Firazyr Use In Pregnancy & Lactation

Pregnancy: For icatibant, no clinical data on exposed pregnancies are available. Animal studies showed effects on uterine implantation and parturition (see Pharmacology: Toxicology: Preclinical safety data under Actions), but the potential risk for humans is unknown.
Firazyr should be used during pregnancy only, if the potential benefit justifies the potential risk for the foetus, (e.g for treatment of potentially life threatening laryngeal attacks).
Breast-feeding: Icatibant is excreted in the milk of lactating rats at concentrations similar to those in maternal blood.
No effects were detected in the post-natal development of rat pups.
It is unknown whether icatibant is excreted in human breast milk but it is recommended that breastfeeding women, who wish to take Firazyr, should not breastfeed for 12 hours after treatment.
Fertility: In both rats and dogs, repeated use of icatibant resulted in effects on reproductive organs. Icatibant had no effect on the fertility of male mice and rats (see Pharmacology: Toxicology: Preclinical safety data under Actions). In a study of 39 healthy adult men and women treated with 30 mg every 6 hours for 3 doses every 3 days for a total of 9 doses, there were no clinically significant changes from baseline in basal and GnRH-stimulated concentration of reproductive hormones in either females or males. There were no significant effects of icatibant on the concentration of luteal phase progesterone and luteal function, or on menstrual cycle length in females and there were no significant effects of icatibant on sperm count, motility and morphology in males. The dosing regimen used for this study is unlikely to be sustained in the clinical setting.