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Erdafitinib is an oral small molecule fibroblast growth factor receptor (FGFR) inhibitor that selectively inhibits the activity of FGFR1-4 and blocks downstream signaling pathways, thereby inhibiting tumor cell proliferation and survival.
1. Generic name: Erdafitinib (Erdafitinib)
Trade name: BALVERSA
For the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 gene alterations, and the following conditions must be met:
1. Progression during or after at least first-line platinum-containing chemotherapy (including within 12 months after neoadjuvant or adjuvant platinum-containing chemotherapy).
2. Genetic changes need to be confirmed through FDA-approved companion diagnostics.
Tablet : 3mg, 4mg, 5mg.
1. Active ingredient: Erdafitinib
2. Excipients: Crosscarmellose sodium, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, etc.
1. Initial dose of : 8 mg (2 tablets of 4 mg) orally once a day. After 14-21 days, it can be increased to 9 mg (3 tablets of 3 mg) according to serum phosphorus level (≥5.5 mg/dL) and tolerance.
2. How to take : Swallow the whole tablet before or after meals.
1. Missed dose of : Take it as soon as possible, and return to the original planned dose the next day. Do not double the dose.
2. Vomiting : If you vomit after taking the medicine, continue taking it at the original dose the next day.
3. Adverse reaction adjustment : Suspend or reduce the dose according to the grade of adverse reactions (such as hyperphosphatemia, eye diseases) (see the dose adjustment table for details).
1. Eye monitoring : Check monthly for the first 4 months of treatment, and every 3 months thereafter. Check immediately if visual symptoms occur.
2. Management of hyperphosphatemia : Limit phosphorus intake (600-800mg/day), and use phosphate binders if necessary.
3. Contraceptive requirements : Patients of childbearing age need to take effective contraceptive measures during treatment and within 1 month after stopping the drug.
1. Pregnant women : Contraindicated as it may cause fetal malformation.
2. Lactation period : Breastfeeding is prohibited during treatment and within 1 month of drug withdrawal.
3. Elderly : No need to adjust the dose.
4. Liver and kidney insufficiency : No adjustment is needed for mild to moderate, but insufficient data for severe.
1. Common (≥20%) : Hyperphosphatemia, stomatitis, fatigue, diarrhea, dry mouth, onycholysis, abnormal liver function, hyponatremia, etc.
2. Serious adverse reactions : Central serous retinopathy (CSR/RPED), hyperphosphatemia-related organ damage.
There are no absolute contraindications, but it is prohibited for pregnant women.
1. Avoid combined use of : Strong CYP2C9/CYP3A4 inducers (such as rifampicin), serum phosphorus regulators (initial).
2. Use with caution: Strong CYP2C9/CYP3A4 inhibitors (such as fluconazole), OCT2/P-gp substrates (such as metformin).
Save at room temperature, away from moisture and light.