Patient Medication Information: uses, side effects, how to take - Anthrasil

Serious Warnings and Precautions

Maltose in immunoglobulin products, including ANTHRASIL, may give falsely high blood glucose levels with some point-of-care blood glucose testing systems (for example those based on the GDH-PQQ or glucose-dye-oxidoreductase methods) resulting in inappropriate administration of insulin and life-threatening hypoglycemia. To avoid interference by maltose contained in ANTHRASIL, perform blood glucose measurement in patients receiving ANTHRASIL with a glucose-specific method (monitor and test strips).
Thrombosis may occur with immunoglobulin products, including ANTHRASIL. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
For patients at risk of thrombosis, administer ANTHRASIL at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

What is ANTHRASIL used for?

ANTHRASIL is used to treat inhalational anthrax, a serious disease caused by a germ called Bacillus anthracis. This germ makes a poison called a toxin. People who are exposed to anthrax germs are at risk of serious illness, including death. You/your child cannot get anthrax from another person. Symptoms of anthrax disease usually start within seven days of breathing in anthrax germs, but can take up to six or seven weeks to appear.

Early symptoms can be any of the following: fever, chills, tiredness, cough, muscle aches and headache.
Later symptoms can be any of the following: shortness of breath, chest discomfort, confusion or nausea.

How does ANTHRASIL work?

Medicines like antibiotics can kill anthrax germs. However, the anthrax poison (toxin) may continue to cause severe sickness even after the germs are gone. When someone gets the anthrax vaccine, their body’s immune system makes antibodies against anthrax. Antibodies help to fight off disease and can also help to fight off the anthrax poison.

ANTHRASIL is made by taking anthrax antibodies from well people who have been vaccinated. It does not contain the anthrax germ or poison. The antibodies in ANTHRASIL can then be given to someone with anthrax. This may make the sick person’s disease less severe, decrease the duration of illness and increase their chance of surviving.

The effectiveness of ANTHRASIL has been studied only in animals.

The safety of ANTHRASIL was studied in healthy adults. There have been no studies of ANTHRASIL in persons less than 17 years of age.

What are the ingredients in ANTHRASIL?

Medicinal ingredients: Each vial of ANTHRASIL contains human anthrax immunoglobulin.

Non-medicinal ingredients: Maltose, Polysorbate 80, Water for Injection

ANTHRASIL comes in the following dosage forms:

ANTHRASIL is a sterile solution for intravenous infusion provided in single use 50 mL glass vials.

Do not use ANTHRASIL if:

You have experienced an allergic reaction to ANTHRASIL or other human immunoglobulin drug products in the past.
You have, or have been told that you have an IgA deficiency, or antibodies to IgA, or a history of IgA hypersensitivity (allergic reaction).
You have experienced an allergic reaction to any ingredient in this product or component of the container.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ANTHRASIL. Talk about any health conditions or problems you may have, including if you:

are diabetic. ANTHRASIL contains maltose, which can give false readings on some glucose testing meters. If you are diabetic, ask your doctor what types of glucose testing meters can be used safely while you are getting ANTHRASIL.
have recently received a vaccine.
are pregnant or breastfeeding.

Other warnings you should know about:

ANTHRASIL is made from human plasma. The plasma donors are carefully screened and the plasma is carefully cleaned, but there is a small risk that it may give you a virus. Talk to your doctor if you have any symptoms that concern you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ANTHRASIL:

ANTHRASIL contains maltose that can interfere with certain types of blood glucose monitoring systems (tests that check the level of sugar in your body).
Immunoglobulins like ANTHRASIL may reduce the effectiveness of certain live virus vaccines such as measles, rubella (i.e. German measles), mumps and varicella (i.e. chickenpox). Talk to your doctor if you have been recently vaccinated.
Other drugs that may interact with ANTHRASIL have not been established.

How to take ANTHRASIL:

ANTHRASIL is given as an infusion into your vein. Your doctor will determine the dose of ANTHRASIL. The treatment may take several hours to administer. Your doctor will decide if you need more than one infusion.

What are possible side effects from using ANTHRASIL?

These are not all the possible side effects you may feel when taking ANTHRASIL. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

The most common side effects of ANTHRASIL are:

Headache
Pain at site of needle entry
Nausea
Swelling at site of needle entry
Back pain

Talk to your doctor about any side effects that concern you. You can ask your doctor for additional prescribing information that is available to healthcare professionals.

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional			Stop taking drug and get immediate medical help
Symptom / effect	Only if severe	In all cases
RARE Anaphylaxis			√		√
Allergic Reaction (trouble breathing, swollen tongue or lips, fast heart rate)			√		√

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345;

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store frozen at or below -20°C until used. Do not refreeze.

Keep out of reach and sight of children.

If you want more information about ANTHRASIL:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website
- (https://www.emergentbiosolutions.com/products-services/our-products), or by calling 1-800-768-2304.

Last Revised: FEB 17, 2025

Anthrasil^®and BIOTHRAX^®and any and all Emergent BioSolutions Inc. brand, product, service and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All rights reserved.

DIN	02469588
Schedule(s)	SCHEDULE D
Active ingredient(s)	Anthrax immunoglobulin (human) 60 UNIT
Dosage form(s)	Solution
Route(s) of administration	Intravenous
Drug class (WHO ATC)	J Antiinfectives for systemic use J06 Immune sera and immunoglobulins J06B Immunoglobulins J06BB Specific immunoglobulins J06BB19 Anthrax immunoglobulin
Company	EMERGENT BIOSOLUTIONS CANADA INC.
Current status	Restricted Access
Current status date	September 26, 2018

Anthrasil: Uses, Side Effects and Dosage