Octaplex: Uses, Side Effects and Dosage

What octaplex is used for:

• Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.
• Treatment of bleeding in acquired deficiency of prothrombin-complex coagulation factors, such as deficiency that occurs during cardiac surgery.

How octaplex works:

The administration of octaplex can temporarily stop bleeding in patients with deficiency of one or several of the coagulation factors II, VII, IX and X, which are commonly called the Prothrombin Complex. octaplex will start working immediately upon injection. octaplex should only be used when rapid correction of major bleeding or emergency surgery is warranted.

The ingredients in octaplex are:

Medicinal ingredients:

Human Coagulation Factor II, VII, IX and X, and Proteins C and S.

Non-medicinal ingredients:

Heparin, sodium citrate, solvent (Water for Injection)

octaplex comes in the following dosage form(s):

Powder and solvent for solution for injection. One package of octaplex contains:

One powder vial containing the active ingredients (coagulation factors) and excipients, a second vial containing 20mL/40 mL of solvent and a transfer device with integrated filter.

Serious warnings and precautions box

As you are treated with Vitamin K antagonist (VKA) therapy you have an underlying disease state that predispose you to thromboembolic events especially if you have a history of thromboembolic events. Your doctor should carefully consider resumption of anticoagulation as soon as the risk of thromboembolic events outweighs the risk of acute bleeding (see WARNINGS AND PRECAUTIONS - Cardiovascular).

This product is made from human plasma, which may contain hepatitis and other viral diseases. Your doctor should discuss the risks and benefits of this product with you before giving you this product (see WARNINGS AND PRECAUTIONS - General).

Do not use octaplex if:

• if you are allergic to the drug or one of the ingredients of this product (listed in section 6).
• if you are allergic to heparin or if heparin has ever caused a reduction in the level of platelets in your blood.
• if you have IgA deficiency with known antibodies against IgA.
• if you recently had a heart attack, or have a high risk of blood clots, or if you have coronary artery disease, or chronic liver disease.

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

• You recently had a heart attack, have a high risk of blood clots, or have coronary artery disease, or liver disease;
• You are predisposed to allergies. Antihistamines and corticosteroids may be given prior to receiving this drug;
• You have not received appropriate vaccinations for hepatitis A and B. These vaccinations should be considered if you will be receiving regular/repeated treatments with this drug;
• You are allergic against heparin;

• You are pregnant or nursing. A pregnancy test is recommended before receiving octaplex

• You will be undergoing any scheduled surgical procedures; or
• You are allergic to the active substance or to any of the nonmedicinal ingredients.

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 octaplex:

There is no known drug interaction to octaplex.

How to take octaplex:

octaplex should be administered under the supervision of a qualified Health Care Professional. Your Health Care Professional will prepare octaplex for intravenous administration.

Any unused product or waste material should be disposed of immediately in accordance with local requirements.

Overdose:

No symptoms of overdose with octaplex have been reported.

If you think you, or a person you are caring for, have taken too much octaplex, contact a healthcare professional, hospital emergency department, regional poison control center or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Possible side effects from using octaplex:

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

Allergic or allergic-type reactions: early signs include hives, swelling of the face or tongue, injection site reactions, chills, rapid reddening of neck/ facial region, headache, tightness of the chest, wheezing, drop in blood pressure, anxiety, nausea, vomiting, sweating, increased heart rate, and anaphylaxis. If allergic symptoms occur, discontinue the administration immediately and contact your physician. In case of shock, the current medical standards for treatment of shock are to be observed.

Immune system disorders: Replacement therapy may rarely lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. If such inhibitors occur, the condition will manifest itself as a poor clinical response. A final statement on the development of inhibitors in previously treated patients cannot be made.

There is a risk of blood clots in your vessels.

Increase of body temperature has been observed.

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

Storage:

Store protected from light at 2°C to 25°C. Do not freeze. After reconstitution as recommended (see Instructions for reconstitution), octaplex should be administered immediately. However, if it is not administered immediately, the reconstituted solution can be stored for up to 8 hours at 2°C to 25°C, provided sterility of the stored product is maintained. Any solution remaining should be discarded.

If you want more information about octaplex:

• 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: (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.

Date of Authorization: 2026-08-13