سعر بالفيرسا 4 مجم 14قرص 2026

Balversa (erdafitinib 4 mg) film-coated tablets by Janssen Cilag, an oral fibroblast growth factor receptor (FGFR) kinase inhibitor for FGFR3-altered urothelial carcinoma; pack of 14 film-coated tablets (2 strips).

• Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, progressed on or after at least one prior systemic therapyPopulation: Adults; not recommended for patients eligible for and not yet treated with PD-1 or PD-L1 inhibitor therapyDailyMed (U.S. National Library of Medicine)

• Most common (20% or more), including laboratory abnormalities: increased phosphate, nail disorders, stomatitis, diarrhoea, increased creatinine, increased ALP, increased ALT, decreased haemoglobin, decreased sodium, increased AST, fatigue, dry mouth, dry skin, decreased phosphate, decreased appetite, dysgeusia, constipation, increased calcium, dry eye, palmar-plantar erythrodysaesthesia, increased potassium, alopecia and central serous retinopathy.International label, same product · DailyMed (U.S. National Library of Medicine)

• None (US labeling lists no contraindications).International label, same product · DailyMed (U.S. National Library of Medicine)

• Ocular disorders: central serous retinopathy/retinal pigment epithelial detachment in 22% (median onset 46 days); dry eye common. Perform ophthalmological exams monthly for the first 4 months, then every 3 months, and urgently for visual symptoms; withhold and reduce or discontinue per severity.International label, same product · DailyMed (U.S. National Library of Medicine)
• Hyperphosphatemia in 73% of patients (median onset 20 days); monitor phosphate, restrict dietary phosphate to 600-800 mg/day, consider phosphate binders, and modify the dose as labeled.International label, same product · DailyMed (U.S. National Library of Medicine)
• Embryo-fetal toxicity: can cause fetal harm; advise effective contraception during treatment and for 1 month after the last dose (females and males with female partners).International label, same product · DailyMed (U.S. National Library of Medicine)

• Moderate CYP2C9 inhibitors or strong CYP3A4 inhibitorsIncrease erdafitinib exposure; consider alternatives or monitor closely and reduce the dose as needed; if the inhibitor is stopped, the dose may be increased in the absence of toxicity.DailyMed (U.S. National Library of Medicine)
• Strong CYP3A4 inducersDecrease erdafitinib exposure; avoid concomitant use.DailyMed (U.S. National Library of Medicine)
• Moderate CYP3A4 inducersDecrease erdafitinib exposure; start at 9 mg once daily and, if needed, adjust based on phosphate and tolerability.DailyMed (U.S. National Library of Medicine)

• Based on animal findings and mechanism of action, erdafitinib can cause fetal harm; in rats it was embryotoxic and teratogenic at exposures below human exposure. Advise pregnant women of the potential risk.International label, same product · DailyMed (U.S. National Library of Medicine)
• Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 1 month after the last dose.International label, same product · DailyMed (U.S. National Library of Medicine)

• Erdafitinib: Kinase inhibitor that binds to and inhibits the enzymatic activity of FGFR1, FGFR2, FGFR3 and FGFR4, inhibiting FGFR phosphorylation and signalling and decreasing cell viability in cell lines expressing FGFR genetic alterations (US labeling).