Vizimpro 45 mg Tablet

Description

Vizimpro (dacomitinib) is a once‑daily, first‑generation, irreversible EGFR tyrosine kinase inhibitor used for adults with metastatic non‑small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations. It’s taken orally with or without food

Benefits

• In the pivotal ARCHER 1050 trial, Vizimpro demonstrated a median progression‑free survival (PFS) of 14.7 months, compared to 9.2 months with gefitinib (hazard ratio 0.59; p < 0.0001)

• Real‑world data suggest even longer median PFS (~16.7 months), with an overall response rate of 84.3%

• Trend toward improved overall survival versus first-generation EGFR TKIs

Indications and Usage

• First-line treatment of metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution, confirmed via FDA‑approved tests

• The safety and efficacy of this medication have not been established in children.

How it Works

Dacomitinib irreversibly binds and inhibits mutated EGFR family proteins, blocking downstream signaling that drives cancer proliferation. As a second-generation EGFR TKI, it also targets HER2, offering broader kinase suppression

Dosage & Administration

• Recommended dose: 45 mg orally once daily (with or without food) until disease progression or unacceptable toxicity.

• Take at the same time each day. If vomiting occurs shortly after dosing, skip that day’s dose and continue with the next day’s dose. Do not double up.

Side Effects

Common (≥20% incidence):

• Diarrhea, rash, paronychia (nail infections), stomatitis, decreased appetite, dry skin, weight loss, alopecia, cough, pruritus

Serious Adverse Events:

• Interstitial lung disease (ILD)/pneumonitis (incidence: 0.5%; fatality: 0.3%): monitor for worsening respiratory symptoms

• Severe diarrhea and risk of dehydration: prompt treatment with fluids and agents such as loperamide.

• Dermatologic reactions: dry skin, acneiform rash, and peeling. Prophylactic moisturizers and sun protection are advised.

• Other symptoms include mouth sores, nail issues, eye irritation, and weight loss.

Warning and Precaution

• ILD/pneumonitis: permanently discontinue on confirmed diagnosis; monitor for dyspnea, cough, fever.

• Diarrhea may be severe; manage aggressively with hydration and anti-diuretics.

• Skin toxicity: moisturize, use sunscreen, avoid tanning beds. Protective clothing is advised. Visit

• Reproductive risks: contraindicated in pregnancy — effective contraception required during treatment and for 17 days after the last dose. Not to be used while breastfeeding.

• Drug interactions: Acid-reducing agents should be spaced at least 6 hours apart from Vizimpro.

Clinical Trial & Approvals

• ARCHER 1050 (NCT01774721): randomized trial comparing Vizimpro vs gefitinib; significant PFS benefit (14.7 vs 9.2 months; HR 0.59)

• FDA Approval: September 2018 for first-line treatment of EGFR-mutated metastatic NSCLC

• Real-world studies have validated efficacy with PFS around 16.7 months and high response rates.