BALVERSA (Erdafitinib) – Urothelial Cancer | HongKong DengYue Medicine

Erdafitinib Application Scope

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 genetic alterations, whose disease has progressed after at least one prior systemic therapy.

Erdafitinib Characteristics

• Ingredients: Erdafitinib

• Properties:​ Pan-FGFR tyrosine kinase inhibitor

• Packaging Specification:​ Oral tablets, 3 mg and 4 mg

• Storage:​ Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F

• Expiry Date: As indicated on the package

• Executive Standard: ​FDA/EMA approved prescription medicine standard

• Approval Number: NDA 212018

• Date of Revision: January 2024

• Manufacturer: Janssen Pharmaceuticals, Inc.

Guidelines for the Use of BALVERSA

• Dosage and Administration:

  • Recommended Dose: 8 mg orally once daily; may increase to 9 mg daily based on phosphate levels and tolerability.

  • Administration: Swallow tablets whole, with or without food.

  • Missed Dose: Take as soon as possible on the same day; do not take extra to make up for a missed dose. Resume normal dosing the next day.​

• Adverse Reactions:

  • Common Adverse Reactions (≥5%):

    • Hyperphosphatemia, diarrhea, dry mouth, stomatitis, fatigue, dry skin, alopecia, decreased appetite, dysgeusia, nausea, constipation, nail disorders, dry eyes, anemia, elevated creatinine.

  • Serious Adverse Reactions:

    • Central serous retinopathy/retinal pigment epithelial detachment, hyperphosphatemia requiring medical management.​

• Contraindications: None listed in the labeling.

• Precautions:

  • • Ocular Disorders: Perform eye examinations at baseline, monthly for the first 4 months, and every 3 months thereafter.

    • Hyperphosphatemia: Monitor serum phosphate at baseline, at 14–21 days, and monthly thereafter.

    • Pregnancy and Lactation: Advise patients of potential fetal harm; avoid breastfeeding during treatment and for 1 month after the last dose.

Erdafitinib Interactions

• Avoid strong CYP2C9 or CYP3A4 inhibitors/inducers; monitor for altered drug levels when co-administered with other substrates of these enzymes.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.