des dry skin and xerostomia e Includes dry eye, xerophthalmia, keratitis, foreign body sensation, and corneal erosion
f Includes dyspnea and dyspnea exertional
g Includes back pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal chest pain, neck pain, pain in extremity h Includes weight decreased and cachexia
Table 4: Laboratory Abnormalities Reported in ≥ 10% (All Grade) or ≥ 5% (Grade 3-4) ofPatients
Laboratory Abnormality
BALVERSA 8 mg daily (N=86a
)
All Grades (%) Grade 3-4 (%)
Hematology
Hemoglobin decreased 35 3
Platelets decreased 19 1
Leukocytes decreased 17 0
Neutrophils decreased 10 2
Chemistry
Phosphate increased 76 1
Creatinine increased 52 5
Sodium decreased 40 16
Alanine aminotransferase increased 41 1
Alkaline phosphatase increased 41 1
Albumin decreased 37 0
Aspartate aminotransferase increased 30 0
Magnesium decreased 30 1
Phosphate decreased 24 9
Calcium increased 22 3
Potassium increased 16 0
Fasting glucose increased 10 0 a One of the 87 patients had no laboratory tests.
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on BALVERSA
Table 5 summarizes drug interactions that affect the exposure of BALVERSA or serum phosphate leveland their clinical management.
Table 5: Drug Interactions that Affect BALVERSA
Strong CYP2C9 or CYP3A4 Inhibitors
Clinical Impact
• Co-administration of BALVERSA with strong inhibitors of CYP2C9 orCYP3A4 increased erdafitinib plasma concentrations [see ClinicalPharmacology (12.3)].
• Increased erdafitinib plasma concentrations may lead to increased drug-relatedtoxicity [see Warnings and Precautions (5)].
Clinical Management
• Consider alternative therapies that are not strong inhibitors of CYP2C9 orCYP3A4 during treatment with BALVERSA.
• If co-administration of a strong inhibitor of CYP2C9 or CYP3A4 isunavoidable, monitor closely for adverse reactions and consider dosemodifications accordingly [see Dosage and Administration (2.3)]. If the stronginhibitor is discontinued, the BALVERSA dose may be increased in theabsence of drug-related toxicity.
Strong CYP2C9 or CYP3A4 Inducers
Clinical Impact
• Co-administration of BALVERSA with strong inducers of CYP2C9 orCYP3A4 may decrease erdafitinib plasma concentrations significantly [seeClinical Pharmacology (12.3)].
• Decreased erdafitinib plasma concentrations may lead to decreased activity.
Clinical Management • Avoid co-administration of strong inducers of CYP2C9 or CYP3A4 with BALVERSA.
Moderate CYP2C9 or CYP3A4 Inducers
Clinical Impact
• Co-administration of BALVERSA with moderate inducers of CYP2C9 orCYP3A4 may decrease erdafitinib plasma concentrations [see ClinicalPharmacology (12.3)].
• Decreased erdafitinib plasma concentrations may lead to decreased activity.
Clinical Management
• If a moderate CYP2C9 or CYP3A4 inducer must be co-administered at the startof BALVERSA treatment, administer BALVERSA dose as recommended (8mg once daily with potential to increase to 9 mg once daily based on serumphosphate levels on Days 14 to 21 and tolerability).
• If a moderate CYP2C9 or CYP3A4 inducer must be co-administered after theinitial dose increase period based on serum phosphate levels and tolerability,increase BALVERSA dose up to 9 mg.
• When a moderate inducer of CYP2C9 or CYP3A4 is di |
