The recommended dosage of Anthim in adult patients is a single dose of 16 mg/kg administered intravenously over 90 minutes (1 hour and 30 minutes).
The recommended dosage of Anthim in pediatric patients greater than 40 kg is 16 mg/kg.
The recommended dosage of Anthim in pediatric patients greater than 15 kg to 40 kg is 24 mg/kg.
The recommended dosage of Anthim in pediatric patients less than or equal to 15 kg is 32 mg/kg.
If Anthim is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Obiltoxaximab is stored in the US Strategic National Stockpile (SNS). FDA-approved vial and carton labeling and separate NDC numbers distinguish stockpile units of the drug from any units intended for commercial use.1 2
Injection, for IV use
100 mg /1 mL
Elusys Therapeutics Inc.
Warnings and Precautions
Hypersensitivity and Anaphylaxis
Hypersensitivity reactions were the most common adverse reactions in the safety trials of Anthim, occurring in 34/320 healthy subjects (10.6%). Three (0.9%) cases of anaphylaxis occurred during or immediately after the infusion. In clinical trials, manifestations of anaphylaxis were rash/urticaria, cough, dyspnea, cyanosis, postural dizziness and chest discomfort. Anthim infusion was discontinued in 8 (2.5%) subjects due to hypersensitivity or anaphylaxis. The adverse reactions reported in these 8 subjects included urticaria, rash, cough, pruritus, dizziness, throat irritation, dysphonia, dyspnea and chest discomfort. The remaining subjects with hypersensitivity had predominantly skin-related symptoms such as pruritus and rash, and 6 subjects reported cough [see Adverse Reactions 6.1].
Due to the risk of anaphylaxis, Anthim should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Patients should be monitored closely throughout the infusion period and for a period of time after administration [see Patient Counseling Information (17)]. If anaphylaxis or hypersensitivity reactions occur, stop the infusion immediately and treat appropriately.
Premedication with diphenhydramine is recommended prior to administration of Anthim [see Dosage and Administration (2.1) and Adverse Reactions (6.1)]. Diphenhydramine premedication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity.
Black Box Warnings
Hypersensitivity and anaphylaxis have been reported during IV administration of obiltoxaximab
Because of the risk of hypersensitivity and anaphylaxis, administer the IV infusion in monitored settings by trained personnel who are equipped to manage anaphylaxis
Monitor patients closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration
Immediately stop the infusion if hypersensitivity or anaphylaxis occur and treat appropriately
Hypersensitivity reactions were the most common adverse reactions in the safety trials (see Black Box Warnings)
Premedication with diphenhydramine is recommended prior to administration; diphenhydramine does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity