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 are (incidence >20%) 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: 9/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
2.2 Recommended Dosage
2.3 Dosage Modifications for Adverse Reactions
2.4 Dosage Modifications for Acid-Reducing Agents
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Interstitial Lung Disease (ILD)
5.2 Diarrhea
5.3 Dermatologic Adverse Reactions
5.4 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on VIZIMPRO
7.2 Effect of VIZIMPRO on CYP2D6 Substrates
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14. CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESC |
