Intended for licensed healthcare professionals located in the United Kingdom and Republic of Ireland only
Frequently Asked Questions
Pregnancy and breastfeeding
There are no data on the impact of PEMAZYRE on human fertility. Animal fertility studies have not been conducted with PEMAZYRE. Based on the pharmacology of PEMAZYRE, impairment of male and female fertility cannot be excluded.1
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
Based on the mechanism of action and findings in an animal reproduction study, PEMAZYRE can cause foetal harm when administered to a pregnant woman. Pregnant women should be advised of the potential risk to the foetus. Women of childbearing potential being treated with PEMAZYRE should be advised not to become pregnant and men being treated with PEMAZYRE should be advised not to father a child during treatment. An effective method of contraception should be used in women of childbearing potential and in men with women partners of childbearing potential during treatment with PEMAZYRE and for 1 week following completion of therapy. Since the effect of pemigatinib on the metabolism and efficacy of contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.1
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
Based on the mechanism of action and findings in an animal reproduction study, PEMAZYRE can cause foetal harm when administered to a pregnant woman. Pregnant women should be advised of the potential risk to the foetus. Women of childbearing potential being treated with PEMAZYRE should be advised not to become pregnant and men being treated with PEMAZYRE should be advised not to father a child during treatment. A pregnancy test should be performed before treatment initiation to exclude pregnancy.1
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
It is unknown whether PEMAZYRE or its metabolites are excreted in human milk. A risk to the breast-fed child cannot be excluded. Breastfeeding should be discontinued during treatment with PEMAZYRE and for 1 week following completion of therapy.1
- 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.
