DOCSLIB.ORG

Mononine Diagnostic Codes

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Mononine Diagnostic Codes 12/4/2017 Mononine ® United States Home > US Products > Mononine® Mononine ® Coagulation Factor IX (Human) Monoclonal Antibody Purified Full Prescribing Information for Mononine® Important Safety Information Mononine is indicated for the prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease. A high-purity factor IX product with a track record of over half a billion units infused since 1992 without any confirmed cases of thrombotic events or viral transmissions Unique three-step viral inactivation and removal process designed to protect against both lipid-enveloped and certain non-lipid- enveloped viruses Peel-off labels designed for patient convenience Diagnostic Codes (ICD-10-CM) ICD-10-CM Codes Used to identify patient medical conditions (for claims with a date of service on or after October 1, 2015) Code Description D67 Hereditary factor IX deficiency 30233W1 Transfusion of Nonautologous Factor IX into peripheral vein, percutaneous approach 30243W1 Transfusion of Nonautologous Factor IX into central vein, percutaneous approach Billing Codes (HCPCS, NDC, CPT) HCPCS Codes The following HCPCS codes describe supplies (including drugs) rendered by the billing provider. CMS publishes and maintains the HCPCS code set. These codes are entered to paper claim form CMS-1500 in Field 24; or, to electronic claim form ASC 837P in Loop 2400, Segment SV101-2, with the Qualifier "HC" entered to Segment SV101-1, unless otherwise directed by the payor. Code Description J7193 FACTOR IX (ANTIHEMOPHILIC FACTOR, PURIFIED, NON-RECOMBINANT) PER IU NDC Codes Certain payors may require the entry of NDC information to the claim form, as directed by the payor. Approximate FVIII activity per NDC Number vial 500 IU 00053-6232-02 1000 IU 00053-6233-02 CPT Codes If the billing provider performs administration services in conjunction with a patient's infusion, the following administration codes may be used to bill for this service if the service meets the requirements of the code description. Code Description 96365 Intravenous infusion for therapy, prophylaxis or diagnosis (specify substance or drug); intial up to 1 hour. 96366 Each additional hour 96374 Intravenous push, single or initial substance/drug 96376 Each additional sequential intravenous push of the same substance/drug provided in a facility http://www.cslbehring-us.com/products/Mononine.htm 1/2 12/4/2017 Mononine ® Authorized Distributors Companies ABO Pharmaceuticals ASD Healthcare/AmeriSourceBergen Atlantic Biologics Corp BCA BDI Pharma BioCare Cardinal Health Specialty Pharmaceutical Distribution CT International FFF Enterprises Health Coalition HMPG Pharmacy LLC Lifeline Pharmaceuticals LLC McKesson Plasma & Biologicals LLC National Hospital Specialties New York Blood Center Prodigy Health Provider Smith Medical Partners Safety Data Sheets Safety Data Sheets (SDS) for Mononine. Important Safety Information for Mononine Coagulation Factor IX (Human), 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. http://www.cslbehring-us.com/products/Mononine.htm 2/2.
Load more

Recommended publications
  • CSL Behring Letterhead Template
    AFSTYLA®, for Haemophilia A, Receives Positive Opinion from European Medicines Agency CHMP MARBURG, Germany — 14 November 2016 CHMP positive opinion moves AFSTYLA one step closer to approval in the European Union AFSTYLA is the first and only single-chain therapy for haemophilia A. The therapy has been specifically designed for greater molecular stability and duration of action through strong affinity to von Willebrand factor (VWF) AFSTYLA has been shown to offer excellent haemostatic efficacy in both prophylaxis and on-demand treatment, and the option of twice weekly dosing with low unit consumption Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AFSTYLA® [Recombinant Human Coagulation Factor VIII, Single Chain] for patients with haemophilia A. AFSTYLA, CSL Behring’s novel, recombinant factor VIII therapy for adults and children, is the first and only single-chain product for haemophilia A. It is specifically designed for protection from bleeds with two or three times weekly dosing and low unit consumption at both dosing regimens. In clinical trials, AFSTYLA demonstrated a strong safety profile with no inhibitors observed in previously treated patients undergoing prophylaxis. “For 100 years, CSL has focused on researching and developing innovative therapies that meet the treatment challenges patients face,” said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. “CHMP’s positive opinion for AFSTYLA® moves us one step closer to bringing this novel treatment option to haemophilia A patients in the European Union. Once approved, AFSTYLA will provide adults and children with a therapy that delivers on our promise to develop and bring to market innovative specialty biotherapies that help patients live full lives.” About Haemophilia A Primarily affecting males, haemophilia A is a congenital bleeding disorder characterised by deficient or defective factor VIII.
