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

RiaSTAP (fibrinogen concentrate (human) for intravenous use) is not indicated for dysfibrinogenemia

For intravenous use only. Reconstitute prior to use.

Should be administered under the supervision of a physician.

Treatment of Congenital Fibrinogen Defciency

RiaSTAP (fibrinogen concentrate (human) for intravenous use) 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 (fibrinogen concentrate (human) for intravenous use) 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 Pharmacokinetics):

RiaSTAP (fibrinogen concentrate (human) for intravenous use) 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.

Monitoring of patient's  fibrinogen level is recommended during treatment with RiaSTAP (fibrinogen concentrate (human) for intravenous use) . A target  fibrinogen level of 100 mg/dL should be maintained until hemostasis is obtained.

Preparation and Reconstitution

The procedures below are provided as general guidelines for preparation and reconstitution of RiaSTAP (fibrinogen concentrate (human) for intravenous use) .

Do not use RiaSTAP (fibrinogen concentrate (human) for intravenous use) beyond the expiration date. RiaSTAP (fibrinogen concentrate (human) for intravenous use) contains no preservative. Use aseptic technique when preparing and reconstituting RiaSTAP (fibrinogen concentrate (human) for intravenous use) .

Reconstitute RiaSTAP (fibrinogen concentrate (human) for intravenous use) at room temperature as follows:

1. Remove the cap from the product vial to expose the central portion of the rubber stopper.
2. Clean the surface of the rubber stopper with an antiseptic solution and allow it to dry.
3. Using an appropriate transfer device or syringe, transfer 50 mL of Sterile Water for Injection into the product vial.
4. Gently swirl the product vial to ensure the product is fully dissolved. Do not shake the vial.

After reconstitution, the RiaSTAP (fibrinogen concentrate (human) for intravenous use) 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 (fibrinogen concentrate (human) for intravenous use) solution. Discard partially used vials.

RiaSTAP (fibrinogen concentrate (human) for intravenous use) 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 (fibrinogen concentrate (human) for intravenous use) with other medicinal products or intravenous solutions, and should be administered through a separate injection site.

Use aseptic technique when administering RiaSTAP (fibrinogen concentrate (human) for intravenous use)

Administer RiaSTAP (fibrinogen concentrate (human) for intravenous use) at room temperature by slow intravenous injection at a rate not exceeding 5 mL per minute.

Dosage Forms And Strengths

RiaSTAP (fibrinogen concentrate (human) for intravenous use) is available as a single-use vial containing 900 mg to 1300 mg lyophilized fibrinogen concentrate powder for reconstitution with 50 mL of Sterile Water for Injection. The actual fibrinogen potency for each lot is printed on the vial label and carton.

RiaSTAP (fibrinogen concentrate (human) for intravenous use) is supplied in a single-use vial. Each carton contains one vial of RiaSTAP (fibrinogen concentrate (human) for intravenous use) . The components used in the packaging for RiaSTAP (fibrinogen concentrate (human) for intravenous use) are latex-free.

The actual potency of fibrinogen concentrate in milligram (mg) is stated on each RiaSTAP (fibrinogen concentrate (human) for intravenous use) vial label and carton.

The following dosage form is available:

When stored at temperatures of 2-25°C (36-77°F), RiaSTAP (fibrinogen concentrate (human) for intravenous use) is stable for the period idicated by the expiration date on the carton and vial label (up to 30 months). Keep RiaSTAP (fibrinogen concentrate (human) for intravenous use) in its original carton until ready to use. Do not freeze. Protect from light.

Manufactured by: CSL Behring GmbH. 35041 Marburg Germany. Distributed by: CSL Behring LLC Kankakee, IL 60901 USA

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