What is octaplas? Solvent/Detergent Treated, Pooled Human Plasma

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
- Undergoing cardiac surgery or liver transplantation
Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP)

13.5 Mill Stat@2x

*Includes octaplas and other SD-treated plasma products manufactured using the Octapharma process. Number of patients estimated based on 3 bags transfused per patient.

Produced at two FDA-approved manufacturing sites (Vienna, Austria and Stockholm, Sweden)
Only U.S. plasma (frozen within 8 hours of collection) is used for production
Blood-group specific (A, B, AB, O)
Available in 200 mL polyvinyl chloride bags
NDC Number

Blood group A	68982-952 – 01
Blood group B	68982-953 – 01
Blood group AB	68982-954 – 01
Blood group O	68982-955 – 01

Reference:

Octapharma. Data on file; 2013

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

FOR U.S. HEALTHCARE PROFESSIONALS ONLY

The information on this website has been specifically created for U.S. healthcare professionals (HCPs)