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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
Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Warnings and Precautions
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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Adverse Reactions
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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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
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Description
11 DESCRIPTION
Dacomitinib is an oral kinase inhibitor with a molecular formula of C24H25ClFN5O2 ∙ H2...
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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been performed with VIZIMPRO.
Dacomitinib...
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Clinical Studies
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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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
VIZIMPRO is supplied in strengths and package configurations as described in Table 6 below:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Interstitial...
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Report Adverse Event
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:
*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.
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.
(800)-332-1088.