Plasma protein fraction

Octaplas is a solvent / detergent (S/D) treated, pooled human plasma indicated for: Replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease undergoing cardiac surgery and liver transplantation Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP) Octaplas is a solvent/detergent (S/D) treated, pooled human plasma indicated for Replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease undergoing cardiac surgery or liver transplantation Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP)

Octaplas replaces human plasma proteins.

For intravenous use only Administer Octaplas based on ABO-blood group compatibility. For intravenous use only. Administer Octaplas based on AB0-blood group compatibility. Indication Dosage Replacement of multiple coagulation factors in patients with acquired deficiencies 10 to 15 milliliters per kg, Adjust the dose based on the desired clinical response Plasma exchange in patients with TTP 1 to 1.5 plasma volumes (40 to 60 milliliters per kg)

Do not use Octaplas in patients with: IgA deficiency Severe deficiency of Protein S History of hypersensitivity to fresh frozen plasma (FFP) or to plasma-derived products including any plasma protein History of hypersensitivity reaction to Octaplas IgA deficiency Severe deficiency of Protein S History of hypersensitivity to fresh frozen plasma (FFP) or to plasma-derived products including any plasma protein History of hypersensitivity reaction to Octaplas

Transfusion reactions can occur with ABO blood group mismatch. High infusion rates can induce hypervolemia with consequent pulmonary edema or heart failure. Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha 2-antiplasmin. Thrombosis can occur due to low levels of Protein S. Citrate toxicity can occur with volumes exceeding one milliliter of Octaplas per kg per minute. Octaplas is made from human blood and may carry the risk of transmitting infectious agents, e.g., viruses and theoretically, the variant Creutzfeldt-Jakob disease and Creutzfeldt-Jakob disease agent

Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and severe hypotension. The most common adverse reactions observed in ≥ 1% of subjects included pruritis, urticaria, nausea, headache and paresthesia. The most common adverse reactions observed in ≥ 1% of patients included pruritis, urticaria, nausea, headache, paresthesia. Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and hypotension.

Do not inject drugs containing calcium in the same intravenous line with Octaplas because precipitants may block the line. Passive transmission of analytes (e.g., β-human chorionic gonadotropin) may result in misleading positive results [ 3 ].

Store at ≤ -18°C (-0.4°F) for 3 years from the date of manufacture. Use thawed product within 24 hr. if stored at 1 - 6°C (33.8°F to 42.8°F) or within 8 hr. if stored at 20 - 25°C (68°F to 77°F). Store protected from light.