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Critical Care & Immunology
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RAPID Extension Data Published in Lancet ...
FDA Approves Berinert®
for Pediatric ...
Now Available in the U.S.
FDA Approves AFSTYLA®
FDA Grants IDELVION®
7 Years of ...
rIX-FP for Hemophilia B Phase III Data Presented ...
NTAP Extended by CMS
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.
Important Safety Information for Berinert
Berinert®, C1 Esterase Inhibitor (Human), is used in adults and children to treat swelling and/or painful attacks of hereditary angioedema (HAE) affecting the abdomen, face or throat. The safety and efficacy of Berinert in preventing HAE attacks have not been established.
Do not use Berinert if you have experienced life-threatening allergic reactions or severe
hypersensitivity to the product. Inform your healthcare provider of all medications you
are taking and of any medical conditions, especially any history of blood-clotting
Blood clots have occurred in patients receiving Berinert. Tell your healthcare provider
if you have a history of heart or blood vessel disease, stroke, or blood clots, or if you
have thick blood, an indwelling catheter/access device in a vein, or have been immobile
for some time. Certain medications, such as birth control pills, may also increase your risk of clotting problems.
Report to your physician or an emergency room any signs and symptoms of a blood
clot, including pain and/or swelling or discoloration of an arm or leg, with warmth over
affected area; unexplained shortness of breath; chest pain or discomfort that worsens on
deep breathing; rapid pulse; and numbness or weakness on one side of the body.
In addition, report immediately any signs or symptoms of allergic reactions to Berinert,
including hives, chest tightness, wheezing, difficulty breathing, turning blue, faintness,
facial swelling and fast heartbeat.
If you have been trained to self-administer Berinert, immediately prepare the prescribed
dose at the first symptoms of an attack. Seek immediate medical attention and do not
begin to self-adminster if an HAE attack has progressed to a point where you will be
unable to prepare or administer a dose of Berinert.
If you self-administer to treat a laryngeal attack, immediately seek medical attention
afterward. If you self-administer for an abdominal attack, inform your physician so that
other possible causes can be ruled out.
Call your doctor right away if swelling is not controlled after use of Berinert.
In clinical studies, the most serious adverse reaction reported in subjects who received
Berinert was an increased severity of the pain associated with HAE. In the placebocontrolled
clinical trial, the most common adverse reaction reported more often among
subjects who received Berinert than those receiving placebo was dysgeusia (a bad taste
in mouth). Tell your healthcare provider about any side effect that bothers you or does
not go away.
Because Berinert is made from human blood, the risk that it may transmit infectious
agents, including viruses and theoretically, the agents of Creutzfeldt-Jakob Disease (CJD)
and its variant form (vCJD), cannot be completely eliminated.
Please see full prescribing information for Berinert, including 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.