Obiltoxaximab

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. 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. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. 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. ANTHIM does not have direct antibacterial activity.

Obiltoxaximab is a monoclonal antibody that binds the PA of B. anthracis.

Pre-medicate with diphenhydramine. Recommended Dosage of ANTHIM: Adult Patients: 16 mg/kg. Pediatric Patients: ➢ Greater than 40 kg: 16 mg/kg ➢ Greater than 15 kg to 40 kg: 24 mg/kg ➢ 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. Administer ANTHIM in a monitored setting equipped to manage anaphylaxis. See Full Prescribing Information for instructions on preparation, dilution and administration of ANTHIM injection.

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Boxed warning (hypersensitivity and anaphylaxis): Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Hypersensitivity reactions, including anaphylaxis ( Boxed Warning, 1.2, 2.1, 12.4, 5.1 ) 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 following clinically important adverse reactions are described elsewhere in the labeling: Hypersensitivity and Anaphylaxis. 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.

Ciprofloxacin Co-administration of 16 mg/kg ANTHIM intravenously with intravenous or oral ciprofloxacin in human subjects did not alter the PK of either ciprofloxacin or obiltoxaximab.

Store in refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do Not Freeze. Do Not Shake.