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Coagulation and Bleeding Disorders
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Coagulation and Bleeding Disorders

According to the National Hemophilia Foundation, Hemophilia is a genetic disorder marked by prolonged bleeding due to low levels or absence of one of the coagulation factors needed to form blood clots. Caused by a faulty gene that impairs the body's ability to produce enough factor to cause clotting, hemophilia affects approximately 1 in 5000 males. In the most common types of hemophilia, levels of either factor VIII (eight) or factor IX (nine) are low or missing.

CSL Behring offers a wide range of plasma-derived and recombinant therapies and pharmaceuticals for the treatment of bleeding disorders. We also provide a variety of support services specially targeted to address the needs of people with bleeding disorders, their families, and their healthcare providers.

Hemophilia A

Hemophilia A is a deficiency of factor VIII. About 80% of people with hemophilia have hemophilia A.

People with hemophilia A need to increase the level of factor VIII in their blood. This is done with what is known as "factor replacement therapy." One type of therapy involves injection of replacement factor VIII directly into their blood, a process called "infusion." Some people with the mild type of hemophilia A can be infused with the chemical DDAVP (desmopressin acetate) or use a nasal spray containing highly concentrated DDAVP. DDAVP causes the release of factor VIII from storage sites in the body.

Hemophilia B

Hemophilia B is a deficiency of factor IX. About 15% of people with hemophilia have hemophilia B.

People with hemophilia B need to increase the level of factor IX in their blood. This can also be accomplished with "factor replacement therapy." People with this type of hemophilia must inject replacement factor IX directly into their blood, a process known as infusion.

von Willebrand Disease

von Willebrand disease (VWD) is a hereditary disorder characterized by abnormally slow clotting of the blood. Patients with von Willebrand disease may have spontaneous and prolonged bleeding from the nose and gums. VWD occurs in about one in 100 persons and is equally likely to affect males and females.

von Willebrand disease occurs when one of the coagulation factors, called von Willebrand factor, is not sufficiently present in the blood or does not work properly. The lower the level of active von Willebrand factor in a person's blood, the more severe the disease. In many patients with von Willebrand disease, another coagulation factor, factor VIII, is also affected.

For more information about Hemophilia A, Hemophilia B, and von Willebrand disease, and the CSL Behring products available to treat these disorders, please visit these CSL Behring websites:

www.helixatefs.com
www.Hemophiliamoms.com
www.humate-p.com
www.mysourcecsl.com
www.stimate.com


Important Safety Information for Corifact

Corifact®, FXIII Concentrate (Human), provides routine preventive treatment and management of surgical bleeding in adults and children with congenital Factor XIII deficiency. Corifact must be given by a healthcare professional through an intravenous injection.

Do not use Corifact if you have experienced severe, immediate sensitivity reactions (including shock) to human plasma-derived products. Before being treated with Corifact, tell your healthcare provider about all medical conditions you may have (including pregnancy and breastfeeding), as well as all prescription and non-prescription medications you are using.

Contact your physician, treatment administrator or local emergency department right away if you notice any of the following symptoms after using Corifact: shortness of breath, hives, rash, tightness or pain in the chest, wheezing, fainting or dizziness, and signs of a blood clot (including pain, swelling, warmth, redness, or a lump in the legs or arms).

Other possible side effects include chills or fever, joint pain, headache,and breakthrough bleeding and pain (caused by formation of antibodies against Corifact). These are not all the possible side effects of Corifact. Tell your healthcare professional about any undesirable side effect that bothers you or does not go away.

Corifact is made from human blood plasma, and the risk of transmitting infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Please see full prescribing information for Corifact.

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.


Important Safety Information for HELIXATE FS

Helixate® FS is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product.

Hypersensitivity reactions, including anaphylaxis have been reported with Helixate FS. Reported symptoms included facial swelling, flushing, hives, decrease in blood pressure, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, and vomiting. Discontinue Helixate FS if symptoms occur and seek immediate emergency treatment

Neutralizing antibodies (inhibitors) have been reported following administration of Helixate FS predominately in previously untreated patients. Carefully monitor patients for the development of factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.

Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk of developing cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with factor VIII.

Serious adverse reactions seen with Helixate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

The most common adverse reactions (≥4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion-site reactions, and central venous access device (CVAD) associated infections.

Indications for HELIXATE FS

HELIXATE FS, Antihemophilic Factor (Recombinant), is indicated for:

  • On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.
  • Perioperative management of bleeding in adults and children with hemophilia A.
  • Routine prophylactic treatment to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without preexisting joint damage.
  • Routine prophylactic treatment to reduce the frequency of bleeding episodes in adults with hemophilia A.

HELIXATE FS is not indicated for the treatment of von Willebrand disease.

Please see full prescribing information for HELIXATE FS.


Important Safety Information for Humate-P

Antihemophilic Factor/von Willebrand Factor Complex (Human), Humate-P® is approved to treat and prevent bleeding in adult patients with hemophilia A (classical hemophilia). Humate-P also treats spontaneous or trauma-induced bleeding episodes in adults and children with von Willebrand disease (VWD) and prevents excessive bleeding during and after surgery in patients with mild, moderate or severe VWD. Humate-P is not known to prevent spontaneous bleeding episodes.

Do not take Humate-P if you have had extreme sensitivity or an allergic response to antihemophilic or von Willebrand factor preparations. Your doctor will monitor you for events related to abnormal blood clotting.

Humate-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing.

In studies, more than 5% of patients reported the following adverse reactions to Humate-P: allergic/anaphylactic reactions, including hives, chest tightness, rash, itching, and swelling. The most common adverse reactions after surgery were bleeding at the wound or infusion site, and nosebleeds.

Please see full prescribing information.

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.


Important Safety Information for Stimate

Stimate® (desmopressin acetate) Nasal Spray, 1.5 mg/mL is a treatment used to stop some types of bleeding in people with mild hemophilia A or mild to moderate von Willebrand disease (VWD) Type 1. Stimate Nasal Spray should not be used in children under 11 months of age.

All patients using Stimate Nasal Spray are at risk of water intoxication, fluid overload and low sodium levels in the blood. Follow your healthcare provider’s instructions on limiting the amount of fluid you drink when using Stimate Nasal Spray, as too much fluid intake can lead to serious adverse reactions, including seizures, coma, and even death. Fluid restrictions are especially important for children and elderly patients, as they are at higher risk for these reactions.

See the patient information leaflet in the prescribing information for Stimate Nasal Spray for symptoms that could mean your blood sodium level is low—including headache, hallucinations, confusion, restlessness, weight gain and muscle spasms. Immediately report any of these symptoms to your physician or, if necessary, an emergency department. Also contact your doctor immediately if you have uncontrolled bleeding.

Before being prescribed Stimate Nasal Spray, make sure your doctor knows about all your medical conditions and about any medications you are taking. Use Stimate Nasal Spray exactly as your healthcare provider has instructed.

Side effects of Stimate Nasal Spray generally come from having too much water in the body. The most common include facial flushing, nasal congestion, runny nose, nose bleed, sore throat, cough, and upper respiratory infections. Tell your healthcare provider if you experience a side effect that does not go away.

Please see full prescribing information for Stimate Nasal Spray

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.


CRP16-05-0001 05/2016
© 2017 CSL Behring