    [Show full text]
  • MONONINE (“Difficulty ® Monoclonal Antibody Purified in Concentrating”; Subject Recovered)
    CSL Behring IU/kg (n=38), 0.98 ± 0.45 K at doses >95-115 IU/kg (n=21), 0.70 ± 0.38 K at doses >115-135 IU/kg (n=2), 0.67 K at doses >135-155 IU/kg (n=1), and 0.73 ± 0.34 K at doses >155 IU/kg (n=5). Among the 36 subjects who received these high doses, only one (2.8%) Coagulation Factor IX (Human) reported an adverse experience with a possible relationship to MONONINE (“difficulty ® Monoclonal Antibody Purified in concentrating”; subject recovered). In no subjects were thrombo genic complications MONONINE observed or reported.4 only The manufacturing procedure for MONONINE includes multiple processing steps that DESCRIPTION have been designed to reduce the risk of virus transmission. Validation studies of the Coagulation Factor IX (Human), MONONINE® is a sterile, stable, lyophilized concentrate monoclonal antibody (MAb) immunoaffinity chromatography/chemical treatment step and of Factor IX prepared from pooled human plasma and is intended for use in therapy nanofiltration step used in the production of MONONINE doc ument the virus reduction of Factor IX deficiency, known as Hemophilia B or Christmas disease. MONONINE is capacity of the processes employed. These studies were conducted using the rel evant purified of extraneous plasma-derived proteins, including Factors II, VII and X, by use of enveloped and non-enveloped viruses. The results of these virus validation studies utilizing immunoaffinity chromatography. A murine monoclonal antibody to Factor IX is used as an a wide range of viruses with different physicochemical properties are summarized in Table affinity ligand to isolate Factor IX from the source material.
    [Show full text]
  • (Human) Monoclate-P® Factor VIII: C Pasteurized Monoclonal Antibody Purified
    CSL Behring 1020 First Avenue PO Box 61501 King of Prussia, PA 19406-0901 Tel 610-878-4000 March 2018 Important availability information for Antihemophilic Factor (Human) Monoclate-P® Factor VIII: C Pasteurized Monoclonal Antibody Purified Dear Valued Customer: Throughout CSL Behring’s long history of providing leading hemophilia treatments, we have offered a broad portfolio of products, including Antihemophilic Factor (Human) Monoclate- P® Factor VIII:C Pasteurized Monoclonal Antibody Purified. We are writing now to keep you updated about product availability. CSL Behring has made the difficult decision to discontinue Monoclate-P and we estimate that supply will be available through December 2018, giving you time to consider your patients’ treatment options. Please note that due to expiration dating, availability of the 1500 IU vial size may be limited. We recognize that Monoclate-P has been an important part of your patients’ lives, and we remain committed to keeping you informed so you can appropriately advise them. We also want to share the rationale behind this decision. As hemophilia A treatment has advanced, and patients have transitioned from plasma-derived to recombinant and longer-acting therapies, it has been increasingly difficult to sustain the production and distribution of Monoclate-P. We encourage your Monoclate-P patients to speak with their physician regarding treatment options. As a patient-focused company, CSL Behring strives to create innovative therapies for the hemophilia community. That’s why we will continue to offer two therapies, AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, a next-generation Factor VIII therapy, and plasma-derived Antihemophilic Factor/von Willebrand Factor Complex (Human), Humate-P®.
