Fibrinogen Concentrate (Human)

Trade Names:
RiaSTAP
- Injection, lyophilized powder for solution 900 to 1,300 mg (approximately 1 g)

Pharmacology

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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.

Pharmacokinetics

Absorption

Mean C _max is 140 mg/dL. Mean AUC following a dose of 70 mg/kg is 124.3 mg•h/mL.

Distribution

Mean Vd is 52.7 mL/kg.

Elimination

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.

Contraindications

Severe, immediate hypersensitivity reactions to any component of the product.

Dosage and Administration

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.

General Advice

• 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.

Storage/Stability

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.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Thromboembolic complications including deep vein thrombosis, MI, pulmonary embolism (postmarketing).

CNS

Headache (more than 1%).

GI

Nausea, vomiting (postmarketing).

Hypersensitivity

Allergic anaphylactic reactions, including dyspnea and rash (postmarketing).

Miscellaneous

Fever (more than 1%); chills (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Clinical studies have included children younger than 16 yr of age; however, because of the number of subjects, statistical interpretation is limited.

Elderly

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.

Hypersensitivity

Allergic reactions may occur.

Thrombosis

Thromboembolic events have been reported. Thrombosis may occur spontaneously in patients with congenital fibrinogen deficiency with or without use of fibrinogen replacement therapy.

Infections

Because fibrinogen concentrate is prepared from human plasma, there is a risk of transmitting infectious agents (eg, viruses), including Creutzfeldt-Jakob disease.

Overdosage

Symptoms

None reported.

Patient Information

• 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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