| Select fibrinogen replacement therapies |
| |
Fresh Frozen Plasma (FFP) 1-2 |
Cryoprecipitate (Cryo) 1-2 |
RiaSTAP |
| Fibrinogen content per unit volume |
~500 mg per 250 mL |
≥150 mg per 5-20 mL |
~900-1300 mg per 50 mL |
| Fibrinogen content per mL |
~2 mg per mL |
≥10 mg per mL |
~20 mg per mL |
| Exact fibrinogen content per unit |
Unknown |
Unknown |
Listed on vial label |
| Thawing required |
Yes |
Yes |
No |
| ABO matching required |
Yes |
Yes |
No |
| Virus inactivation/removal |
No |
No |
Yes |
| Shelf life |
12 months (frozen) |
12 months (frozen) |
up to 60 months (when stored at temperatures of 2-8°C or 36-46°F) |
- RiaSTAP has the highest, on average, fibrinogen content per mL
- Each vial of RiaSTAP is clearly labeled with the exact fibrinogen content to assist
with coagulation management
- Virus inactivation/removal reduces risk of exposure to infectious agents
- The risk of virus transmission cannot be completely eliminated
- Long shelf-life maximizes accessibility
The comparable safety and efficacy of these products have not been established in
head-to-head clinical trials.
- Blood Centers of America. Blood Products. http://www.bca-hemerica.com/products-services/blood-products/ Accessed September 19, 2016.
- American Association of Blood Banks, America's Blood Centers, American Red Cross.
Circular of Information for the Use of Human Blood and Blood Components. Bethesda,
MD: American Association of Blood Banks, 2013.
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.
