OctaplasLG Powder Emergency Use Authorization

OctaplasLG Powder is an unapproved lyophilized form of Octapharma’s FDA‑approved pooled plasma octaplas

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of Octapharma’s octaplasLG Powder (blood group types A and AB) by U.S. military forces for the emergent treatment of hemorrhage or coagulopathy involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available or when the use of plasma is not practical. This EUA also permits the treatment of other individuals, such as troops, civilians, contractors, and allied military personnel operating with Department of Defense.

OctaplasLG Powder does not require refrigeration and is supplied in a form compatible with the logistical constraints of a military operational environment.

EUA for combat-related hemorrhage

Given the urgent need for a therapeutic to treat life-threatening hemorrhage and/or coagulopathy under austere combat conditions for U.S. military personnel, the Secretary of Health and Human Services (HHS) has declared that circumstances exist to justify the emergency use of freeze dried plasma for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat.

About octaplasLG Powder

OctaplasLG Powder is an unapproved lyophilized form of Octapharma’s FDA‑approved pooled plasma octaplas. Octaplas is a solvent/detergent (S/D) treated, pooled human plasma that has been on the global market since 1992 (12.8 million bags sold) with an established safety profile based on substantial post-marketing data.

Product description
Octaplas is manufactured from human plasma collected in U.S. licensed plasma donation centers. All plasma donations are tested for relevant transfusion‑transmitted infections in accordance with U.S. federal regulations. Octaplas is created from pooled plasma (comprising 370-1,520 individual donations) of single ABO blood groups which undergoes solvent/detergent treatment and nanofiltration. The octaplas product is then dried using a freeze‑drying process to create the octaplasLG Powder. The authorized octaplasLG Powder is of blood groups A and AB. Titers of blood group antibodies were tested in 113 octaplas batches with blood group A. Mean anti-B antibody titers in blood group A plasma were relatively low, in a range of 4‑128. Since the manufacturing processes of octaplas and octaplasLG Powder are identical, except for the freezing vs. freeze‑drying process, similar antibody levels are expected for both products.

How octaplasLG Powder is supplied

Each pack of octaplasLG Powder is packaged as follows:

9-14 g human plasma protein in a bottle (type I glass), with a stopper (bromobutyl rubber), and a flip-off cap
190 ml solvent (water for injection) in a bag
1 transfer set

2 alcohol swabs
Transfusion set with filter
Vented spike adaptor

Reconstitution and storage

The shelf-life of octaplasLG Powder is 2 years.
Store between 2°C to 25°C. Stable for 24 months. Do not freeze. Protect from light.
The reconstituted solution should be used immediately if possible and must not be frozen or stored in a refrigerator.

Significant excursions from the labelled storage conditions should be documented if conditions permit.
Reconstituted octaplasLG Powder is stable for 8 hours at standard room temperature (25°C).

For information about the FDA‑authorized emergency use of octaplasLG^® Powder, please click here.

Reference:

U.S. Food and Drug Administration. EUA Fact Sheet for Health Care Professionals or Other Authorized Providers: octaplasLG Powder. Octapharma USA, Inc; 2025. Accessed January 20, 2026.

OctaplasLG® Powder: Emergency Use Authorization (EUA)