HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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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 a Pfizer product 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 to report an adverse event related to a Pfizer product, please call Pfizer Medical Information 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.