Pooled Plasma, Solvent Detergent Treated – octaplasLG

Octapharma AG - Manuf,; R&D; Tech.; Intl. mark.

Octapharma USA, Inc. – USA mark.

Status: BLA approved in Jan. 2013; long marketed in Europe

Description: octaplasLG is an aqueous formulation of pooled ABO blood group-specific (requires matching with recipient) Plasma (Human), with processing including It is prepared from pooled human ABO blood group specific Plasma frozen to preserve its labile coagulation factors and treated with solvent/detergent (S/D) inactivation against enveloped viruses plus immune neutralization against non-enveloped viruses. Virus inactivation is carried out using Tri (N-Butyl) Phosphate (TNBP) and Octoxynol (Triton X-100). These S/D reagents are removed during the purification process. The maximum amounts of TNBP and Octoxynol in the finished product are 2 μg/ml and 5 μg/ml, respectively.

OctaplasLG possesses the same clinical activity as normal human fresh frozen plasma (FFP). After SD treatment and subsequent removal of the SD reagents, the plasma protein content and distribution in Octaplas remain at comparable levels to those in FFP, i.e. 45-70 mg/ml

octaplasLG® is filled into sterile, plasticised polyvinyl chloride blood bags that are over-wrapped with a polyamide/polyethylene film. One bag contains 200 mL of octaplasLG. octaplasLG (in Europoe) is presented as a solution for infusion containing 45 - 70 mg human plasma proteins/mL. octaplasLG is available in 200 ml bags in A, B, O and AB blood groups, with Octapharma claiming: Standardised coagulation factors content; Enhanced prion safety & virally inactivated; No risk of TRALI; and Solvent-detergent (S/D) treatment optimised.

Excipients are sodium citrate dihydrate; sodium dihydrogenphosphate dihydrate; and glycine

The shelf-life of octaplasLG is 4 years when stored at ≤ -18 °C and protected from light. After thawing octaplasLG can be stored for up to 8 hours at +4°C, or 4 hours at room temperature (+20-25°C), before use.

Nomenclature: octaplasLG [TR]; Solvent Detergent (S/D) Treated Human Plasma [used in EU]; Pooled Plasma, Solvent Detergent Treated [FDA]; SD Plasma [SY]

Companies Octapharma developed and markets the product. It is manufactured at company facilities in Vienna, Austria.

FDA class: Biologic BLA

Indications: [Full text of the "Therapeutic indications" section of the EMA/EU EPAR]:

• Complex deficiencies of coagulation factors such as coagulopathy due to severe hepatic failure or massive transfusion.
• Substitution therapy in coagulation factor deficiencies, when a specific coagulation factor concentrate (e.g. factor V or factor XI) is not available for use or in emergency situations when a precise laboratory diagnosis is not possible.
• Rapid reversal of the effects of oral anticoagulants (coumarin or indanedione type), when a prothrombin complex concentrate is not available for use or administration of vitamin K is insufficient due to impaired liver function or in emergency situations.
• Potentially dangerous haemorrhages during fibrinolytic therapy, using e.g. tissue plasminogen activators, in patients who fail to respond to conventional measures. • Therapeutic plasma exchange procedures, including those in thrombotic thrombocytopenic purpura (TTP).

Status: Marketed for many years in Europe.

On Feb. 24, 2012, the BLA was filed for managing preoperative or bleeding patients who require replacement of multiple plasma coagulation factors.. The application also seeks to gain marketing approval for the substitution of intentionally removed plasma, such as plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP), a blood disorder that causes clot formation in small blood vessels.

Medical: Administration of octaplasLG® must be based on ABO-blood group compatibility. In emergency cases, octaplasLG blood group AB can be regarded as universal plasma since it can be given to all patients regardless of blood group. The dosage depends upon the clinical situation and underlying disorder, but 12-15 ml octaplasLG/kg body weight is a generally accepted starting dose. This should increase the patient's plasma coagulation factor levels by approximately 25%.

Market: In mid-2012, Octapharma reported that more than 6 million units had been use to date.