Erdanib 4

• Locally Advanced or Metastatic Urothelial Carcinoma: Indicated for adult patients with susceptible FGFR3 or FGFR2 genetic alterations who have progressed during or following at least one line of prior platinum-containing chemotherapy.

Adult Dose:

• Urothelial Carcinoma: Initial: 8 mg PO qDay; increase to 9 mg PO qDay based on serum phosphate levels and tolerability at 14-21 days.
• Mild Hepatic Impairment: No dosage adjustment needed.
• Moderate Hepatic Impairment: No dosage adjustment needed.
• Severe Hepatic Impairment: Unknown.

Renal Dose:

• Mild or Moderate Renal Impairment (eGFR 30-89 mL/min/1.73 m²): No dosage adjustment needed.
• Severe or Dialysis: Unknown.

Common Side Effects (≥20%):

• Phosphate increased (76%)
• Stomatitis (56%)
• Fatigue (54%)
• Creatinine increased (52%)
• Diarrhea (47%)
• Dry mouth (45%)
• ALT increased (41%)
• Alkaline phosphatase increased (41%)
• Onycholysis (41%)
• Sodium decreased (40%)
• Decreased appetite (38%)
• Albumin decreased (37%)
• Dysgeusia (37%)
• Hemoglobin decreased (35%)
• Dry skin (34%)
• AST increased (30%)
• Magnesium decreased (30%)
• Constipation (28%)
• Dry eye (28%)
• Palmar-plantar erythrodysesthesia (26%)
• Alopecia (26%)
• Phosphate decreased (24%)
• Abdominal pain (23%)
• Calcium increased (22%)
• Nausea (21%)
• Musculoskeletal pain (20%)

Precautions:

• Ocular Disorders: Can cause central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED). Perform monthly ophthalmological examinations during first 4 months, then every 3 months, and urgently at any time for visual symptoms.
• Hyperphosphatemia: Increases in serum phosphate levels are a pharmacodynamic effect. Monitor and manage with dose modifications when required. Patients may require phosphate binders.
• Embryo-fetal Toxicity: Can cause fetal harm when administered to pregnant women. Advise patients to use effective contraception.
• Dry Eye Symptoms: Common; all patients should receive dry eye prophylaxis with ocular demulcents as needed.