(dacomitinib)
8 USE IN SPECIFIC POPULATIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from animal studies and its mechanism of action, VIZIMPRO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on VIZIMPRO use in pregnant women. In animal reproduction studies, oral administration of dacomitinib to pregnant rats during the period of organogenesis resulted in an increased incidence of post-implantation loss and reduced fetal body weight at doses resulting in exposures near the exposure at the 45 mg human dose (see Data). The absence of EGFR signaling has been shown to result in embryolethality as well as post-natal death in animals (see Data). Advise pregnant women of the potential risk to a fetus [see Use in Special Populations (8.3)].
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal Data
Daily oral administration of dacomitinib to pregnant rats during the period of organogenesis resulted in an increased incidence of post-implantation loss, maternal toxicity, and reduced fetal body weight at 5 mg/kg/day (approximately 1.2 times the exposure based on area under the curve [AUC] at the 45 mg human dose).
Disruption or depletion of EGFR in mouse models has shown EGFR is critically important in reproductive and developmental processes including blastocyst implantation, placental development, and embryo-fetal/post-natal survival and development. Reduction or elimination of embryo-fetal or maternal EGFR signaling in mice can prevent implantation, and can cause embryo-fetal loss during various stages of gestation (through effects on placental development), developmental anomalies, early death in surviving fetuses, and adverse developmental outcomes in multiple organs in embryos/neonates.
8.2 Lactation
Risk Summary
There is no information regarding the presence of dacomitinib or its metabolites in human milk or their effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants from VIZIMPRO, advise women not to breastfeed during treatment with VIZIMPRO and for at least 17 days after the last dose.
8.3 Females and Males of Reproductive Potential
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating VIZIMPRO [see Use in Specific Populations (8.1)].
Contraception
VIZIMPRO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].
8.5 Geriatric Use
Of the total number of patients (N=394) in five clinical studies with EGFR mutation-positive NSCLC who received VIZIMPRO at a dose of 45 mg orally once daily [ARCHER 1050 (N=227), Study A7471009 (N=38), Study A7471011 (N=83), Study A7471028 (N=16), and Study A7471017 (N=30)] 40% were 65 years of age and older.
Exploratory analyses across this population suggest a higher incidence of Grade 3 and 4 adverse reactions (67% versus 56%, respectively), more frequent dose interruptions (53% versus 45%, respectively), and more frequent discontinuations (24% versus 10%, respectively) for adverse reactions in patients 65 years or older as compared to those younger than 65 years.
8.6 Renal Impairment
No dosage modification is recommended for patients with mild or moderate renal impairment (creatinine clearance [CLcr] 30 to 89 mL/min estimated by Cockcroft-Gault). The recommended dose of VIZIMPRO has not been established for patients with severe renal impairment (CLcr <30 mL/min) [see Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
No dosage modification is recommended in patients with mild, moderate or severe hepatic impairment (Child-Pugh A, B or C) [see Clinical Pharmacology (12.3)].
MEDICATION GUIDE
| This Patient Information has been approved by the U.S. Food and Drug Administration. | Issued: September 2018 | |
| PATIENT INFORMATION VIZIMPRO® (vih-ZIM-pro) (dacomitinib) tablets | ||
| What is VIZIMPRO? VIZIMPRO is a prescription medicine used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic):
It is not known if VIZIMPRO is safe and effective in children. | ||
Before taking VIZIMPRO, tell your healthcare provider about all your medical conditions, including if you:
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How should I take VIZIMPRO?
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What should I avoid during treatment with VIZIMPRO?
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| What are the possible side effects of VIZIMPRO? VIZIMPRO may cause serious side effects, including:
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| Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||
How should I store VIZIMPRO?
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| General information about the safe and effective use of VIZIMPRO. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VIZIMPRO for a condition for which it was not prescribed. Do not give VIZIMPRO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about VIZIMPRO that is written for health professionals. | ||
| What are the ingredients in VIZIMPRO? Active ingredient: dacomitinib Inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. Film coating contains: Opadry II® Blue 85F30716 containing: Polyvinyl alcohol – partially hydrolyzed, Talc, Titanium dioxide, Macrogol/PEG 3350, and FD&C Blue #2/Indigo Carmine Aluminum Lake.
For more information, go to www.VIZIMPRO.com or call 1-800-438-1985. | ||
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