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 (incidence >20%) are 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: 12/2020

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Highlights

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 (incidence >20%) are 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: 12/2020
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