    [Show full text]
  • RIASTAP®, Fibrinogen Concentrate (Human) Lyophilized Powder for Solution for Intravenous Injection
    HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------------CONTRAINDICATIONS ------------------------------------ These highlights do not include all the information needed to use RIASTAP • Known anaphylactic or severe systemic reactions to human plasma-derived products (4). safely and effectively. See full prescribing information for RIASTAP. ---------------------------------WARNINGS AND PRECAUTIONS---------------------------- RIASTAP®, Fibrinogen Concentrate (Human) • Monitor patients for early signs of anaphylaxis or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment (5.1). Lyophilized Powder for Solution for Intravenous Injection • Thrombotic events have been reported in patients receiving RIASTAP. Weigh the benefits of administration versus the risks of thrombosis (5.2). Initial U.S. Approval: 2009 • Because RIASTAP is made from human blood, it may carry a risk of transmitting ------------------------------------RECENT MAJOR CHANGES--------------------------------- infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent Indications and Usage (1) 06/2021 and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent (5.3). Dosage and Administration (2.2) 07/2020 -------------------------------------ADVERSE REACTIONS-------------------------------------- ----------------------------------INDICATIONS AND USAGE----------------------------------- • The most serious adverse reactions observed are thrombotic episodes (pulmonary RIASTAP, Fibrinogen
    [Show full text]
  • 1. NAME of the MEDICINAL PRODUCT Beriplast P Combi-Set 0.5 Ml, 1 Ml, 3 Ml Powders and Solvents for Sealant. 2. QUALITATIVE and Q
    CSL Behring Beriplast P Combi-Set 1. NAME OF THE MEDICINAL PRODUCT Beriplast P Combi-Set 0.5 ml, 1 ml, 3 ml Powders and solvents for sealant. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative composition Combi-Set I: Active substances Human fibrinogen, Coagulation Factor XIII (human), Aprotinin (bovine) Combi-Set II: Active substances Human thrombin, Calcium Chloride Quantitative composition Combi-Set I per 1 ml Vial 1 Fibrinogen Concentrate: total dried substance 174 mg fibrinogen (human plasma protein fraction) 90 mg coagulation factor XIII (human plasma protein fraction) 60 IU Vial 2 Aprotinin Solution: volume 1.0 ml bovine lung aprotinin 1000 KIU* corresponding to 0.56 PEU** * KIU = Kallikrein Inactivator Unit ** PEU = Ph. Eur. Unit (1 PEU ^ 1800 KIU) Combi-Set II per 1 ml Vial 3 Thrombin: total dried substance 7.6 mg with a human plasma protein fraction thrombin activity 500 IU Vial 4 Calcium Chloride Solution: volume 1.0 ml calcium chloride dihydrate 5.9 mg For the full list of excipients, see section 6.1. CSL Behring Beriplast P Combi-Set 3. PHARMACEUTICAL FORM Powders and solvents for sealant. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis (including endoscopic treatment of bleeding gastroduodenal ulcer) as a tissue glue to promote adhesion/sealing or as suture support 4.2 Posology and method of administration The use of Beriplast is restricted to experienced physicians and/or surgeons. Posology The volume of Beriplast to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.
    [Show full text]
  • HIGHLIGHTS of PRESCRIBING INFORMATION These Highlights Do Not Include All the Information Needed to Use IDELVION® Safely and Ef
    HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------DOSAGE FORMS AND STRENGTHS------------------- These highlights do not include all the information needed to use IDELVION is available as a lyophilized powder in single-use vials containing IDELVION® safely and effectively. See full prescribing information for nominally 250, 500, 1000 or 2000 IU. (3) IDELVION. -------------------------------CONTRAINDICATIONS ----------------------------- IDELVION [Coagulation Factor IX (Recombinant), Albumin Fusion Do not use in patients who have had life-threatening hypersensitivity reactions Protein] to IDELVION or its components, including hamster proteins. (4) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2016 ---------------------------WARNINGS AND PRECAUTIONS-------------------- • Hypersensitivity reactions, including anaphylaxis, are possible. Should ----------------------------INDICATIONS AND USAGE--------------------------- symptoms occur, discontinue IDELVION and administer appropriate IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein treatment. (5.1) (rIX-FP), a recombinant human blood coagulation factor, is indicated in • Development of neutralizing antibodies (inhibitors) to IDELVION may children and adults with hemophilia B (congenital Factor IX deficiency) for: occur. If expected Factor IX plasma recovery in patient plasma is not • On-demand control and prevention of bleeding episodes attained, or if bleeding is not controlled with an appropriate dose, perform • Perioperative
    [Show full text]
  • Coding and Reimbursement Guide
    Eligible patients can save up to $12, IDELVION CMS-1500 CLAIM FORM Claim Form Example Important Safety Information IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP), is indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes CALL 1-800-676-4266 IDELVION is not indicated for induction of immune tolerance in patients with hemophilia B. TO SPEAK WITH A CASE MANAGER IDELVION is contraindicated in patients who have had life-threatening hypersensitivity to the product Monday–Friday, 8 AM–8 PM ET or its components, including hamster proteins. Through IDELVION ConnectSM, your patients can find a centralized collection of services, such as financial support, the advocate IDELVION is for intravenous use only. IDELVION can be self-administered or administered by a caregiver with mentorship program, community connections, and additional information on hemophilia B. Look to IDELVION Connect as the training and approval from a healthcare provider or hemophilia treatment center. Higher dose per kilogram source for support as your patients begin and continue their experience with IDELVION. body weight or more frequent dosing may be needed for pediatric patients. Hypersensitivity reactions, including anaphylaxis, are possible. Advise patients who self-administer to IDELVION Advocate Program immediately report symptoms of hypersensitivity, including angioedema, chest tightness, hypotension, A free trial of IDELVION Patients can have one-on-one generalized urticaria, wheezing, and dyspnea. If symptoms occur, discontinue IDELVION and administer Get your patients a one-month trial conversations with advocates about appropriate treatment.
