DOCSLIB.ORG

MANAGING ADVERSE REACTIONS That May Occur with LENVIMA®

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
MANAGING ADVERSE REACTIONS That May Occur with LENVIMA® MANAGING ADVERSE REACTIONS That May Occur With LENVIMA® For Treatment of Advanced Renal Cell Carcinoma INDICATION LENVIMA is indicated in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. SELECTED SAFETY INFORMATION Warnings and Precautions Hypertension. In DTC, hypertension occurred in 73% of patients on LENVIMA (44% grade 3-4). In RCC, hypertension occurred in 42% of patients on LENVIMA + everolimus (13% grade 3). Systolic blood pressure ≥160 mmHg occurred in 29% of patients, and 21% had diastolic blood pressure ≥100 mmHg. In HCC, hypertension occurred in 45% of LENVIMA-treated patients (24% grade 3). Grade 4 hypertension was not reported in HCC. Serious complications of poorly controlled hypertension have been reported. Control blood pressure prior to initiation. Monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least monthly thereafter during treatment. Withhold and resume at reduced dose when hypertension is controlled or permanently discontinue based on severity. Please see additional Selected Safety Information throughout and full Prescribing Information. Advanced Renal Cell Carcinoma (RCC) Recognize, Monitor, and Manage ARs With Recognize ARs With LENVIMA + everolimus LENVIMA® + everolimus In Study 205 RECOGNIZE ARs that may occur with LENVIMA + everolimus Most common ARs (≥30%) observed in LENVIMA + everolimus–treated patients Understand possible ARs with LENVIMA + everolimus to help you and your • Diarrhea (81%), fatigue (73%), arthralgia/myalgia (55%), decreased appetite (53%), vomiting patients prepare for the treatment journey (48%), nausea (45%), stomatitis/oral inflammation (44%), hypertension (42%), peripheral edema (42%), cough (37%), abdominal pain (37%), dyspnea (35%), rash (35%), decreased weight (34%), hemorrhagic events (32%), and proteinuria (31%)1 MONITOR ARs that may occur with LENVIMA + everolimus Most common serious ARs (≥5%) in LENVIMA + everolimus-treated patients Identify points in treatment when ARs emerged in Study 205, so you can • Renal failure (11%), dehydration (10%), anemia (6%), thrombocytopenia (5%), diarrhea (5%), provide timely management vomiting (5%), and dyspnea (5%)1 Most common grade 3-4 ARs (≥5%)1 MANAGE ARs that may occur with LENVIMA + everolimus Consider ways to approach ARs to help your patients LENVIMA 18 mg + everolimus 5 mg everolimus 10 mg on treatment Adverse reaction (n=62) (n=50) Diarrhea 19% 2% AR=adverse reaction. Fatigue 18% 2% Hypertension/increase blood pressure 13% 2% Renal failure eventb 10% 2% Proteinuria/urine protein present 8% 2% Vomiting 7% 0% SELECTED SAFETY INFORMATION Hemorrhagic eventsc 6% 2% Warnings and Precautions (cont'd) Nausea 5% 0% Cardiac Dysfunction. Serious and fatal cardiac dysfunction can occur with LENVIMA. Across Decreased appetite 5% 0% clinical trials in 799 patients with DTC, RCC, and HCC, grade 3 or higher cardiac dysfunction Arthralgia/myalgiad 5% 0% occurred in 3% of LENVIMA-treated patients. Monitor for clinical symptoms or signs of cardiac Dyspnea/exertional dyspnea 5% 8% dysfunction. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity. Study 205 was not designed to demonstrate a statistically significant difference in AR Arterial Thromboembolic Events. Among patients receiving LENVIMA or LENVIMA + rates for LENVIMA in combination with everolimus, as compared to everolimus alone.