Fibrinogen human
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From MedlinePlus, U.S. National Library of Medicine
Human Blood Coagulation Factor
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Reconstitution The procedures below are provided as general guidelines for preparation and reconstitution of RiaSTAP. Do not use RiaSTAP beyond the expiration date. RiaSTAP contains no preservative. Use aseptic technique when preparing and reconstituting RiaSTAP. Reconstitute RiaSTAP at room temperature as follows: Remove the cap from the product vial to expose the central portion of the rubber stopper.
Clean the surface of the rubber stopper with an antiseptic solution and allow it to dry. Using an appropriate transfer device or syringe, transfer 50 mL of Sterile Water for Injection into the product vial. Gently swirl the product vial to ensure the product is fully dissolved. Do not shake the vial. After reconstitution, the RiaSTAP solution should be colorless and clear to slightly opalescent.
Inspect visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Do not freeze RiaSTAP solution. Discard partially used vials. RiaSTAP is stable for 24 hours after reconstitution when stored at 20-25ºC and should be administered within this time period.
Administration Do not mix RiaSTAP with other medicinal products or intravenous solutions, and should be administered through a separate injection site. Use aseptic technique when administering RiaSTAP. Administer RiaSTAP at room temperature by slow intravenous injection at a rate not exceeding 5 mL per minute.
Drug interactions
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- Fibrinogen human
Contraindications
RiaSTAP is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP or its components. Anaphylactic or severe reactions to RiaSTAP or its components ( 4 ).
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for fibrinogen human. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with RiaSTAP. It is not known whether RiaSTAP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RiaSTAP should be used during pregnancy only if clearly needed.
Lactation
8.3 Nursing Mothers RiaSTAP has not been studied in nursing mothers with congenital fibrinogen deficiency.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.