The following adverse drug reactions are described elsewhere in the labeling:
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.
| Adverse Reaction | VIZIMPRO (N=227) | Gefitinib (N=224) | ||
|---|---|---|---|---|
| All Grades† % | Grades 3 and 4 % | All Grades % | Grades 3 and 4 % | |
| ||||
| Gastrointestinal | ||||
| Diarrhea‡ | 87 | 8 | 56 | 0.9 |
| Stomatitis§ | 45 | 4.4 | 19 | 0.4 |
| Nausea | 19 | 1.3 | 22 | 0.4 |
| Constipation | 13 | 0 | 14 | 0 |
| Mouth ulceration | 12 | 0 | 6 | 0 |
| Skin and Subcutaneous Tissue | ||||
| Rash¶ | 69 | 23 | 47 | 0.4 |
| Paronychia# | 64 | 8 | 21 | 1.3 |
| Dry skinÞ | 30 | 1.8 | 19 | 0.4 |
| Alopecia | 23 | 0.4 | 13 | 0 |
| Pruritusß | 21 | 0.9 | 15 | 1.3 |
| Palmar-plantar erythrodysesthesia syndrome | 15 | 0.9 | 3.1 | 0 |
| Dermatitis | 11 | 1.8 | 4 | 0.4 |
| Metabolism and Nutrition | ||||
| Decreased appetite | 31 | 3.1 | 25 | 0.4 |
| Decreased weight | 26 | 2.2 | 17 | 0.4 |
| Respiratory | ||||
| Cough | 21 | 0 | 19 | 0.4 |
| Nasal mucosal disorderà | 19 | 0 | 4.9 | 0 |
| Dyspnea | 13 | 2.2 | 13 | 1.8 |
| Upper respiratory tract infection | 12 | 1.3 | 13 | 0 |
| Chest pain | 10 | 0 | 14 | 0 |
| Eye | ||||
| Conjunctivitis | 19 | 0 | 4 | 0 |
| Musculoskeletal | ||||
| Pain in extremity | 14 | 0 | 12 | 0 |
| Musculoskeletal pain | 12 | 0.9 | 13 | 0 |
| General | ||||
| Asthenia | 13 | 2.2 | 13 | 1.3 |
| Psychiatric | ||||
| Insomnia | 11 | 0.4 | 15 | 0 |
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%
| Laboratory Test Abnormality† | VIZIMPRO | Gefitinib | ||
|---|---|---|---|---|
| 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. | ||||
| Hematology | ||||
| Anemia | 44 | 0.9 | 26 | 2.7 |
| Lymphopenia | 42 | 6 | 35 | 2.7 |
| Chemistry | ||||
| Hypoalbuminemia | 44 | 0 | 34 | 0 |
| Increased ALT | 40 | 1.4 | 63 | 13 |
| Hyperglycemia | 36 | 1.0 | 38 | 2.5 |
| Increased AST | 35 | 0.5 | 57 | 8 |
| Hypocalcemia | 33 | 1.4 | 28 | 2.0 |
| Hypokalemia | 29 | 7 | 18 | 2.0 |
| Hyponatremia | 26 | 2.9 | 20 | 1.5 |
| Increased creatinine | 24 | 0 | 16 | 0.5 |
| Increased alkaline phosphatase | 22 | 0.5 | 21 | 2.0 |
| Hypomagnesemia | 22 | 0.5 | 9 | 0 |
| Hyperbilirubinemia | 16 | 0.5 | 22 | 0.5 |
The following adverse drug reactions are described elsewhere in the labeling:
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.
| Adverse Reaction | VIZIMPRO (N=227) | Gefitinib (N=224) | ||
|---|---|---|---|---|
| All Grades† % | Grades 3 and 4 % | All Grades % | Grades 3 and 4 % | |
| ||||
| Gastrointestinal | ||||
| Diarrhea‡ | 87 | 8 | 56 | 0.9 |
| Stomatitis§ | 45 | 4.4 | 19 | 0.4 |
| Nausea | 19 | 1.3 | 22 | 0.4 |
| Constipation | 13 | 0 | 14 | 0 |
| Mouth ulceration | 12 | 0 | 6 | 0 |
| Skin and Subcutaneous Tissue | ||||
| Rash¶ | 69 | 23 | 47 | 0.4 |
| Paronychia# | 64 | 8 | 21 | 1.3 |
| Dry skinÞ | 30 | 1.8 | 19 | 0.4 |
| Alopecia | 23 | 0.4 | 13 | 0 |
| Pruritusß | 21 | 0.9 | 15 | 1.3 |
| Palmar-plantar erythrodysesthesia syndrome | 15 | 0.9 | 3.1 | 0 |
| Dermatitis | 11 | 1.8 | 4 | 0.4 |
| Metabolism and Nutrition | ||||
| Decreased appetite | 31 | 3.1 | 25 | 0.4 |
| Decreased weight | 26 | 2.2 | 17 | 0.4 |
| Respiratory | ||||
| Cough | 21 | 0 | 19 | 0.4 |
| Nasal mucosal disorderà | 19 | 0 | 4.9 | 0 |
| Dyspnea | 13 | 2.2 | 13 | 1.8 |
| Upper respiratory tract infection | 12 | 1.3 | 13 | 0 |
| Chest pain | 10 | 0 | 14 | 0 |
| Eye | ||||
| Conjunctivitis | 19 | 0 | 4 | 0 |
| Musculoskeletal | ||||
| Pain in extremity | 14 | 0 | 12 | 0 |
| Musculoskeletal pain | 12 | 0.9 | 13 | 0 |
| General | ||||
| Asthenia | 13 | 2.2 | 13 | 1.3 |
| Psychiatric | ||||
| Insomnia | 11 | 0.4 | 15 | 0 |
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%
| Laboratory Test Abnormality† | VIZIMPRO | Gefitinib | ||
|---|---|---|---|---|
| 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. | ||||
| Hematology | ||||
| Anemia | 44 | 0.9 | 26 | 2.7 |
| Lymphopenia | 42 | 6 | 35 | 2.7 |
| Chemistry | ||||
| Hypoalbuminemia | 44 | 0 | 34 | 0 |
| Increased ALT | 40 | 1.4 | 63 | 13 |
| Hyperglycemia | 36 | 1.0 | 38 | 2.5 |
| Increased AST | 35 | 0.5 | 57 | 8 |
| Hypocalcemia | 33 | 1.4 | 28 | 2.0 |
| Hypokalemia | 29 | 7 | 18 | 2.0 |
| Hyponatremia | 26 | 2.9 | 20 | 1.5 |
| Increased creatinine | 24 | 0 | 16 | 0.5 |
| Increased alkaline phosphatase | 22 | 0.5 | 21 | 2.0 |
| Hypomagnesemia | 22 | 0.5 | 9 | 0 |
| Hyperbilirubinemia | 16 | 0.5 | 22 | 0.5 |
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