Urothelial carcinoma, locally advanced or metastatic

Urothelial carcinoma, locally advanced or metastatic

• Dose – Oral:  8 mg daily, increased to 9 mg daily based on serum phosphate levels and tolerability, continuously until disease progression or unacceptable toxicity

Available as 3, 4, and 5 mg film-coated tablets. Tablets should NOT be crushed or broken. Store at room temperature.

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Fibroblast growth factor receptor (FGFR) kinase inhibitor

Take with or without food

If a dose is missed, patients should be instructed to take it as soon as they can if it is remembered on the same day. Otherwise, patients should skip the missed dose and resume with the next scheduled dose.

Common: Alopecia, Nail disease, Hand-foot skin reaction, Dry skin, Electrolyte imbalances (magnesium, phosphate, sodium, calcium, potassium), notably hyperphosphatemia, Weight loss, Constipation, Diarrhea, Decreased appetite, Nausea, Taste alterations, Dry mouth, Decreased hemoglobin, Increases in liver transaminases, Fatigue, Increased serum creatinine.

Less Common: Vomiting, Stomatitis, Urinary tract infections, Neutropenia, Thrombocytopenia, Ocular toxicities, including Central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED), Fever, Arthralgia, Peripheral edema, Nose bleeds.

The adverse effects listed above are not exhaustive. Please refer to the relevant product monograph for full details.

Baseline before treatment: CBC & differential, platelets, creatinine, sodium, potassium, magnesium, AST, ALT, bilirubin, alkaline phosphatase, hemoglobin, ophthalmological exam.

During treatment: CBC & differential, platelets, creatinine, sodium, potassium, magnesium, AST, ALT, bilirubin, alkaline phosphatase, hemoglobin, ophthalmological exam.

i. Serum phosphate should be measured at baseline and then again 14 to 21 days after initiation, then monthly or as clinically indicated. Monitoring frequency may increase if hyperphosphatemia occurs
ii. Ophthalmological exam should be performed at baseline, then monthly for the first 4 months, then every 3 months thereafter or as clinically indicated. Monitoring frequency may increase if ocular toxicity occurs

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• This drug can impact or be impacted by metabolic enzymes for absorption and excretion. Many drugs can also affect or be affected by these enzymes, so please consult with pharmacy to assess for interactions.
• Current drug interaction databases should be consulted for more information.

• Avoid in pregnancy and lactation.
• Erdafitinib can significantly impact serum phosphate levels. Patients should be educated on restricting their dietary phosphate intake to 600-800 mg daily.
• Ocular toxicities can commonly occur with erdafitinib, and can range from severe (Central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED)) to less severe (dry eyes, blurred vision).

Lexicomp. Balversa Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc. Accessed May 19th, 2025.

Janssen. Balversa Product Monograph. In: Health Canada, Drug Product Database. Available at: /https://pdf.hres.ca/dpd_pm/00077812.PDF Updated November 20th, 2024. Accessed May 19th, 2025.