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General Information
Cyfendus is comprised of Anthrax Vaccine Adsorbed (AVA) and an additional adjuvant.
Cyfendus is specifically indicated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.
Cyfendus is supplied as an intramuscular injection. Administer Cyfendus by intramuscular injection as a series of two doses (0.5 mL each) two weeks apart (at Week 0 and 2) post-exposure combined with antibacterial therapy.
Mechanism of Action
Anthrax is an infectious disease caused by the Gram-positive, spore-forming bacterium B. anthracis. Cyfendus induces antibodies against protective antigen protein that may contribute to protection by neutralizing the activities of the cytotoxic lethal toxin and edema toxin of B. anthracis.
Side Effects
Adverse effects associated with the use of Cyfendus may include, but are not limited to, the following:
- tenderness
- pain
- arm motion limitation
- warmth
- induration
- itching
- swelling
- erythema/redness
- systemic adverse reactions including muscle aches, tiredness and headache
Clinical Trial Results
The FDA approval of Cyfendus is based on data from a series of studies supported by the U.S. government and conducted by Emergent, including:
- a pivotal Phase 3 clinical study that evaluated the lot consistency, immunogenicity, and safety of the vaccine following a two-dose schedule administered intramuscularly in healthy adults,
- a Phase 2 study that evaluated non-interference between the vaccine and antibacterial drugs approved for post-exposure prophylaxis of anthrax disease, and
- non-clinical studies that assessed protective efficacy of the vaccine against lethal challenge with anthrax spores and helped identify neutralizing antibody levels associated with protection against disease.
- The efficacy of Cyfendus vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.