RiaSTAP

No information provided.

You should not use fibrinogen if you are allergic to it, or if you have ever had a severe allergic reaction.

To make sure fibrinogen is safe for you, tell your doctor if you have:

• a history of stroke or blood clot.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether fibrinogen passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

Acute Bleeding Episodes

Used to control acute bleeding episodes in patients with congenital fibrinogen deficiency (i.e., afibrinogenemia [absence or extremely low concentrations of plasma fibrinogen], hypofibrinogenemia [reduced concentrations of plasma fibrinogen]); designated an orphan drug by FDA for use in this condition.1 2 3 4

Not indicated in patients with dysfibrinogenemia (presence of abnormal or dysfunctional fibrinogen).1

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

• It is used to stop bleeding.

For intravenous use only. Reconstitute prior to use.

Should be administered under the supervision of a physician.

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 Pharmacokinetics [12.3]):

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.

Monitoring of patient's fibrinogen level is recommended during treatment with RiaSTAP. 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.

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:

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 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.

Allergic Reactions

Allergic reactions may occur. If symptoms of allergic or early signs of hypersensitivity reactions (including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) occur, immediately discontinue administration (see Patient Counseling Information [17.1]). The treatment required depends on the nature and severity of the reaction.

Thrombosis

Thrombosis may occur spontaneously in patients with congenital fibrinogen deficiency with or without the use of fibrinogen replacement therapy.1 Thromboembolic events have been reported in patients treated with RiaSTAP. Weigh the benefits of RiaSTAP administration versus the risk of thrombosis. Patients receiving RiaSTAP should be monitored for signs and symptoms of thrombosis. (see Patient Counseling Information [17.2])

Transmissible Infectious Agents

RiaSTAP is made from human plasma. Products made from human plasma may contain infectious agents (e.g., viruses and theoretically the Creutzfeldt-Jakob disease agent [CJD]) that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by a process demonstrated to inactivate and/or remove certain viruses during manufacturing. (see Description [11]). Despite these measures, such products may still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products (see Patient Counseling Information [17.3]). All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 1-866-915-6958.

1. Peyvandi F, Haertal S, Knaub S, et al. Incidence of bleeding symptoms in 100 patients with inherited afibrinogenemia or hypofibrinogenemia. J Thromb Haemost 2006; 4:1634-7.
2. Kreuz W, Meili E, Peter-Salonen K, et al. Pharmacokinetic properties of a pasteurized fibrinogen concentrate. Transfusion and Apheresis Science 2005;32:239-46.
3. Colman R, Clowes A, George J, et al. Overview of Hemostasis. In: Hemostasis and Thrombosis: Basic Principles and Clinical Practice (5th ed.). Colman R, Clowes A, George J, Goldhaber S, Marder VJ (eds.). Lippincott Williams & Wilkins, Philadelphia 2006:11-14.
4. Kreuz W, Meili E, Peter-Salonen K, et al. Efficacy and tolerability of a pasteurized human fibrinogen concentrate in patients with congenital fibrinogen deficiency. Transfusion and Apheresis Science 2005;32:247-253.
5. Fries D, Innerhofer P, Reif C, et al. The Effect of Fibrinogen Substitution on Reversal of Dilutional Coagulopathy: An In Vitro Model. Anesth Analg 2006; 102:347-351.
6. Kalina U, Stöhr HA, Bickhard H, et. al. Rotational thromboelastography for monitoring of fibrinogen concentrate therapy in fibrinogen deficiency. Blood Coagulation and Fibrinolysis. 2008; 19:777-783.

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

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

The following dosage form is available:

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

Other drugs may interact with fibrinogen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.