Valbesogen 5 mg (Erdafitinib)

Adult dose

The recommended starting dose is 8mg orally once daily. The dose may be increased to 9mg once daily based on serum phosphate levels and tolerability assessed between 14 and 21 days after starting treatment. This medicine should be swallowed whole with or without food. If vomiting occurs after taking this medicine, take the next dose according to the regular schedule the following day. Treatment should continue until disease progression or unacceptable toxicity occurs. If a dose of this medicine is missed, take it as soon as possible on the same day. Resume the regular dosing schedule for this medicine the next day. Do not take an additional dose of this medicine to make up for the missed dose. Serum phosphate (PO4) levels should be assessed between 14 and 21 days after starting treatment. If the serum phosphate (PO4) level is less than 9.0 mg/dL and there is no eye disorder or adverse reaction of Grade 2 or higher, increase the dose to 9mg once daily. Phosphate levels should be monitored monthly. If the phosphate level is 9.0mg/dL or higher, refer to Table 2 and follow the corresponding dose adjustment. After 21 days, serum phosphate levels should not be used as a basis for dose escalation. Dose reduction schedule: Dose 9mg: First dose reduction 8mg, second dose reduction 6mg, third dose reduction 5mg, fourth dose reduction 4mg, fifth dose reduction discontinue Dose 8mg: First dose reduction 6mg, second dose reduction 5mg, third dose reduction 4mg, fourth dose reduction discontinue Management of hyperphosphatemia: Phosphate levels should be monitored monthly. For increased phosphate levels in patients treated with this medicine, follow the dose adjustment guidelines in Table 2. Patients with phosphate levels of 5.50 mg/dL (1.75 mmol/L) or higher should restrict their diet to consume 600 ∼ 800mg of phosphate per day. <6.99mg/dL (<2.24mmol/L): Continue this medicine at the current dose. 7.00∼8.99mg/dL (2.25∼2.90mmol/L): Continue this medicine at the current dose. Administer phosphate binders with food until the serum phosphate level is less than 7.00mg/dL. If the serum phosphate level remains at 7.00mg/dL or higher for more than 2 months, or if clinically necessary, reduce the dose. 9.00~10.00mg/dL (2.91~ 3.20mmol/L): Withhold this medicine until the level returns to less than 7.00mg/dL. (Weekly reassessment is recommended) Administer phosphate binders with food until the serum phosphate level is less than 7.00mg/dL. Then restart this medicine at the same dose. If the serum phosphate level remains at 9.00mg/dL or higher for more than 1 month, or if clinically necessary, reduce the dose. Above 10.00mg/dL (above 3.20mmol/L): Withhold this medicine until the level returns to less than 7.00mg/dL. (Weekly reassessment is recommended) Then restart this medicine at the next lower dose level. If the serum phosphate level remains at 10.00mg/dL or higher for more than 2 weeks, this medicine should be permanently discontinued. Manage symptoms as clinically appropriate. Significant change in baseline renal function or Grade 3 hypocalcemia due to hyperphosphatemia: This medicine should be permanently discontinued. To prevent and treat dry eyes, use artificial tear substitutes, hydration, or lubricating eye gels or ointments frequently, at least every 2 hours while awake. Grade 1: Refer for an ophthalmologic examination. If an ophthalmologic examination cannot be performed within 7 days, withhold this medicine until an ophthalmologic examination can be performed. If there is no evidence of ocular toxicity on ophthalmologic examination, continue this medicine at the same dose level. If keratitis or retinal abnormality (e.g., CSRa) is diagnosed on ophthalmologic examination, withhold this medicine until recovery. If recovered within 4 weeks on ophthalmologic examination (complete recovery and asymptomatic), restart this medicine at the next lower dose. Monitor for recurrence every 1~2 weeks for one month after restarting treatment and thereafter as clinically appropriate. If there is no recurrence, consider gradual dose escalation. Grade 2: Immediately withhold this medicine and refer for an ophthalmologic examination. If there is no evidence of drug-related corneal or retinal pathology on ophthalmologic examination, withhold this medicine until recovery. If recovered, restart this medicine at the next lower dose. If keratitis or retinal abnormality (e.g., CSR) is diagnosed on ophthalmologic examination, withhold this medicine until recovery. If recovered within 4 weeks on ophthalmologic examination (complete recovery and asymptomatic), restart at the next lower dose. Monitor for recurrence every 1∼2 weeks for one month after restarting treatment and thereafter as clinically appropriate. Grade 3: Immediately withhold this medicine and refer for an ophthalmologic examination. If recovered within 4 weeks (complete recovery and asymptomatic), this medicine may be restarted at a dose level 2 levels lower. Monitor for recurrence every 1∼2 weeks for one month after restarting treatment and thereafter as clinically appropriate. Consider permanent discontinuation of this medicine if recurrence occurs. Grade 4: Permanently discontinue this medicine. Monitor until complete recovery or stabilization. Nail disorder Grade 1: Maintain the current dose Nail disorder Grade 2: Consider withholding treatment and reassess within 1~2 weeks. If resolved to Grade 1 or baseline within 2 weeks after the first occurrence, resume treatment at the same dose; if recurrent or if resolution to Grade 1 or baseline takes more than 2 weeks, resume treatment at a dose 1 level lower Nail disorder Grade 3: Withhold treatment and reassess within 1~2 weeks. If resolved to Grade 1 or baseline, resume treatment at a dose 1 level lower Nail disorder Grade 4: Permanently discontinue treatment Dry skin and skin toxicity Grade 1: Maintain the current dose Dry skin and skin toxicity Grade 2: Maintain the current dose Dry skin and skin toxicity Grade 3: Withhold treatment (for up to 28 days) and reassess weekly. If resolved to Grade 1 or baseline, resume treatment at a dose 1 level lower Dry skin and skin toxicity Grade 4: Permanently discontinue treatment Oral mucositis Grade 1: Maintain the current dose Oral mucositis Grade 2: Consider withholding treatment if accompanied by another adverse reaction of Grade 2 or higher. Withhold treatment if symptom management has been required for more than 1 week. If treatment is withheld, reassess within 1~2 weeks. If resolved to Grade 1 or baseline within 2 weeks, resume treatment at the same dose. If recurrent or if resolution to Grade 1 or baseline takes more than 2 weeks, resume treatment at a dose 1 level lower Oral mucositis Grade 3: Withhold treatment and reassess within 1~2 weeks. If resolved to Grade 1 or baseline, resume treatment at a dose 1 level lower Oral mucositis Grade 4: Permanently discontinue treatment Dry mouth Grade 1: Maintain the current dose Dry mouth Grade 2: Maintain the current dose Dry mouth Grade 3: Withhold treatment (for up to 28 days) and reassess weekly. If resolved to Grade 1 or baseline, resume treatment at a dose 1 level lower Dry mouth Grade 4: Permanently discontinue treatment Other adverse reactions Grade 1: Maintain the current dose Other adverse reactions Grade 2: Maintain the current dose; withhold treatment if not recovered within 1 week. If resolved to Grade 1 or baseline, resume treatment at the same dose or a dose 1 level lower Other adverse reactions Grade 3: Withhold treatment for up to 28 days, with weekly reassessment of clinical status. If resolved to Grade 1 or baseline, resume treatment at a dose 1 level lower Other adverse reactions Grade 4: Discontinue treatment No dose adjustment is necessary for patients with mild or moderate renal impairment. Data are limited for patients with severe renal impairment. No dose adjustment is necessary for patients with mild or moderate hepatic impairment. No data are available for patients with severe hepatic impairment.

