佩米替尼(pemigatinib)的用法用量:用药指南,剂量调整,特殊人群用药,用药注意事项

The correct timing of pemetinib administration, reasonable dosage adjustment, and its interaction with food all play a very important role in improving patients' treatment compliance and reducing adverse reactions.

Pemigatinib (pemigatinib) patient selection‌

‌1. Cholangiocarcinoma patient selection‌

Patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 can try this treatment, but it must be confirmed by an FDA-approved detection method before it can be used as a clinically feasible treatment.

‌2. Selection of patients with myeloid/lymphoid tumors‌

Select patients with relapsed or refractory myeloid/lymphoid tumors with FGFR1 rearrangements to be treated with pemigatinib. There are currently no FDA-approved tests for screening patients with FGFR1 rearrangements who are treated with pemigatinib.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

‌Recommended dose of pemigatinib‌

Take pemigatinib by mouth at approximately the same time each day, with or without food.

Swallow the tablet whole. Do not crush, chew, break or dissolve the tablet.

If a dose is missed for more than 4 hours or vomiting occurs, skip the dose and take the next dose as originally planned.

1‌. Cholangiocarcinoma treatment plan‌

The recommended dose is 13.5mg, once a day, taken for 14 days and then stopped for 7 days, forming a 21-day treatment cycle.

Treatment continued until disease progression or intolerable toxicity.

2‌. Treatment plan for FGFR1-rearranged myeloid/lymphoid tumors‌

The recommended dose is 13.5 mg, taken once a day continuously (without intermittent period).

Treatment continued until disease progression or intolerable toxicity.

‌Dose adjustment plan for adverse reactions of pemigatinib‌

‌Cholecystocarcinoma (FGFR2 fusion/rearrangement)‌

First dose reduction: 9mg/day, taken in the first 14 days of every 21-day cycle.

Second dose reduction: 4.5mg/day, taken in the first 14 days of every 21-day cycle.

Third dose reduction: permanent discontinuation.

‌Myeloid/lymphoid tumors (FGFR1 rearrangement)‌

First dose reduction: 9 mg/day for continuous use.

Second dose reduction: 4.5mg/day for continuous use.

However, the final discontinuation dose is 4.5mg/day, and long-term continuous use is required (if there are adverse reactions to this dose, treatment should be terminated).

Pemigatinib adverse reaction treatment plan‌

‌Retinal pigment epithelial detachment (RPED)‌

Asymptomatic and stable, continue taking the medication.

Suspend medication if symptoms or worsening occur.

Asymptomatic and improved, resume medication and reduce dose.

If symptoms persist or do not improve, consider permanently discontinuing the drug.

‌Hyperphosphatemia‌

(1) Serum phosphorus 7-10 mg/dL:

Initiate phosphate-lowering treatment and monitor weekly.

If it does not drop to <7mg/dL after 2 weeks, the medication will be suspended.

However, when the blood pressure drops below 7mg/dL for the first time, the original drug dose can be restored. For those who relapse, the dose should be reduced or other antihypertensive drugs should be used.

(2) Serum phosphorus>10mg/dL:

According to the current clinical guidelines and the specific situation of the patient, phosphorus-lowering treatment should be initiated in a timely manner, and the indicators of phosphorus poisoning should be monitored every week to make timely corrections and prevent further deterioration of the condition.

If the dose does not drop to ≤10mg/dL after 1 week, the medication will be suspended.

Use the next lower dose after falling to <7 mg/dL.

If the dose is still >10mg/dL after 2 reductions, discontinue the drug permanently.

‌Other adverse reactions (graded according to NCICTCAE4.03)‌

For grade 3, the medication should be suspended until it returns to grade 1 or baseline. If recovery occurs within 2 weeks, the dose will be reduced, otherwise the medication will be permanently discontinued; if the medication recurs after 2 dose reductions, the medication will be permanently discontinued.

Grade 4 is permanent discontinuation.

‌Dose adjustment when pemigatinib is used with strong/moderate CYP3A inhibitors‌

Concomitant use of pemigatinib with strong or moderate CYP3A inhibitors should be avoided. If combined use cannot be avoided:

The initial dose is 13.5mg, and finally the dosage is adjusted to 9mg.

If it is already 9mg, it needs to be further reduced to 4.5mg.

After discontinuing a strong/moderate CYP3A inhibitor (after 3 plasma half-lives of the inhibitor), the dose of pemigatinib before combination can be restored.

‌Recommended dose of pemigatinib in patients with severe renal insufficiency‌

For patients with severe renal insufficiency (eGFR15-29mL/min/1.73m², estimated using the MDRD formula):

The recommended dose is 9 mg, and should be used according to the intermittent or continuous dosage regimen corresponding to the indication.

‌Recommended dose of pemigatinib in patients with severe hepatic insufficiency‌

For patients with severe hepatic insufficiency (total bilirubin >3 times ULN with any AST elevation):

The recommended dose is 9 mg, and should be used according to the intermittent or continuous dosage regimen corresponding to the indication.