What is RiaSTAP?
RiaSTAP is a lyophilized fibrinogen concentrate (clotting factor I) for intravenous administration, which supplements or replaces missing or low fibrinogen protein. When time is of the essence, it can be reconstituted within minutes.
What is the FDA-approved indication for RiaSTAP?
RiaSTAP is indicated for
the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (CFD), including afibrinogenemia and hypofibrinogenemia.
How should RiaSTAP be stored?
When stored at temperatures of 2-8°C (36-46°F), RiaSTAP is stable for the period indicated by the expiration date on the carton and vial label (up to 60 months). Do not use RiaSTAP beyond the expiration date. Keep RiaSTAP in its original carton until ready to use. Do not freeze. Protect from light.
What stabilizers are used in RiaSTAP?
The stabilizers used in RiaSTAP are human albumin and
L-arginine
hydrochloride.
Does RiaSTAP contain preservatives?
No. RiaSTAP does not contain preservatives.
What are the contraindications for RiaSTAP?
RiaSTAP is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.
Where is the plasma for RiaSTAP collected?
The pooled, human plasma used to manufacture RiaSTAP is currently obtained from FDA-licensed centers in the United States, which are overseen and regularly inspected by CSL Behring.
What tests are conducted on donor plasma?
All pooled, human plasma used in the manufacturing of RiaSTAP is tested using FDA-licensed serological assays for hepatitis B surface antigen, antibodies to hepatitis C virus (HCV), human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2), and nucleic acid testing for HCV, HBV, HIV-1 and HIV-2 and found to be nonreactive (negative).
RiaSTAP is made from pooled human plasma. Products made from human plasma may contain infectious agents,
e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
How are viruses inactivated/removed from RiaSTAP?
After fractionation, the intermediate product is submitted to processes that inactivate and remove viruses. These virus inactivation/removal processes include:
- Cryoprecipitation
- Lyophilization
- Heat-treatment
- Glycine precipitation (two subsequent steps)
Learn more about virus inactivation.
What are adverse reactions to RiaSTAP?
The most serious adverse reactions that have been reported in subjects in clinical studies who received RiaSTAP are thromboembolic episodes, including myocardial infarction and pulmonary embolism, deep vein thrombosis, arterial thrombosis, and anaphylactic reactions.
the most common adverse reaction observed in clinical studies (frequency >1%) were fever and headache. Patients should be monitored for early signs of allergic or hypersensitivity reactions and if necessary, treatment should be discontinued.
For more information, see
Full Prescribing Information.
What is the recommended dosing for RiaSTAP?
RiaSTAP dosing, duration of dosing, and frequency of administration should be individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient.
When the baseline fibrinogen level is known, the dose should be individually calculated for each patient. When the baseline fibrinogen level is not known, the recommended dose is 70 mg/kg of body weight administered intravenously.
Monitoring of patient’s fibrinogen level is recommended during treatment with RiaSTAP. A target fibrinogen level of 100 mg/dL should be maintained until hemostasis is obtained.
For complete dosing information, see
Full Prescribing Information.
Is there a pediatric dose of RiaSTAP?
Dosing for pediatric patients follows the same body-weight based guidelines as for adult patients. In study subjects under 16, shorter half-life and faster clearance was seen than in other subjects. These results are difficult to interpret, however, because of the limited number of pediatric subjects (n=4).
Can RiaSTAP be used during pregnancy?
There are no studies of RiaSTAP use in pregnant women. Animal reproduction studies have not been conducted with RiaSTAP. It is not known whether RiaSTAP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RiaSTAP should be used during pregnancy only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
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.