This drug should not be used in patients who are allergic to this medication or its components. Various side effects may occur during treatment with this drug, with the most common side effects including increased phosphate levels, nail problems, stomatitis, diarrhea, kidney function abnormalities, liver function abnormalities, anemia, electrolyte imbalance, fatigue, dry mouth, dry skin, decreased appetite, taste alterations, constipation, hair loss, dry eyes, and central serous retinopathy that can affect vision. Particular attention is required for eye-related symptoms, and regular ophthalmologic examinations should be undertaken after treatment initiation. If there are any disturbances in vision or discomfort in the eyes, immediate consultation with medical staff is recommended. Additionally, as blood phosphate levels may increase, it may be necessary to periodically check phosphate levels during treatment and adjust diet or medications accordingly. Women who are pregnant or may become pregnant should use effective contraception during, prior to, and for a certain period after treatment, as this drug may be harmful to the fetus. Nursing mothers are also advised to discontinue breastfeeding while taking this medication. This drug is used in patients with advanced urothelial carcinoma with specific gene mutations, so genetic testing should be performed to confirm suitability before treatment. There may be interactions with other medications, particularly those that inhibit or induce enzymes involved in drug metabolism in the liver, so you should inform your medical staff if you are taking such medications and dosage adjustments may be necessary. In case of overdose, stop taking the medication immediately and seek supportive treatment as directed by medical staff. It is advisable to avoid driving or operating machinery if any symptoms that may affect the eyes are present. This medication should be kept out of reach of children and stored in its original container to maintain quality and prevent misuse.

• Increased phosphate
• nail disorders
• stomatitis
• diarrhea
• increased creatinine
• increased alkaline phosphatase
• increased alanine aminotransferase
• decreased hemoglobin
• decreased sodium
• increased aspartate aminotransferase

This drug may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is advisable to maintain room temperature between 1 and 30 degrees Celsius. This will help preserve the drug's effectiveness for a longer time.

Appearance

Brown, double-convex, round film-coated tablet

Package unit

28 tablets/bottle