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VIZIMPRO® Tablets (dacomitinib) Adverse Reactions

6 ADVERSE REACTIONS

The following adverse drug reactions are described elsewhere in the labeling:

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).

The most common (>20%) adverse reactions in patients treated with VIZIMPRO were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritus (21%).

Serious adverse reactions occurred in 27% of patients treated with VIZIMPRO. The most common (≥1%) serious adverse reactions were diarrhea (2.2%) and interstitial lung disease (1.3%). Dose interruptions occurred in 57% of patients treated with VIZIMPRO. The most frequent (>5%) adverse reactions leading to dose interruptions were rash (23%), paronychia (13%), and diarrhea (10%). Dose reductions occurred in 66% of patients treated with VIZIMPRO. The most frequent (>5%) adverse reactions leading to dose reductions were rash (29%), paronychia (17%), and diarrhea (8%).

Adverse reactions leading to permanent discontinuation of VIZIMPRO occurred in 18% of patients. The most common (>0.5%) adverse reactions leading to permanent discontinuation of VIZIMPRO were: rash (2.6%), interstitial lung disease (1.8%), stomatitis (0.9%), and diarrhea (0.9%).

Tables 3 and 4 summarize the most common adverse reactions and laboratory abnormalities, respectively, in ARCHER 1050. ARCHER 1050 was not designed to demonstrate a statistically significant difference in adverse reaction rates for VIZIMPRO or for gefitinib for any adverse reaction or laboratory value listed in Table 3 or 4.

Table 3. Adverse Reactions Occurring in ≥10% of Patients Receiving VIZIMPRO in ARCHER 1050*
Adverse ReactionVIZIMPRO
(N=227)
Gefitinib
(N=224)
All Grades
%
Grades 3 and 4
%
All Grades
%
Grades 3 and 4
%
*
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Grades 1 through 5 are included in All Grades.
One Grade 5 (fatal) event in the VIZIMPRO arm.
§
Stomatitis includes mucosal inflammation and stomatitis.
Rash includes dermatitis acneiform, rash, and rash maculo-papular.
#
Paronychia includes nail infection, nail toxicity, onychoclasis, onycholysis, onychomadesis, paronychia.
Þ
Dry skin includes dry skin, xerosis.
ß
Pruritus includes pruritus, pruritus generalized, rash pruritic.
à
Nasal mucosal disorder includes epistaxis, nasal inflammation, nasal mucosal disorder, nasal mucosal ulcer, rhinitis.
Gastrointestinal
Diarrhea878560.9
Stomatitis§454.4190.4
Nausea191.3220.4
Constipation130140
Mouth ulceration12060
Skin and Subcutaneous Tissue
Rash6923470.4
Paronychia#648211.3
Dry skinÞ301.8190.4
Alopecia230.4130
Pruritusß210.9151.3
Palmar-plantar erythrodysesthesia syndrome150.93.10
Dermatitis111.840.4
Metabolism and Nutrition
Decreased appetite313.1250.4
Decreased weight262.2170.4
Respiratory
Cough210190.4
Nasal mucosal disorderà1904.90
Dyspnea132.2131.8
Upper respiratory tract infection121.3130
Chest pain100140
Eye
Conjunctivitis19040
Musculoskeletal
Pain in extremity140120
Musculoskeletal pain120.9130
General
Asthenia132.2131.3
Psychiatric
Insomnia110.4150

Additional adverse reactions (All Grades) that were reported in <10% of patients who received VIZIMPRO in ARCHER 1050 include:

General: fatigue 9%

Skin and subcutaneous tissue: skin fissures 9%, hypertrichosis 1.3%, skin exfoliation/exfoliative skin reactions 3.5%

Gastrointestinal: vomiting 9%

Nervous system: dysgeusia 7%

Respiratory: interstitial lung disease 2.6%

Ocular: keratitis 1.8%

Metabolism and nutrition: dehydration 1.3%

Table 4. Laboratory Abnormalities Worsening from Baseline in >20% of Patients in ARCHER 1050*
Laboratory Test AbnormalityVIZIMPROGefitinib
Change from Baseline All Grades
(%)
Change from Baseline to Grade 3 or Grade 4
(%)
Change from Baseline All Grades
(%)
Change from Baseline to Grade 3 or Grade 4
(%)
ALT=alanine aminotransferase; AST=aspartate aminotransferase.
*
NCI CTCAE v4.03, except for increased creatinine which only includes patients with creatinine increase based on upper limit of normal definition.
Based on the number of patients with available baseline and at least one on-treatment laboratory test.
Hematology
  Anemia440.9262.7
  Lymphopenia426352.7
Chemistry
  Hypoalbuminemia440340
  Increased ALT401.46313
  Hyperglycemia361.0382.5
  Increased AST350.5578
  Hypocalcemia331.4282.0
  Hypokalemia297182.0
  Hyponatremia262.9201.5
  Increased creatinine240160.5
  Increased alkaline phosphatase220.5212.0
  Hypomagnesemia220.590
  Hyperbilirubinemia160.5220.5

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