¹ everolimus, arterial thromboembolic events of any severity occurred in 2% of patients in RCC and HCC and 5% in DTC. Grade 3-5 arterial thromboembolic events ranged from 2% to 3% AR=adverse reaction. aIncludes asthenia, fatigue, lethargy and malaise across all clinical trials. Permanently discontinue following an arterial thrombotic event. The bIncludes blood creatinine increased, blood urea increased, creatinine renal clearance decreased, safety of resuming after an arterial thromboembolic event has not been established, and nephropathy toxic, renal failure, renal failure acute, and renal impairment c LENVIMA has not been studied in patients who have had an arterial thromboembolic event Includes hemorrhagic diarrhea, epistaxis, gastric hemorrhage, hemarthrosis, hematoma, hematuria, hemoptysis, lip hemorrhage, renal hematoma, and scrotal hematocele within the previous 6 months. dIncludes arthralgia, back pain, extremity pain, musculoskeletal pain, and myalgia 2 Please see additional Selected Safety Information throughout 3 and full Prescribing Information. Advanced Renal Cell Carcinoma (RCC) Recognize ARs That May Occur With LENVIMA® + everolimus In Study 205 LENVIMA + everolimus AR profile (>15%)1* LENVIMA + everolimus AR profile (>15%)1* LENVIMA 18 mg + LENVIMA 18 mg + everolimus 5 mg everolimus 10 mg everolimus 5 mg everolimus 10 mg n=62 n=50 n=62 n=50 Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Adverse reaction (%) (%) (%) (%) Adverse reaction (%) (%) (%) (%) Endocrine Musculoskeletal and connective tissue Hypothyroidism 24 0 2 0 Arthralgia/myalgiae 55 5 32 0 Gastrointestinal Musculoskeletal chest pain 18 2 4 0 Constipation 16 0 18 0 Nervous system Diarrhea 81 19 34 2 Headache 19 2 10 2 Dyspepsia/gastroesophageal reflux 21 0 12 0 Psychiatric Abdominal paina 37 3 8 0 Insomnia 16 2 2 0 Renal and urinary Nausea 45 5 16 0 Proteinuria/urine protein present 31 8 14 2 Oral painb 23 2 4 0 Renal failure eventf 18 10 12 2 Stomatitis/oral inflammationc 44 2 50 4 Respiratory, thoracic, and mediastinal Vomiting 48 7 12 0 Cough 37 0 30 0 General Dyspnea/exertional dyspnea 35 5 28 8 Fatigued 73 18 40 2 Dysphonia 18 0 4 0 42 2 20 0 Peripheral edema Skin and subcutaneous tissue Pyrexia/increased body temperature 21 2 10 2 Rashg 35 0 40 0 Metabolism and nutrition Vascular Decreased appetite 53 5 18 0 Hemorrhagic eventsh 32 6 26 2 Decreased weight 34 3 8 0 Hypertension/increased blood pressure 42 13 10 2 Study 205 was not designed to demonstrate a statistically significant difference in AR rates eIncludes arthralgia, back pain, extremity pain, musculoskeletal pain, and myalgia. fIncludes blood creatinine increased, blood urea increased, creatinine renal clearance decreased, for LENVIMA in combination with everolimus, as compared to everolimus alone.¹ nephropathy toxic, renal failure, renal failure acute, and renal impairment. g Includes erythema, erythematous rash, genital rash, macular rash, maculopapular rash, papular rash, AR=adverse reaction. pruritic rash, pustular rash, and septic rash. *The safety data are derived from Study 205 and an additional 11 patients in the dose escalation portion hIncludes hemorrhagic diarrhea, epistaxis, gastric hemorrhage, hemarthrosis, hematoma, hematuria, of the study who received LENVIMA 18 mg + everolimus 5 mg. hemoptysis, lip hemorrhage, renal hematoma, and scrotal hematocele. aIncludes abdominal discomfort, gastrointestinal pain, lower abdominal pain, and upper abdominal pain. bIncludes gingival pain, glossodynia, and oropharyngeal pain. cIncludes aphthous stomatitis, gingival inflammation, glossitis, and mouth ulceration. dIncludes asthenia, fatigue, lethargy, and malaise. 