Fibrinogen Concentrate (Human)
Class: Hematologic agent
- Injection, lyophilized powder for solution 900 to 1,300 mg (approximately 1 g)
Fibrinogen is a physiological substrate of the 3 enzymes thrombin, factor XIIIa, and plasmin, which act to cross-link fibrin, the end result of the coagulation cascade.
Mean C max is 140 mg/dL. Mean AUC following a dose of 70 mg/kg is 124.3 mg•h/mL.
Mean Vd is 52.7 mL/kg.
Mean Cl is 0.59 mL/h/kg. The mean half-life is 78.7 h.
Indications and Usage
Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Severe, immediate hypersensitivity reactions to any component of the product.
Dosage and AdministrationAdults and Children 16 yr of age and older
IV The dose should be individually calculated based on the target plasma fibrinogen level based on the type of bleeding, actual measured plasma fibrinogen level, and body weight using the following formula: Dose = [target level (mg/dL) − measured level (mg/L)] / 1.7 (mg/dL per mg/kg body weight). If the patients fibrinogen level is not known, the recommended dose is 70 mg/kg.
- Monitor fibrinogen level during treatment. A target fibrinogen level of 100 mg/dL should be maintained until hemostasis is obtained.
- Gently swirl the reconstituted product vial to ensure full dissolution. Do not shake the vial.
- Do not administer with other medicinal products or IV solutions. Administer through a separate injection site.
- Administer at room temperature by slow IV injection at a rate not exceeding 5 mL/min.
Store at 36° to 77°F. Do not freeze. Protect from light. Reconstituted product may be stored for 24 h at 68° to 77°F. Do not freeze.
None well documented.
Laboratory Test Interactions
None well documented.
Thromboembolic complications including deep vein thrombosis, MI, pulmonary embolism (postmarketing).
Headache (more than 1%).
Nausea, vomiting (postmarketing).
Allergic anaphylactic reactions, including dyspnea and rash (postmarketing).
Fever (more than 1%); chills (postmarketing).
Monitor patient's fibrinogen level during treatment. Maintain a target fibrinogen level of 100 mg/dL until hemostasis is obtained.
Category C .
Clinical studies have included children younger than 16 yr of age; however, because of the number of subjects, statistical interpretation is limited.
Safety and efficacy not established because the number of subjects in this age group were insufficient to determine whether elderly patients respond differently form younger individuals.
Allergic reactions may occur.
Thromboembolic events have been reported. Thrombosis may occur spontaneously in patients with congenital fibrinogen deficiency with or without use of fibrinogen replacement therapy.
Because fibrinogen concentrate is prepared from human plasma, there is a risk of transmitting infectious agents (eg, viruses), including Creutzfeldt-Jakob disease.
- Advise patients to notify health care provider immediately if they experience the following symptoms: anaphylaxis, chest and/or leg pain or edema, chest tightness, dyspnea, hemoptysis, hives, hypotension, tachypnea, unexplained neurologic symptoms, unexplained pleuritic, or wheezing.
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