For: Anthrax Prophylaxis, Inhalation Bacillus anthracis
Anthim (obiltoxaximab) is a monoclonal antibody (mAb) anthrax antitoxin for the treatment and prevention of inhalational anthrax.These highlights do not include all the information needed to use ANTHIM safely and effectively. See full prescribing information for ANTHIM.
ANTHIM� (obiltoxaximab) injection, for intravenous use
Initial U.S. Approval: 2016
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
See full prescribing information for complete boxed warning.
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion (5.1)
ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis (1.2, 2.4, 5.1)
Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs (2.4, 5.1)
INDICATIONS AND USAGE
ANTHIM� is a monoclonal antibody directed against the protective antigen of Bacillus anthracis. It 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. (1.1)
Limitations of Use
ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. (1.2, 5.1)
The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. (1.2, 14)
There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. (1.2, 8.4)
ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. (1.2)
ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis. (1.2)
DOSAGE AND ADMINISTRATION
Pre-medicate with diphenhydramine. (2.1, 5.1)
Recommended Dosage of ANTHIM:
Adult Patients: 16 mg/kg. (2.1)
Pediatric Patients: (2.2)
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Greater than 40 kg: 16 mg/kg
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Greater than 15 kg to 40 kg: 24 mg/kg
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Less than or equal to 15 kg: 32 mg/kg
Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous (IV) infusion over 1 hour and 30 minutes. (2.3)
Administer ANTHIM in a monitored setting equipped to manage anaphylaxis. (2.4, 5.1)
See Full Prescribing Information for instructions on preparation, dilution and administration of ANTHIM injection. (2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 600 mg/6 mL (100 mg/mL) solution in single-dose vial. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions, including anaphylaxis (Boxed Warning, 1.2, 2.1, 2.4, 5.1)
ADVERSE REACTIONS
Most frequently reported adverse reactions in healthy adult subjects (?1.5%) were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, nasal congestion, infusion site pain, urticaria and pain in extremity. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Elusys Therapeutics, Inc. at 1-844-808-0222 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population. (1.2, 8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2019
