Pemetinib detailed instructions

1. Indications and Usage

Pemigatinib/Pemigatinibis a kinase inhibitor with indications:

1.For the treatment of adult patients with previously treated unresectable locally advanced or metastatic cholangiocarcinoma who have fibroblast growth factor receptor2 (fgfr 2) fusion or other rearrangement detected by a U.S. Food and Drug Administration (FDA)-approved test.

This indication received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and characterization of clinical benefit in confirmatory trials.

2.For the treatment of adults with FGFR1rearranged relapsed or refractory myeloid/lymphoid neoplasms (MLNs).

2. Dosage and usage

Cholangiocarcinoma:

Confirm the presence ofFGFR2fusion or rearrangement before initiatingpemetinibtreatment.

The recommended dose is 13.5 mg taken orally once daily for 14 days followed by discontinuation of treatment for 7 days in a 21 day cycle. Continue treatment until disease progression or unacceptable toxicity.

Myeloid neoplasms withFGFR1rearrangements/Lymphoid neoplasms:

The recommended dose is 13.5 mg taken orally once daily, continue treatment until disease progression or unacceptable toxicity.

All patients who received pemetinib treatment:

Swallow the tablet whole, with or without food.

Severe Renal Impairment:The recommended dose of pemetrexed is 9 mg with the indicated schedule (intermittent or continuous) as indicated. Severe hepatic impairment:The recommended dose of pemetrexed is 9 mg and the dosing regimen (intermittent or continuous) is specified according to the indication.

Three. Dosage form and strength

Tablets: 4.5mg, 9mg and 13.5mg.

Four. Contraindications

No.

Five. Warnings and Precautions

Ocular toxicity: Pemetinib can cause retinal pigment epithelial detachment. Obtain an eye exam, including optical coherence tomography (OCT), before starting treatment, every 2 months for 6 months before treatment, every 3 months thereafter, and urgently for visual symptoms at any time.

Hyperphosphatemia and soft tissue mineralization:Can cause hyperphosphatemia, leading to soft tissue mineralization, skin calcification, calcinosis, and non-uremic calcium allergy. Monitor for hyperphosphatemia and withhold, reduce dose, or permanently discontinue therapy based on duration and severity of hyperphosphatemia.

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

6. Adverse reactions

Cholangiocarcinoma:The most common adverse reactions (incidence≥ 20%) are hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eyes, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, hypophosphatemia, back pain, and dry skin.

Myeloid/Lymphoid neoplasms withFGFR1 rearrangements:The most common (≥ 20%) Adverse reactions are hyperphosphatemia, nail toxicity, alopecia, stomatitis, diarrhea, dry eye, fatigue, rash, abdominal pain, anemia, constipation, dry mouth, epistaxis, serous retinal detachment, limb pain, decreased appetite, dry skin, dyspepsia, back pain, nausea, blurred vision, peripheral edema and dizziness.

7. Drug interactions

Strong and ModerateCYP3AInducers:Avoid concurrent use of pemetinib.

Strong and moderateCYP3Ainhibitors:Avoid combined use. If concomitant use cannot be avoided, reduce the dose of pemetinib.

8. Use among specific groups of people

Lactation:It is recommended not to breastfeed.

There are generic drugs in Laos, and they are all officially marketed generic drugs with government approval. The retail price of Lucius Pharmaceuticals in Laos is around 1000 yuan for 4.5mg*14 tablets. If you want to get more high-quality information, you can contact Yaode, and Yaode will do its best to help you learn more about high-quality overseas drugs.

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