Intended for licensed healthcare professionals located in the United Kingdom and Republic of Ireland only
Frequently Asked Questions
Pharmacodynamics and pharmacokinetics
Pemigatinib (the active ingredient in PEMAZYRE) is a kinase inhibitor of fibroblast growth factor receptor (FGFR) 1, 2 and 3. It increases serum phosphate levels as a consequence of FGFR inhibition. In PEMAZYRE clinical studies, phosphate-lowering therapy and dose modifications were permitted to manage hyperphosphataemia.1
Consult the Summary of Product Characteristics for a full list of pharmacodynamic effects
Summary of Product Characteristics (SmPC) – United Kingdom
Summary of Product Characteristics (SmPC) – Republic of Ireland
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
Pemigatinib (the active ingredient in PEMAZYRE) exhibits linear pharmacokinetics in the dose range of 1 to 20 mg. Following oral administration of PEMAZYRE 13.5 mg once daily, steady state was reached by 4 days with a geometric mean accumulation ratio of 1.6. The geometric mean steady-state area under the curve 0–24 h (AUC0-24) was 2620 nM·h (54% coefficient of variation [CV]) and the maximum plasma concentration (Cmax) was 236 nM (56% CV) for 13.5 mg once daily.1
Consult the Summary of Product Characteristics for more information on pharmacokinetic data.
Summary of Product Characteristics (SmPC) – United Kingdom
Summary of Product Characteristics (SmPC) – Republic of Ireland
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited.
