Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse drug reactions are described elsewhere in the labeling: • Interstitial Lung Disease [see Warnings and Precautions (5.1) ] • Diarrhea [see Warnings and Precautions (5.2) ] • Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence >20%) are 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.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data in the Warnings and Precautions section reflect exposure to VIZIMPRO in 394 patients with first-line or previously treated NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations who received VIZIMPRO at the recommended dose of 45 mg once daily in 4 randomized, active-controlled trials [ARCHER 1050 (N=227), Study A7471009 (N=38), Study A7471011 (N=83), and Study A7471028 (N=16)] and one single-arm trial [Study A7471017 (N=30)].
The median duration of exposure to VIZIMPRO was 10.8 months (range 0.07–68) [see Warnings and Precautions (5) ].
The data described below reflect exposure to VIZIMPRO in 227 patients with EGFR mutation-positive, metastatic NSCLC enrolled in a randomized, active-controlled trial (ARCHER 1050 ) ;
224 patients received gefitinib 250 mg orally once daily in the active control arm [see Clinical Studies (14) ] .
Patients were excluded if they had a history of ILD, interstitial pneumonitis, or brain metastases.
The median duration of exposure to VIZIMPRO was 15 months (range 0.07–37).
5 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.
Like all medications, Vizimpro can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: