DOSING FOR FESILTY

The target plasma fibrinogen level is 100 mg/dL for minor bleeding and 150 mg/dL for major bleeding.1



 

When baseline fibrinogen levels are known, the dose of FESILTY for each patient must be individually calculated, taking into consideration age, the location and extent of bleeding, the plasma level of fibrinogen (mg/dL), and the clinical condition of the patient.1

 

Dosing calculator

Calculate doses for adults and pediatric patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.

Dosing
Disclaimer

Disclaimer

This calculator is provided for informational purposes only and is not a substitute for clinical judgment.

The recommended dose of FESILTY must be individualized based on patient age, baseline fibrinogen level, extent of bleeding, and clinical condition. Monitor plasma fibrinogen levels and adjust dosing as needed to achieve and maintain target levels.

Please refer to the full Prescribing Information before prescribing.

Dosing

This field is required.
The allowed range is between 0.01 and 550
10 79.5 149
This field is required.
The allowed range is between 10 and 149
100 125 150
This field is required.
The allowed range is between 100 and 150

Warning

Measured fibrinogen level must be lower than the target fibrinogen level.

$fesilty_plus_six_years_calc_measured_fibrinogen_level>$fesilty_plus_six_years_calc_target_fibrinogen_level

Maintenance dose

How is it calculated

Calculated dose (mg/kg)

[($fesilty_plus_six_years_calc_target_fibrinogen_level-$fesilty_plus_six_years_calc_measured_fibrinogen_level)/1.6|2] mg/kg

Total dose required (mg)

[(($fesilty_plus_six_years_calc_target_fibrinogen_level-$fesilty_plus_six_years_calc_measured_fibrinogen_level)/1.6)*$fesilty_plus_six_years_calc_patient_weight|2] mg

Calculation details

Edit
This field is required.
The allowed range is between 1 and 550
10 79.5 149
This field is required.
The allowed range is between 10 and 149
100 125 150
This field is required.
The allowed range is between 100 and 150

Warning

Measured fibrinogen level must be lower than the target fibrinogen level.

$fesilty_minus_six_years_calc_measured_fibrinogen_level>$fesilty_minus_six_years_calc_target_fibrinogen_level

Maintenance dose

How is it calculated

Calculated dose (mg/kg)

[($fesilty_minus_six_years_calc_target_fibrinogen_level-$fesilty_minus_six_years_calc_measured_fibrinogen_level)/1.8|2] mg

Total dose required (mg)

[(($fesilty_minus_six_years_calc_target_fibrinogen_level-$fesilty_minus_six_years_calc_measured_fibrinogen_level)/1.8)*$fesilty_minus_six_years_calc_patient_weight|2] mg

Calculation details

Edit
This field is required.
The allowed range is between 1 and 550
40 70 100
This field is required.
The allowed range is between 40 and 100

Maintenance dose

How is it calculated

Calculated dose (mg/kg)

[$fesilty_baseline_unknown_calc_measured_fibrinogen_level|2] mg/kg

Total dose required (mg)

[$fesilty_baseline_unknown_calc_patient_weight*$fesilty_baseline_unknown_calc_measured_fibrinogen_level|2] mg

Calculation details

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The target plasma fibrinogen level is 100 mg/dL for minor bleeding and 150 mg/dL for major bleeding.

When baseline fibrinogen levels are not known, the recommended dose of FESILTY is 70 mg/kg BW for patients of all ages.

≥ 6 years old dose (mg/kg BW) = Target fibrinogen level (mg/dL) − Measured fibrinogen level (mg/dL) 1.8 (mg/dL per mg/kg BW)
< 6 years old dose (mg/kg BW) = Target fibrinogen level (mg/dL) − Measured fibrinogen level (mg/dL) 1.6 (mg/dL per mg/kg BW)
Baseline fibrinogen level not known dose (mg/kg BW) = 70 mg/kg BW

RECONSTITUTION STEPS

Reconstitution for FESILTY is fast and easy and can be completed in approximately 3 minutes.


Follow these simple steps.1*

Step 1

Insert the transfer device into the water vial.

Step 2

Turn both the transfer device and the water vial upside down and connect it to the FESILTY vial.

Step 3

FESILTY is now ready to use and can be drawn into a syringe.

*These are shortened instructions. Full instructions in the prescribing information must be read before use.

RECONSTITUTION PROCESS FOR FESILTY

This video demonstrates the full reconstitution process for FESILTY, guiding you through each step from vial preparation to drawing the final solution.

INFUSION RATES

Infuse FESILTY intravenously using an infusion pump at an infusion rate not to exceed 5 mL/min.