4 Please see additional Selected Safety Information throughout 5 and full Prescribing Information. Advanced Renal Cell Carcinoma (RCC) Grade 3-4 laboratory abnormalities in ≥3% of An established plan for AR management1 patients in the LENVIMA + everolimus arm1†‡ LENVIMA 18 mg + Managing ARs with interruptions, reductions, and/or discontinuations everolimus 5 mg everolimus 10 mg In Study 205, most patients (89%) required a dose reduction or interruption of LENVIMA® + everolimus.1 Laboratory abnormality % (n=62) % (n=50) • In the combination arm, the median of the average daily dose of LENVIMA was 13.6 mg per day Chemistry per patient2* Increased aspartate aminotransferase (AST) 3 0 • Most patients who had a dose reduction in the combination arm (74.5%) required the first dose Increased alanine aminotransferase (ALT) 3 2 reduction of LENVIMA within 3 cycles of treatment2* Increased alkaline phosphatase 3 0 *Limitations: the above 2 bullets were prespecified descriptive analyses. No conclusions can be drawn. Hyperkalemia 6 2 Hypokalemia 6 2 Adverse reaction Severitya Dose modifications for LENVIMA1 Hyponatremia 11 6 Hypertension Grade 3 • Withhold for grade 3 that persists despite optimal Hypocalcemia 6 2 antihypertensive therapy Hypophosphatemia 11 6 • Resume at reduced dose when hypertension is controlled at less than or equal to grade 2 Hyperglycemia 3 16 Grade 4 • Permanently discontinue Hypertriglyceridemia 18 18 Cardiac dysfunction Grade 3 • Withhold until improves to grade 0 to 1 or baseline Hypercholesterolemia 11 0 • Resume at a reduced dose or discontinue depending on Increased creatine kinase 3 4 the severity and persistence of AR Increased lipase 13 12 Grade 4 • Permanently discontinue Hematology Arterial thromboembolic Any grade • Permanently discontinue Anemia 8 16 event Thrombocytopenia 5 0 Hepatotoxicity Grade 3 or 4 • Withhold until improves to grade 0 to 1 or baseline • Either resume at a reduced dose or discontinue Lymphopenia 10 20 depending on severity and persistence of hepatotoxicity • Permanently discontinue for hepatic failure Study 205 was not designed to demonstrate a statistically significant difference in AR Renal failure or impairment Grade 3 or 4 • Withhold until improves to grade 0 to 1 or baseline rates for LENVIMA in combination with everolimus, as compared to everolimus alone.¹ • Resume at a reduced dose or discontinue
Load more

Recommended publications
  • WFH Treatment Guidelines 3Ed Chapter 7 Treatment Of
    96 TREATMENT OF SPECIFIC 7 HEMORRHAGES Johnny Mahlangu1 | Gerard Dolan2 | Alison Dougall3 | Nicholas J. Goddard4 | Enrique D. Preza Hernández5 | Margaret V. Ragni6 | Bradley Rayner7 | Jerzy Windyga8 | Glenn F. Pierce9 | Alok Srivastava10 1 Department of Molecular Medicine and Haematology, University of the Witwatersrand, National Health Laboratory Service, Johannesburg, South Africa 2 Guy’s and St. Thomas’ Hospitals NHS Foundation Trust, London, UK 3 Special Care Dentistry Division of Child and Public Dental Health, School of Dental Science, Trinity College Dublin, Dublin Dental University Hospital, Dublin, Ireland 4 Department of Trauma and Orthopaedics, Royal Free Hospital, London, UK 5 Mexico City, Mexico 6 Division of Hematology/Oncology, Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA 7 Cape Town, South Africa 8 Department of Hemostasis Disorders and Internal Medicine, Laboratory of Hemostasis and Metabolic Diseases, Institute of Hematology and Transfusion Medicine, Warsaw, Poland 9 World Federation of Hemophilia, Montreal, QC, Canada 10 Department of Haematology, Christian Medical College, Vellore, India All statements identified as recommendations are • In general, the main treatment for bleeding episodes in consensus based, as denoted by CB. patients with severe hemophilia is prompt clotting factor replacement therapy and rehabilitation. However, different types of bleeds and bleeding at particular anatomical sites 7.1 Introduction may require more specific management with additional
