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BALVERSA(erdafitinib)tablets,(六)
treated with BALVERSA at 8 mg orally once daily; with a dose increase to 9 mg in patients withphosphate levels <5.5 mg/dL on Day 14 of Cycle 1. Median duration of treatment was 5.3 months(range: 0 to 17 months).
The most common adverse reactions (ARs) including laboratory abnormalities (≥20%) were phosphateincreased, stomatitis, fatigue, creatinine increased, diarrhea, dry mouth, onycholysis, alanineaminotransferase increased, alkaline phosphatase increased, sodium decreased, decreased appetite,albumin decreased, dysgeusia, hemoglobin decreased, dry skin, aspartate aminotransferase increased,magnesium decreased, dry eye, alopecia, palmar-plantar erythrodysesthesia syndrome, constipation,
phosphate decreased, abdominal pain, calcium increased, nausea, and musculoskeletal pain. The mostcommon Grade 3 or greater ARs (>1%) were stomatitis, nail dystrophy, palmar-plantarerythrodysesthesia syndrome, paronychia, nail disorder, keratitis, onycholysis, and hyperphosphatemia.
An adverse reaction with a fatal outcome in 1% of patients was acute myocardial infarction.
Serious adverse reactions occurred in 41% of patients including eye disorders (10%).
Permanent discontinuation due to an adverse reaction occurred in 13% of patients. The most frequentreasons for permanent discontinuation included eye disorders (6%).
Dosage interruptions occurred in 68% of patients. The most frequent adverse reactions requiring dosageinterruption included hyperphosphatemia (24%), stomatitis (17%), eye disorders (17%), and palmarplantarerythro-dysaesthesia syndrome (8%).
Dose reductions occurred in 53% of patients. The most frequent adverse reactions for dose reductionsincluded eye disorders (23%), stomatitis (15%), hyperphosphatemia (7%), palmar-plantar erythrodysaesthesiasyndrome (7%), paronychia (7%), and nail dystrophy (6%).
Table 3 presents ARs reported in ≥10% of patients treated with BALVERSA at 8 mg once daily.
Table 3: Adverse Reactions Reported in ≥ 10% (Any Grade) or ≥5% (Grade 3-4) of Patients
Adverse Reaction
BALVERSA 8 mg daily (N=87)
All Grades (%) Grade 3-4 (%)
Any 100 67
Gastrointestinal disorders 92 24
Stomatitis 56 9
Diarrhea 47 2
Dry mouth 45 0
Constipation 28 1
Abdominal paina 23 2
Nausea 21 1
Vomiting 13 2
Metabolism and nutrition disorders 90 16
Decreased appetite 38 0
General disorders and admin. site conditions 69 13
Fatigueb 54 10
Pyrexia 14 1
Skin and subcutaneous disorders 75 16
Onycholysisc 41 10
Dry skind 34 0
Palmar-plantar erythrodysaesthesia 26 6
Alopecia 26 0
Nail discoloration 11 0
Eye disorders 62 11
Dry eyee 28 6
Vision blurred 17 0
Lacrimation increased 10 0
Nervous system disorders 57 5
Dysgeusia 37 1
Infections and infestations 56 20
Paronychia 17 3
Urinary tract infection 17 6
Conjunctivitis 11 0
Respiratory, thoracic and mediastinal disorders 40 7
Oropharyngeal pain 11 1
Dyspneaf 10 2
Renal and urinary tract disorders 38 10
Hematuria 11 2
Musculoskeletal and connective tissue disorders 31 0
Musculoskeletal paing 20 0
Arthralgia 11 0
Investigations 44 5
Weight decreasedh 16 0 a Includes abdominal pain, abdominal discomfort, abdominal pain upper, and abdominal pain lower
b Includes asthenia, fatigue, lethargy, and malaise
c Includes onycholysis, onychoclasis, nail disorder, nail dystrophy, and nail ridging
d Inclu |
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