HUMAN PROTHROMBIN COMPLEX

Human Prothrombin Complex is a clotting factor that belongs to the class of medications known as prothrombin complex concentrates. The FDA approved this medicine on December 13, 2013, for prevention and treatment of bleeding.

Human prothrombin complex is an intravenously administered drug. It is used to treat and prevent acute major bleeding caused by certain medicines called vitamin K antagonists (warfarin). It is also indicated in people born with low vitamin K-dependent coagulation factors II and X. It is used when a purified specific clotting factor product is unavailable.

A doctor or other healthcare provider in a hospital or clinic setting will give it to you. Your physician will decide the dose and for how long you will receive this injection based on the severity of your illness, bleeding area, and general condition. It is given as an intravenous infusion drip (into your vein). Do not self-administer the injection.

The common side effects of the human prothrombin complex are decreased blood pressure, nausea, vomiting, muscle and bone pain, and headache. Other serious side effects include bleeding, blood clots, skin hypersensitivity reaction, and lung infection.

This drug is intended to cause hypersensitivity reactions. This medicine may increase your risk of thrombosis (blood clots); notify your physician immediately if you face any signs and symptoms of thrombosis, such as limb or abdomen swelling or pain, chest pain, drop in blood pressure, shortness of breath, loss of sensation or motor power, altered consciousness, vision or speech disturbances, confusion, and fever. This medicine is made from donated human blood. Some human blood products have transmitted viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you are concerned about this risk.

Inform your physician if you have IgA (immunoglobulin A) deficiency with known antibodies against IgA. Tell your physician if you have a history of heart problems, liver diseases or if you are going to have any surgery before initiating the treatment. Limited information is available regarding the use of human prothrombin complex in children and adolescents. Inform your doctor if you are pregnant or breastfeeding. Inform your healthcare provider about all the medicines you take, including prescription medications, over-the-counter medications, nutritional and vitamin supplements, and herbal products. Certain medications may interact with the human prothrombin complex and reduce its effectiveness by causing undesirable side effects.

Store below 25°C. Keep away from excessive moisture and direct light. Store the injection out of reach of children and pets. Inform your doctor if you have missed any dosing appointments and schedule immediately. Ensure your doctor is aware if you have experienced a stroke, heart attack, deep vein thrombosis (DVT), or any other heart or blood clot problem within the last 3 months. This medicine may increase your risk of blood clots. Inform your physician immediately if you experience a sudden or severe headache, vision or speech problems, chest pain, difficulty breathing or swallowing, swelling or tenderness in your leg, or numbness or weakness.

Octaplex 500 IU - Summary of Product Characteristics (SmPC) - (Emc).” Medicines.org.uk , Revised Mar. 2020, www.medicines.org.uk/emc/product/6566/smpc . Accessed May 24 2023. Prothrombin Complex Concentrate (Human), Kcentra .; Revised 2020. Accessed May 24, 2023. https://www.fda.gov/media/85512/download Q.M. Anstee, D.E.J. Jones, Liver and biliary tract disease, Davidson’s Principles and Practice of Medicine, 22nd Edition, 2014, 921-988.