    [Show full text]
  • Trauma-Associated Pulmonary Laceration in Dogs—A Cross Sectional Study of 364 Dogs
    veterinary sciences Article Trauma-Associated Pulmonary Laceration in Dogs—A Cross Sectional Study of 364 Dogs Giovanna Bertolini 1,* , Chiara Briola 1, Luca Angeloni 1, Arianna Costa 1, Paola Rocchi 2 and Marco Caldin 3 1 Diagnostic and Interventional Radiology Division, San Marco Veterinary Clinic and Laboratory, via dell’Industria 3, 35030 Veggiano, Padova, Italy; [email protected] (C.B.); [email protected] (L.A.); [email protected] (A.C.) 2 Intensive Care Unit, San Marco Veterinary Clinic and Laboratory, via dell’Industria 3, 35030 Veggiano, Padova, Italy; [email protected] 3 Clinical Pathology Division, San Marco Veterinary Clinic and Laboratory, via dell’Industria 3, 35030 Veggiano, Padova, Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-0498561098 Received: 5 March 2020; Accepted: 8 April 2020; Published: 12 April 2020 Abstract: In this study, we describe the computed tomography (CT) features of pulmonary laceration in a study population, which included 364 client-owned dogs that underwent CT examination for thoracic trauma, and compared the characteristics and outcomes of dogs with and without CT evidence of pulmonary laceration. Lung laceration occurred in 46/364 dogs with thoracic trauma (prevalence 12.6%). Dogs with lung laceration were significantly younger than dogs in the control group (median 42 months (interquartile range (IQR) 52.3) and 62 months (IQR 86.1), respectively; p = 0.02). Dogs with lung laceration were significantly heavier than dogs without laceration (median 20.8 kg (IQR 23.3) and median 8.7 kg (IQR 12.4 kg), respectively p < 0.0001). When comparing groups of dogs with thoracic trauma with and without lung laceration, the frequency of high-energy motor vehicle accident trauma was more elevated in dogs with lung laceration than in the control group.
    [Show full text]
  • Case Report a Case of a Patient Who Is Diagnosed with Mild Acquired Hemophilia a After Tooth Extraction Died of Acute Subdural Hematoma Due to Head Injury
    Hindawi Case Reports in Dentistry Volume 2018, Article ID 7185263, 3 pages https://doi.org/10.1155/2018/7185263 Case Report A Case of a Patient Who Is Diagnosed with Mild Acquired Hemophilia A after Tooth Extraction Died of Acute Subdural Hematoma due to Head Injury Tomohisa Kitamura,1 Tsuyoshi Sato ,1 Eiji Ikami,1 Yosuke Fukushima,1 and Tetsuya Yoda2 1Department of Oral and Maxillofacial Surgery, Saitama Medical University, 38 Moro-hongou, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan 2Department of Maxillofacial Surgery, Tokyo Medical and Dental University, Tokyo, Japan Correspondence should be addressed to Tsuyoshi Sato; [email protected] Received 13 September 2018; Revised 12 November 2018; Accepted 25 November 2018; Published 9 December 2018 Academic Editor: Yuk-Kwan Chen Copyright © 2018 Tomohisa Kitamura et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Acquired hemophilia A (AHA) is a rare disorder which results from the presence of autoantibodies against blood coagulation factor VIII. The initial diagnosis is based on the detection of an isolated prolongation of the activated partial thromboplastin time (aPTT) with negative personal and family history of bleeding disorder. Definitive diagnosis is the identification of reduced FVIII levels with evidence of FVIII neutralizing activity. Case report. We report a case of a 93-year-old female who was diagnosed as AHA after tooth extraction at her home clinic. Prolongation of aPTT and a reduction in factor VIII activity levels were observed with the presence of factor VIII inhibitor.
