Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 900-1300mg/vial (RiaSTAP)
- ~1000mg/vial (Fibryga)
Fibrinogen Deficiency
Indicated for on-demand treatment of acute bleeding episodes due to congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia
RiaSTAP
- Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.7 (mg/dL per mg/kg body weight) given IV
- If fibrinogen baseline level unknown: 70 mg/kg IV
- Target fibrinogen: 100 mg/dL until hemostasis
Fibryga
- Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.8 (mg/dL per mg/kg body weight) given IV
- If fibrinogen baseline level unknown: 70 mg/kg IV
- Target fibrinogen level (minor bleeding): 100 mg/dL
- Target fibrinogen level (major bleeding): 150 mg/dL
- Administered additional doses if the plasma fibrinogen level is below the accepted lower limit (80 mg/dL for minor bleeding, 130 mg/dL for major bleeding) of the target level until hemostasis is achieved
Dosage Forms & Strengths
powder for injection
- 900-1300mg/vial (RiaSTAP)
- ~1000mg/vial (Fibryga)
Fibrinogen Deficiency
Indicated for on-demand treatment of acute bleeding episodes due to congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia, in adults and children
Faster clearance and shorter half-life observed in children aged 1 to <12 years compared with adults and adolescents; higher may be required in this age group
RiaSTAP
- Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.7 (mg/dL per mg/kg body weight) given IV
- If fibrinogen baseline level unknown: 70 mg/kg IV
- Target fibrinogen: 100 mg/dL until hemostasis
Fibryga
- ≥12 years: Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.8 (mg/dL per mg/kg body weight) given IV
- <12 years: Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)]/1.4 (mg/dL per mg/kg body weight) given IV
- If fibrinogen baseline level unknown: 70 mg/kg IV
- Target fibrinogen level (minor bleeding): 100 mg/dL
- Target fibrinogen level (major bleeding): 150 mg/dL
- Administered additional doses if the plasma fibrinogen level is below the accepted lower limit (80 mg/dL for minor bleeding, 130 mg/dL for major bleeding) of the target level until hemostasis is achieved
Adverse Effects
Frequency Not Defined
Allergic reactions
Fever
Headache
Arterial thrombosis
Chills
DVT
Dyspnea
MI
Nausea
Rash
Vomiting
Thromboembolism
Thrombocytosis
Pulmonary embolism
Warnings
Contraindications
Hypersensitivity
Cautions
Risk of anaphylactic reactions
Not indicated for dysfibrinogenemia
Risk of thrombosis in patients with congenital fibrinogen deficiency with or without fibrinogen replacement therapy
Although risk is rare, products from human plasma may contain infectious agents
Pregnancy & Lactation
Pregnancy
Data are not available regard use in pregnant females
Animal reproduction studies have not been conducted
Unknown if it can cause fetal harm
Lactation
Data are not available regarding the presence in human milk, effect on breastfed infants, or effects on milk production
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.Pharmacology
Mechanism of Action
Fibrinogen concentrate pooled from human plasma replaces this protein in patients with congenital fibrinogen deficiency
Absorption
Peak plasma concentration
- RiaSTAP: 140 mg/dL (70 mg/kg x 1)
-
Fibryga
- Adults and adolescents: 139 mg/dL
- Children aged 6 to <12 years: 112.4 mg/dL
- Children aged <6 years: 99 mg/dL
AUC (Fibryga)
- Adults and adolescents: 124.8 mg·hr/mL; 113.7 mg·hr/mL (70 mg/kg x1)
- Children aged 6 to <12 years: 102.1 mg·hr/mL; 97.2 mg·hr/mL (70 mg/kg x1)
- Children aged <6 years: 83.8 mg·hr/mL; 79.8 mg·hr/mL (70 mg/kg x1)
Distribution
Vd
- RiaSTAT: 45-60 mL/kg
-
Fibryga
- Adults and adolescents: 70.2 mL/kg
- Children aged 6 to <12 years: 67.2 mL/kg
- Children aged <6 years: 68.6 mL/kg
Elimination
Half-life
- RiaSTAP: 61-97 hr; may be decreased in children aged <16 yr
-
Fibryga
- Adults and adolescents: 75.9 hr
- Children aged 6 to <12 years: 66.1 hr
- Children aged <6 years: 56.9 hr
Clearance (Fibryga)
- Adults and adolescents: 0.7 mL/hr kg
- Children aged 6 to <12 years: 0.7 mL/hr kg
- Children aged <6 years: 0.9 mL/hr kg
Administration
IV Preparation
Warm both the powder and sterile water for injection (SWI) in their closed bottles to room temperature; this temperature should be maintained during reconstitution
If a water bath is used for warming, prevent water from coming into contact with the rubber stoppers or the caps of the bottles; water bath should not exceed 37°C (98°F)
Reconstitute lyophilized powder with 50 mL SWI (see prescribing information for technique)
Gently swirl vial to dissolve (do not shake); should result in a colorless solution
RiaSTAP: Filter reconstituted solution with 17-mcron filter into an appropriate syringe before administering
IV Administration
Administer through dedicated IV line
Administer by slow IV injection; not to exceed 5 mL/min
Storage
Single-use vials; these products do not contain preservatives
Unopened vial
- Store at 2-25°C (36-77°F)
- Do not freeze
- Store in original container to protect from light
Reconstituted vial
- Do not refrigerate or freeze
- RiaSTAP: Up to 8 hr at 20-25°C
- Fibryga: Up to 4 hr at 20-25°C
Images
Patient Handout
Formulary
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