Anthim

Name: Anthim

Anthim Dosage

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.

Anthim Overdose

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.

Preparations

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

Obiltoxaximab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV use

100 mg /1 mL

Anthim

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.

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