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Octaplas™ - Pooled Plasma (Human), Solvent/Detergent Treated Solution For Intravenous Infusion
 
  AVAILABLE BLOOD GROUPS
Octaplas Blood Group A
NDC# 68982-952-01
NDC# 68209-952-01
Octaplas Blood Group B
NDC# 68982-953-01
NDC# 68209-952-02
Octaplas Blood Group AB
NDC# 68982-954-01
NDC# 68209-952-03
Octaplas Blood Group O
NDC# 68982-955-01
NDC# 68209-952-04
 
 
  ADDITIONAL INFORMATION
U.S. Biologics License #: 1646
HCPCS Code: P9023
 
 
  BLOOD ESTABLISHMENT
REGISTRATION (FEI) NUMBERS
Stockholm: 3005559915
Vienna: 3002809097
 
 
 

Octaplas™ S/D Pooled Human Plasma

Octaplas™ is a solvent/detergent (S/D) treated, pooled human plasma indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant. It is also indicated for plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).

To order Octaplas™ call 800-828-6941 or 201-488-1174

How Octaplas™ is Supplied
• Octaplas™ is supplied in 200mL polyvinyl chloride blood bags.
• Octaplas™ is available in blood groups A, B, AB and O.
• Octaplas™ is administered based on ABO compatibility.
• Only US plasma frozen within 8 hours of collection is used for the production of Octaplas™.

Storage and Handling
• Store at ≤ -18°C (-0.4°F) for 3 years from the date of manufacture
• Use thawed product within 24 hours if stored at 1 - 6°C (33.8°F to 42.8°F)
• Use thawed product within 8 hours if stored at 20 - 25°C (68°F to 77°F)

For more information, please see full Prescribing Information.





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

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

Warnings and Precautions
Transfusion reactions can occur with AB0 blood group mismatches. 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. 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 blood and therefore, may carry the risk of transmitting infectious agents, e.g., viruses and theoretically, the variant Creutzfeldt-Jakob disease and Creutzfeldt-Jakob disease agent.


For more information, please see full Prescribing Information.



For additional information on Octaplas™ please contact Octapharma USA, Inc.

Medical Affairs
Email: usmedicalaffairs@octapharma.com
Office: 888-429-4535

Drug Safety Officer (for all inquiries related to drug safety)
Office: 201-604-1137
Cell: 201-772-4546
Fax: 201-604-1141
   
www.octapharmausa.com
www.octaplasus.com


References:
1. Octaplas™, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion, complete prescribing information. March 2015.