There are no human data to establish the presence or absence of anthrax immunoglobulin associated risk.
There are no data to assess the presence or absence of anthrax immunoglobulin in human milk, the effects on the breastfed child or the effects on milk production/excretion.
The most common adverse reactions to anthrax immunoglobulin observed in >5% of subjects in the healthy volunteer clinical trial were headache, infusion site pain, nausea, infusion site swelling, and back pain. The safety profile of the product may be different in patients with severe inhalational/systemic anthrax from that seen in the healthy volunteer trial. The incidence and/or severity of some adverse reactions to anthrax immunoglobulin and other intravenous immune globulin products may be related to the total protein/polyclonal antibody load administered.
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