Pemazyre (Pemigatinib) – Cholangiocarcinoma | HongKong DengYue Medicine

Pemigatinib Application Scope

• Treatment of cholangiocarcinoma with FGFR2 fusions or rearrangements (previously treated, unresectable, locally advanced or metastatic).

• Treatment of relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

  

Pemigatinib Characteristics

• Ingredients: Pemigatinib

• Properties:​ FGFR inhibitor; targeted anticancer therapy

• Packaging Specification:​ Film-coated tablets, 4.5 mg / 9 mg / 13.5 mg

• Storage:​ Store at 20–25°C (68–77°F); protect from moisture

• Expiry Date: As per package label

• Executive Standard: ​International / FDA / EMA approval standard

• Approval Number: Varies by region (FDA NDA 212616)

• Date of Revision: August 2022

• Manufacturer: Incyte Corporation

Guidelines for the Use of Pemazyre

• Dosage and Administration:

  • Recommended Dose: 13.5 mg orally once daily, on a 2-weeks-on / 1-week-off cycle

  • Administration: Take orally, with or without food

  • Missed Dose:​ If missed by ≤4 hours, take as soon as remembered; otherwise, skip and resume next dose

• Adverse Reactions:

  • Common Adverse Reactions:

    • Hyperphosphatemia

    • Nail toxicity, alopecia

    • Fatigue, diarrhea, dry mouth

    • Stomatitis, dry eyes

  • Serious Adverse Reactions:

    • Retinal pigment epithelial detachment (RPED)

    • Severe hyperphosphatemia

    • Hepatotoxicity

    ​

• Contraindications: Hypersensitivity to Pemazyre or excipients

• Precautions:

  • Monitor serum phosphate levels regularly

  • Ophthalmologic exams during treatment

  • Adjust dose for severe adverse events or renal/hepatic impairment

Pemigatinib Interactions

• CYP3A4 inhibitors/inducers may alter Pemazyre levels

• Avoid strong/moderate CYP3A inhibitors (e.g., itraconazole, clarithromycin) and inducers (e.g., rifampin, phenytoin)

• Dose adjustments may be required with moderate inhibitors

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.