Obiltoxaximab
Class: Antitoxins and Immune Globulins
Chemical Name: Immunoglobulin G1, anti-(Bacillus anthracis anthrax protective antigen) (human-Mus musculus monoclonal ETI-204 heavy chain), disulfide with human-Mus musculus monoclonal ETI-204 κ-chain, dimer
Molecular Formula: C6444H9994N1734O2022S44
CAS Number: 1351337-07-9
Brands: Anthim
Warning
Warning: Hypersensitivity and Anaphylaxis
See full prescribing information for complete boxed warning.
Hypersensitivity reactions, including anaphylaxis, have been reported during obiltoxaximab infusion.
Obiltoxaximab should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis.
Stop obiltoxaximab infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.
Introduction
Obiltoxaximab is a chimeric IgG1 kappa monoclonal antibody that binds the protective antigen (PA) component of Bacillus anthracis toxin.
Uses for Obiltoxaximab
Obiltoxaximab has the following uses:
Obiltoxaximab is indicated in adult and pediatric patients for treatment of inhalational anthrax due to B. anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
Obiltoxaximab has the following limitations of use:
Obiltoxaximab should be used for prophylaxis only when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis.
The effectiveness of obiltoxaximab is based solely on efficacy studies in animal models of inhalational anthrax.
There have been no studies of the safety or pharmacokinetics (PK) of obiltoxaximab in the pediatric population. Dosing in pediatric patients was derived using a population PK approach.
Obiltoxaximab does not have direct antibacterial activity and should be used in combination with appropriate antibacterial drugs.
Obiltoxaximab is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.
Obiltoxaximab Dosage and Administration
General
Obiltoxaximab is available in the following dosage form(s) and strength(s):
Injection: 600 mg/6 mL (100 mg/mL) solution in single-dose vial.
Dosage
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Premedicate with diphenhydramine.
Administer in a monitored setting equipped to manage anaphylaxis.
Dilute in 0.9% Sodium Chloride Injection, USP, as directed by the manufacturer and administer as an intravenous (IV) infusion over 1 hour and 30 minutes.
Adults: 16 mg/kg.
Pediatric Patients Weighing Greater than 40 kg: 16 mg/kg.
Pediatric Patients Weighing Greater than 15 kg to 40 k...
