Infiglatinib is a fibroblast growth factor receptor (FGFR) - specific tyrosine kinase inhibitor.

1、 Drug name

1. Common name: Infiglatinib

2. Product Name: TRUSELTIQ

2、 Indications

Used to treat adult patients with FGFR2 gene fusion or rearrangement detected, suitable for locally advanced or metastatic cholangiocarcinoma that has received previous treatment and cannot be surgically removed. This indication has been granted accelerated approval based on overall response rate and duration of response.

3、 Specifications and characteristics

100mg、 capsule

4、 Main components

1. Active ingredient: Infaglatinib phosphate

2. Accessories: Colloidal silica, cross-linked polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.

5、 Usage and dosage

1. Standard dose: 125mg (1 capsule 100mg+1 capsule 25mg) once daily, taken continuously for 21 days and stopped for 7 days, with 28 days as one cycle.

2. Usage: Take on an empty stomach (1 hour before or 2 hours after meals), swallow the whole pill, do not crush or chew.

3. Omission treatment: If missed for more than 4 hours or vomiting occurs, take the medication according to the original plan the next day without the need for supplementation.

6、 Dose adjustment

1. Renal insufficiency: For mild to moderate patients, adjust to 100mg once daily.

2. Liver dysfunction: Mild adjustment to 100mg once daily, moderate adjustment to 75mg once daily.

3. Adverse reaction adjustment: Suspend, reduce or permanently discontinue the dosage based on toxicity grading (if hyperphosphatemia requires adjustment of phosphate binders).

7、 Medication precautions

1. Dietary impact: Avoid taking grapefruit products together; Take acid suppressants at intervals (H2 receptor antagonists at intervals of 2 hours, antacids at intervals of 2 hours).

2. Eye monitoring: Regular eye examinations are necessary before and during treatment to be alert to retinal pigment epithelial detachment (RPED).

3. Hyperphosphatemia management: It is necessary to monitor blood phosphorus levels and use phosphate binders if necessary.

8、 Medication for special populations

1. Pregnancy/lactation: May cause fetal damage, contraception is necessary during medication and within one month of discontinuation; Prohibited during lactation.

2. Children: Safety has not been established.

3. Elderly: No need to adjust dosage.

9、 Adverse reactions

1. Common (≥ 20%) conditions include: nail toxicity, stomatitis, dry eye syndrome, fatigue, hair loss, hand foot syndrome, etc;

2. Laboratory abnormalities include elevated blood creatinine, hypophosphatemia, elevated ALT, etc.

10、 Contraindications

There are no clear contraindications.

11、 Drug interactions

1. CYP3A inhibitors/inducers: Avoid combination with strong/medium acting CYP3A inhibitors (such as itraconazole) or inducers (such as rifampicin).

2. Gastric acid regulator: Avoid combination with PPI and adjust the timing of H2 antagonists or antacids if necessary.

12、 Storage method

Store at 20 ° C-25 ° C, allowing for short-term fluctuations of 15 ° C-30 ° C.

Infigratinibinformation