Fibrinogen (Human)
Class: Hemostatics
Chemical Name: Fibrinogen concentrate (human)
CAS Number: 9001-32-5
Brands: RiaSTAP
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.