No animal reproduction studies have been conducted with alpha1-antitrypsin and its safety for use in human pregnancy has not been established in controlled clinical trials. Since alpha1-antitrypsin is an endogenous human protein, it is considered unlikely that it will cause harm to the foetus when given at recommended doses. However, alpha1-antitrypsin should be given with caution to pregnant women.
It is unknown whether alpha1-antitrypsin/metabolites are excreted in human milk. The excretion of human alpha1-antitrypsin in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with alpha1-antitrypsin should be made, taking into account the benefit of breast-feeding to the child and the benefit of human alpha1-antitrypsin therapy to the woman.
No animal fertility studies have been conducted with alpha1-antitrypsin and its effect on human fertility has not been established in controlled clinical trials. Since human alpha1-antitrypsin is an endogenous human protein, no adverse effects on fertility are expected when given at recommended doses.
Dizziness may occur following the administration of alpha1-antitrypsin. Therefore, alpha1-antitrypsin may have a minor influence on the ability to drive and use machines.
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