Panzyga: Uses, Side Effects and Dosage

What is Panzyga® used for?

1. 1) Panzyga® is used to treat adults and children:
2. • Who are either born with (PID) or develop (SID) not enough protective proteins (Immunoglobulins) in their blood to defend against infections.
3. 2) Panzyga® is used to treat adults:
4. • Who do not have enough blood platelets and who are at high risk of bleeding (immune thrombocytopenic purpura, ITP).
5. • Who suffer from moderate to severe Guillain-Barré Syndrome (GBS).
6. • Who suffer from chronic inflammatory demyelinating polyneuropathy (CIDP) which is a chronic disease and is characterized by inflammation of peripheral nerves which may lead to muscle weakness/numbness mainly in the limbs.

How does Panzyga® work?

Panzyga® is used as antibody replacement therapy, in people who have low levels of these infection-fighting proteins. By replacing these important antibodies, Panzyga® helps make people better able to avoid infections and fight them when they do occur.

How Panzyga® works in immune thrombocytopenic purpura is unknown, but it is believed to block platelet removal from the bloodstream. The mechanism of action in GBS and CIDP is not fully understood, but includes modulatory effects of the immune system which consequently helps improve function of muscles and nerves.

Serious Warnings and Precautions

What are the ingredients in Panzyga®?

Medicinal ingredients: Immunoglobulin Intravenous (Human)

Non-medicinal ingredients: Glycine, Water for Injections

Panzyga® comes in the following dosage forms:

Panzyga® is a 100 mg/mL solution for intravenous infusion and comes in the following dosage forms:

Fill Size Grams IgG

10 mL 1 g

25 mL 2.5 g

50 mL 5 g

100 mL 10 g

200 mL 20 g

300 mL 30 g

Do not use Panzyga® if:

• You have a history of severe allergic reactions to immunoglobulin/antibody treatment.
• You have a condition known as selective IgA deficiency.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Panzyga®. Talk 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.
• Have a history of heart disease, problems with your circulation or have had blood clots.
• Have a history of migraine.
• Have a history of kidney disease or diabetes.

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

• Have recently been vaccinated.

Other warnings you should know about:

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 Panzyga®:

• 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.
• In order to infuse any product that may remain in the infusion tubing at the end of the infusion the tubing may be flushed with either 0.9% (9 mg/ml) saline or 5% (50 mg/ml) dextrose solution.

How to take Panzyga®:

Panzyga® is injected into a vein. It should not be used if it looks cloudy or is leaking. It should be warmed up to room or body temperature before use. Discard any remaining contents after use. Do not use the product after its expiry date (printed on the bottle).

Usual dose:

Your doctor will determine the dose(s) of Panzyga®.

• The usual dose of Panzyga® for patients with Primary or Secondary Immune Deficiency is 200 to 800 mg/kg body weight, every 3 to 4 weeks. Doses may be adjusted over time to achieve the desired clinical response and serum IgG levels.
• The usual dose for patients with Immune Thrombocytopenic Purpura is 1g/kg body weight for 2 consecutive days.
• The usual starting dose of Panzyga® for patients with Guillain-Barré Syndrome is 2 g/kg body weight given in divided doses over 2 to 5 consecutive days.
• The usual starting dose of Panzyga® for patients with Chronic Inflammatory Demyelinating Polyneuropathy is 2 g/kg bodyweight, best given divided in 2 equal doses on 2 consecutive days. For maintenance treatment the usual dose is 1-2 g/kg body weight given every 3 weeks.

In case of measles exposure your dose might need to be adjusted. Please consult your doctor or healthcare professional, if you have been exposed to measles.

Overdose:

Overdose may lead to fluid overload, particularly in the elderly and in patients with kidney problems.

Missed Dose:

A missed dose should be given as soon as possible.

What are possible side effects from using Panzyga®?

These are not all the possible side effects you may feel when taking Panzyga^®. If you experience any side effects not listed here, contact your healthcare professional.

The following symptoms are common:

• Headache
• Nausea
• Fever
• Skin inflammation (dermatitis)

The following symptoms are uncommonly or rarely observed:

• Dizziness
• Chills
• Drowsiness
• Reduced sense of touch
• Shivering
• Anxiety
• Eye itching
• Ear pain
• Fast heart rate
• Increase in blood pressure
• Cough
• Vomiting
• Belly pain or discomfort
• Diarrhoea
• Rash
• Hives
• Itching
• Redness of the skin
• Flu-like symptoms
• Joint or muscle pain
• Pain in a limb or the neck
• Chest pain
• Feeling cold
• Physical weakness
• Fatigue
• Changes in liver function parameters (lab test)
• Drop in white or red blood cells (lab test)
• Abnormally low levels of specific white blood cells called neutrophils (decreased neutrophils counts)

If any of the above listed symptoms occur, are severe or if they worry you, talk to your doctor or pharmacist.

In rare cases, treatment with IVIG can also result in the following rare but serious symptoms. Tell your doctor right away if you have any of the following symptoms.

• Severe headache with nausea, vomiting, neck stiffness, fever, and sensitivity to light. These could be signs of a temporary and reversible, non-infectious swelling of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• Pain, swelling, warmth, redness, or a lump in your legs or arms, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body, sudden confusion, or trouble speaking. These could be signs of a blood clot.
• Hives, swelling of the lips, tongue or throat, difficulty breathing, faintness, nausea, vomiting. These could be signs of an allergic reaction. Allergic reactions are rare, but can induce an anaphylactic shock, even in patients who had tolerated the previous treatments.
• Fatigue, weakness, dizziness, headache, dark urine, jaundice and/or paleness. These may be symptoms of hemolytic anemia, a condition where you have not enough red blood cells.
• Severe difficulty in breathing, chest pain, chest discomfort, painful respiration typically appearing within 1 to 6 hours after receiving treatment. These could be signs of a reaction called Transfusion-related Acute Lung Injury (TRALI).
• Lower back pain, fatigue, decrease in the amount of urine, in patients with kidney problems these could be signs of acute renal failure.

Panzyga® has been manufactured with specific 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 fluids and Panzyga® may be injected at a slower speed.

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

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

Storage:

Store refrigerated (+2 °C to +8 °C) for up to 36 months. Within this shelf-life the product may be stored up to 12 months at ≤ 25°C. After the storage at ≤ 25°C the product must be used or discarded.

Warm up to room or body temperature before use. Do not freeze. Protect from light. Discard any remaining contents after use. Do not use after expiry date.

Keep out of reach and sight of children.

If you want more information about Panzyga®:

• 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; the manufacturer’s website http://www.octapharma.ca, or by calling 1-888-438-0488.

Last Revised: May 19, 2021