Octaplas Generic Name & Formulations
Legal Class
Rx
General Description
Pooled plasma (human) 45–70mg/mL; soln for IV infusion; solvent/detergent treated; frozen; pyrogen-free.
Pharmacological Class
Pooled plasma (human).
How Supplied
Soln—200mL
Manufacturer
Generic Availability
NO
Octaplas Indications
Indications
Replacement of multiple coagulation factors with acquired deficiencies due to liver disease, undergoing cardiac surgery, or liver transplant. Plasma exchange in thrombotic thrombocytopenic purpura (TTP).
Octaplas Dosage and Administration
Adults and Children
For IV infusion only after thawing. Administer based on ABO-blood group compatibility. Coagulation factors replacement: initially 10–15mL/kg to increase plasma coagulation factor levels approx. 15–25%; if hemostasis is not achieved, use higher doses. Adjust based on response; monitor aPTT, PT, and/or specific coagulation factors. TTP: usually 1–1.5 plasma volumes (40–60mL/kg) to completely replace plasma volume removed during plasmapheresis.
Octaplas Contraindications
Contraindications
IgA deficiency. Severe Protein S deficiency. Prior hypersensitivity to fresh frozen plasma or plasma-derived products including plasma protein.
Octaplas Boxed Warnings
Not Applicable
Octaplas Warnings/Precautions
Warnings/Precautions
Risk of transfusion reactions with ABO blood group mismatches. Risk of hypervolemia with high infusion rates; monitor for signs/symptoms of pulmonary edema or cardiac failure. Hyperfibrinolysis may develop due to low levels of alpha2-antiplasmin; monitor for signs of excessive bleeding in liver transplantation. Monitor for thrombosis. Risk of citrate toxicity; use max infusion rate: 0.020–0.025mmol citrate/kg/min (eg, Octaplas <1mL/kg/min). Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Elderly. Pregnancy. Nursing mothers.
Octaplas Pharmacokinetics
See Literature
Octaplas Interactions
Interactions
Avoid injecting calcium-containing drugs in same IV line. Passive transmission of analytes (eg, β-human chorionic gonadotropin) may cause misleading positive results.
Octaplas Adverse Reactions
Adverse Reactions
Pruritus, urticaria, nausea, headache, paresthesia; anaphylactic shock, citrate toxicity, severe hypotension.
Octaplas Clinical Trials
See Literature
Octaplas Note
Not Applicable
Octaplas Patient Counseling
See Literature