VIZIMPRO® Description (dacomitinib) | Pfizer Medical Information - US

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11 DESCRIPTION

Dacomitinib is an oral kinase inhibitor with a molecular formula of C24H25ClFN5O2 ∙ H2O and a molecular weight of 487.95 Daltons. The chemical name is: (2E)-N-{4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-yl}-4-(piperidin-1-yl)but-2-enamide monohydrate and its structural formula is:

Chemical Structure

Dacomitinib is a white to pale yellow powder.

VIZIMPRO tablets contain 45, 30, or 15 mg of dacomitinib with the following inactive ingredients in the tablet core; lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating consists of Opadry II® Blue 85F30716 containing: Polyvinyl alcohol – partially hydrolyzed, Talc, Titanium dioxide, Macrogol/PEG 3350, and FD&C Blue #2/Indigo Carmine Aluminum Lake.

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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.

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Resources

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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 Warnings and Precautions (5.1)...

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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:

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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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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.