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 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.

Virus Inactivation

RiaSTAP is made from pooled human plasma and thus may contain infectious agents. However, virus inactivation/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.

Cumulative (log10) virus inactivation/reduction in RiaSTAP
Manufacturing Step Virus Reduction Factor (log10)
Enveloped Viruses Non-enveloped Viruses
HIV BVDV WNV PRV HAV CPV B19V*
Cryoprecipitation n.d. n.d. n.d. 1.6 n.d. 1.9 n.d.
Heat treatment ≥ 5.7 ≥ 9.1 ≥ 8.3 5.4 5.9 1.4 ≥ 4.5*
Glycine precipitation (two subsequent steps) 3.9 2.1 n.d. 1.8 1.0 1.6 n.d.
Lyophilization n.d. n.d. n.d. n.d. 1.7 n.d. n.d.
Cumulative virus reduction (log10) ≥ 9.6 ≥ 11.2 ≥ 8.3 8.8 8.6 4.9 ≥ 4.5

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 is reduced by cryoprecipitation by 1.6 log10; ‡Not included in the calculation of the cumulative virus reduction factor; n.d., not determined.

Learn about the efficacy of RiaSTAP

Learn about RiaSTAP: Dosing and Administration.

Important Safety Information

RiaSTAP®, Fibrinogen Concentrate (Human), is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

RiaSTAP 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 pooled human plasma. Products made from human plasma may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

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.

Please see full prescribing information for RiaSTAP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.