Pemazyre
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Pemigatinib
- Made by
- Incyte Biosciences Distribution B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (PEMAZYRE). It describes the substance, not this exact product.
Pemigatinib is a small molecule kinase inhibitor that targets FGFR1, 2 and 3 with IC 50 values of less than 2 nM.
Pemigatinib also inhibited FGFR4 in vitro at a concentration approximately 100 times higher than those that inhibit FGFR1, 2, and 3.
Pemigatinib is predominantly metabolized by CYP3A4 in vitro.
Effect of Food Administration of PEMAZYRE with a high-fat and high-calorie meal (approximately 1000 calories with 150 calories from protein, 250 calories from carbohydrate, and 500‑600 calories from fat) had no clinically significant effect on pemigatinib pharmacokinetics.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-09
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Incyte Biosciences Distribution B.V. |
|---|---|
| Active substance | Pemigatinib |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L01EN02 · Cancer treatments and immune-system medicines |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2021-03-26 |
| Last updated by the regulator | 2026-03-17 |
| EMA product number | EMEA/H/C/005266 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).