【最新翻译】培美替尼（pemigatinib）中文说明书

[Drug name], pemetinib, pemigatinib, pemazyre.

[Indications] Cholangiocarcinoma has metastasized (spread to other parts of the body) or is locally advanced and cannot be treated by surgery. For the treatment of adults with diseases involving FGFR2 gene fusions or other changes in the structure of the FGFR2 gene.

[Mechanism of action] Pemigatinib is a small molecule kinase inhibitor targeting FGFR1, 2 and 3, with an IC50 value of less than 2nM. Pemigatinib also inhibited FGFR4 in vitro at concentrations approximately 100-fold higher than those inhibiting FGFR1, 2, and 3. Pemigatinib leads to constitutive activation of FGFR by activating FGFR amplification and fusion, thereby inhibiting FGFR1-3 phosphorylation and signaling and reducing cell viability.

[Usage and Dosage] The recommended dose is 13.5 mg orally per day for 1 consecutive day for 14 consecutive days, and then 7 days off within a 21-day cycle. Continue treatment until disease progression or unacceptable toxicity. Swallow the tablets whole, with or without food.

[Side Effects] Common side effects are diarrhea, nausea, taste change, vomiting, loss of appetite, weight loss, constipation, stomach pain, aphtha, dry mouth and/or dry skin; decreased urine output; or rapid heartbeat. Nailitis, hair loss, headache, fatigue, joint pain, painful urination, swelling and pain in limbs or joints. Blurred vision, eye floaters, seeing flashes of light or other vision changes, muscle cramps, numbness, or dry mouth.

【Notes】

1.PEMAZYRE can cause retinal pigment epithelial detachment. Ophthalmological examinations, including optical coherence tomography (OCT), were performed before the start of treatment, every 2 months for the first 6 months of treatment and every 3 months thereafter, and at any time visual symptoms emerged urgently.

2. Hyperphosphatemia: Increased phosphate levels are a pharmacodynamic effect of PEMAZYRE. Monitor for and prevent hyperphosphatemia and reduce dose.

3. Permanently discontinue treatment based on the duration and severity of hyperphosphatemia.

4. Embryo-fetal toxicity: Can cause fetal harm. Inform patients of the potential risk to the fetus of reproductive potential and to use effective contraception.

The above is the instruction manual for pemetinib. Please use it correctly under the guidance of a doctor.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.