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Dosing & Administration
Restore Fibrinogen Levels Quickly & Conveniently.

Dosing flexibility with ~1 g or ~2 g vial options1

Familiar Reconstitution Protocol

Fibryga is supplied as a lyophilized powder containing ~1 g or ~2 g fibrinogen concentrate (FC) per vial. It's reconstituted prior to administration.1

Recommended Dosage1

In Acquired Fibrinogen Deficiency (AFD), the recommended dose is as follows:

Adults 18 and over

Adults
4 g

Adolescents 12 years old and younger

Adolescents
50 mg/kg Body Weight

Children over 12 years old

Children
70 mg/kg Body Weight

Additional doses may be given to bleeding patients when plasma fibrinogen level is ≤200 mg/dL or thromboelastometry FIBTEM A10 is ≤10 mm (or equivalent values generated by other viscoelastic testing methods). Dosage may be adjusted depending on plasma fibrinogen levels or viscoelastic testing, severity of bleeding, body weight, or patient's clinical condition. Monitor the patient's plasma fibrinogen level or the viscoelastic properties of the fibrin-based clot during treatment with fibryga.1

Dosage for CFD

Administration & Monitoring

For intravenous use only after reconstitution.

Administration1

  • Do not administer fibryga in the same tubing or container as other medications
  • Use aseptic technique when administering fibryga
  • Administer fibryga at room temperature by slow intravenous injection at a rate not exceeding 20 mL per minute

Monitoring1

  • Monitoring of patient's plasma fibrinogen level or the viscoelastic properties of the fibrin-based clot is recommended during treatment
  • Administer additional doses as needed to bleeding patients when plasma fibrinogen level is ≤200 mg/dL or thromboelastometry FIBTEM A10 is ≤10 mm (or equivalent values generated by other viscoelastic testing methods)
  • Dosing may be adjusted depending on plasma fibrinogen levels or viscoelastic testing, severity of bleeding, body weight, or patients clinical condition

Fibryga is Ready in Minutes

Quick and Convenient Administration for Adult Patients:

Fibryga1

step
1

Retrieve from automated dispensing cabinet

2

Mix, hang, & infuse

Vs.

Cryo3-5

step
1

Determine ABO compatibility

2

Calculate
dose

3

Request cryo
from blood bank

4

Blood bank
thaws cryo*

5

Transport cryo to
point-of-care

6

Hang &
infuse

Vs.

IFC6

step
1

Thaw†

2

Determine ABO
compatibility

3

Calculate
dose

4

Request IFC
from blood bank

5

Transport IFC to
point-of-care

6

Hang &
infuse

cryo=cryoprecipitate; IFC=INTERCEPT® Fibrinogen Complex.
*~30 minute delay after cryo is ordered before it can be transported.
†IFC can be thawed up to 5 days before use.

Fibryga can be ready ~45 minutes faster than cryo2

Familiar reconstitution protocol

Fibryga is supplied as a lyophilized powder containing ~1 g or ~2 g fibrinogen concentrate (FC) per vial. It's reconstituted prior to administration.

Each single-dose fibryga kit contains:

  • One single-dose vial of fibryga concentrate
  • One transfer device (nextaro®)
  • One 50 mL or one 100 mL vial of diluent (Sterile Water for Injection)

nextaro® is a registered trademark of sfm medical devices GmbH.

How to mix fibryga

This simple, yet rapid preparation process enables HCPs to administer fibryga quickly and efficiently.

Preparing fibryga for administration follows standard aseptic protocols minimizing the need for extensive training.1

Open

Open package and attach
the nextaro® transfer device
to the diluent vial.

Mix

Mix by turning the diluent and transfer device upside down and attaching
the fibryga vial. Gently swirl for
~5–10 minutes until the powder is fully dissolved. Remove the diluent vial.

Transfer

Transfer fibryga to the syringe
via the Luer lock connector on the nextaro® device and draw the solution
into the syringe.

The Fibryga Reconstitution Guide Video Shows How To Reconstitute Fibryga Step‑By‑Step Using nextaro®:

Get full administration detailsDosing for CFD

Ready When Required. Shelf Stable for 4 Years.

Store fibryga for up to 48 months at +2°C to +25°C (36°F to 77°F) from the date of manufacture.1
Do not use fibryga beyond the expiration date printed on the carton and vial.1
Do not freeze. Store in the original container to protect from light.1
Connect with a RepHCP resources

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 in congenital fibrinogen deficiency 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.