Dosing and uses of RiaSTAP (fibrinogen, human)
Adult dosage forms and strengths
powder for injection
- 900-1300mg
Fibrinogen Deficiency
Indicated for acute bleeding episodes due to congenital fibrinogen deficiency, including afibrinogenemia & hypofibrinogenemia
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 basline level unknown: 70 mg/kg IV
Target fibrinogen: 100 mg/dL until hemostasis
Pediatric dosage forms and strengths
powder for injection
- 900-1300mg
Fibrinogen Deficiency
Indicated for acute bleeding episodes due to congenital fibrinogen deficiency, including afibrinogenemia & hypofibrinogenemia
<16 years: Safety & efficacy not established
>16 years
- As adults; 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 level unknown: 70 mg/kg IV
- Target fibrinogen: 100 mg/dL until hemostasis
RiaSTAP (fibrinogen, human) adverse (side) effects
Frequency not defined
Alllergic reactions
Fever
Headache
Arterial thrombosis
Chills
DVt
Dyspnea
MI
Nausea
Rash
Vomiting
Thromboembolism
Pulmonary embolism
Warnings
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 and lactation
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.
Pharmacology of RiaSTAP (fibrinogen, human)
Mechanism of action
Fibrinogen concentrate pooled from human plasma replaces this protein in patients with congenital fibrinogen deficiency
Pharmacokinetics
Half-Life: 61-97 hr; may be decreased in children < 16 years of age
Peak Plasma (70 mg/kg x1): 140 mg/dL
Vd: 45-60 mL/kg
Administration
IV Preparation
Aseptically transfer 50 mL SWI (supplied diluent) into product vial; swirl to dissolve (do not shake), should be a colorless solution
Stable for 24 hours after reconstitution when stored at room temp
IV Administration
Administer through a separate injection site
Aseptically administer at room temperature by slow injection at NMT 5 mL/min
