Octaplas

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders

Octaplas Generic Name & Formulations

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