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RiaSTAP™, fibrinogen concentrate (human), is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. RiaSTAP™ is not indicated for dysfibrinogenemia.
RiaSTAP™ was approved using maximum clot firmness (MCF) as a surrogate marker likely to predict clinical benefit. Thus, the hemostatic efficacy of RiaSTAP™ in acute bleeding episodes has not been established. A post-marketing study is being conducted to verify clinical endpoints.
RiaSTAP™ is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP™ or its components.
Monitor patients for early signs of allergic or hypersensitivity reactions, and if necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving RiaSTAP™; weigh the benefits of administration versus the risks of thrombosis.
RiaSTAP™ is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The most serious adverse reactions that have been reported in subjects in clinical studies who received RiaSTAP™ are thromboembolic episodes, including myocardial infarction and pulmonary embolism, and allergic-anaphylactic reactions. The most common adverse reactions observed are allergic reactions, including chills, fever, nausea, and vomiting. Monitor patients for early signs of allergic or hypersensitivity reactions, and if necessary, discontinue administration.
Please see full Prescribing Information.
RiaSTAP™ is a trademark of CSL Behring GmbH
Helixate® FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the treatment of hemophilia A.
The most frequently reported adverse events were local injection-site reactions, dizziness, and rash.
Known intolerance or allergic reactions to constituents of the preparation is a contraindication to the use of Helixate® FS. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Helixate® FS.
Please see the full prescribing information for Helixate® FS.
Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, Humate-P® is indicated in adult patients for treatment and prevention of bleeding in hemophilia A (classical hemophilia). Humate-P® is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate.
Humate-P® is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations or to any of its components.
Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement, especially in the setting of known risk factors for thrombosis. Caution should be exercised and antithrombotic measures considered.
Humate-P® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Although few adverse reactions have been reported the most common are allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, edema, shock, chills and fever, and hypervolemia. For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding.
Please see the full prescribing information for Humate-P®.
Monoclate-P® is contraindicated in patients with known hypersensitivity to mouse protein.
Products of this type are known to cause allergic reactions, mild chills, nausea or stinging at the infusion site. In
some cases, inhibitors of FVIII may occur.
Monoclate-P® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease agent, cannot be completely eliminated.
Please see the full prescribing information for Monoclate-P®.
Mononine® is contraindicated in patients with known
hypersensitivity to mouse protein.
The following adverse reactions may be observed after administration:
headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, hives,
stinging or burning at the infusion site, or other manifestations of allergic
reactions, including anaphylaxis.
Mononine® is derived from human plasma. As with all plasma-derived
products, the risk of transmission of infectious agents, including viruses and,
theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely
eliminated.
Since the use of Factor IX Complex concentrates has historically been
associated with the development of thromboembolic complications, the use of
Factor IX-containing products may be potentially hazardous in patients with
signs of fibrinolysis and in patients with disseminated intravascular
coagulation.
Please see the full prescribing information for Mononine®.
Stimate® Nasal Spray is indicated for patients with mild to moderate classic type 1 von
Willebrand disease (VWD) with Factor VIII levels greater than 5%. Stimate® Nasal Spray is not
indicated for the treatment of severe classic VWD (type 1) and when there is evidence of an abnormal molecular
form of Factor VIII antigen.
Stimate® Nasal Spray is contraindicated in individuals with a known hypersensitivity to
desmopressin or any of the components of Stimate®. Stimate® should not be
used in patients with type 2B VWD, since platelet aggregation may be induced. Stimate® Nasal
Spray is for intranasal use only.
To decrease the potential for hyponatremia or water intoxication, especially in the young and the elderly,
patients using desmopressin who are not in need of antidiuretic hormone for its antidiuretic effect should be
cautioned to reduce fluid intake, ingesting only enough to satisfy thirst. Such patients should be monitored
for the rare occurrence of an extreme decrease in plasma osmolality that could result in seizures, possibly
leading to coma.
Other adverse reactions reported with use of injectable and/or intranasal desmopressin acetate include
headache, nausea, somnolence, dizziness, chest pain, palpitations and tachycardia, and severe allergic
reactions, including anaphylaxis.
Please see the full prescribing
information for Stimate®.
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