Obiltoxaximab

What is Obiltoxaximab?

• Obiltoxaximab (ANTHIM) is a monoclonal antibody directed against the protective antigen of Bacillus anthracis used to treat people with inhalational anthrax.

What are the uses of this medicine?

• This medicine is used along with antibiotic medicines to treat people with inhalational anthrax. ANTHIM can also be used to prevent anthrax disease when there are no other treatment options.

How does this medicine work?

• Obiltoxaximab is a monoclonal antibody that binds free PA with an affinity equilibrium dissociation constant (Kd) of 0.33 nM.
• Obiltoxaximab inhibits the binding of PA to its cellular receptors, preventing the intracellular entry of the anthrax lethal factor and edema factor, the enzymatic toxin components responsible for the pathogenic effects of anthrax toxin.

Who Should Not Use this medicine ?

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 has been studied only in animals with inhalational anthrax.
• There have been no studies in people who have inhalational anthrax.
• The safety of ANTHIM was studied in healthy adults.
• There have been no studies of ANTHIM in children younger than 18 years.
• ANTHIM is not used in prevention or treatment of anthrax meningitis.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with ANTHIM.

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

• Pre-medicate with diphenhydramine prior to administering ANTHIM.

Recommended Dosage: Dosage for Adult Patients

• 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)

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

Administration

• Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion.
• You will be given 1 dose of ANTHIM by a healthcare provider through a vein (IV or intravenous infusion). It takes about 1 hour and 30 minutes to give you the full dose of medicine.
• Your healthcare provider should give you a medicine called diphenhydramine (Benadryl®) before you receive ANTHIM to help reduce your chances of developing a skin reaction from ANTHIM. Benadryl may be given to you to take by mouth or through a vein.
• Benadryl may make you sleepy, and you should use caution if you will be driving or operating equipment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 600 mg/6 mL (100 mg/mL) solution in single-dose vial.

This medicine is available in fallowing brand namesː

• ANTHIM

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• itching
• upper respiratory tract infections
• cough
• IV site bruising
• swelling and/or pain
• stuffy nose (nasal congestion)
• hives
• pain in the hands or feet.

ANTHIM can cause serious side effects, including:

• Serious allergic reactions

What special precautions should I follow?

• Hypersensitivity reactions were the most common adverse reactions in the safety trials of ANTHIM.
• 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 .
• If anaphylaxis or hypersensitivity reactions occur, stop the infusion immediately and treat appropriately.
• Premedication with diphenhydramine is recommended prior to administration of ANTHIM.

What to do in case of emergency/overdose?

• There is no clinical experience with overdosage of ANTHIM.

Management for overdosage:

• In case of overdosage, monitor patients for any signs or symptoms of adverse effects.

Can this medicine be used in pregnancy?

• There are no data on the use of ANTHIM in pregnant women to inform on drug-associated risk.

Can this medicine be used in children?

• There have been no studies of ANTHIM in children younger than 18 years.

What are the active and inactive ingredients in this medicine?

• Active ingredient: Obiltoxaximab
• Inactive ingredients: L-histidine, sorbitol and polysorbate 80

Who manufactures and distributes this medicine?

• Manufactured by: Elusys Therapeutics, Inc., Parsippany, NJ.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Obiltoxaximab
• FDA Obiltoxaximab

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