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What is AFD? What Is Acquired 
Fibrinogen Deficiency (AFD)?

AFD =
Acquired Fibrinogen Deficiency

AFD, also known as acquired hypofibrinogenemia, is a reduction in circulating blood fibrinogen levels, often resulting from hemodilution and consumption of fibrinogen during massive hemorrhage. Fibrinogen, also known as coagulation factor I, is a critical component of the clotting cascade that is crucial for platelet aggregation and the formation of a stable fibrin clot.1-3

Hemorrhaging
patients need
help fast4

During major bleeds, achieving rapid hemostasis is crucial. Clinical evidence has shown that fibrinogen is the first coagulation factor to reach critically low levels, resulting in AFD.2,4,5

When fibrinogen
levels drop,
risks increase6

Guidelines suggest initiating action when levels reach less than 150–200 mg/dL, as clot strength enhances linearly, with at least 200 mg/dL necessary in vitro for the optimal clot formation rate.6-9

Low Fibrinogen
Has Major
 Consequences6,10,11

Patients with fibrinogen deficiency face higher mortality rates than those with normal levels, with fibrinogen levels serving as an independent predictor of mortality at 24 hours and 28 days.6,10,11

See The Impact
In Cardiac Surgery, PPH, & Trauma:

Cardiac Burden

During CARDIAC SURGERIES, fibrinogen levels can fall below 215 mg/dL due to dilution and consumption leading to prolonged bleeding.12-15

Trauma burden

Low fibrinogen levels are strongly associated with high mortality rates in TRAUMA patients, with survival decreasing dramatically (OR= 0.08) with fibrinogen levels below 229 mg/dL.17

Cardiac Burden

During CARDIAC SURGERIES, fibrinogen levels can fall below 215 mg/dL due to dilution and consumption leading to prolonged bleeding.12-15

PPH burden

In pregnancy, fibrinogen levels below 200 mg/dL have a 100% positive predictive value for progressing to severe POSTPARTUM HEMORRHAGE (PPH).16

Trauma burden

Low fibrinogen levels are strongly associated with high mortality rates in TRAUMA patients, with survival decreasing dramatically (OR= 0.08) with fibrinogen levels below 229 mg/dL.17

Cardiac Burden

During CARDIAC SURGERIES, fibrinogen levels can fall below 215 mg/dL due to dilution and consumption leading to prolonged bleeding.12-15

PPH burden

In pregnancy, fibrinogen levels below 200 mg/dL have a 100% positive predictive value for progressing to severe POSTPARTUM HEMORRHAGE (PPH).16

See How fibryga Can Help

Guidelines Recommend
Fibrinogen Concentrate

Clinical guidelines recommend Fibrinogen Concentrate (FC) as an option for fast fibrinogen replacement:7,18-20

ASA & ACS

The American Society of Anesthesiologists (ASA) and the American College of Surgeons (ACS) recognize FC as a suitable alternative to cryoprecipitate (cryo) in patients with excessive bleeding and hypofibrinogenemia–scenarios where rapid and precise hemostasis is essential.19,20

ACOG

The American College of Obstetricians and Gynecologists suggest the need for fibrinogen therapy to prevent PPH when levels drop below 200 mg/dL. It also suggests that FC may be preferred over cryo to reduce the risk of viral transmission.18

EU Guidelines

EU guidelines recommend fibrinogen supplementation treatment with FC or cryo if major bleeding is accompanied by hypofibrinogenemia. The guidelines point to greater elevation in fibrin-based clot amplitude after the first administration with FC vs cryo.7

Why Fibrinogen Concentrate for Major Bleeding?

Why Fibrinogen Concentrate for Major Bleeding?

During CARDIAC surgeries, choosing FC for targeted replenishment of fibrinogen has demonstrated a 100% success rate* in surgical bleeding.

*Success was defined as control of bleeding or hemoglobin loss <20%.21

Limitations Of Cryo

1
Variability

Fibrinogen levels are
not consistent in a
standard dose of cryo23

2
Timing

Cryo must be stored frozen,
takes up to 45 mins to thaw and
transport, and must be used
within 4 to 6 hours of thawing24,25

3
Waste

Wastage rates for cryoprecipitate
can be as high as 33%, exceeding
rates for red blood cells, plasma,
and platelets25

4
Risk

Even with enhanced safety measures,
donor screening, and use of ABO-
compatible cryo whenever possible,
infection transmission and infusion-
related reaction risks persist26,27

5
Uncertainty

Clotting factor concentrations in
cryo vary widely, complicating
dosage accuracy and requiring
additional monitoring23

Connect with a RepWhy Fibryga?

Indications & Important Safety Information for Fibryga, Fibrinogen (Human)

Indications and Usage

Fibryga is a human fibrinogen concentrate indicated for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency and in treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Fibryga is not indicated for dysfibrinogenemia.

Contraindications

Fibryga is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to fibryga or its components (Sodium Citrate Dihydrate; Glycine; L-Arginine Hydrochloride).

Warnings and Precautions

Monitor patients for early signs of hypersensitivity or allergic reactions. If necessary, discontinue administration and institute appropriate treatment.

Thrombotic events have been reported in patients receiving fibryga. Treatment with human fibrinogen concentrate has been associated with thrombosis at target plasma fibrinogen levels that were below 150 mg/dL. The thrombotic risks may be greater when the target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of administration versus the risks of thrombosis.

Fibryga is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Adverse Reactions

The most serious adverse reactions observed with fibryga are thromboembolic episodes and anaphylactic-type reactions.

The most common adverse reactions observed in clinical studies with fibryga in acquired fibrinogen deficiency (>5% of patients) were abnormal hepatic function, acute kidney injury, anemia, atrial fibrillation, delirium and renal failure.

The most common adverse reactions observed in clinical studies with fibryga in congenital fibrinogen deficiency (>5% of patients) were nausea, vomiting, pyrexia (fever) and thrombocytosis.

Please see fibryga full Prescribing Information.

To report suspected adverse reactions, contact Octapharma USA, Inc. at 1-866-766-4860 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.