Note: Administer based on ABO-blood compatibility.
Replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or when undergoing cardiac surgery or liver transplantation: IV: Initial: 10 to 15 mL/kg. Note: Initial dose should increase plasma coagulation factors by ~15% to 25%; if hemostasis is not attained, may use higher doses.
Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP): IV: 40 to 60 mL/kg. Note: Dose amount corresponds to 1 to 1.5 plasma volumes. Completely replace plasma volume removed during plasmapheresis with pooled plasma (human).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Octaplas Blood Group A: (200 mL)
Octaplas Blood Group AB: (200 mL)
Octaplas Blood Group B: (200 mL)
Octaplas Blood Group O: (200 mL)
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Octaplasma: (200 mL)
IV: Visually inspect for particulate matter or discoloration prior to administration. Do not use if turbid. Administer IV at a rate ≤1 mL/kg/minute using an infusion set with a filter.
Replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or when undergoing cardiac surgery or liver transplantation; plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP)
Octaplas may be confused with Octaplex
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Pruritus (≥1%), urticaria (≥1%)
Gastrointestinal: Nausea (≥1%)
Nervous system: Headache (≥1%), paresthesia (≥1%)
Frequency not defined:
Cardiovascular: Severe hypotension
Hypersensitivity: Anaphylactic shock
Postmarketing:
Cardiovascular: Chest discomfort, chest pain, tachycardia, thromboembolism
Dermatologic: Erythema of skin, skin rash
Endocrine & metabolic: Alkalosis, hypervolemia
Gastrointestinal: Abdominal pain, vomiting
Hematologic & oncologic: Increased fibrinolysis
Hypersensitivity: Hypersensitivity reaction, nonimmune anaphylaxis
Immunologic: Passive immunization
Nervous system: Chills
Respiratory: Apnea, bronchospasm, dyspnea, pulmonary edema, respiratory failure, tachypnea
Miscellaneous: Fever
History of hypersensitivity to pooled plasma (human), fresh frozen plasma (FFP), or to plasma-derived products including any plasma protein; IgA deficiency; severe protein S deficiency.
Canadian labeling: Additional contraindications (not in the US labeling): IgA deficiency with documented antibodies against IgA.
Concerns related to adverse effects:
• Citrate toxicity: Hypocalcemia and associated symptoms (eg, fatigue, paresthesia, muscle spasm) due to citrate toxicity may occur with infusion rates >1 mL/kg/minute (or 0.02 to 0.025 mmol citrate/kg/minute) especially in patients with hepatic dysfunction. If administering calcium gluconate to minimize citrate toxicity, administer calcium gluconate via another vein.
• Hyperfibrinolysis: Because of reduced concentrations of alpha-2 antiplasmin, a physiologic inhibitor of t-PA-induced fibrinolysis, in solvent-detergent treated plasma, an increase in the incidence of hyperfibrinolysis has been observed in patients undergoing liver transplantation; monitor for signs of excessive bleeding (de Jonge 2002).
• Hypersensitivity reactions: Hypersensitivity (including anaphylactoid or allergic reactions) has been reported.
• Hypervolemia: High infusion rates may induce hypervolemia and subsequent pulmonary edema or heart failure. Monitor patients for signs and symptoms of pulmonary edema or heart failure and begin appropriate therapy if necessary.
• Thrombosis: Solvent-detergent treated plasma contains low concentrations of protein S; during therapy, monitor for signs and symptoms of thrombosis in patients at risk. Use is contraindicated in patients with severe protein S deficiency.
• Transfusion reactions: Administer pooled plasma (human) based on ABO compatibility; transfusion reactions may occur if ABO is mismatched.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment; may be at increased risk of citrate toxicity.
Dosage form specific issues:
• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease, including a theoretical risk of Creutzfeldt-Jakob disease transmission. Infections thought to be transmitted by this product should be reported to the manufacturer or the FDA.
None known.
There are no known significant interactions.
False positive pregnancy tests may occur following passive transmission of β-human chorionic gonadotropin (Jilma-Stohlawetz 2017).
Treatment of thrombotic thrombocytopenic purpura (TTP) during pregnancy is generally the same as in nonpregnant women (Scully 2012; Scully 2016).
Immunoglobulins, albumin and other components of pooled human plasma are endogenous components of breast milk (IOM 1991).
Monitor response including activated partial thromboplastin time (aPTT), prothrombin time (PT), and/or specific coagulation factors. Monitor for signs of excessive bleeding (patients undergoing liver transplantation); signs and symptoms of pulmonary edema or heart failure; signs and symptoms of thrombosis (in patients at risk).
Replaces human plasma proteins (eg, albumin, immunoglobulin and other globulins, coagulation factors, complement proteins, protease inhibitors)
