Patient Information

Leaflet

What is Panzyga®?1

Panzyga® is an intravenous immunoglobulin (IVIG) product. Panzyga® is made up of immunoglobulins (Ig), which are also called antibodies. Antibodies are made by the immune system and are proteins that are mostly found in the blood.

What is Panzyga® used to treat?1

Panzyga® can be used to treat persons with primary immune deficiency (PID) and secondary immune deficiency (SID). These conditions result from missing or impaired immune system of the body. Panzyga® helps replace missing antibodies. By replacing these important antibodies, Panzyga® helps make patients with PID and SID better able to avoid infections and fight them when they do occur.

Panzyga® is also used to treat persons with chronic immune thrombocytopenic purpura (ITP). ITP is a bleeding disorder in which the immune system destroys platelets, which are necessary for normal blood clotting. How Panzyga® works in ITP is unknown, but it is believed to block platelet removal from the bloodstream.

Where do I go to get more information on Panzyga®?1

Your healthcare provider is the best source of information for questions and concerns.

For access to the product monograph, visit the Health Canada website: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp; the manufacturer’s website: www.octapharma.ca, or by calling 1-888-438-0488.

Octapharma Canada Inc.308-214 King Street WestToronto, Ontario M5H 3S6www.octapharma.ca

(Immune Globulin Intravenous (Human))Human Normal Immunoglobulin (IVIg)

Copyright © 2016. All rights reserved. Date of preparation: February 2017.PAN032016E

What are the serious warnings and precautions?1

• As with all IVIGs, thromboembolic events such as heart attack, stroke, and obstructions of a deep vein e.g. in the calves or of a blood vessel in the lung (pulmonary embolism) may occur with administration of human immunoglobulin intravenous (IVIG) products.

• Thromboembolic events occur more commonly in patients with pre-existing risk factors for thromboembolism receiving IVIG products.

• In general the risk factors for thromboembolic events include: obesity; advance age; hypertension; diabetes mellitus; previous events of heart attack, stroke, and obstructions of a deep vein etc.; prolonged periods of immobilisation; intake of certain hormones (e.g. the pill).

• Thrombosis may occur even in the absence of known risk factors.

Why is my doctor prescribing Panzyga®?1

Panzyga® is used as antibody replacement therapy, in people who have low levels of these infection-fi ghting proteins. For patients with ITP, Panzyga® is believed to block platelet removal from the bloodstream. Your doctor will explain why you are receiving IVIG.

How will I be given Panzyga®?1

Panzyga® is administered by intravenous infusion and supervised by a skilled nurse usually in a hospital. The word “intravenous” (IV) means that the IVIG is put directly into your vein. A small needle is placed into a vein and the solution drips slowly into your veins. IVIG is infused slowly over several hours and may be given over one or more days, depending on various factors. An infusion pump may be used to control the rate of administration. The frequency of your IVIG treatments will be determined by your condition, your clinical response, and tolerance to the treatment.

What side effects can I expect?1

Most persons receiving regular infusions of IVIG tolerate treatment well. However, there are potential side effects with treatment that you must learn to recognize. Common side effects include: headaches, nausea, and fever. Uncommonly observed side effects include: dizziness, chills, eye itching, ear pain, fast heart rate, increase in blood pressure, cough, vomiting, belly pain or discomfort, rash, joint or muscle pain, chest pain, feeling cold, physical weakness, fatigue, changes in liver function parameters (lab test), and drop in white or red blood cells (lab test). Therefore, administration of IVIG is carefully monitored by the nurse and treating physician. Any side effects should be reported to the nurse and physician caring for you.

When should Panzyga® not be used?1

• You have a history of severe allergic reactions to immunoglobulin treatment.

• You have a condition known as selective IgA defi ciency.

How can I help to avoid side effects?1

Talk to your healthcare professional about any health conditions or problems you may have, including:

• If you have a history of allergic or other reactions to immunoglobulins or to any of the ingredients.

• If you have a history of heart disease, problems with your circulation or have had blood clots.

• If you have a history of migraine.

• If you have a history of kidney disease or diabetes.

• If you are pregnant or think that you are pregnant or if you are nursing.

• If you have recently been vaccinated.

Are there medications that may interact with Panzyga®?1

• Panzyga® may reduce the effect of certain virus vaccines, such as measles, mumps and rubella. Inform the immunizing physician of recent treatments with Panzyga® so appropriate precautions can be taken.

• Panzyga® should not be mixed with other products.

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

Can you reduce the side effects of IVIG?1

If you experience any side effects during or after an infusion, you should tell the nurse. Panzyga® has been manufactured with specifi c steps to reduce the risk of complications due to formation of blood clots. However, patients with known risk factors should be well hydrated by taking adequate fl uids and Panzyga® may be injected at a slower speed. Sometimes other medicines can also help reduce the side effects. If you have had problems with IVIG before, the doctor may prescribe medicine for you before the IVIG is started.

Immune Globulin Intravenous (Human) Human Normal Immunoglobulin (IVIg)

Reference:1. Panzyga® Product Monograph, June 2016