Dacomitinib
VIZIMPRO
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.
FDA label
Read the full label on DailyMed ↗
| 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
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
NO BOXED WARNINGS
Principal riskNo FDA boxed warning.
Cost, est. cash$5,000–$30,000+/month or cycle
Generic entryNo US generic
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.
Mechanism of action: Dacomitinib ballicule
