Edatinib is an oral small molecule fibroblast growth factor receptor (FGFR) inhibitor that selectively inhibits the activity of FGFR1-4, blocks downstream signaling pathways, and thus inhibits tumor cell proliferation and survival.

1、 Drug name

1. Common name: Erdafitinib

Product Name: BALVERSA

2、 Indications

Used to treat locally advanced or metastatic adult patients with susceptibility to FGFR3 or FGFR2 gene alterations, and must meet the following conditions:

1. Progression occurs during or after at least first-line platinum based chemotherapy (including within 12 months after neoadjuvant or adjuvant platinum based chemotherapy).

2. Genetic changes need to be confirmed through FDA approved accompanying diagnosis.

3、 Specifications and characteristics

Tablets: 3mg, 4mg, 5mg.

4、 Main components

1. Active ingredient: Erdafitinib

2. Accessories: cross-linked carboxymethyl cellulose sodium, magnesium stearate, mannitol, glucosamine, microcrystalline cellulose, etc.

5、 Usage and dosage

1. Initial dose: 8mg (2 tablets 4mg) orally once daily, and can be increased to 9mg (3 tablets 3mg) after 14-21 days based on blood phosphorus levels (≥ 5.5mg/dL) and tolerance.

2. Usage: Take the whole tablet orally, before or after meals.

6、 Dose adjustment

1. Missed dose: Take it as soon as possible and restore the original planned dose the next day. Do not double the dose.

2. Vomiting: If vomiting occurs after taking medication, continue taking the original dose the next day.

3. Adverse reaction adjustment: Pause or reduce the dosage according to the level of adverse reactions (such as hyperphosphatemia, eye disease) (see dosage adjustment table for details).

7、 Medication precautions

1. Eye monitoring: Monthly check ups for the first 4 months before treatment, and every 3 months thereafter. Check up immediately if visual symptoms appear.

2. Hyperphosphatemia management: Limit phosphorus intake (600-800mg/day) and use phosphate binders if necessary.

3. Contraceptive requirements: Patients of childbearing age must take effective contraceptive measures during treatment and within one month after discontinuing medication.

8、 Medication for special populations

1. Pregnant women: Prohibited, may cause fetal malformation.

2. Breastfeeding period: Breastfeeding is prohibited during the treatment period and within one month of discontinuation of medication.

3. Elderly: No need to adjust dosage.

4. Liver and kidney dysfunction: Mild to moderate without adjustment, severe with insufficient data.

9、 Adverse reactions

1. Common (≥ 20%): hyperphosphatemia, stomatitis, fatigue, diarrhea, dry mouth, nail dissection, liver dysfunction, hyponatremia, etc.

2. Serious adverse reactions: Central serous retinopathy (CSR/RPED), hyperphosphatemia related organ damage.

10、 Contraindications

There are no absolute contraindications, but it is contraindicated for pregnant women.

11、 Drug interactions

1. Avoid combination use: strong CYP2C9/CYP3A4 inducers (such as rifampicin), serum phosphate modulators (initial stage).

2. Caution in combination: Strong CYP2C9/CYP3A4 inhibitors (such as fluconazole), OCT2/P-gp substrates (such as metformin).

12、 Storage method

Store at room temperature, moisture-proof and light proof.

Erdafitinibinformation