Generic Name: pooled plasma (human)
Date of Approval: January 17, 2013
Treatment for: Bleeding Disorders
FDA Approves Octaplas
The U.S. Food and Drug Administration has approved Octaplas, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.
Octaplas is a sterile, frozen solution of pooled human plasma from several donors that has been treated with a solvent detergent process. This process kills certain viruses and thereby minimizes the risk of serious virus transmission. The plasma used to manufacture Octaplas is collected from U.S. donors who have been screened and tested for diseases transmitted by blood, and determined to be suitable donors.
The most common adverse reactions observed in clinical studies included shortness of breath, dizziness, chest discomfort, skin itchiness and rashes, headache and tingling sensations.
Highlights of Prescribing Information
These highlights do not include all the information needed to use Octaplas safely and effectively. See full prescribing information for Octaplas.
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
- undergoing cardiac surgery or liver transplant
- Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP)
Dosage and Administration
For intravenous use only.
Administer Octaplas based on AB0-blood group compatibility.
|Replacement of multiple coagulation factors in patients with acquired deficiencies||10 to 15 milliliters per kg, Adjust the dose based on the desired clinical response|
|Plasma exchange in patients with TTP||1 to 1.5 plasma volumes (40 to 60 milliliters per kg)|
Dosage Forms and Strengths
Solution for infusion containing 45 to 70 mg human plasma protein per mL in a 200 mL volume.
- IgA deficiency
- Severe deficiency of Protein S
- History of hypersensitivity to fresh frozen plasma (FFP) or to plasma- derived products including any plasma protein
- History of hypersensitivity reaction to Octaplas
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 bleedings 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; therefore, may carry the risk of transmitting infectious agents, e.g., viruses and theoretically, the variant Creutzfeldt-Jakob disease and Creutzfeldt-Jakob disease agent
Use In Specific Populations
- Pregnancy: No human or animal data. Use only if clearly needed.
Octaplas side effects
The most common adverse reactions observed in ≥ 1% of patients included pruritis, urticaria, nausea, headache, paresthesia.
Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and severe hypotension.
To report SUSPECTED ADVERSE REACTIONS, contact Octapharma USA Inc. at phone # 866-766-4860 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Patient Counseling Information
Inform patients to report:
- Early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, or anaphylaxis.
- Development of edema or volume overload including shortness of breath or breathing difficulties
Remind patients that Octaplas is made from human blood and may contain infectious agents that can cause disease. Report flu-like or other symptoms or viral infection.