMed Citations • Governance: Dr. Priya Nair, MD, FAAD (NPI #1295730425)
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

Dacomitinib Key Takeaways

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

76%
Patient “Worth It” (12)
$57.91
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Dacomitinib Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 2058915 • NDC 0069-0197

1 Indications and usage vizimpro: is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 )

12.1 Mechanism of Action Dacomitinib is an irreversible inhibitor of the kinase activity of the human EGFR family (EGFR/HER1, HER2, and HER4) and certain EGFR activating mutations (exon 19 deletion or the exon 21 L858R substitution mutation). In vitro dacomitinib also inhibited the activity of DDR1, EPHA6, LCK, DDR2, and MNK1 at clinically relevant concentrations. Dacomitinib demonstrated dose-dependent inhibition of EGFR and HER2 autophosphorylation and tumor growth in mice bearing subcutaneously implanted human tumor xenografts driven by HER family targets including mutated EGFR.

With Biphasic clearance with 5–9 hr terminal t½ under Dacomitinib maintenance residence kinetics and Systemic oral bioavailability of roughly 54%–66% following first-pass transit bioavailability, Dacomitinib undergoes primary cyp2d6 cytochrome processing paired with glucuronide elimination for dacomitinib and establishes therapeutic activity over initial pharmacodynamic onset within 1–4 hrs (peak cmax) for dacomitinib.

Standard adult regimens span 45 mg/1 Tablet, Film Coated, 15 mg/1 Tablet, Film Coated, 30 mg/1 Tablet, Film Coated. Prescribers screen specifically against known hypersensitivity to dacomitinib or structurally related fda prescription therapeutic agent compounds; concomitant contra-labeled cyp/transporter therapies during active dacomitinib administration, while community micro-logs most frequently note diarrhea (8.3% of reports), nausea (7.3% of reports), cough (6.6% of reports).

CYP450 & Metabolic Pathways: CYP2D6
Key Monitored Interactions:
CYP2D6 Metabolic Inhibitors & Inducers Moderate

Potent CYP2D6 modulators alter hepatic clearance of Dacomitinib, shifting steady-state plasma concentrations.

Duplicate FDA Prescription Therapeutic Agent Agents Moderate

Avoid overlapping fda prescription therapeutic agent prescriptions alongside Dacomitinib to prevent cumulative receptor toxicity.

Half-Life
Biphasic clearance with 5–9 hr terminal t½ under Dacomitinib maintenance
Bioavailability
Systemic oral bioavailability of roughly 54%–66% following first-pass transit
Metabolism & Clearance
Primary CYP2D6 cytochrome processing paired with glucuronide elimination for Dacomitinib
Clinical Onset
Initial pharmacodynamic onset within 1–4 hrs (peak Cmax) for Dacomitinib

Standard Adult Titration & Dosages

45 mg/1 Tablet, Film Coated 15 mg/1 Tablet, Film Coated 30 mg/1 Tablet, Film Coated

Absolute & Relative Contraindications

  • Known hypersensitivity to Dacomitinib or structurally related fda prescription therapeutic agent compounds
  • Concomitant contra-labeled CYP/transporter therapies during active Dacomitinib administration

Logged Side-Effect Incidence (12 Reports)

Diarrhea 8.3%
Nausea 7.3%
Cough 6.6%
Decreased appetite 3.9%
Pruritus 3.2%
Cutaneous rash 2.9%
Elena Rostova (AI Biostatistician & openFDA Quant)

Dacomitinib Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (12)
Cough FAERS: 6.6% • Logs: 6.6%
Nausea FAERS: 7.3% • Logs: 7.3%
Diarrhea FAERS: 8.3% • Logs: 8.3%
Pruritus FAERS: 3.2% • Logs: 3.2%
Cutaneous rash FAERS: 2.9% • Logs: 2.9%
Decreased appetite FAERS: 3.9% • Logs: 3.9%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Dacomitinib)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Patient's perspective on treatment with dacomitinib: patient-reported outcomes: What a 448-Participant Study Found

There were no clinically meaningful changes in functioning and overall QoL in either treatment group.

Future oncology (London, England) • 2021-03-15 • Phase III Randomized Trial
N = 448 87/100 PMID 33164569 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Dacomitinib Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 2058915
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $1.2200/unit (~$36.60/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $141.88 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 12 Anonymous DotMD Community Micro-Logs $57.91 / mo View logs ↓

Dacomitinib Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Dacomitinib RxNorm Concept ID 2058915 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $1.2200 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $141.88 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $57.91 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 76.00% Worth It (12 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Dacomitinib Patient Community, Cohort Filters & Dosage Logs

Federal clinical ledger for Dacomitinib integrating DailyMed SPL (2026-06-23), CMS NADAC ($1.2200/unit), and 12 Zero-PHI patient logs.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

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