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VIZIMPRO®Highlights (dacomitinib)

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)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

  • Interstitial Lung Disease (ILD): Permanently discontinue VIZIMPRO if ILD is confirmed. (5.1)
  • Diarrhea: Withhold and reduce the dose of VIZIMPRO based on the severity. (2.3, 5.2)
  • Dermatologic Adverse Reactions: Withhold and reduce the dose of VIZIMPRO based on the severity. (2.3, 5.3)
  • Embryo-Fetal Toxicity: VIZIMPRO can cause fetal harm. Advise females of reproductive potential to use effective contraception. (5.4, 8.1, 8.3)

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

  • Proton Pump Inhibitors (PPIs): Avoid use with VIZIMPRO; use locally-acting antacids or H2-receptor antagonist; administer VIZIMPRO at least 6 hours before or 10 hours after H2-receptor antagonist. (2.4, 7.1)
  • CYP2D6 Substrates: Avoid concomitant use with VIZIMPRO where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities (7.2)

USE IN SPECIFIC POPULATIONS

  • Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 9/2018

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch