BALVERSA 3MG /4MG /5MG TABLET (ERDAFITINIB)

            Balversa (Erdafitinib) is an oral targeted therapy approved for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC)

              harboring susceptible FGFR3 genetic alterations, particularly in cases where the disease has progressed following at least one prior systemic therapy.

🧬 Composition & Classification

• Generic Name: Erdafitinib

• Brand Name: Balversa

• Drug Class: Fibroblast Growth Factor Receptor (FGFR) kinase inhibitor

• Manufacturer: Janssen Pharmaceuticals

📋 Indications

           Balversa is indicated for the treatment of adult patients with:

           Locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, whose disease has progressed on

            or after at least one line of prior systemic therapy. Patients should be selected for therapy based on the presence of susceptible FGFR3 genetic alterations,

            as detected by an FDA-approved companion diagnostic test.

💊 Dosage & Administration

• Starting Dose: 8 mg orally once daily (two 4 mg tablets)

• Dose Adjustment: Increase to 9 mg once daily (three 3 mg tablets) based on serum phosphate levels and tolerability, assessed between days 14 and 21 of treatment.

• Administration: Take with or without food; swallow tablets whole.

• Missed Dose: If a dose is missed, it can be taken as soon as possible on the same day. Resume the regular dosing schedule the next day. Do not take extra tablets to make up for the missed dose.

⚠️ Warnings & Precautions

• Eye Disorders: Balversa may cause central serous retinopathy/retinal pigment epithelial detachment, leading to visual field defects. Regular ophthalmologic evaluations are recommended.

• Hyperphosphatemia: High phosphate levels in the blood are common and can be serious. Monitor serum phosphate levels regularly and manage as needed.

• Embryo-Fetal Toxicity: Balversa can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for one month after the final dose.

• Drug Interactions: Avoid concomitant use with strong CYP3A4 inducers. Monitor for adverse reactions when coadministered with moderate CYP2C9 or strong CYP3A4 inhibitors.

⚠️ Side Effects

          Common Side Effects:

• Nail disorders (e.g., separation from the nail bed)

• Mouth sores

• Diarrhea

• Increased creatinine levels

• Altered liver function tests

• Anemia

• Fatigue

• Dry mouth and skin

• Decreased appetite

• Changes in taste

• Constipation

• Hair loss

• Redness, swelling, or tenderness on hands and feet (hand-foot syndrome)

           Serious Side Effects:

• Eye problems, including blurred vision, vision loss, or other visual changes

• High phosphate levels leading to muscle cramps, numbness, or tingling around the mouth

• Skin reactions, including painful skin lesions

✅ Conclusion

                Balversa (Erdafitinib) offers a targeted treatment option for patients with advanced urothelial carcinoma harboring FGFR3 genetic alterations, especially after progression on prior therapies. Due to potential serious side effects, including eye disorders and hyperphosphatemia, careful patient selection and regular monitoring are essential. Patients should discuss the risks and benefits of Balversa with their healthcare provider to determine its suitability for their treatment plan For more detailed information, please refer to the official information or consult your healthcare provider.