福巴替尼 福巴替尼是一种激酶抑制剂，用于治疗患有成纤维细胞生长因子受体 2 (FGFR2) 基因融合或其他重排的、既往接受过治疗的、不可切除的、局部晚期或转移性肝内胆管癌的成年患者。

LuciFutib Tablets Simple Instructions

Please use under the guidance of a physician

Product Name: LuciFutib

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Fobatinib tablets

English name: Futibatinib tablets

Drug approval number: 09 L 1212/24

 

【Indications】

LuciFutib is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement.

 

【Usage and Dosage】

• Confirm the presence of FGFR2 gene fusion or other rearrangement prior to initiating treatment with LuciFutib.

• The recommended dose is 20 mg (five 4 mg tablets) orally once daily until disease progression or unacceptable toxicity.

• Tablets may be swallowed whole, with or without food.

 

【Specification】

4mg/tablet, 35 tablets/box.

 

【 Contraindications 】

none.

 

【 Warnings and precautions 】

• Ocular Toxicity: LuciFutib can cause retinal pigment epithelial detachments (RPED). Perform a comprehensive ophthalmologic examination including optical coherence tomography (OCT) urgently prior to initiating treatment, every 2 months for the first 6 months, every 3 months thereafter, and any time visual symptoms occur.

• Hyperphosphatemia and Soft Tissue Mineralization: Elevated phosphate levels can lead to hyperphosphatemia, which can result in soft tissue calcification, calcification, non-uremic calciphylaxis, and vascular calcification. Monitor for hyperphosphatemia and withhold, reduce dose, or permanently discontinue based on duration and severity of hyperphosphatemia.

• Embryo-Fetal Toxicity: Can cause fetal harm. Inform patients of reproductive potential of the potential risk to a fetus and to use effective contraception.

 

【Adverse Reactions】

• The most common (≥20%) adverse reactions were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eyes, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.

• The most common laboratory abnormalities (≥20%) were increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, increased aspartate aminotransferase, thrombocytopenia, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.

 

【Drug Interactions】

• Dual P-gp and strong CYP3A inhibitors: Avoid coadministration.

• Dual P-gp and strong CYP3A inducers: Avoid coadministration.

 

【Use by specific groups】

• Lactation: Breastfeeding is not recommended.

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.