Efficacy

RiaSTAP effectively raises fibrinogen levels

RiaSTAP has a demonstrated ability to effectively raise fibrinogen levels to within specified target levels. Targets vary depending on the clinical situation.

Pharmacokinetic parameters for fibrinogen activity (n=14)
Parameters Mean ± SD (range)
Half-life (hours) 78.7 ± 18.13 (55.73-117.26)
Cmax(mg/dL) 140 ± 27 (100-210)
AUC for dose of 70 mg/kg (mg*hr/ml) 124.3 ± 24.16 (81.73-156.40)
Clearance (mL/h/kg) 0.59 ± 0.13 (0.45-0.86)
Mean residence time (hours) 92.8 ± 20.11 (66.14-126.44)
Volume of distribution at steady state (mL/kg) 52.7 ± 7.48 (36.22-67.67)

In a prospective, open-label uncontrolled multicenter pharmacokinetic study:

  • - 14 patients with congenital fibrinogen deficiency (afibrinogenemia) received a single intravenous dose of 70mg/kg of RiaSTAP
  • - Blood samples were drawn from patients to determine the fibrinogen activity at baseline and up to 14 days after the infusion
  • The median incremental in vivo recovery (IVR) was 1.7mg/dL increase per mg/kg
  • Based on this IVR, a dose of 70 mg/kg will increase fibrinogen plasma concentration by approximately 120 mg/dL

RiaSTAP improves maximum clot firmness (MCF), a surrogate laboratory measure of hemostatic efficacy. (click here for information)

Learn about convenience with RiaSTAP.

Learn about RiaSTAP: Dosing and Administration.

Important Safety Information

RiaSTAP®, Fibrinogen Concentrate (Human), is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.

Monitor patients for early signs of anaphylaxis or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving RiaSTAP; weigh the benefits of administration versus the risks of thrombosis.

RiaSTAP is made from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

The most serious adverse reactions observed are thrombotic episodes (pulmonary embolism, myocardial infarction, deep vein thrombosis) and anaphylactic reactions. The most common adverse reactions observed in clinical studies (frequency >1%) were fever and headache.

Indications

RIASTAP is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Please see full prescribing information for RiaSTAP.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.