Octaplasma: Uses, Side Effects and Dosage

What OCTAPLASMA is used for:

• Complex disorders of the blood clotting system due to severe liver failure, massive transfusion (this is the process of transferring blood or blood-based products from one person into the circulatory system of another), or repeated large volume plasma exchange. This is a removal procedure of (components of) blood plasma from the circulation (especially in patients with damaged liver function).
• OCTAPLASMA may be used for emergency therapy in clotting factor deficiencies, in special situations, e.g. when acute bleeding does not allow a precise laboratory diagnosis, or when a specific clotting factor concentrate is not available.
• Rapid conversion of the effects of oral anticoagulants (substances that prevent coagulation, i.e. they stop blood from clotting) when vitamin K is insufficient in emergency situations, or in patients with damaged liver function.

How OCTAPLASMA works:

Your blood is made up of cells floating in a clear liquid called plasma.

Plasma carries special proteins - called clotting factors - that help your blood form a clot and stop bleeding. OCTAPLASMA is:

• Human plasma collected from many carefully screened donors.
• Treated with special steps to remove or inactivate viruses (solvent‑detergent treatment) for extra safety.

Serious warnings and precautions box

• This product is made from human plasma, which may contain infectious agents, such as viruses that cause hepatitis and other viral diseases. However, OCTAPLASMA is treated to either remove or inactivate certain viruses. Pathogen inactivation of lipid enveloped viruses such as HIV, HBV and HCV is achieved through solvent detergent (S/D) treatment of plasma and the production process also allows immune neutralization of non-lipid enveloped viruses such as HAV and Parvovirus B19. Your doctor should discuss the risks and benefits of this product with you before giving you this product.

When OCTAPLASMA is given to you through an IV drip, it replaces the clotting factors and other important proteins your own blood may be missing or low on. By topping up these proteins, OCTAPLASMA helps your blood clot properly and reduces the risk of uncontrolled bleeding.

The ingredients in OCTAPLASMA are:

Medicinal ingredients: Human plasma proteins

Non-medicinal ingredients: Glycine, Octoxynol, Sodium citrate dihydrate, Sodium dihydrogenphosphate dihydrate, TNBP

OCTAPLASMA comes in the following dosage form:

OCTAPLASMA (Solvent Detergent (S/D) Treated Human Plasma) is supplied frozen in bags of 200 mL containing 45-70 mg/mL Human Plasma Proteins.

Do not use OCTAPLASMA if:

• IgA deficiency with documented antibodies against IgA
• Severe deficiency of protein S
• Hypersensitivity to this drug or to any ingredient

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

• You recently had a heart attack, have a high risk of blood clots, or have coronary artery disease.
• If you have fluid in the lungs or cardiac failure.
• If you have IgA deficiency.
• If you had previous reactions to plasma proteins, fresh frozen plasma or OCTAPLASMA.

• If you are pregnant or nursing. A pregnancy test is recommended before receiving OCTAPLASMA.

• You have a disease that causes marked fibrinolysis that is responsible for breaking down blood clots.

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 OCTAPLASMA:

• There is no known drug interaction to OCTAPLASMA. OCTAPLASMA administration may slow the protection of live attenuated vaccines such as measles, mumps, rubella (also known as three-day or liberty measles) and chicken pox for at least six weeks, and possibly up to three months or longer.

How to take OCTAPLASMA:

• OCTAPLASMA will be given to you by a healthcare professional in a healthcare setting.

Usual dose:

The dose you receive will depend on your clinical situation and disease, but 12-15 mL OCTAPLASMA/kg body weight is a generally accepted starting dose. The duration of administration will be determined by your doctor.

Overdose:

Overdose may lead to volume overload and thereby water in the lung and/or heart failure. In such cases, OCTAPLASMA transfusion should be stopped immediately.

If you think you, or a person you are caring for, have taken too much OCTAPLASMA, 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.

Missed dose:

Not applicable because OCTAPLASMA is usually given in a hospital setting.

Possible side effects from using OCTAPLASMA:

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

Side effects may include:

• Nausea, flushing, hives, fast heart rate, drop in blood pressure, reduction or cessation of breathing, and reduction or cessation of a sufficient amount of blood flow from the heart throughout the body that may result in impaired function of internal organs.
• In the course of plasma exchange, symptoms attributable to citrate overdose (e.g. fatigue, a sensation of tingling, numbness or prickling, tremor and low calcium concentrations) may occur.
• Acute lung injury, a syndrome known as transfusion related acute lung injury, may occur and is characterized by chills, fever, a non-productive cough, and difficulty or shortness of breath.
• Passive post-transfusion purpura (PTP) may occur which is characterized by difficulty or shortness of breath, rash, fever, discoloration of the skin that may include a reddish purple to brown color and marked reduction in platelets.

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 frozen at < -18 °C for up to 48 months, protect from exposure to light. After thawing, OCTAPLASMA can be stored for up to 5 days at +2 to 8 °C or for up to 8 hours at room temperature (+20 to 25°C) before use. Thawed OCTAPLASMA must not be refrozen. Unused product must be discarded.

Keep out of reach and sight of children.

If you want more information about OCTAPLASMA:

• 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 (Drug Product Database: Access the database); the manufacturer’s website https://www.octapharma.ca, or by calling 1-888-438-0488.

Date of Authorization: 2026-05-21