Introduction

A lyophilized concentrate of highly purified fibrinogen (blood coagulation factor I) prepared from pooled human plasma from suitable donors.

Uses for Fibrinogen (Human)

Acute Bleeding Episodes

Used to control acute bleeding episodes in patients with congenital fibrinogen deficiency (i.e., afibrinogenemia [absence or extremely low concentrations of plasma fibrinogen], hypofibrinogenemia [reduced concentrations of plasma fibrinogen]); designated an orphan drug by FDA for use in this condition.

Not indicated in patients with dysfibrinogenemia (presence of abnormal or dysfunctional fibrinogen).

Fibrinogen (Human) Dosage and Administration

General

Monitor fibrinogen level. Target level is 100 mg/dL; maintain this level until hemostasis is obtained.

Each single-use vial contains between 900–1300 mg of fibrinogen (human). The actual fibrinogen potency for each lot is indicated on the vial label.

Administration

IV Administration

Administer by slow IV injection using a dedicated line.

Reconstitution

Reconstitute vial with 50 mL of sterile water for injection. Gently swirl until the lyophilized powder is completely dissolved. Do not shake the vial. The reconstituted solution should be colorless and clear to slightly opalescent and should be inspected visually for particulate matter; discard solution if cloudy or if particles are present.

Rate of Administration

Maximum rate is 5 mL/minute.

Dosage

Individualize dosage based on extent of bleeding, laboratory test results, and clinical condition of the patient.

Dosage is expressed in mg of fibrinogen and is based on weight. Administration of 70 mg/kg of fibrinogen (human) increased plasma concentration of fibrinogen by approximately 120 mg/dL in a pharmacokinetic study in 14 patients.

Pediatric Patients

Acute Bleeding Episodes

IV

When the baseline fibrinogen level is known, use the following formula:

Target fibrinogen level (mg/dL) - measured fibrinogen level (mg/dL) / 1.7 (mg/dL per mg/kg body weight) = mg of fibrinogen/body weight (in kg)

When the baseline fibrinogen level is not known, recommended dose is 70 mg/kg.

Adults

Acute Bleeding Episodes

IV

When the baseline fibrinogen level is known, use the following formula:

Target fibrinogen level (mg/dL) - measured fibrinogen level (mg/dL) / 1.7 (mg/dL per mg/kg body weight) = mg of fibrinogen/body weight (in kg)

When the baseline fibrinogen level is not known, recommended dose is 70 mg/kg.

Special Populations

No special population dosage recommendations at this time.

Contraindications

• History of serious immediate hypersensitivity reactions (e.g., anaphylaxis) to fibrinogen (human) or any ingredient in the formulation.

Warnings/Precautions

Warnings

Sensitivity Reactions

Allergic and/or hypersensitivity reactions may occur. Closely monitor for manifestations of hypersensitivity (e.g., hives, generalized urticaria, chest tightness, wheezing, hypotension, anaphylaxis). Immediately discontinue drug and administer appropriate treatment if hypersensitivity occurs.

Thrombosis

Thromboembolic events (e.g., MI, pulmonary embolism, DVT, arterial thrombosis) may occur. Weigh benefits of the drug against risk of thrombosis. Monitor for thrombosis.

Risk of Transmissible Agents in Plasma-derived Preparations

Potential vehicle for transmission of human viruses (e.g., HIV, hepatitis B virus [HBV], hepatitis C virus [HCV]) and other infectious agents.

Improved donor screening and viral eliminating/reducing procedures have reduced, but not completely eliminated risk of pathogen transmission with plasma-derived preparations. Possibility still exists for disease transmission. Report any suspected infections to the manufacturer at 866-915-6958.

Specific Populations

Pregnancy

Category C.

Lactation

Not studied in nursing women with congenital fibrinogen deficiency.

Pediatric Use

Evaluated in a limited number of children ≤16 years of age.

Geriatric Use

Experience in those ≥65 years of age insufficient to determine whether geriatric adults respond differently than younger adults.

Common Adverse Effects

Fever, headache.

General

Monitor fibrinogen level. Target level is 100 mg/dL; maintain this level until hemostasis is obtained.

Each single-use vial contains between 900–1300 mg of fibrinogen (human). The actual fibrinogen potency for each lot is indicated on the vial label.

Administration

IV Administration

Administer by slow IV injection using a dedicated line.

Reconstitution

Reconstitute vial with 50 mL of sterile water for injection. Gently swirl until the lyophilized powder is completely dissolved. Do not shake the vial. The reconstituted solution should be colorless and clear to slightly opalescent and should be inspected visually for particulate matter; discard solution if cloudy or if particles are present.

Rate of Administration

Maximum rate is 5 mL/minute.

Dosage

Individualize dosage based on extent of bleeding, laboratory test results, and clinical condition of the patient.

Dosage is expressed in mg of fibrinogen and is based on weight. Administration of 70 mg/kg of fibrinogen (human) increased plasma concentration of fibrinogen by approximately 120 mg/dL in a pharmacokinetic study in 14 patients.

Pediatric Patients

Acute Bleeding Episodes

IV

When the baseline fibrinogen level is known, use the following formula:

Target fibrinogen level (mg/dL) - measured fibrinogen level (mg/dL) / 1.7 (mg/dL per mg/kg body weight) = mg of fibrinogen/body weight (in kg)

When the baseline fibrinogen level is not known, recommended dose is 70 mg/kg.

Adults

Acute Bleeding Episodes

IV

When the baseline fibrinogen level is known, use the following formula:

Target fibrinogen level (mg/dL) - measured fibrinogen level (mg/dL) / 1.7 (mg/dL per mg/kg body weight) = mg of fibrinogen/body weight (in kg)

When the baseline fibrinogen level is not known, recommended dose is 70 mg/kg.

Special Populations

No special population dosage recommendations at this time.