TTP Treatment - Octaplas® Efficacy Study

Effects of octaplas as primary treatment of acute TTP¹

Single center, open label, non-randomized, case report study of 3 patients with acute TTP (one E coli-induced)
Patients were treated with octaplas (3 L per day) plasma infusion or exchange until stable remission was achieved (normal platelet count and stable hemoglobin concentration) and resolution of neurological symptoms if present at diagnosis

STUDY OBJECTIVES: ASSESS EFFICACY, SAFETY, AND TOLERABILITY OF OCTAPLAS IN PATIENTS WITH TTP
Patient Population
Age/Sex	64 years/M	36 years/M	25 years/F
Platelet count (x10⁹/L)	18	8	19
Hemoglobin (g/dL)	8.4	11.0	13.7
Octaplas
Dosage	3 L daily	3 L daily	3 L daily
Normal platelet count (≥150×10⁹/L)
Achieved on day	7	3	10

Conclusions

All three patients attained platelet counts of > 50 x 10⁹/L by day 10
All patients remained in remission for at least one post-treatment year
No patient experienced febrile or other adverse reactions to octaplas
No viral transmission/infections

Reference:

Solvent/detergent fresh frozen plasma as primary treatment of acute thrombotic thrombocytopenic purpura. Clin Lab Haematol. 1999;21:119-123.

Indications and Important Safety Information for octaplas^®, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion

Please see octaplas full Prescribing Information.

Indications and Important Safety Information for octaplas^®, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion

Please see octaplas full Prescribing Information.

Indications and Usage

Octaplas^® is a solvent/detergent (S/D) treated, pooled human plasma indicated for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or who are undergoing cardiac surgery or liver transplantation; and plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).

Contraindications

Octaplas is contraindicated in patients with immunoglobulin A (IgA) deficiency; severe deficiency of protein S; history of hypersensitivity to fresh frozen plasma or to plasma-derived products including any plasma protein; or a history of hypersensitivity reaction to octaplas.

Warnings and Precautions

Transfusion reactions can occur with ABO blood group mismatches. Administration of octaplas must be based on ABO-blood group compatibility. 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 alpha2-antiplasmin (also named plasmin inhibitor). Thrombosis can occur due to low levels of Protein S. Citrate toxicity can occur with volumes exceeding one milliliter of octaplas per kg per minute. octaplas is made from human plasma and 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.

Adverse Reactions

The most common adverse reactions observed in ≥ 1% of patients included pruritus, urticaria, nausea, headache, paresthesia. Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and severe hypotension.

Please see octaplas full Prescribing Information

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