Baseline studies indicated; see Monitor.
Administer pooled plasma (Octaplas) based on ABO blood group compatibility.
a Patient’s plasma coagulation factor levels should increase by approximately 15% to 25%. If hemostasis is not achieved, use higher doses. b Completely replace plasma volume removed during plasmapheresis with Octaplas. In general, 1 to 1.5 plasma volumes corresponds to 40 to 60 mL/kg. | ||||||||||||||||
Replacement of multiple coagulation factors in patients with acquired deficiencies:
Adjust dose based on desired clinical response.
Available as a frozen solution for infusion (specific to blood group A, B, AB, or O) containing 45 to 70 mg human plasma proteins per mL in a 200-mL volume. Administer after thawing using an infusion set with a filter. Avoid shaking.
Thaw in outer wrapper for up to 30 minutes in a circulating water bath at 30° to 37° C (86° to 98.6° F). An overwrap bag may be used to provide further protection of contents if appropriate. Prevent water from contaminating the entry port. Thawing should not take more than 30 minutes.
To thaw by a dry tempering system:
See specific instructions in prescribing information.
Administration through an in-line filter required.
Store at –18° C (–0.4° F) or lower, protected from light. Thaw according to manufacturer’s instructions. Use thawed product within 12 hours if stored at 2° to 4° C (35.6° to 39.2° F) or within 3 hours if stored at 20° to 25° C (68° to 77° F). Do not refreeze Octaplas. Discard unused product. Discard after expiration date on container label.
Manufacturer states, “Do not inject drugs containing calcium in the same IV line with Octaplas because precipitants may block the line.”
Infusion rate should not exceed 0.020 to 0.025 mmol citrate/kg/min (i.e., less than 1 mL pooled plasma [Octaplas]/kg/min); see Precautions.
Octaplas replaces human plasma proteins. It is a sterile, pyrogen-free, frozen solution of solvent/detergent (S/D) treated, pooled human plasma. It is manufactured from pooled plasma of a single ABO blood group (A, B, AB, or O). The finished product is tested for coagulation factors II, V, VII, VIII, X, and XI; protein C; protein S; alpha 2-antiplasmin (plasmin inhibitor); fibrinogen; and ADAMTS13. The content and distribution of plasma proteins in Octaplas are comparable to reference ranges for healthy blood donors, except for Protein S and alpha 2-antiplasmin, which are labile to S/D treatment and are controlled to ensure levels in the final product of equal to or greater than 0.4 IU/mL. Coagulation factor activities are controlled to obtain levels within the range of normal human plasma.
Replacement of multiple coagulation factors in patients who have acquired deficiencies due to liver disease or are undergoing cardiac surgery or liver transplant.
■ Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).
History of hypersensitivity to fresh frozen plasma (FFP) or plasma-derived products, including any plasma protein.
■ History of hypersensitivity reaction to Octaplas.
■ IgA deficiency.
■ Severe deficiency of Protein S.
Administration of Octaplas must be based on ABO blood group compatibility. Transfusion reactions can occur with ABO blood group mismatches.
■ Administer in a facility with equipment for monitoring the patient and responding to any medical emergency.
■ High infusion rates can induce hypervolemia with consequent pulmonary edema or cardiac failure.
■ Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha 2-antiplasmin (plasmin inhibitor).
■ Thrombosis can occur due to low levels of Protein S.
■ Citrate toxicity can occur with volumes exceeding 1 mL/kg/min.
■ Made from human plasma and may contain infectious agents (e.g., HIV, Creutzfeldt-Jakob disease, hepatitis B, hepatitis C). Numerous steps in the manufacturing process are used to make the potential for infection extremely remote. Report suspected infections to manufacturer or FDA.
Replacement of multiple coagulation factors in patients with acquired deficiencies:
Obtain baseline aPTT, PT, and/or specific coagulation factors and monitor response with additional measurements.
Monitor for S/S of a hypersensitivity reaction (e.g., chest pain, chills, dizziness, dyspnea, fever, flushing, hypotension, nausea, pruritus, rash, urticaria).
■ Monitor for S/S of pulmonary edema or cardiac failure.
■ Monitor for S/S of thrombosis in patients at risk.
■ Monitor for S/S of citrate toxicity (hypocalcemia [e.g., fatigue, muscle spasms, paresthesia]). Potential for citrate toxicity may be increased in patients with impaired hepatic function.
Monitor for S/S of excessive bleeding; may be due to hyperfibrinolysis.
Promptly report S/S of a hypersensitivity reaction (e.g., chest pain, chills, dizziness, dyspnea, fever, flushing, hypotension, nausea, pruritus, rash, urticaria).
■ Report development of edema or volume overload, including shortness of breath and/or difficulty breathing.
Category C: use during pregnancy only if clearly needed.
■ Use caution in labor and delivery and during breast-feeding; safety and effectiveness unknown.
■ Safety and effectiveness for use in pediatric patients not evaluated.
Safety and effectiveness for use in geriatric patients not evaluated.
Headache, nausea, paresthesia, pruritus, and urticaria are most common. Anaphylactic shock, citrate toxicity, and severe hypotension are the most serious side effects reported.
Abdominal pain, alkalosis, bronchospasm, cardiac arrest or failure, chest discomfort or pain, chills, circulatory overload, dyspnea, erythema, fever, hyperfibrinolysis, hypersensitivity reactions (including anaphylaxis), pulmonary edema, rash, respiratory arrest or failure, seroconversions (passive transfer of antibodies), tachycardia, tachypnea, thromboembolism, and vomiting have been reported.
Notify the physician of all side effects. Minor side effects may be tolerated and treated symptomatically. For major side effects (e.g., hypervolemia, hyperfibrinolysis, thrombosis), discontinue Octaplas and treat symptomatically. Treat anaphylaxis immediately with oxygen, epinephrine, antihistamines (e.g., diphenhydramine), vasopressors (e.g., dopamine), corticosteroids, albuterol, IV fluids, and ventilation equipment as indicated. Treat citrate toxicity with calcium gluconate IV into another vein. Resuscitate as necessary.