Octagam: Uses, Side Effects and Dosage

What is OCTAGAM® used for?

OCTAGAM® is used for:

• Immune thrombocytopenic purpura (ITP) patients at high risk of bleeding or prior to surgery to correct the platelet count.
• patients who need antibody replacement therapy due to primary or secondary immune deficiency.
• adult patients who suffer from moderate to severe Guillain-Barré Syndrome (GBS).
• adult patients who suffer from Dermatomyositis (DM)

How does OCTAGAM® work?

OCTAGAM® is known as antibody replacement therapy, because it replaces the missing and much-needed IgG antibodies in people who have low levels of these infection-fighting proteins ie. PID/SID patients.

The mechanism of action in ITP, GBS and DM is not fully understood but includes modulatory effects of the immune system.

Serious Warnings and Precautions

What are the ingredients in OCTAGAM®?

Medicinal ingredients: Immunoglobulin Intravenous (Human), 10%

Non-medicinal ingredients: Maltose, Triton X-100, TNBP, Water for Injections, IgA

OCTAGAM® comes in the following dosage forms:

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

• 1 infusion bottle with 20 mL
• 1 infusion bottle with 50 mL
• 1 infusion bottle with 100 mL
• 1 infusion bottle with 200 mL
• 1 infusion bottle with 300 mL

Do not use OCTAGAM® if:

• You have a history of an allergic reaction to any human immunoglobulin/antibody preparation or if you are allergic to any of the other components of the preparation.
• You have immunoglobulin A (IgA) deficiency, with known antibodies against IgA. Octagam® contains trace amounts of IgA (average 106 µg/mL in a 10% solution).

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

• recently have heart disease or have had blood clots.

• are pregnant or nursing.

• have the following risk factors: kidney disease, diabetes mellitus, seriously dehydrated, overweight, take kidney damaging medications or are over the age of 65.
• are allergic to the immunoglobulins or to any of the nonmedicinal ingredients.
• have a history of allergy to corn products.
• use any device to measure blood or urine glucose, as the maltose in this product may interfere with these measurements.

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 OCTAGAM®:

• There is no known drug interaction to OCTAGAM®. OCTAGAM® administration may slow the protection of live attenuated viral vaccines such as measles, mumps, rubella and varicella for at least six weeks, and possibly up to three months or longer.
• The infusion line may be flushed before and after administration of OCTAGAM® with either normal saline or 5% dextrose in water.
• Components used in the packaging of OCTAGAM® are latex-free.

How to take OCTAGAM®:

• OCTAGAM® will be given to you by a healthcare professional in a healthcare setting.
• OCTAGAM® should be inspected visually for particulate matter and discolouration prior to administration. Do not use non-homogenous solutions, or those that have a deposit.
• OCTAGAM® should be brought to room or body temperature before administration.
• OCTAGAM® should not be mixed with other products.
• Filtration of OCTAGAM® is not required.

Usual dose:

Your doctor will determine the dose(s) of OCTAGAM® that you are to receive as an infusion, which is an injection given slowly in a vein. The dose you receive will depend on your clinical situation and disease, but the following are a generally accepted starting doses of OCTAGAM®:

Immune modulatory treatment in

• ITP: 2 g/kg body weight divided into two doses of 1 g/kg (10 mL/kg) given on two consecutive days.

  Treatment can be repeated if relapse occurs.

• GBS: The usual starting dose of OCTAGAM® - 2 g/kg body weight given in divided doses over 2 to 5 consecutive days.
• Dermatomyositis (DM): 2 g/kg body weight given in divided doses over 2 to 5 consecutive days every 4 weeks.

Replacement therapy in

• PID/SID - 100 to 600 mg/kg body weight, every 3 to 4 weeks.

Overdose:

Overdose is possible in patients that are overweight, elderly, or those with impaired kidney function.

Missed Dose:

A missed dose should be given as soon as possible.

What are possible side effects from using OCTAGAM®?

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

Hypersensitivity (such as changes in blood pressure, difficulty breathing a blue discoloration of the skin or mucous membranes, fast heart rate, skin reactions - rash/itching/hives), headache, increased blood pressure, nausea, fever, chills, blurred vision, dizziness, tremor, increased heart rate, vomiting, pain in extremity, back pain, chest pain, muscle pain, muscle spasms, joint pain, difficulty breathing, fatigue, injection site reactions, weakness, swelling of extremities, abdominal pain, diarrhea, flushing, cough, feeling unwell.

In rare cases, treatment with IVIG can also result in the following rare but serious symptoms. Tell your doctor immediately 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.

If you have a troublesome symptom or side effect that is not listed here or if a side effect becomes bad enough to interfere with your daily activities, tell 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 9 months at ≤ 25°C. After the storage at ≤ 25°C the product must be used or discarded.

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 OCTAGAM®:

• 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 http://www.octapharma.ca, or by calling 1-888-438-0488.

Last Revised May 6, 2022