Grade 3 CSR/RPED, involving central field of vision, was reported in 3% of patients.
CSR/RPED resolved in 13% of patients and was ongoing in 13% of patients at the study cutoff.
CSR/RPED led to dose interruptions and reductions in 9% and 14% of patients, respectively and 3% ofpatients discontinued BALVERSA.
Dry eye symptoms occurred in 28% of patients during treatment with BALVERSA and were Grade 3 in6% of patients. All patients should receive dry eye prophylaxis with ocular demulcents as needed.
Perform monthly ophthalmological examinations during the first 4 months of treatment and every 3months afterwards, and urgently at any time for visual symptoms. Ophthalmological examination shouldinclude assessment of visual acuity, slit lamp examination, fundoscopy, and optical coherencetomography.
Withhold BALVERSA when CSR occurs and permanently discontinue if it does not resolve within 4weeks or if Grade 4 in severity. For ocular adverse reactions, follow the dose modification guidelines[see Dosage and Administration (2.3)].
5.2 Hyperphosphatemia
Increases in phosphate levels are a pharmacodynamic effect of BALVERSA [see Pharmacodynamics(12.2)]. Hyperphosphatemia was reported as adverse reaction in 76% of patients treated withBALVERSA. The median onset time for any grade event of hyperphosphatemia was 20 days (range: 8 –116) after initiating BALVERSA. Thirty-two percent of patients received phosphate binders duringtreatment with BALVERSA.
Monitor for hyperphosphatemia and follow the dose modification guidelines when required [see Dosageand Administration 2.2, 2.3].
5.3 Embryo-Fetal Toxicity
Based on the mechanism of action and findings in animal reproduction studies, BALVERSA can causefetal harm when administered to a pregnant woman. In an embryo-fetal toxicity study, oraladministration of erdafitinib to pregnant rats during the period of organogenesis caused malformationsand embryo-fetal death at maternal exposures that were less than the human exposures at the maximumhuman recommended dose based on area under the curve (AUC). Advise pregnant women of thepotential risk to the fetus. Advise female patients of reproductive potential to use effective contraceptionduring treatment with BALVERSA and for one month after the last dose. Advise male patients withfemale partners of reproductive potential to use effective contraception during treatment withBALVERSA and for one month after the last dose [see Use in Specific Populations (8.1, 8.3) andClinical Pharmacology (12.1)].
6 ADVERSE REACTIONS
The following serious adverse reactions are also described elsewhere in the labeling:
• Ocular Disorders [see Warning and Precautions (5.1)].
• Hyperphosphatemia [see Warning and Precautions (5.2)].
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed inthe clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug andmay not reflect the rates observed in practice.
The safety of BALVERSA was eva luated in the BLC2001 study that included 87 patients with locallyadvanced or metastatic urothelial carcinoma which had susceptible FGFR3 or FGFR2 geneticalterations, and which progressed during or following at least one line of prior chemotherapy includingwithin 12 months of neoadjuvant or adjuvant chemotherapy [see Clinical Studies (14.1)].
Patients were |
