Dacomitinib - Early Identification of Interstitial Lung Disease (ILD)

Dacomitinib - Early Identification of Interstitial Lung Disease (ILD)

Although the incidence of ILD is low, its potentially fatal nature requires a "zero-tolerance" monitoring and intervention protocol in clinical practice.

(1) In the pooled safety population, the incidence of ILD/pneumonitis was 0.5%, of which 0.3% were fatal, indicating that every patient presenting with respiratory symptoms warrants high vigilance.

(2) Monitoring points include: any new or worsening dyspnea, dry cough, fever, or hypoxemia should prompt temporary discontinuation of VIZIMPRO and immediate chest imaging (HRCT) and pulmonary function tests.

(3) Once ILD is confirmed (after excluding infection and other etiologies), permanent discontinuation is required; dose reduction or rechallenge should not be attempted, as re‑exposure may trigger more severe lung injury. This principle is the core of management.

Dacomitinib - Other Common Adverse Reactions

Dacomitinib also affects the periungual, oral, appetite, weight, hair, and multiple other systems, necessitating comprehensive patient education.

(1) Other adverse reactions occurring in over 20% of patients include: paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), weight loss (26%), alopecia (23%), cough (21%), and pruritus (21%).

(2) Serious adverse reactions (≥1%) are predominantly diarrhea (2.2%) and ILD (1.3%); most others are mild to moderate. However, stomatitis and paronychia often cause pain and difficulty in eating, requiring topical analgesia, oral rinses, and nail care.

(3) Weight loss and decreased appetite need nutritional support; alopecia and dry skin, although not life‑threatening, significantly affect psychological well‑being. Patients should be informed in advance and provided with psychological support, and when necessary, moisturizing products and wigs or other auxiliary measures may be used.

Dacomitinib - Use in Special Populations

Specific recommendations or warnings are provided for patients with different physiological characteristics, with particular emphasis on embryotoxicity and decreased tolerance in the elderly.

(1) Women of childbearing potential: highly effective contraception (e.g., intrauterine device or oral contraceptives plus a barrier method) must be used during treatment and for at least 17 days after the last dose. If pregnancy occurs accidentally, the teratogenic risk should be communicated.

(2) Lactating women: because of possible excretion into breast milk and immature organ development in infants, breastfeeding should not be resumed until at least 17 days after the last dose.

(3) Elderly patients (≥65 years): exploratory analyses show higher rates of grade 3/4 adverse reactions and dose interruptions/discontinuations; therefore, this population should be monitored more frequently for symptoms and more proactive preventive measures should be considered.

(4) Hepatic and renal impairment: no dose adjustment is required for mild to moderate renal impairment; data are lacking for severe renal impairment.