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东盟制药

Erdaini ERDAFITINIB 5 MG 28'S Approval No. 09 L 0923/22 Valid until 13-9-2025

Erdaini ERDAFITINIB 5 MG 28'S Approval No. 09 L 0923/22 Valid until 13-9-2025

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The following is an overview of the erdafitinib package insert :

Drug Name

  • Generic Name : Erdafitinib
  • English name : Erdafitinib
  • Product Name : Erdaini

Pharmacological action and mechanism

Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) inhibitor that is mainly targeted at patients with FGFR gene mutations or gene rearrangements. By inhibiting the tyrosine kinase activity of FGFR1, FGFR2, FGFR3 and FGFR4, Erdafitinib can inhibit the proliferation and survival of tumor cells.

Indications

  • For the treatment of patients with locally advanced or metastatic bladder cancer (urothelial carcinoma) who carry FGFR2 or FGFR3 gene mutations or rearrangements and who are refractory to or intolerant of platinum-containing chemotherapy.

Dosage

Recommended dose

  • The initial dose is 8 mg per day (two 4 mg tablets) orally once daily.
  • The dose can be adjusted to 9 mg per day based on patient tolerance and serum phosphorus levels.

How to take the medicine

  • It has nothing to do with food and can be taken with or without food.
  • Swallow the tablet whole; do not chew, crush, or break it.

Adverse Reactions

Common adverse reactions (incidence ≥ 20%):

  • Eye problems : blurred vision, dry eyes, eye pain.
  • Metabolic abnormalities : hyperphosphatemia, hypophosphatemia.
  • Skin reactions : rash, dryness, itching.
  • Gastrointestinal problems : diarrhea, stomatitis, nausea.
  • Others : fatigue, hand-foot syndrome.

Serious adverse reactions include:

  • Severe metabolic abnormalities caused by hyperphosphatemia.
  • Retinopathy or significant loss of vision.

Precautions

  1. Ocular Monitoring : Regular ophthalmological examinations are required during treatment, particularly in patients who develop visual changes.
  2. Monitoring of serum phosphorus levels : Check serum phosphorus levels before and regularly during treatment and adjust the dose to maintain it within the normal range.
  3. Pregnancy and breast-feeding : It is forbidden for use by pregnant women as it may be harmful to the fetus; it should be avoided during breast-feeding.
  4. Patients with abnormal liver and kidney function : Use with caution and adjust the dose individually.

Drug interactions

  1. CYP3A4 inhibitors or inducers : May affect the metabolism of erdafitinib and require dose adjustment.
  2. Phosphate binders : May affect drug absorption, use with caution.

Storage

  • Store at room temperature (15-30°C), away from light and moisture, and out of reach of children.

If you need further elaboration, or would like to know about specific dosage adjustments and precautions, please let me know!

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