Obiltoxaximab Brand Name– Anthim
What is Obiltoxaximab
Obiltoxaximab is a monoclonal antibody that neutralizes toxins produced by Bacillus anthracis for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs or when alternative therapies are not available or not appropriate in adult and pediatric patients.
Obiltoxaximab was approved under the FDA’s Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans.
In this case, because inhalational anthrax is a rare and lethal disease, it is not possible to conduct adequate efficacy trials in humans.
Safety and pharmacokinetics were studied in healthy adult volunteers. Results were extrapolated from adult trials to determine pediatric dosing.
Obiltoxaximab was FDA-approved in March 2016.
Indications
- anthrax
- anthrax prophylaxis
- Bacillus anthracis
Side Effects
- antibody formation
- chest pain (unspecified)
- cough
- cyanosis
- dizziness
- dysphonia
- dyspnea
- erythema
- fatigue
- fever
- headache
- hematoma
- infection
- injection site reaction
- musculoskeletal pain
- myalgia
- nasal congestion
- palpitations
- pruritus
- rash
- rhinorrhea
- serious hypersensitivity reactions or anaphylaxis
- urticaria
- vomiting
- xerostomia
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- breast-feeding
- pregnancy
- serious hypersensitivity reactions or anaphylaxis
Interactions
No information is available regarding drug interactions associated with Obiltoxaximab
