Coagulation therapies
Important Safety Information About Helixate FS
Helixate FS is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Helixate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.
The most serious adverse reactions are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to antihemophilic factor. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.
Helixate FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.
Please see full prescribing information for Helixate FS.
Important Safety Information About Humate-P
Humate-P is indicated for treatment and prevention of bleeding in adult patients with 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 not indicated for the prophylaxis of spontaneous bleeding episodes.
Humate-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations.
Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.
Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement. Caution should be exercised and antithrombotic measures considered, particularly in patients with known risk factors for thrombosis.
Humate-P is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions observed by >5% of subjects are allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, and edema. For patients undergoing surgery, the most common adverse reactions are postoperative wound and injection-site bleeding, and epistaxis.
The most commonly reported adverse reactions in patients receiving Humate-P are allergic-anaphylactic reactions, including urticaria (hives), chest tightness, rash, pruritus (itching), and edema (swelling). For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, or nosebleed.
Please see full prescribing information for Humate-P.
Important Safety Information About Monoclate-P
Monoclate-P is indicated for treatment of classical hemophilia (Hemophilia A). Affected individuals frequently require therapy following minor accidents. Surgery, when required in such individuals, must be preceded by temporary corrections of the clotting abnormality. Monoclate-P is not effective in controlling the bleeding of patients with von Willebrand's disease.
Monoclate-P is contraindicated in individuals with a known hypersensitivity to mouse protein. Products of this type are known to have caused allergic reactions, mild chills, nausea, or stinging at the infusion site. In some cases, inhibitors of Factor VIII may occur.
Monoclate-P is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Please see full prescribing information for Monoclate-P.
Important Safety Information About Mononine
Mononine is indicated for the prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas disease.
Mononine is not indicated in the treatment or prophylaxis of Hemophilia A patients with inhibitors to Factor VIII.
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. 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 (DIC).
Please see full prescribing information for Mononine.
Important Safety Information About RiaSTAP
RiaSTAP 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 for RiaSTAP.
RiaSTAP is a trademark of CSL Behring GmbH
Important Safety Information About Stimate
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. See full prescribing information for a complete list of adverse reactions.
Please see full prescribing information for Stimate.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Last Updated:
5/19/2010 12:13 PM