    [Show full text]
  • Blood Counts
    Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report April 2009 Clinical Diagnostic Laboratory Services Health & Human Services Department Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 CMS Email Point of Contact: [email protected] TDD 410.786.0727 Fu Associates, Ltd. Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report This is CMS Logo. NCD Manual Changes Date Reason Release Change Edit The following section represents NCD Manual updates for April 2009. 04/01/09 Per CR 6383 add 2009200 *525.71 Osseointegration *190.15 Blood Counts ICD-9-CM codes failure of dental implant 525.71, 525.72 and 525.73 to the list of ICD-9-CM codes that *525.72 Post- do not support osseointegration Medical necessity for biological failure of the Blood Counts dental implant NCD. *525.73 Post- Transmittal # 1684 osseointegration mechanic failure of dental implant 04/01/09 Per CR 6383 add 2009200 *535.70 Eosinophilic *190.16 Partial ICD-9-CM codes gastritis, without Thromboplastin Time 535.70 and 535.71 to mention of obstruction (PTT) the list of ICD-9-CM codes covered by Medicare for the *535.71 Eosinophilic Partial gastritis, with Thromboplastin Time obstruction NCD. Transmittal # 1684 04/01/09 Per CR 6383 add 2009200 *414.3 Coronary *190.17 Prothrombin ICD-9-CM codes atherosclerosis due to Time 414.3, 535.70 and lipid rich plaque 535.71 to the list of ICD-9-CM codes *535.70 Eosinophilic covered by Medicare gastritis, without mention for the Prothrombin of obstruction Time NCD.
    [Show full text]
  • Familial Multiple Coagulation Factor Deficiencies
    Journal of Clinical Medicine Article Familial Multiple Coagulation Factor Deficiencies (FMCFDs) in a Large Cohort of Patients—A Single-Center Experience in Genetic Diagnosis Barbara Preisler 1,†, Behnaz Pezeshkpoor 1,† , Atanas Banchev 2 , Ronald Fischer 3, Barbara Zieger 4, Ute Scholz 5, Heiko Rühl 1, Bettina Kemkes-Matthes 6, Ursula Schmitt 7, Antje Redlich 8 , Sule Unal 9 , Hans-Jürgen Laws 10, Martin Olivieri 11 , Johannes Oldenburg 1 and Anna Pavlova 1,* 1 Institute of Experimental Hematology and Transfusion Medicine, University Clinic Bonn, 53127 Bonn, Germany; [email protected] (B.P.); [email protected] (B.P.); [email protected] (H.R.); [email protected] (J.O.) 2 Department of Paediatric Haematology and Oncology, University Hospital “Tzaritza Giovanna—ISUL”, 1527 Sofia, Bulgaria; [email protected] 3 Hemophilia Care Center, SRH Kurpfalzkrankenhaus Heidelberg, 69123 Heidelberg, Germany; ronald.fi[email protected] 4 Department of Pediatrics and Adolescent Medicine, University Medical Center–University of Freiburg, 79106 Freiburg, Germany; [email protected] 5 Center of Hemostasis, MVZ Labor Leipzig, 04289 Leipzig, Germany; [email protected] 6 Hemostasis Center, Justus Liebig University Giessen, 35392 Giessen, Germany; [email protected] 7 Center of Hemostasis Berlin, 10789 Berlin-Schöneberg, Germany; [email protected] 8 Pediatric Oncology Department, Otto von Guericke University Children’s Hospital Magdeburg, 39120 Magdeburg, Germany; [email protected] 9 Division of Pediatric Hematology Ankara, Hacettepe University, 06100 Ankara, Turkey; Citation: Preisler, B.; Pezeshkpoor, [email protected] B.; Banchev, A.; Fischer, R.; Zieger, B.; 10 Department of Pediatric Oncology, Hematology and Clinical Immunology, University of Duesseldorf, Scholz, U.; Rühl, H.; Kemkes-Matthes, 40225 Duesseldorf, Germany; [email protected] B.; Schmitt, U.; Redlich, A.; et al.
