PEMIGATINIB 4.5MG 42 TABLETS Approval No. 01 L 1058/24 Validity Date 30-1-2027

Pemitinib (trade name: pemimas) is a targeted therapy drug targeting specific gene mutations. It is mainly used to treat cancers caused by specific gene mutations, especially cholangiocarcinoma (bile duct cancer) associated with FGFR2 gene mutations . The following is the basic information of Pemitinib:

1. Drug classification :

• Pemitinib is a FGFR (fibroblast growth factor receptor) inhibitor that slows or inhibits the growth of cancer cells by targeting and inhibiting mutations in fibroblast growth factor receptor 2 (FGFR2). FGFR2 mutations play an important role in certain cancers (such as bile duct cancer), so Pemitinib is used to treat cancers associated with these gene mutations.

2. Indications :

• Biliary tract cancer (cholangiocarcinoma) with a FGFR2 gene mutation : Pemitinib is used to treat adult patients with locally advanced or metastatic bile duct cancer who have a known or confirmed FGFR2 gene mutation. This drug is a targeted therapy for this specific type of cancer.

3. Usage and dosage :

• Adults : Pemitinib is usually administered orally, with the recommended dose being 9 mg once daily .
• Dosage : Pemitinib can be taken before or after meals. It is recommended to swallow the whole tablet without chewing or breaking it.
• Dose Adjustment : The dose may need to be adjusted based on the patient's tolerance. If severe side effects occur, the dose may be reduced or treatment may be suspended.
• Special populations : For patients with impaired liver function, the dose should be adjusted according to the doctor's advice.

4. Notes :

• Liver function : Pemitinib has a certain effect on liver function and may cause liver dysfunction. Liver function needs to be checked regularly during use, especially in the early stages of treatment.
• Eye problems : Pemitinib may cause blurred vision, dry eyes, or other eye symptoms. Patients should undergo regular eye examinations during use.
• Pregnancy and lactation : Pemitinib may be harmful to the fetus, so pregnant women should avoid using it. If it must be used during pregnancy, it should be done under the guidance of a doctor. For lactating women, Pemitinib may be secreted through breast milk, so breastfeeding should be avoided during treatment.
• Drug interactions : Pemitinib may interact with certain drugs (e.g., strong CYP3A4 inhibitors and inducers), so you should inform your doctor of all medications you are currently taking before taking this drug.

5. Side effects :

• Common side effects include: diarrhea, dry mouth, fatigue, rash, loss of appetite, nausea, eye discomfort, etc.
• Serious side effects may occur, such as abnormal liver function (such as jaundice), eye diseases (such as blurred vision, dry eyes), hyperphosphatemia, rash, etc.

If serious side effects occur, patients should contact their doctor immediately and adjust or stop the medication as directed.

6. Contraindications :

• Patients with hypersensitivity to Pemitinib or its components are contraindicated.
• Pregnant women should not use this drug unless there are no other treatment options.
• This drug should also be used with caution in patients with possible severe hepatic impairment.

7. Pregnancy and lactation :

• Pregnancy : Pemitinib is a Category D drug (according to the FDA classification), which means there is a potential risk to the fetus. This drug should not be used during pregnancy unless your doctor evaluates that the potential benefits of treatment outweigh the risks.
• Lactation : Pemitinib may be secreted in breast milk and breastfeeding should be avoided during use.

8. Storage :

• Pemitinib should be stored at room temperature (15°C to 30°C) away from moisture and direct sunlight.

9. Other matters needing attention :

• During treatment, patients need to undergo regular blood tests and liver function monitoring to ensure safe use of the drug.
• Eye exams: Eye health should be checked regularly during treatment, especially if vision problems occur.

Please note : This information is general information only and does not cover all details. Before using Pemitinib, please read the drug instructions carefully and follow your doctor's advice to ensure safe and effective treatment.