    [Show full text]
  • See Full Prescribing Information for Helixate FS
    HIGHLIGHTS OF PRESCRIBING INFORMATION ---------------------------------CONTRAINDICATIONS---------------------------------------- These highlights do not include all the information needed to use Helixate FS Do not use in patients who have life-threatening hypersensitivity reactions, including ana- safely and effectively. See full prescribing information for Helixate FS. phylaxis to mouse or hamster protein or other constituents of the product (4). ® Helixate FS ------------------------------WARNINGS AND PRECAUTIONS------------------------------- [Antihemophilic Factor (Recombinant), Formulated with Sucrose] • Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, For Intravenous Use, Lyophilized Powder for Reconstitution discontinue treatment with Helixate FS and administer appropriate treatment (5.1). • Development of activity-neutralizing antibodies can occur in patients receiving factor Initial U.S. Approval: 1993 VIII-containing products, including Helixate FS. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform --------------------------------INDICATIONS AND USAGE------------------------------------- an assay that measures factor VIII inhibitor concentration (5.2). Helixate FS is an Antihemophilic Factor (Recombinant) indicated for: • When clotting is normalized by treatment with factor VIII, development of cardiovas- • On-demand treatment and control of bleeding episodes in adults and children with cular risk factors may
    [Show full text]
  • Plasma Protein Products ‐ Product Information August 2018
    Plasma Protein Products ‐ Product Information August 2018 Shipping Max RT Temp for Storage (<25°C) Product & Product Sizes Supplier 24hrs Temp (°C) Storage (°C) Period ** Anti‐Inhibitor Coagulant FEIBA™NF (1000,2500 IU) Shire 2 to 25 2 to 25 Labelled Date Plasbumin®5% (50mL, 250mL) Grifols 2 to 30 2 to 30 Labelled Date Albumin 25%/Plasbumin® (100mL,250mL) Grifols/CBS 2 to 30 2 to 30 Labelled Date Albumin Alburex®5% (250mL, 500mL) 2 to 30 2 to 30 Labelled Date CSL Berhing Alburex®25% (50mL, 100mL) 2 to 30 2 to 30 Labelled Date Antithrombin III Antithrombin III NF (1000 IU) Shire 2 to 82 to 8 N/A Berinert® (500,1500 IU) CSL Berhing 2 to 25 2 to 25 Labelled Date C1 Inhibitor CINRYZE® (500 IU) Shire 2 to 25 2 to 25 Labelled Date Factor VII *Factor VII (600 IU) Shire 2 to 82 to 8 N/A Recombinate Factor VIIa (rFVIIa) NiaStase RT® (1.0mg,2.0mg,5.0mg) Novo Nordisk 2 to 25 2 to 25 Labelled Date *Hemofil M NF (1000 IU) Shire 2 to 30 2 to 30 Labelled Date Factor VIII *Koate‐DVI (500,1000 IU) Grifols 1 to 25 2 to 86 months Kovaltry FS (250, 500, 1000, 2000, 3000 IU) Bayer 2 to 25 2 to 812 months Pfizer Canada Recombinate Factor VIII Xyntha® (250, 500, 1000, 2000,3000 IU) Inc 2 to 82 to 8 3 months (>8C) Eloctate™ (250, 500, 750, 1000, 1500, 2000, 3000 IU) Bioverativ 2 to 82 to 86 months Nuwiq (250, 500, 1000, 2000,3000,4000 IU) Octapharma 2 to 82 to 812 months Shipping Max RT Temp for Storage (<25°C) Product & Product Sizes Supplier 24hrs Temp (°C) Storage (°C) Period ** Factor VIII/von Willebrand Humate P® (1000 RcoF, 2000 RcoF IU) CSL Behring 2
    [Show full text]
  • Sufficient Thrombin Generation Despite 95% Hemodilution: an in Vitro Experimental Study
    Journal of Clinical Medicine Article Sufficient Thrombin Generation Despite 95% Hemodilution: An In Vitro Experimental Study Johannes Gratz 1 , Christoph J. Schlimp 2,3, Markus Honickel 4, Nadine Hochhausen 4 , Herbert Schöchl 2,5 and Oliver Grottke 4,* 1 Department of Anaesthesiology, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Waehringer Guertel 18–20, 1090 Vienna, Austria; [email protected] 2 Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Research Centre, Donaueschingenstraße 13, 1200 Vienna, Austria; [email protected] (C.J.S.); [email protected] (H.S.) 3 Department of Anesthesiology and Intensive Care Medicine, AUVA Trauma Centre Linz, Garnisonstrasse 7, 4010 Linz, Austria 4 Department of Anesthesiology, University Hospital of the RWTH Aachen, Pauwelsstrasse 30, 52074 Aachen, Germany; [email protected] (M.H.); [email