PREGNANCY SUMMARY

No reports describing the use of ecallantide in human pregnancy have been located. The protein caused developmental toxicity (death) in one animal species, but the dose comparison was based on body weight, not BSA or AUC, and maternal toxicity was present. Although a rare genetic disorder, acute episodic attacks of hereditary angioedema can cause localized swelling, inflammation, and pain. If a pregnant woman requires ecallantide, consideration should be given to avoiding early gestation. She should be informed of the lack of human pregnancy experience and the potential risk of embryo death. Moreover, the woman should be informed of the risk of anaphylaxis that has occurred in 3.9% of treated patients (1).