HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VIZIMPRO safely and effectively. See full prescribing information for VIZIMPRO.
VIZIMPRO® (dacomitinib) tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
Recommended Dosage: 45 mg orally once daily with or without food. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg, 30 mg, and 45 mg. (3)
WARNINGS AND PRECAUTIONS
Most common adverse reactions are (incidence >20%) diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.