Dacomitinib

VIZIMPRO

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Pronunciation: dak-oe-MI-ti-nib (vi-ZIM-proe)

Dacomitinib ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Dacomitinib ballicule

What it isA second-generation irreversible pan-HER (EGFR/HER2/HER4) tyrosine kinase inhibitor.

Why this oneFirst-line therapy for metastatic NSCLC with EGFR exon 19 deletions or L858R substitutions.

What limits itCauses high rates of diarrhea, dermatologic toxicity, and interstitial lung disease; it inhibits CYP2D6, and acid-reducing agents lower its exposure.

Dacomitinib molecular structure (skeletal formula) — Molecular structure: Dacomitinib

FDA label

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FDA dosing	Population	Start	Target	Max
First-line metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution (FDA-approved test)	Adults	45 mg QD	45 mg QD until progression or unacceptable toxicity	45 mg QD

Renal No adjustment for mild or moderate impairment (CrCl 30–89 mL/min); dose not established for severe (CrCl <30 mL/min)

Hepatic No adjustment needed (Child-Pugh A, B, or C)

Instructions

With or without food; take at same time each day
If patient vomits or misses a dose, do not take extra or make up — take next scheduled dose
Dose reductions for adverse reactions: 30 mg QD, then 15 mg QD (permanently discontinue for any-grade ILD)
Avoid concomitant proton pump inhibitors; use locally acting antacids instead, or take dacomitinib ≥6 h before or 10 h after an H2-receptor antagonist

Available strengths

tab 15, 30, 45 mg

Cautions

Interstitial lung disease/pneumonitis (0.5%, may be fatal) — permanently discontinue if confirmed
Severe/fatal diarrhea (86%, Grade 3–4 in 11%) — withhold/reduce; treat promptly with loperamide or diphenoxylate-atropine
Rash and exfoliative skin reactions (rash 78%, Grade 3–4 21%) — worsened by sun; start moisturizers and sun protection at initiation; topical then oral antibiotics by grade
Embryo-fetal toxicity — effective contraception during treatment and ≥17 days after final dose

Adverse reactions

Diarrhea
Rash
Paronychia
Stomatitis
Decreased appetite
Dry skin
Decreased weight
Alopecia
Cough
Pruritus

Pregnancy Can cause fetal harm (animal data/mechanism); verify pregnancy status before starting; advise of fetal risk

Lactation Do not breastfeed during treatment and for at least 17 days after last dose

Cost

Dacomitinib (VIZIMPRO)

Strength		#/mo	CostPlus
15 mg	tab	30 qd	not offered
30 mg	tab	30 qd	not offered
45 mg	tab	30 qd	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Dacomitinib is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entryNo US generic

NO BOXED WARNINGS

Principal riskNo FDA boxed warning.

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk3 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.

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