CSL Behring develops, manufactures and markets protein based therapies, including:
Coagulation & Bleeding Disorders
Critical Care & Immunology
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FDA Approves Berinert®
for Pediatric ...
Now Available in the U.S.
FDA Approves AFSTYLA®
FDA Grants IDELVION®
7 Years of ...
Webinar series aims to help young adults with PI ...
rIX-FP for Hemophilia B Phase III Data Presented ...
NTAP Extended by CMS
Important Safety Information for Hizentra
Immune Globulin Subcutaneous (Human), Hizentra®, treats various forms of primary immunodeficiency (PI) in patients age 2 and over.
WARNING: Thrombosis (blood clotting) can occur with immune globulin products, including Hizentra. Risk factors can include: advanced age, prolonged immobilization, a history of blood clotting or hyperviscosity (blood thickness), use of estrogens, installed vascular catheters, and cardiovascular risk factors.
If you are at high risk of thrombosis, your doctor will prescribe Hizentra at the minimum dose and infusion rate practicable and will monitor you for signs of thrombosis and hyperviscosity. Always drink sufficient fluids before administration.
Tell your doctor if you have had a serious reaction to other immune globulin medicines or have been told you also have a deficiency of the immunoglobulin called IgA, as you might not be able to take Hizentra. You should not take Hizentra if you know you have hyperprolinemia (too much proline in your blood).
Infuse Hizentra under your skin only; do not inject into a blood vessel.
Allergic reactions can occur with Hizentra. If your doctor suspects you are having a bad allergic reaction or are going into shock, treatment will be discontinued. Immediately tell your doctor or go to the emergency room if you have signs of such a reaction, including hives, trouble breathing, wheezing, dizziness, or fainting.
Tell your doctor about any side effects that concern you. Immediately report symptoms that could indicate a blood clot, including pain and/or swelling of an arm or leg, with warmth over affected area; discoloration in arm or leg; unexplained shortness of breath; chest pain or discomfort that worsens with deep breathing; unexplained rapid pulse; and numbness or weakness on one side of the body. Your doctor will also monitor symptoms that could indicate hemolysis (destruction of red blood cells), and other potentially serious reactions that have been seen with Ig treatment, including aseptic meningitis syndrome (brain swelling); kidney problems; and transfusion-related acute lung injury.
The most common drug-related adverse reactions in the clinical trial for Hizentra were swelling, pain, redness, heat or itching at the site of injection; headache; back pain; diarrhea; tiredness; cough; rash; itching; nausea and vomiting.
Hizentra is made from components of human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Before being treated with Hizentra, inform your doctor if you are pregnant, nursing or plan to become pregnant. Vaccines (such as measles, mumps and rubella) might not work well if you are using Hizentra. Before receiving any vaccine, tell the healthcare professional you are being treated with Hizentra.
Please see full prescribing information for Hizentra, including boxed warning and the patient product 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 Kcentra
Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.
WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS
Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.
Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).
Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.
In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.
Kcentra 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.
The safety and efficacy of Kcentra in pediatric use have not been studied, and Kcentra should be used in women who are pregnant or nursing only if clearly needed.
Please see full prescribing information for Kcentra.
Important Safety Information for IDELVION
IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP), is contraindicated in patients who have had life-threatening hypersensitivity to the product or its components, including hamster proteins.
IDELVION is for intravenous use only. IDELVION can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center. Higher dose per kilogram body weight or more frequent dosing may be needed for pediatric patients.
Hypersensitivity reactions, including anaphylaxis, are possible. Advise patients who self-administer to immediately report symptoms of hypersensitivity, including angioedema, chest tightness, hypotension, generalized urticaria, wheezing, and dyspnea. If symptoms occur, discontinue IDELVION and administer appropriate treatment.
Development of neutralizing antibodies (inhibitors) to IDELVION may occur. If expected Factor IX activity plasma levels are not attained or bleeding is not controlled with appropriate dose, perform an assay to measure Factor IX inhibitor concentration. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
Thromboembolism (eg, pulmonary embolism, venous thrombosis, and arterial thrombosis) can occur when using Factor IX-containing products. In addition, nephrotic syndrome has been reported following immune tolerance induction in hemophilia B patients with Factor IX inhibitors and allergic reactions to Factor IX.
The most common adverse reaction (incidence ≥1%) reported in clinical trials was headache.
Indications for IDELVION
IDELVION is indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for:
- On-demand control and prevention of bleeding episodes
- Perioperative management of bleeding
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
IDELVION is not indicated for induction of immune tolerance in patients with hemophilia B.
Please see full prescribing information for IDELVION.
Important Safety Information for AFSTYLA
AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is contraindicated in patients who have had life-threatening hypersensitivity reactions to AFSTYLA or its excipients, or to hamster proteins.
AFSTYLA is for intravenous use only. AFSTYLA can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center. Higher and/or more frequent dosing may be needed for patients under 12 years of age.
Hypersensitivity reactions, including anaphylaxis, are possible. Advise patients to immediately report symptoms of a hypersensitivity reaction. If symptoms occur, discontinue AFSTYLA and administer appropriate treatment.
Development of Factor VIII (FVIII) neutralizing antibodies (inhibitors) can occur. If expected FVIII activity levels are not attained or bleeding is not controlled with appropriate dose, perform an assay to measure FVIII inhibitor concentration.
Monitor plasma FVIII activity using a chromogenic assay or one-stage clotting assay. If one-stage clotting assay is used, multiply result by a conversion factor of 2 to determine FVIII activity level.
The most common adverse reactions reported in clinical trials (>0.5%) were dizziness and hypersensitivity.
Indications for AFSTYLA
AFSTYLA is indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
- On-demand treatment and control of bleeding episodes
- Routine prophylaxis to reduce frequency of bleeding episodes
- Perioperative management of bleeding
AFSTYLA is not indicated for the treatment of von Willebrand disease.
Please see full prescribing information for AFSTYLA.