Intended for licensed healthcare professionals located in the United Kingdom and Republic of Ireland only
Frequently Asked Questions
Adverse reactions
The safety of PEMAZYRE was investigated in the FIGHT-202 clinical study, a multicentre, open-label, single-arm study in previously treated patients with locally advanced/metastatic or surgically unresectable cholangiocarcinoma (N=147).1,2
The most common adverse reactions observed were hyperphosphataemia (60.5% [n=89]), alopecia (49.7% [n=73]), diarrhoea (47.6% [n=70]), nail toxicity (44.9% [n=66]), fatigue (43.5% [n=64]), nausea (41.5% [n=61]), stomatitis (38.1% [n=56]), constipation (36.7% [n=54]), dysgeusia (36.1% [n=53]), dry mouth (34.0% [n=50]), arthralgia (29.9% [n=44]), dry eye (27.9% [n=41]), hypophosphataemia (23.8% [n=35]), dry skin (21.8% [n=32]) and palmar-plantar erythrodysaesthesia syndrome (16.3% [n=24]).1,2
Consult the Summary of Product Characteristics for further safety information.
Summary of Product Characteristics (SmPC) – United Kingdom
Summary of Product Characteristics (SmPC) – Republic of Ireland
- References
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
- Incyte Data on File.
The safety of PEMAZYRE was investigated in the FIGHT-202 clinical study, a multicentre, open-label, single-arm study in previously treated patients with locally advanced/metastatic or surgically unresectable cholangiocarcinoma (N=147).1,2
The most common serious adverse reactions observed were hyponatraemia (2.0% [n=3]) and blood creatinine increase (1.4% [n=2]). No serious adverse reaction led to dose reduction. One serious adverse reaction of hyponatraemia (0.7%) led to dose interruption. One serious adverse reaction of blood creatinine increase (0.7%) led to dose discontinuation. Eye disorder serious adverse reactions were retinal detachment (0.7% [n=1]), non-arteritic optic ischaemic neuropathy (0.7% [n=1]) and retinal artery occlusion (0.7% [n=1]).1,2
Consult the Summary of Product Characteristics for further safety information.
Summary of Product Characteristics (SmPC) – United Kingdom
Summary of Product Characteristics (SmPC) – Republic of Ireland
- References
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
- Incyte Data on File.
▼ 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.
