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VIZIMPRO®(dacomitinib)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

VIZIMPRO® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

VIZIMPRO is 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...

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2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Select patients for the first-line treatment of metastatic NSCLC with VIZIMPRO based on the presence of an EGFR exon...

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3 DOSAGE FORMS AND STRENGTHS

Tablets:

  • 45 mg: blue film-coated, immediate release, round biconvex tablet, debossed with "Pfizer" on one side and "DCB45" on the other side.
  • 30 mg: blue film-...
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4 CONTRAINDICATIONS

None.

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5 WARNINGS AND PRECAUTIONS

5.1 Interstitial Lung Disease (ILD)

Severe and fatal ILD/pneumonitis occurred in patients treated with VIZIMPRO and occurred in 0.5% of the...

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6 ADVERSE REACTIONS

The following adverse drug reactions are described elsewhere in the labeling:

  • Interstitial Lung Disease [see

    6.1 Clinical Trials Experience

    ...
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7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on VIZIMPRO

Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce VIZIMPRO efficacy. Avoid...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

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11 DESCRIPTION

Dacomitinib is an oral kinase inhibitor with a molecular formula of C24H25ClFN5O2 ∙ H2...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Dacomitinib is an irreversible inhibitor of the kinase activity of the human EGFR family (EGFR/HER1, HER2, and HER4...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been performed with VIZIMPRO.

Dacomitinib...

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14 CLINICAL STUDIES

The efficacy of VIZIMPRO was demonstrated in a randomized, multicenter, multinational, open-label study (ARCHER 1050; [NCT01774721]). Patients were required to have unresectable, metastatic NSCLC with no...

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16 HOW SUPPLIED/STORAGE AND HANDLING

VIZIMPRO is supplied in strengths and package configurations as described in Table 6 below:

Table 6. VIZIMPRO Strengths and Package Configurations...
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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Interstitial...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.VIZIMPRO.com.

...

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