RiaSTAP

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;
  • ...

Read All Potential Side Effects and See Pictures of RiaSTAP


RiaSTAP Patient Information Including Side Effects

Brand Names: RiaSTAP

Generic Name: fibrinogen (Pronunciation: fye BRIN oh gen)

  • What is fibrinogen (RiaSTAP)?
  • What are the possible side effects of fibrinogen (RiaSTAP)?
  • What is the most important information I should know about fibrinogen (RiaSTAP)?
  • What should I discuss with my health care provider before using fibrinogen (RiaSTAP)?
  • How should I use fibrinogen (RiaSTAP)?
  • What happens if I miss a dose (RiaSTAP)?
  • What happens if I overdose (RiaSTAP)?
  • What should I avoid while taking fibrinogen (RiaSTAP)?
  • What other drugs will affect fibrinogen (RiaSTAP)?
  • Where can I get more information?

What is fibrinogen (RiaSTAP)?

Fibrinogen is a man-made form of a protein that occurs naturally in the body and helps the blood clot.

Fibrinogen is used to treat bleeding episodes in people who have a congenital fibrinogen deficiency.

Fibrinogen may also be used for other purposes not listed in this medication guide.

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 shoulder, nausea, sweating, general ill feeling; or
  • pain or swelling in one or both legs.

Less serious side effects may include:

  • fever
  • chills;
  • nausea; or
  • vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fibrinogen (RiaSTAP)?

You should not use this medication if you have ever had an allergic reaction to it, or if you have ever had any life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using fibrinogen, tell your doctor if you have a history of stroke or blood clot.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not mix the medicine until you are ready to give the injection.

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.

Other serious side effects may include sudden numbness or weakness, chest pain, confusion, pain or swelling in your one or both legs, and problems with vision, speech, or balance.

Fibrinogen is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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