protected] (N.H.) 5 Department of Anaesthesia and Intensive Care Medicine, AUVA Trauma Centre Salzburg, Academic Teaching Hospital of the Paracelsus Medical University Salzburg, Doktor-Franz-Rehrl-Platz 5, 5010 Salzburg, Austria * Correspondence: [email protected]; Tel.: +49-241-80-80972 Received: 27 October 2020; Accepted: 24 November 2020; Published: 25 November 2020 Abstract: Guidelines for the treatment of severe bleeding comprise viscoelastic-test-guided use of coagulation factor concentrates as part of their recommendations. The aim of this study is to investigate the effects of substituting fibrinogen, prothrombin complex concentrate, and a combination of both on conventional coagulation tests, viscoelastic test results, and thrombin generation. Blood was drawn from seven healthy volunteers to obtain platelet-free plasma, which later was diluted by replacing 40%, 60%, 80%, 90%, 95%, and 99% with a crystalloid solution.
    [Show full text]
  • Humate-P Diagnostic Codes
    12/4/2017 Humate-P® United States Home > US Products > Humate-P® Humate-P ® Antihemophilic Factor/von Willebrand Factor Complex (Human) Full Prescribing Information for Humate-P® Important Safety Information Humate-P is an Antihemophilic Factor/von Willebrand Factor (VWF) Complex (Human) indicated for: Hemophilia A — Treatment and prevention of bleeding in adults (1.1). Von Willebrand disease (VWD) — in adults and pediatric patients in the (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 as well as patients with mild to moderate VWD where the use of desmospressin is known or suspected to be inadequate (1.2). Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes in VWD. Visit www.humate-p.com to learn more. Diagnostic Codes (ICD-10-CM) ICD-10-CM Codes Used to identify patient medical conditions (for claims with a date of service on or after October 1, 2015) Code Description D66 Hereditary factor VIII deficiency D68.0 von Willebrand's Disease 30233V1 Transfusion of Nonautologous Antihemophilic factors into peripheral vein, percutaneous approach 30243V1 Transfusion of Nonautologous antihemophilic factors into central vein, percutaneous approach Billing Codes (HCPCS, NDC, CPT) HCPCS Codes The following HCPCS codes describe supplies (including drugs) rendered by the billing provider. CMS publishes and maintains the HCPCS code set. These codes are entered to paper claim form CMS-1500 in Field 24; or, to electronic claim form ASC 837P in Loop 2400, Segment SV101-2, with the Qualifier "HC" entered to Segment SV101-1, unless otherwise directed by the payor.
    [Show full text]
  • Product Labeling
    CSL Behring Prothrombin Complex Concentrate (Human), Kcentra™ 1.14.1.3 Draft Labeling Text HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------DOSAGE FORMS AND STRENGTHS------------------- These highlights do not include all the information needed to use • Kcentra is available as a single-use vial containing coagulation Factors II, KCENTRA safely and effectively. See full prescribing information for VII, IX and X, and antithrombotic Proteins C and S as a lyophilized KCENTRA. concentrate. (3) KCENTRA (Prothrombin Complex Concentrate (Human)) -------------------------------CONTRAINDICATIONS ----------------------------- For Intravenous Use, Lyophilized Powder for Reconstitution Kcentra is contraindicated in patients with: Initial U.S. Approval: 2013 • Known anaphylactic or severe systemic reactions to Kcentra or any components in Kcentra including heparin, Factors II, VII, IX, X, Proteins C WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC and S, Antithrombin III and Human albumin. (4) COMPLICATIONS • Disseminated intravascular coagulation. (4) Patients being treated with Vitamin K antagonists (VKA) therapy have • Known heparin-induced thrombocytopenia. Kcentra contains heparin. (4) underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the ---------------------------WARNINGS AND PRECAUTIONS-------------------- potential risks of thromboembolic events, especially in patients with the • Hypersensitivity reactions may occur. If necessary, discontinue history
    [Show full text]