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RiaSTAP

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RiaSTAP

RiaSTAP

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

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). 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 (fibrinogen concentrate (human) for intravenous use) . Weigh the benefits of RiaSTAP (fibrinogen concentrate (human) for intravenous use) administration versus the risk of thrombosis. Patients receiving RiaSTAP should be monitored for signs and symptoms of thrombosis. (see Patient Counseling Information)

Transmissible Infectious Agents

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

Use In Specific Populations

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with RiaSTAP (fibrinogen concentrate (human) for intravenous use) It is not known whether RiaSTAP (fibrinogen concentrate (human) for intravenous use) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RiaSTAP (fibrinogen concentrate (human) for intravenous use) should be used during pregnancy only if clearly needed.

Labor and Delivery

RiaSTAP (fibrinogen concentrate (human) for intravenous use) has not been studied for use during labor and delivery

Nursing Mothers

RiaSTAP (fibrinogen concentrate (human) for intravenous use) has not been studied in nursing mothers with congenital fibrinogen deficiency

Pediatric Use

RiaSTAP (fibrinogen concentrate (human) for intravenous use) studies have included subjects below the age of 16 years. In the pharmacokinetic study (see Pharmacokinetics), 2 children (8 and 11 years), 3 adolescents (12, 14 and 16 years), were studied. Subjects less than 16 years of age (n = 4) had shorter half-life (69.9 ± 8.5h) and faster clearance (0.7 ± 0.1 mg/L) compared to adults (half-life: 82.3 ± 20.0h, clearance: 0.53 ± 0.1 mg/L). The number of subjects less than 16 years of age in this study limits statistical interpretation.

Geriatric Use

The safety and efficacy of RiaSTAP (fibrinogen concentrate (human) for intravenous use) in the geriatric population has not been studied. There were an insufficient number of subjects in this age group to determine whether they respond differently from younger subjects.

REFERENCES

1. Peyvandi F, Haertal S, KnaubS, etal. Incidence of bleeding symptoms in 100 patients with inherited afibrinogenemia or hypofibrinogenemia. J Thromb Haemost 2006; 4:1634-7.

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

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