Igivnex: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• Primary Immune Deficiency
• Idiopathic Thrombocytopenic Purpura
• Allogeneic Bone Marrow Transplantation
• Pediatric HIV Infection
• Chronic Inflammatory Demyelinating Polyneuropathy
• Moderate to severe Guillain-Barré Syndrome (GBS) in adults

What it does:

• Immunoprotection: can help prevent infections by playing a protective role in diseases where patients suffer from poorly functioning immune systems
• Immunomodulation: can help to raise platelets in the blood to prevent bleeding in patients who have immune systems that are not working well
• Can improve the function of nerves and muscles in patients with CIDP or GBS. This may be achieved via a variety of different mechanisms and is not completely understood

When it should not be used:

IGIVnex® is contraindicated in individuals with known severe allergic reaction or severe system response to Immunoglobulin (Human).

What the medicinal ingredient is:

Immunoglobulin Intravenous (Human), 10%

What the nonmedicinal ingredients are:

Glycine

What dosage forms it comes in:

Intravenous solution (IGIVnex® can also be administered subcutaneously for some conditions).

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Immunoglobulin Intravenous (Human) products have been reported to be associated with kidney failure. You should talk to your healthcare provider if you have some kind of kidney disease, diabetes, are over 65, seriously dehydrated, have other diseases (called sepsis and paraproteinemia), or are taking drugs that you were told could damage your kidneys.
• Immunoglobulin Intravenous (Human) products have been reported to be associated with the premature destruction of red blood cells, a condition known as hemolytic anemia. Speak with your healthcare professional if you are taking antibiotics, have received a kidney transplant or blood transfusions, or you have a history of blood disorders.
• Immunoglobulin Intravenous (Human) products have been reported to be associated with heart and blood circulation problems such as heart attack, stroke and blood clots (thrombosis). You should talk to your doctor if you have risk factors for these kinds of conditions. Some of these risk factors include obesity, old age, high blood pressure, diabetes, or a history of heart disease. Thrombosis may occur even in the absence of known risk factor.

BEFORE you use IGIVnex® talk to your doctor or pharmacist if you have or have had any of the following conditions:

• have previously been advised that you have Immunoglobulin A (IgA) deficiency
• have a history of allergic or other adverse reactions to immunoglobulins
• have a kidney disease

IGIVnex® has not been studied in pregnant women or animals, and as such it is not known whether IGIVnex® can cause harm to the fetus when given to a pregnant woman. IGIVnex® should be given to a pregnant woman only if clearly needed.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with IGIVnex® include:

• Antibodies in IGIVnex® may interfere with the response to live viral vaccines such as measles, mumps and rubella. Therefore, use of such vaccines should be deferred until approximately 6 months after IGIVnex®administration.
• Do not dilute with saline. If dilution is required, IGIVnex® may be diluted with 5% dextrose in water (D5W).
• IGIVnex® and Heparin should not be administered simulatenously through the same tubing due to incompatibilities between these products. No other drug interactions or compatibilities have been evaluated.

See also ABOUT THIS MEDICATION: When it should not be used, and SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

PROPER USE OF THIS MEDICATION

Usual dose

Your doctor will determine the dose(s) of IGIVnex® that you are to receive. Your doctor or nurse will give you IGIVnex® as an infusion, that is, an injection given slowly in the vein. Alternatively, some conditions can be treated by having patients self-administer IGIVnex® in their own home, with injections under the skin (subcutaneous injections). If you are receiving IGIVnex® infusions at home, rather than a hospital or clinic, or if you are self-administering IGIVnex® with subcutaneous injections, be sure to closely follow all instructions from your doctor.

Overdose

Overdose may lead to fluid overload and hyperviscosity, particularly in the elderly and in patients with renal impairment.

Missed Dose

Not applicable

Stopped Treatment

Not applicable

Aseptic meningitis and hemolytic anemia have been reported to occur infrequently in association with IGIV treatment. Signs and symptoms of aseptic meningitis may include severe headache and/or a stiff neck. Signs and symptoms of hemolytic anemia may include severe generalized weakness, lightheadedness, dark urine, jaundice and/or pale complexion. Please contact your health care provider if you experience these signs or symptoms.

This is not a complete list of side effects. For any unexpected effects while taking IGIVnex®, contact your doctor or pharmacist.

HOW TO STORE IT

IGIVnex® may be stored for 36 months at 2-8ºC (36-46ºF), AND product may be stored at temperatures not to exceed 25ºC

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

(77ºF) for up to 6 months anytime during the 36 month shelf life, after which the product must be immediately used or discarded. Do not freeze. Do not use after expiration date.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance :

By toll-free telephone:

866-234-2345

By toll-free fax:

866-678-6789

Online

www.healthcanada.gc.ca/medeffect

By email:

CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office Marketed Health Products Safety and Effectiveness Information Bureau Marketed Health Products Directorate

Health Products and Food Branch

Health Canada Tunney’s Pasture, AL 0701C Ottawa ON K1A 0K9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the distributor, Grifols Canada Ltd., at 1-866-482-5226.

Grifols Therapeutics LLC (Manufacturer) 8368 US 70 Business Hwy West Clayton, NC 27520

Grifols Canada Ltd. (Distributor and Importer) 5060 Spectrum Way, Suite 405

Mississauga, Ontario L4W 5N5

Last revised: November 15, 2024