    [Show full text]
  • Immune-Pathophysiology and -Therapy of Childhood Purpura
    Egypt J Pediatr Allergy Immunol 2009;7(1):3-13. Review article Immune-pathophysiology and -therapy of childhood purpura Safinaz A Elhabashy Professor of Pediatrics, Ain Shams University, Cairo Childhood purpura - Overview vasculitic disorders present with palpable Purpura (from the Latin, purpura, meaning purpura2. Purpura may be secondary to "purple") is the appearance of red or purple thrombocytopenia, platelet dysfunction, discolorations on the skin that do not blanch on coagulation factor deficiency or vascular defect as applying pressure. They are caused by bleeding shown in table 1. underneath the skin. Purpura measure 0.3-1cm, A thorough history (Table 2) and a careful while petechiae measure less than 3mm and physical examination (Table 3) are critical first ecchymoses greater than 1cm1. The integrity of steps in the evaluation of children with purpura3. the vascular system depends on three interacting When the history and physical examination elements: platelets, plasma coagulation factors suggest the presence of a bleeding disorder, and blood vessels. All three elements are required laboratory screening studies may include a for proper hemostasis, but the pattern of bleeding complete blood count, peripheral blood smear, depends to some extent on the specific defect. In prothrombin time (PT) and activated partial general, platelet disorders manifest petechiae, thromboplastin time (aPTT). With few exceptions, mucosal bleeding (wet purpura) or, rarely, central these studies should identify most hemostatic nervous system bleeding;
    [Show full text]
  • Chronic Scrotal Hematocele: a Rare Entity and Diagnostic Dilemma
    Urology & Nephrology Open Access Journal Review Article Open Access Chronic scrotal hematocele: a rare entity and diagnostic dilemma Abstract Volume 4 Issue 5 - 2017 Objective: A comprehensive literature review performed to highlight the clinical and Mohammed Mahdi Babakri surgical aspect of chronic scrotal hematocele. Urology Unit, Aden University, Yemen Material and method: The National Library of Medicine database searched for relevant article using combination of key words: hematocele, scrotal hematocele, chronic hematocele Correspondence: Mohammed Mahdi Babakri, Urology Unit, up to January 2017, irrelevant abstracts excluded and articles reviewed from the clinical, Surgical Department, Faculty of Medicine and Health Sciences, Aden University, Khormaksar, Yemen, P O Box 6038, Tel 00967 radiological and pathological aspects. 777401971, Fax 00967 2 232298, Results and discussion:Chronic scrotal hematocele presented as slowly progressing Email scrotal mass, differentiation from testicular neoplasm is difficult and, in most cases, only possible after surgical removal of the mass. High index of suspicion, especially in slowly Received: March 08, 2017 | Published: April 25, 2017 growing scrotal mass in men older than 50 years, is required to diagnose this pathology and prevent unnecessary orchiectomy. Conclusion:Chronic scrotal hematocele is a rare pathologywith clinical and radiological characteristics similar to testicular tumor, carful patient history taken is crucial to help in proper management. Keywords: chronic scrotal hematocele,scrotal swelling,testicular tumor,hematocele Introduction references from these articles also reviewed and included. The author’s own cases (one published and another one not published yet The differential diagnosis of scrotal swellings is long and includes is included in this review).6 both benign and malignant conditions.
