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.

Erdafitinib is a kinase inhibitor that binds to and inhibits enzymatic activity of FGFR1, FGFR2, FGFR3 and FGFR4 based on in vitro data. Erdafitinib also binds to RET, CSF1R, PDGFRA, PDGFRB, FLT4, KIT, and VEGFR2. It inhibits FGFR phosphorylation and signaling and decreases cell viability in cell lines expressing FGFR genetic alterations.

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%)

Use in Pregnancy: Based on mechanism of action and animal studies, can cause fetal harm when administered to pregnant women. Pregnancy testing recommended. Advise females to use effective contraception during treatment and for 1 month after last dose.

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.

Overdose: Limited experience with overdosage. In case of overdose, symptomatic treatment should be given and seek immediate medical attention.

Storage: Store below 30°C in a cool and dry place. Keep away from light. Keep out of reach of children.