福巴替尼说明书,医保,价格,疗效,副作用

Introduction: Futibatinib is a highly selective FGFR inhibitor, mainly used to treat locally advanced or metastatic cholangiocarcinoma with FGFR2 gene fusion or rearrangement. The drug blocks tumor cell signaling by irreversibly inhibiting FGFR kinase activity. In September 2022, it received accelerated approval from the US FDA.

Forbatinib Instructions

Understanding the contents of the drug instructions is crucial to standardizing medication. The following is the key information.

Indications, Usage and Dosage

Applicable to adult patients with FGFR2 fusion/rearrangement of cholangiocarcinoma. The recommended dose is 20 mg once a day, taken orally on an empty stomach until disease progression or intolerable toxicity.

Dosage forms and specifications

The original drugs are 4mg, 8mg, 12mg, 16mg and 20mg tablets, and the common specifications of generic drugs are 4mg*35 tablets/box, which facilitates dosage adjustment.

At present, forbatinib has not been approved for marketing in China, and there are certain difficulties in obtaining it for patients. The medical insurance and price of this drug are introduced below.

Forbatinib medical insurance and price

As a new targeted drug, the price and medical insurance policy of forbatinib directly affect patient accessibility.

Medical insurance reimbursement situation

The commercial insurance coverage rate in the United States reaches 85%, and the Japanese medical insurance reimbursement rate is 70%. It has not yet been launched in China and is not included in any medical insurance catalog. Patients must pay the full amount out of their own pocket.

Drug price information

The price of original drugs in the United States is about US$18,000-22,000 per month. Laotian generic medicine costs 480 US dollars (USD) for 4mg*35 tablets, and the monthly treatment cost is about 820 US dollars (USD).

After understanding the cost, patients pay more attention to the actual effect of the drug. The efficacy and side effects are detailed below.

Efficacy and Side Effects of Forbatinib

Forbatinib has shown significant efficacy in specific patients with cholangiocarcinoma, but there are also adverse reactions that require attention.

Clinical treatment effects

Phase II studies show that the objective response rate is high, the median response duration is 9.7 months, most patients have tumor shrinkage, and the median progression-free survival is 9 months.

Common adverse reactions

The most common adverse reactions include hyperphosphatemia (85%), nail toxicity (62%), and dry mouth (54%). The incidence of grade 3-4 adverse reactions is about 30%, mainly hyperphosphatemia and fatigue.

It is prohibited for pregnant women and lactating women should stop breastfeeding. Elderly patients do not need to adjust the dosage, and patients with moderate to severe liver damage need to reduce the dosage. Serum phosphorus and liver function need to be monitored regularly during medication.