Pemigatinib (Pemazyre) is an innovative kinase inhibitor. By specifically targeting the fibroblast growth factor receptor (FGFR) pathway, it provides a precision treatment option for patients with malignant tumors harboring specific genetic abnormalities.

What are the Indications for Pemigatinib (Pemazyre)?

Cholangiocarcinoma

Pemigatinib is indicated for the treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma.

However, it is not suitable for all cholangiocarcinoma patients. A prerequisite is that the patient’s tumor must be confirmed to have fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangements via an FDA-approved detection method.

Myeloid/Lymphoid Neoplasms (MLN) with FGFR1 Rearrangement

Pemigatinib is also indicated for the treatment of relapsed or refractory myeloid/lymphoid neoplasms (MLN) with fibroblast growth factor receptor 1 (FGFR1) gene rearrangement. This is a rare type of hematological malignancy.

Mandatory genetic testing to confirm FGFR2 gene abnormalities is required before administering pemigatinib for cholangiocarcinoma treatment.

For myeloid/lymphoid neoplasms, there is currently no FDA-approved companion diagnostic kit available, and FGFR1 rearrangements need to be detected using alternative methods.

Dosage Forms and Characteristics of Pemigatinib (Pemazyre)

Dosage Specifications

4.5 mg: Round, white to off-white tablets, imprinted with "I" on one side and "4.5" on the other side.

9 mg: Oval, white to off-white tablets, imprinted with "I" on one side and "9" on the other side.

13.5 mg: Round, white to off-white tablets, imprinted with "I" on one side and "13.5" on the other side.

Composition

Active Ingredient: Pemigatinib, with the chemical name 3-(2,6-difluoro-3,5-dimethoxyphenyl)-1-ethyl-8-(morpholin-4-ylmethyl)-1,3,4,7-tetrahydro-2H-pyrrolo[3',2':5,6]pyrido[4,3-d]pyrimidin-2-one.

Inactive Ingredients: The tablet contains magnesium stearate, microcrystalline cellulose, and sodium carboxymethyl starch.

Physicochemical Properties

Pemigatinib is a white to off-white solid, and it is non-hygroscopic.

Its solubility is pH-dependent, with solubility decreasing as pH increases.

Storage Method for Pemigatinib (Pemazyre)

Storage Conditions

Pemigatinib should be stored at room temperature, with the ideal storage temperature ranging from 20°C to 25°C (68°F to 77°F).

Short-term temperature fluctuations between 15°C and 30°C (59°F to 86°F) are permitted during transportation or temporary carrying.

Ensure the medicine is placed out of the reach and sight of children to prevent accidental ingestion.

Keep the medicine in its original packaging bottle and maintain the cap tightly closed to protect it from moisture and light exposure.