اطلاعات دارویی
موبایل دارونما سلامت دارو
Loading

RiaSTAP™ (fibrinogen concentrate human for intravenous use)
(fibrinogen concentrate [human]) for Intravenous Use,
Lyophilized Powder for Reconstitution

DRUG DESCRIPTION

RiaSTAP (fibrinogen concentrate human for intravenous use) is a heat-treated, lyophilized  fibrinogen (coagulation factor I) powder made from pooled human plasma.

Each vial contains 900 to 1300 mg  fibrinogen, 400 to 700 mg human albumin, 375 to 660 mg L-arginine hydrochloride, 200 to 350 mg sodium chloride and 50 to 100 mg sodium citrate. Sodium hydroxide and hydrochloric acid may have been used to adjust the pH.

All plasma used in the manufacture of RiaSTAP (fibrinogen concentrate human for intravenous use) is tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to HIV-1/2 and HCV. Additionally, the plasma is tested with FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and found to be non-reactive (negative). For HBV, an investigational NAT procedure is used; however, the signifcance of a negative result has not been established. In addition, the plasma has been tested by NAT for HAV and B19V. Only plasma that passed virus screening is used for production, and the limit for B19V in the fractionation pool is set not to exceed 104 IU of B19V DNA per mL.

RiaSTAP (fibrinogen concentrate human for intravenous use) is manufactured from cryoprecipitate into a glycine precipitate, which is then further purifed by multiple precipitation/adsorption steps. The manufacturing process has been demonstrated to reduce the risk of virus transmission in an additive manner: cryoprecipitation, Al(OH)3  adsorption/glycine precipitation/Al(OH)3 adsorption, heat treatment (+60?C for 20 hours in an aqueous solution), and two subsequent glycine precipitation steps (initial and main glycine precipitation steps). These steps have been validated independently in a series of in vitro experiments for their capacity to inactivate and/or remove both enveloped and non-enveloped viruses. Table 1 shows the virus clearance during the manufacturing process for RiaSTAP (fibrinogen concentrate human for intravenous use) , expressed as the mean log10 reduction factor (LRF).

Table 1: Cumulative (Log10) Virus Inactivation/Reduction in RiaSTAP (fibrinogen concentrate human for intravenous use)

Manufacturing Step Virus Reduction Factor (log10)
Enveloped viruses Non-enveloped viruses
HIV BVDV WNV HSV-1 PRV H AV CPV B19V*
Cryoprecipitation n.d. n.d. n.d.   1.6 2.4 2.8 n.d.
Al(OH)3 adsorption/ glycine precipitation/ Al(OH)3 adsorption (2.8) (1.5) n.d. (0.9)   n.d.
Heat Treatment ≥ 5.7 ≥ 9.1 ≥ 8.3 ≥ 8.1   ≥ 4.3 1.6 ≥ 4.5*
Glycine precipitation (two subsequent steps) 3.9 2.1 n.d. 1.0   (1.0) (1.6) n.d.
Cumulative virus reduction (log10) ≥ 9.6 ≥ 11.2 ≥ 8.3 ≥ 9 .1 1.6 ≥ 6.7 4.4 ≥ 4.5
BVDV, bovine viral diarrhea virus, model for HCV
WNV,West Nile virus
HSV-1, herpes simplex virus type 1
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 mmunofuorescence-based detection method.
PRV as HSV-1 a 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

What are the possible side effects of fibrinogen (RiaSTAP)?

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any other serious side effect, such as:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • sudden cough, rapid breathing, fast heart rate;
  • chest pain or heavy feeling, pain spreading to the arm or...

Read All Potential Side Effects and See Pictures of RiaSTAP »

Last reviewed on RxList: 10/5/2009
This monograph has been modified to include the generic and brand name in many instances.