    [Show full text]
  • 2004400 October 2004, Change Report and NCD Coding Policy
    Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report April 2012 Clinical Diagnostic Laboratory Services Health & Human Services Department Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 CMS Email Point of Contact: [email protected] TDD 410.786.0727 Fu Associates, Ltd. Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report This is CMS Logo. NCD Manual Changes Date Reason Release Change Edit The following section represents NCD Manual updates for April 2012. *04/01/12 *ICD-9-cm code range *2012200 *376.21-376.22 *(190.15) Blood Counts and descriptors Endocrine exophthalmos revised 376.21-376.9 Disorders of the orbit, *376.40-376.47 except 376.3 Other Deformity of orbit exophthalmic conditions (underlining *376.50-376.52 in original) Enophthalmos *376.6 Retained (old) foreign body following penetrating wound of orbit *376.81-376.82 Orbital cysts; myopathy of extraocular muscles *376.89 Other orbital disorders *376.9 Unspecified disorder of orbit The following section represents NCD Manual updates for January 2012. 01/01/12 Per CR 7621 add ICD-9- 2012100 786.50 Chest pain, (190.17) Prothrombin Time CM codes 786.50 and unspecified (PT) 786.51 to the list of ICD- 9-CM codes that are 786.51 Precordial pain covered by Medicare for the Prothrombin Time (PT) (190.17) NCD. Transmittal # 2344 01/01/12 Per CR 7621 delete ICD- 2012100 425.11 Hypertrophic (190.25) Alpha-fetoprotein 9-CM codes 425.11 and obstructive cardiomyopathy 425.18 from the list of ICD-9-CM codes that are 425.18 Other hypertrophic covered by Medicare for cardiomyopathy the Alpha-fetoprotein (190.25) NCD.
    [Show full text]
  • Subset of Alphabetical Index to Diseases and Nature of Injury for Use with Perinatal Conditions (P00-P96)
    Subset of alphabetical index to diseases and nature of injury for use with perinatal conditions (P00-P96) SUBSET OF ALPHABETICAL INDEX TO DISEASES AND NATURE OF INJURY FOR USE WITH PERINATAL CONDITIONS (P00-P96) Conditions arising in the perinatal period Conditions arising—continued - abnormal, abnormality—continued Note - Conditions arising in the perinatal - - fetus, fetal period, even though death or morbidity - - - causing disproportion occurs later, should, as far as possible, be - - - - affecting fetus or newborn P03.1 coded to chapter XVI, which takes - - forces of labor precedence over chapters containing codes - - - affecting fetus or newborn P03.6 for diseases by their anatomical site. - - labor NEC - - - affecting fetus or newborn P03.6 These exclude: - - membranes (fetal) Congenital malformations, deformations - - - affecting fetus or newborn P02.9 and chromosomal abnormalities - - - specified type NEC, affecting fetus or (Q00-Q99) newborn P02.8 Endocrine, nutritional and metabolic - - organs or tissues of maternal pelvis diseases (E00-E99) - - - in pregnancy or childbirth Injury, poisoning and certain other - - - - affecting fetus or newborn P03.8 consequences of external causes (S00-T99) - - - - causing obstructed labor Neoplasms (C00-D48) - - - - - affecting fetus or newborn P03.1 Tetanus neonatorum (A33) - - parturition - - - affecting fetus or newborn P03.9 - ablatio, ablation - - presentation (fetus) (see also Presentation, - - placentae (see also Abruptio placentae) fetal, abnormal) - - - affecting fetus or newborn
    [Show full text]
  • ARTICULAR BLEEDING (HEMARTHROSIS) in HEMOPHILIA an ORTHOPEDIST’S POINT of VIEW Second Edition
    TREATMENT OF HEMOPHILIA April 2008 · No. 23 ARTICULAR BLEEDING (HEMARTHROSIS) IN HEMOPHILIA AN ORTHOPEDIST’S POINT OF VIEW Second edition E. C. Rodríguez-Merchán Consultant Orthopedic Surgeon La Paz University Hospital Madrid, Spain Associate Professor of Orthopedics University Autonoma Madrid, Spain Published by the World Federation of Hemophilia (WFH), 2000; revised 2008. © Copyright World Federation of Hemophilia, 2008 The WFH encourages redistribution of its publications for educational purposes by not-for-profit hemophilia organizations. In order to obtain permission to reprint, redistribute, or translate this publication, please contact the Programs and Education Department at the address below. This publication is accessible from the World Federation of Hemophilia’s eLearning Platform at eLearning.wfh.org Additional copies are also available from the WFH at: World Federation of Hemophilia 1425 René Lévesque Boulevard West, Suite 1010 Montréal, Québec H3G 1T7 CANADA Tel. : (514) 875-7944 Fax : (514) 875-8916 E-mail: [email protected] Internet: www.wfh.org The Treatment of Hemophilia series is intended to provide general information on the treatment and management of hemophilia. The World Federation of Hemophilia does not engage in the practice of medicine and under no circumstances recommends particular treatment for specific individuals. Dose schedules and other treatment regimes are continually revised and new side-effects recognized. WFH makes no representation, express or implied, that drug doses or other treatment recommendations in this publication are correct. For these reasons it is strongly recommended that individuals seek the advice of a medical adviser and/or to consult printed instructions provided by the pharmaceutical company before administering any of the drugs referred to in this monograph.
