Fibrinogen (Human)

Contraindications

Hypersensitivity

Cautions

Risk of anaphylactic reactions

Not indicated for dysfibrinogenemia

Risk of thrombosis in patients with congenital fibrinoen deficiency with or without fibrinogen replacement therapy

Theoretical risk of bloodborne infectious disease

Pregnancy Category: C

Lactation: Not studied

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Fibrinogen, Human is available in the following forms:

• Injectable Solution

General

Monitor fibrinogen level.1 Target level is 100 mg/dL; maintain this level until hemostasis is obtained.1

Each single-use vial contains between 900–1300 mg of fibrinogen (human).1 The actual fibrinogen potency for each lot is indicated on the vial label.1

Administration

IV Administration

Administer by slow IV injection using a dedicated line.1

Reconstitute vial with 50 mL of sterile water for injection.1 Gently swirl until the lyophilized powder is completely dissolved.1 Do not shake the vial.1 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.1

Maximum rate is 5 mL/minute.1

Dosage

Individualize dosage based on extent of bleeding, laboratory test results, and clinical condition of the patient.1

Dosage is expressed in mg of fibrinogen and is based on weight.1 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.1

Pediatric Patients

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.1

Adults

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.1

Special Populations

No special population dosage recommendations at this time. 1

Contraindications

• History of serious immediate hypersensitivity reactions (e.g., anaphylaxis) to fibrinogen (human) or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Sensitivity Reactions

Allergic and/or hypersensitivity reactions may occur.1 Closely monitor for manifestations of hypersensitivity (e.g., hives, generalized urticaria, chest tightness, wheezing, hypotension, anaphylaxis).1 Immediately discontinue drug and administer appropriate treatment if hypersensitivity occurs.1

Thrombosis

Thromboembolic events (e.g., MI, pulmonary embolism, DVT, arterial thrombosis) may occur.1 Weigh benefits of the drug against risk of thrombosis.1 Monitor for thrombosis.1

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.1

Improved donor screening and viral eliminating/reducing procedures have reduced, but not completely eliminated risk of pathogen transmission with plasma-derived preparations.1 Possibility still exists for disease transmission.1 Report any suspected infections to the manufacturer at 866-915-6958.1

Specific Populations

Category C.1

Not studied in nursing women with congenital fibrinogen deficiency.1

Evaluated in a limited number of children ≤16 years of age.1

Experience in those ≥65 years of age insufficient to determine whether geriatric adults respond differently than younger adults.1

Common Adverse Effects

Fever, headache.1

• Fibrinogen (human) is a highly purified preparation of fibrinogen derived from pooled human plasma.1 Fibrinogen is a substrate of thrombin, factor VIII, and plasmin.1 3 4 During the coagulation process, thrombin cleaves fibrinogen, catalyzing a series of steps that ultimately result in formation of a stable fibrin clot.1 3 4

  Plasma used in the preparation of fibrinogen are screened for human viruses (e.g., hepatitis B virus [HBV], hepatitis C virus [HCV], HIV).1 Additional viral purification steps are employed to further reduce the risk of pathogen transmission.1