Medically reviewed by Drugs.com. Last updated on Sep 2, 2020.
Generic name: FIBRINOGEN HUMAN 1300mg in 50mL
Dosage form: injection, powder, lyophilized, for solution
For intravenous use only.
Treatment of Congenital Fibrinogen Deficiency
RiaSTAP dosing, duration of dosing and frequency of administration should be individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient.
RiaSTAP dose when baseline fibrinogen level is known.
Dose should be individually calculated for each patient based on the target plasma fibrinogen level based on the type of bleeding, actual measured plasma fibrinogen level and body weight, using the following formula [see Clinical Pharmacology (12.3)]:
|[Target level (mg/dL) - measured level (mg/dL)]|
|1.7 (mg/dL per mg/kg body weight)|
RiaSTAP dose when baseline fibrinogen level is not known.
If the patient's fibrinogen level is not known, the recommended dose is 70 mg per kg of body weight administered intravenously.
Monitor patient's fibrinogen level during treatment with RiaSTAP. Maintain a target fibrinogen level of 100 mg/dL until hemostasis is obtained.
Preparation and Reconstitution
The procedures below are provided as general guidelines for preparation and reconstitution of RiaSTAP.
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. Discard partially used vials.
RiaSTAP is stable for 8 hours after reconstitution when stored at 20-25°C; administer within this time period.
Before administration, filter reconstituted RiaSTAP solution with a 17-micron filter (not supplied) into an appropriate syringe.
More about RiaSTAP (fibrinogen)
- Side Effects
- During Pregnancy
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: miscellaneous coagulation modifiers
- FDA Approval History
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