Adult Dosing

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)

Pediatric Dosing

• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or those undergoing cardiac surgery or liver transplant
• Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP)
• Reversal of the effect on fibrinolysis and rapid reversal of effects of oral anticoagulants (coumarin or indanedione type), when vitamin K is insufficient due to impaired liver function or in emergency situations

• Hypersensitivity to any of the ingredients of the product that includes sodium citrate dihydrate, sodium dihydrogenphosphate dihydrate and Glycine
• History of hypersensitivity to fresh frozen plasma (FFP) or to plasmaderived products including any plasma protein
• IgA deficiency with documented antibodies against IgA
• Severe deficiency of Protein S

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• For intravenous use only
• Monitor the response, both clinically and with measurement of prothrombin time (PT), partial thromboplastin time (PTT) and/or specific coagulation factor assays.
• Administer based on AB0-blood group compatibility. Transfusion reactions can occur with AB0 blood group mismatches. If a transfusion reaction is suspected, the transfusion should be stopped, the patient assessed and stabilized, the blood bank notified, and a transfusion reaction investigation initiated
• Massive or rapid transfusion may lead to hypervolemia with consequent pulmonary edema, arrhythmias, hypothermia, hyperkalemia, hypocalcemia, dyspnea, and/or heart failure cardiac failure. Monitor patients for signs and symptoms of pulmonary edema or cardiac failure and institute appropriate management
• Monitor patients for signs of excessive bleeding in patients undergoing liver transplantation. Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha 2-antiplasmin
• Intensive plasma exchange procedures may require the expert advice of a hematologist
• Monitor patients for signs and symptoms of thrombosis in patients at risk. Lower levels of protein S may lead to thrombosis
• The infusion rate should not exceed 0.020-0.025 mmol citrate per kilogram per minute. Symptoms attributable to citrate toxicity (hypocalcaemia) such as fatigue, paresthesia and muscle spasms, especially in patients with liver function disorders may occur. Administer calcium gluconate intravenously into another vein in order to minimize citrate toxicity
• As the drug contains human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob disease (CJD) agent
• Should not be used as volume expander in patients where no coagulation factor deficiency has been documented where a specific factor concentrate is available for use, such as von Willebrand's Disease)
• Recording of batch number of product is recommended in the medical record

Pregnancy Category:C

Breastfeeding: Safety unknown. It is unknown whether the drug is excreted in human milk.

• CNS: Headache, paresthesia, fever, chills, agitation
• GI: Nausea, abdominal pain, vomiting
• DERM: Pruritis, urticaria
• HEMA: Hyperfibrinolysis
• METABOLISM: Alkalosis
• CV: Cardiac arrest, circulatory overload, thromboembolism, tachycardia
• RESP: Respiratory arrest or failure, bronchospasm, pulmonary edema, dyspnea, tachypnoea, acute pulmonary oedema
• MUSC: Pain
• HYPERSENSITIVITY: Anaphylactoid allergic type reactions

• Fresh frozen plasma; provides all plasma proteins and clotting factors to support adequate hemostasis to treat or prevent bleeding or to treat other protein deficiencies that cannot be replaced with protein specific concentrates
• Metabolism: N/A
• Excretion: N/A
• Half-life: N/A

US Trade Name(s)

• Octaplas

US Availability

Octaplas

• SOLN for INF: 45-70 mg human plasma protein/mL in a 200 mL volume

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Other Hematologics