Cnj-016: Uses, Side Effects and Dosage

Serious warnings and precautions box

What VIGIV is used for:

Vaccinia Immunoglobulin Intravenous (Human) [VIGIV] is indicated for the treatment and/or modification of the following conditions following smallpox vaccination:

• Generalized spreading of vaccinia on the skin of a person with eczema
• Severe complication of smallpox vaccination characterized by a non-healing vaccination site
• Severe generalized vaccinia
• Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions
• Abnormal infections brought on by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard
• Prophylaxis of patients with skin conditions that may predispose them to the development of eczema vaccinatum, progressive or generalized vaccinia
• VIGIV is made from human plasma, which may contain the causative agents of viral disease. The risk of getting a disease from this product has been reduced by screening plasma donors, testing for the presence of certain viruses and by utilizing manufacturing steps that kill or remove certain viruses. However, there is still a possibility that plasma products could transmit disease.
• VIGIV contains maltose. Maltose in similar products has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems.
• Allergic reactions are rare. These reactions can occur in patients with a history of allergies to blood products or in patients lacking the IgA blood protein.

How VIGIV works:

Although the exact mechanism by which VIGIV works is not fully known, it is believed that antibodies in VIGIV interact with the virus to prevent or decrease the severity of vaccinia infections in at-risk individuals.

The ingredients in VIGIV are:

Medicinal ingredients: Vaccinia Immunoglobulin (Human)

Non-medicinal ingredients:

• Human plasma protein
• Maltose
• Polysorbate 80

VIGIV may contain trace amounts of tri-n-butyl phosphate and octoxynol.

VIGIV comes in the following dosage form:

VIGIV is provided in a single use glass vial containing ≥50,000 Units of vaccinia antibody activity/vial. VIGIV will be administered by a needle into your veins.

Do not use VIGIV if:

• You have had an allergic reaction to VIGIV or to any ingredient that is in VIGIV or any component of the container.
• You have a history of allergic reactions or prior severe all over body reactions associated with the administration of this or other human immunoglobulin preparations into the bloodstream.
• You have a known IgA deficiency.
• You have isolated vaccinia keratitis.

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

• You have experienced allergic reactions to blood products in the past
• You have a known IgA deficiency
• You have recently received any vaccinations such as measles, mumps, rubella or the chicken pox vaccine
• You are allergic to VIGIV or any of its ingredients or components of the container
• You are taking any other medications including over the counter medications and herbal products.

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 VIGIV:

• Vaccines: Measles, Mumps, Rubella or the Chicken Pox vaccine
• Laboratory tests: Some tests for monitoring blood glucose.

How to take VIGIV:

• VIGIV will be administered by a health care provider by an intravenous line.

Usual dose:

A dose of 6000 U/kg should be given as soon as symptoms appear and are determined to be due to severe vaccinia-related complication. The maximum daily dose of VIGIV should not exceed 12,000 Units per kg in patients with thrombotic risk factors.

Overdose:

Consequences of an overdose are not known.

If you think you, or a person you are caring for, have taken too much VIGIV, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Possible side effects from using VIGIV:

These are not all the possible side effects you may have when taking VIGIV. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects are injection site pain, chills, fever, tremor, headaches, dizziness, vomiting, nausea, joint pain, muscle pain and rash. These side effects are usually mild, but if they require treatment ask your health care professional.

The following symptoms are associated with allergic reactions: hives, rash, chest tightness, wheezing, shortness of breath, or feeling light headed or dizzy when getting up. Seek medical attention immediately when you experience any one or more of the above mentioned symptoms.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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

Storage:

Store VIGIV frozen at ≤-15°C. Do not use after expiration date. Protect from light.

Keep out of reach and sight of children.

If you want more information about VIGIV:

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

Date of Authorization: 2026-03-16

CNJ-016^™ 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.