Minimize Risk of TRAEs during Infusion - Octaplas®

Optimized integration of plasma by pooling 630 to 1,520 single units of FFP¹

Minimizes risk of pathogen transmission^1-4
- Immune neutralization of enveloped and non-enveloped viruses
Minimizes risk of allergic reactions³
- Dilution of substances that can lead to an allergic reaction
Minimizes risk of TRALI³
- Dilution and neutralization of free anti-HLA/HNA antibodies

Cell and cell debris removal by filtration (1.0 µm)³

Minimizes risk of allergic reactions³
- Removal of cell debris and cells such as mast cells, which contain histamine
Minimizes risk of TRALI³
- Removal of cell-bound anti-HLA/HNA antibodies
- Removal of bioactive lipids that are located on outer side of cells

S/D treatment

Minimizes risk of pathogen transmission^2-4
- Inactivation of enveloped viruses

Sterile filtration (0.2 μm)³

Minimizes risk of bacteria and parasite transmission⁵

TRALI = Transfusion-Related Acute Lung Injury, HLA = Human Leukocyte Antigen, HNA = Human Neutrophil Antigen.

References:

Octapharma. Data on file; 2013.
Octaplas Full Prescribing Information. Paramus, NJ: Octapharma; rev 2021.
Bertolini J, Goss N, Curling J, eds. Production of Plasma Proteins for Therapeutic Use. Hoboken, NJ: John Wiley & Sons; 2013:345-351.
Hellstern P, Solheim BG. The use of solvent/detergent treatment in pathogen reduction of plasma. Transfus Med Hemother. 2011;38:65-70.
WHO Technical Report, Series No. 924, 2004, Annex 4, Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products.

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)