Frequently Asked Questions About RiaSTAP®
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.
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What is the FDA-approved indication for RiaSTAP®?
RiaSTAP® (fibrinogen concentrate [human]) is indicated for
the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (CFD), including afibrinogenemia and hypofibrinogenemia. RiaSTAP® is not indicated for dysfibrinogenemia.
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How should RiaSTAP® be stored?
Lyophilized fibrinogen concentrate is stored at room temperature (77° F; 25° C). The product does not require thawing; it is stable in solution for 24 hours. RiaSTAP® has a shelf life of 30 months from date of manufacture in freeze-dried form.
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What stabilizers are used in RiaSTAP®?
The stabilizers used in RiaSTAP® are human albumin and L-arginine hydrochloride.
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Does RiaSTAP® contain preservatives?
No. RiaSTAP® does not contain any preservatives.
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Does RiaSTAP® contain mercury?
No. RiaSTAP® does not contain mercury or thimerosal.
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What are the contraindications for RiaSTAP®?
RiaSTAP® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to RiaSTAP® or its components.
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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.
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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 (HIV-1), and nucleic acid testing for HCV and HIV-1 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.
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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
- A1(OH)3 adsorption/glycine precipitation/A1(OH)3 adsorption
- Heat-treated
- Glycine precipitation (two subsequent steps)
Learn more about virus inactivation.
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What are the possible 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, and allergic-anaphylactic reactions. The most common adverse reactions observed are allergic reactions, including chills, fever, nausea, and vomiting. 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.
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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.
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Is there a pediatric dose of RiaSTAP®?
Dosing for pediatric patients follows the same body-weight based guidelines as for adult patients. When baseline fibrinogen level is not known, the recommended dose is 70 mg/kg of body weight. See Dosing and Administration section, or for complete dosing information see Full Prescribing Information.
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Can RiaSTAP® be used during pregnancy?
There is not sufficient information to recommend its safe use in pregnancy. RiaSTAP® should be used during pregnancy only if absolutely necessary, after assessing the risks and benefits expected from the use of RiaSTAP®.
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