What is Anthrax Immune Globulin (AIGIV)
Anthrax immune globulin is a sterile intravenous solution composed of human polyclonal immune globulin G antibodies isolated from the plasma of healthy donors who were previously vaccinated against anthrax.
The drug is indicated to treat patients infected with inhalational anthrax; however, because AIGIV does not have antibacterial activity, it must be administered in combination with appropriate antibiotics.
Approval of AIGIV was based on data extrapolated from animal studies involving New Zealand white rabbits and cynomolgus macaques, as well as safety and pharmacokinetic data from healthy volunteers.
In the animal studies, administration of AIGIV, as monotherapy and in combination with levofloxacin, resulted in statistically significant increases in survival rates and decreases in toxemia (defined as a serum samples with detectable protective antigen).
At the time of FDA approval, AIGIV had been administered to 19 human adults under the Centers for Disease Control and Prevention (CDC) expanded access use. Of these 19 patients, 3 were infected with inhalational anthrax, 15 with injectable anthrax, and 1 with gastrointestinal anthrax.
Treatment outcomes were as follows: inhalational anthrax (2 survived, 1 died), injectable anthrax (10 survived, 5 died), gastrointestinal anthrax (1 survived).
Anthrax immune globulin was FDA-approved with an Orphan Drug designation in March 2015.
For the treatment of inhalational anthrax, when used in combination with appropriate antibiotics
- headache (20.4%)
- nausea (9.3%)
- injection-site reaction (pain, 9.3%; swelling, 7.4%)
- back pain (3.7%)
- aseptic meningitis
- cardiac disease
- diabetes mellitus
- heart failure
- hemolytic anemia
- IgA deficiency
- infusion-related reactions
- maltose hypersensitivity
- pulmonary edema
- renal disease
- renal failure
- renal impairment
- thromboembolic disease
- viral infection
No information is available regarding drug interactions associated with Anthrax Immune Globulin