The initial infusion rates are provided in the table below. Selection of the infusion rate remains principally at the discretion of the treating physician considering the exact clinical situation of the patient.1

Patient Age
Initial Infusion Rate*

5 mL/min

Initial Infusion Rate*

1.0 mL/min

Initial Infusion Rate*

0.75 mL/min

Initial Infusion Rate*

0.30 mL/min

Initial Infusion Rate*

0.10 mL/min

*Infusion rate not to exceed 5 mL/min.

*Infusion rate not to exceed 5 mL/min.
Patient Age Initial Infusion Rate*

Adults and pediatric patients ≥ 6 years of age

5 mL/min

Pediatric patients 4 to < 6 years of age

1.0 mL/min

Pediatric patients 2 to < 4 years of age

0.75 mL/min

Pediatric patients 28 days to < 2 years of age

0.30 mL/min

Newborns (0 to 27 days)

0.10 mL/min

FIND OUT MORE ABOUT FESILTY

View the safety profile for FESILTY

Safety Info
Safety Info

Consider FESILTY as a first-line treatment for CFD

Learn More
Learn More

IMPORTANT SAFETY INFORMATION

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Indications and Usage
FESILTY (fibrinogen, human-chmt) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.


Limitations of Use:
FESILTY is not indicated for dysfibrinogenemia.
 
Contraindications
FESILTY is contraindicated in patients who have severe hypersensitivity reactions, including anaphylaxis, to FESILTY or its components (arginine hydrochloride, polysorbate 80, sodium citrate dihydrate, trehalose dihydrate).
 
Warnings and Precautions
Hypersensitivity reactions have occurred in patients receiving FESILTY. Should symptoms occur, discontinue FESILTY and administer appropriate treatment.
 
Thrombotic events have occurred in patients receiving FESILTY. Weigh the benefits of administration versus the risks of thrombosis.
 
FESILTY is made from pooled human plasma and may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
 
Adverse Reactions
The most serious adverse reactions observed with FESILTY were thrombotic events, including portal vein thrombosis, deep vein thrombosis, and pain in extremity with clinically suspected thrombosis. One patient had an episode of epilepsy and died due to extradural hematoma 4 weeks after administration of FESILTY.
 
In a clinical study, the most common adverse reactions that occurred in >2% of patients receiving FESILTY were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.
 
Please see full Prescribing Information for FESILTY.
 
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indications and Usage
FESILTY (fibrinogen, human-chmt) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.


Limitations of Use:
FESILTY is not indicated for dysfibrinogenemia.
 
Contraindications
FESILTY is contraindicated in patients who have severe hypersensitivity reactions, including anaphylaxis, to FESILTY or its components (arginine hydrochloride, polysorbate 80, sodium citrate dihydrate, trehalose dihydrate).
 
Warnings and Precautions
Hypersensitivity reactions have occurred in patients receiving FESILTY. Should symptoms occur, discontinue FESILTY and administer appropriate treatment.
 
Thrombotic events have occurred in patients receiving FESILTY. Weigh the benefits of administration versus the risks of thrombosis.
 
FESILTY is made from pooled human plasma and may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
 
Adverse Reactions
The most serious adverse reactions observed with FESILTY were thrombotic events, including portal vein thrombosis, deep vein thrombosis, and pain in extremity with clinically suspected thrombosis. One patient had an episode of epilepsy and died due to extradural hematoma 4 weeks after administration of FESILTY.
 
In a clinical study, the most common adverse reactions that occurred in >2% of patients receiving FESILTY were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.
 
Please see full Prescribing Information for FESILTY.
 
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

IMPORTANT SAFETY INFORMATION

Indications and Usage
FESILTY (fibrinogen, human-chmt) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.


Limitations of Use:
FESILTY is not indicated for dysfibrinogenemia.
 
Contraindications
FESILTY is contraindicated in patients who have severe hypersensitivity reactions, including anaphylaxis, to FESILTY or its components (arginine hydrochloride, polysorbate 80, sodium citrate dihydrate, trehalose dihydrate).
 
Warnings and Precautions
Hypersensitivity reactions have occurred in patients receiving FESILTY. Should symptoms occur, discontinue FESILTY and administer appropriate treatment.
 
Thrombotic events have occurred in patients receiving FESILTY. Weigh the benefits of administration versus the risks of thrombosis.
 
FESILTY is made from pooled human plasma and may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
 
Adverse Reactions
The most serious adverse reactions observed with FESILTY were thrombotic events, including portal vein thrombosis, deep vein thrombosis, and pain in extremity with clinically suspected thrombosis. One patient had an episode of epilepsy and died due to extradural hematoma 4 weeks after administration of FESILTY.
 
In a clinical study, the most common adverse reactions that occurred in >2% of patients receiving FESILTY were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.
 
Please see full Prescribing Information for FESILTY.
 
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reference

  1. FESILTY [package insert]. Grifols, S.A.