Infigratinib Chinese instructions

【Indications】

Infigratinib/Infigratinib (Infigratinib) is a targeted anti-tumor drug mainly used to treat adults with advanced or metastatic disease. Patients with cholangiocarcinoma (CCA), especially those with FGRF2 (fibroblast growth factor receptor 2) gene mutations or fusions. It may also be used as a first-line treatment option, or as a second-line treatment when other treatments are ineffective or not tolerated.

【Mechanism of action】

Infigratinib/Infigratinib is a selective FGRF receptor inhibitor. It interferes with the growth and spread of tumor cells by inhibiting the activity of FGRF receptor 2. FGRF2Abnormal activation of the gene is closely related to the occurrence and development of cholangiocarcinoma. Therefore, Infitinib/Infigratinib inhibits tumor growth by targeting this signaling pathway.

【Pharmacology】

Infigratinib/Infigratinib is an oral medication that is rapidly absorbed. In the body, it is metabolically converted into an active metabolite that is key to its anti-tumor activity. Infigratinib/The main metabolic pathway of Infigratinib is CYP3A4 enzyme-mediated metabolism. Its pharmacokinetic profile allows for controllable drug concentrations to ensure effective inhibition of tumor growth and minimize side effects.

【Dosage and usage】

Infitinib/The recommended dosage of Infigratinib is once a day, taken orally, on an empty stomach, 40mg each time. Patients should take at least 1Do not eat for 1 hour, and then wait at least 1 hour before eating. Treatment should be continued until the patient develops disease progression or intolerable adverse effects. Dosage adjustments may be necessary based on patient tolerance and response to treatment.

【Side effects】

Common adverse reactions of Infigratinib/Infigratinib include but are not limited to:

1.Gastrointestinal reactions: including nausea, vomiting, diarrhea, abdominal pain and loss of appetite.

2.High blood pressure: It may cause high blood pressure, and blood pressure needs to be monitored regularly.

3.Fatigue: Patients may feel tired and weak.

4. Abnormal liver function: may lead to elevated liver enzymes.

5.Bone problems: including fractures and reduced bone density.

6.Visual problems: May cause dry eyes, blurred eyes or other visual impairments.

These adverse effects may require adjustment of treatment dose or other interventions to manage. Patients should be monitored and evaluated by their doctor regularly during treatment.

【Warnings and Precautions】

When using Infigratinib/Infigratinib, you should pay attention to the following matters:

1. Liver function monitoring: Patients should regularly monitor liver function indicators, especially liver enzyme levels, during treatment. If necessary, appropriate intervention measures should be taken.

2. Blood pressure monitoring: Blood pressure should be monitored regularly during treatment, and antihypertensive measures should be taken if necessary.

3.Bone density monitoring: Patients may need to undergo bone density testing and take measures to prevent fractures.

4.Vision examination: Get regular eye exams to monitor for visual problems.

5.Contraindications during pregnancy: Infigratinib/Infigratinib may be harmful to the fetus and should be avoided by pregnant women and women planning pregnancy.

【Contraindications】

Infigratinib/Infigratinib is contraindicated in the following circumstances:

1.A serious allergic reaction to this drug or any of its ingredients.

2.Pregnant and lactating women.

3.Severe liver insufficiency.

[Drug interactions]

Infigratinib/Infigratinib may interact with other drugs, including but not limited to:

1.CYP3A4Inhibitors: Concomitant use with CYP3A4 inhibitors may increase the plasma concentration of infitinib/infigratinib.

2.CYP3A4Inducers: Concurrent use with CYP3A4 inducers may decrease infitinib/infigratinib plasma concentrations.

3.Calcium channel blockers: Concomitant use with certain calcium channel blockers may increase the risk of irregular heartbeats.

Before starting treatment with infigratinib/infigratinib, patients should inform their doctor about all medications they are taking, including prescription drugs, over-the-counter drugs, and supplements.

【Drug use for special groups】

1. Elderly patients: Elderly patients may require additional monitoring and dose adjustments when using Infigratinib/Infigratinib as they may be more susceptible to adverse reactions.

2.Patients with hepatic impairment: For patients with mild to moderate hepatic impairment, a lower starting dose of Infigratinib/Infigratinib may be necessary. However, the use of this drug is prohibited in patients with severe hepatic insufficiency.

3.Children and Adolescents: The safety and effectiveness of Infigratinib/Infigratinib has not been established in patients 18 years of age.

[Listing and price status]

Infigratinib/Infigratinib is not currently on the market in China, and it is unlikely to be included in medical insurance. Patients cannot purchase it domestically and can only purchase it through overseas channels. Foreign Infigratinib/Infigratinib only has original drugs, only American original drugs, and the price is as high as 200,000 yuan.