• About Congenital Fibrinogen Deficiency
• About RiaSTAP™
• • Mechanism of Action
  • Product Attributes
  • Efficacy
  • Safety Profile
  • Convenience
  • Dosing and Administration
  • Worldwide Experience
  • Authorized Distributors
  • Frequently Asked Questions
  • Request More Information
• CSL Coagulation Portfolio
• The CSL Behring Commitment
• Important Safety Information
• Prescribing Information

Safety profile

Safety

RiaSTAP™ is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP™ or its components.

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.

Virus Inactivation

RiaSTAP™ is made from pooled human plasma and thus may contain infectious agents. However, viral activation/removal reduces the risk of exposure to infectious agents.

CSL Behring is committed to maintaining the highest standards of quality and safety throughout the production process. Our integrated safety system helps ensure that only the highest quality plasma is selected for use in manufacturing and that safe and effective product is released. Quality control measures, including numerous inspections, tests, and crosschecks, are performed by highly trained personnel at each stage in the manufacturing process.

All potential donors are carefully screened before being allowed to donate plasma. The plasma undergoes thorough serological and biochemical screening of fractionation pools using nucleic acid amplification technology by polymerase chain reaction method to confirm the absence of hepatitis C virus RNA, hepatitis B virus DNA, and human immunodeficiency virus RNA.

HIV, human immunodeficiency virus; BVDV, bovine viral diarrhea virus, model for HCV; WNV, West Nile virus; HSV-1, herpes simplex virus type 1; PRV, pseudorabies virus; HAV, hepatitis A virus; CPV, canine parvovirus, model for B19V; B19V, human parvovirus B19.

*The virus elimination studies for parvovirus B19 employed a novel experimental infectivity assay utilizing clone of cell line UT7 that contains erythropoietic progeny cells. Virus titer was determined using an immunofluorescence-based detection method; †PRV–as HSV-1 herpes virus–is reduced by cryoprecipitation by 1.6 log₁₀; ‡Not included in the calculation of the cumulative virus reduction factor; n.d., not done.

Learn about the efficacy of RiaSTAP™

Learn about RiaSTAP™: Dosing and Administration.

Next: Convenience of RiaSTAP™