    [Show full text]
  • Anatomical Approach to Scrotal Emergencies: a New
    The Internet Journal of Urology ISPUB.COM Volume 6 Number 2 Anatomical Approach to Scrotal Emergencies: A New Paradigm for the Diagnosis and Treatment of the Acute Scrotum S Khan, J Rehman, B Chughtai, D Sciullo, E Mohan, H Rehman Citation S Khan, J Rehman, B Chughtai, D Sciullo, E Mohan, H Rehman. Anatomical Approach to Scrotal Emergencies: A New Paradigm for the Diagnosis and Treatment of the Acute Scrotum. The Internet Journal of Urology. 2009 Volume 6 Number 2. Abstract Acute scrotal pain is a common reason for emergency room visits in men of all ages, but especially in children and young adults. Differentiating those etiologies that require immediate surgical intervention from those that can be treated medically is often challenging. Excluding testicular torsion and avoiding unnecessary surgery although difficult in the past is easier now with advances in ultrasound and other diagnostic techniques. In this paper we suggest an anatomical approach to the acute scrotum by partitioning the contents of the scrotum and spermatic cord into distinct zones. It is postulated that this will facilitate physical and ultrasound exam making pre-surgical diagnosis more accurate. Zone I extends from the internal ring through the inguinal canal to the end of the spermatic cord. Zone II comprises the scrotum, subcutaneous tissues and the tunica vaginalis. Zone III encompasses the testicle with associated appendage and Zone IV includes the epididymis with its appendage. All pathological conditions affecting each zone and the resulting presentation of the acute scrotum are discussed. INTRODUCTION and scrotum can produce symptoms that make localization Acute scrotal pain is a common reason for emergency room of the disease process difficult.
    [Show full text]
  • The Need for Comprehensive Care for Persons with Chronic Immune Thrombocytopenic Purpura
    Children's Mercy Kansas City SHARE @ Children's Mercy Manuscripts, Articles, Book Chapters and Other Papers 12-2020 The Need for Comprehensive Care for Persons with Chronic Immune Thrombocytopenic Purpura. Kristin T. Ansteatt Chanel J. Unzicker Marsha L. Hurn Oluwaseun O. Olaiya Children's Mercy Hospital Diane J. Nugent See next page for additional authors Follow this and additional works at: https://scholarlyexchange.childrensmercy.org/papers Recommended Citation Ansteatt KT, Unzicker CJ, Hurn ML, Olaiya OO, Nugent DJ, Tarantino MD. The Need for Comprehensive Care for Persons with Chronic Immune Thrombocytopenic Purpura. J Blood Med. 2020;11:457-463. Published 2020 Dec 17. doi:10.2147/JBM.S289390 This Article is brought to you for free and open access by SHARE @ Children's Mercy. It has been accepted for inclusion in Manuscripts, Articles, Book Chapters and Other Papers by an authorized administrator of SHARE @ Children's Mercy. For more information, please contact [email protected]. Creator(s) Kristin T. Ansteatt, Chanel J. Unzicker, Marsha L. Hurn, Oluwaseun O. Olaiya, Diane J. Nugent, and Michael D. Tarantino This article is available at SHARE @ Children's Mercy: https://scholarlyexchange.childrensmercy.org/papers/2899 Journal of Blood Medicine Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW The Need for Comprehensive Care for Persons with Chronic Immune Thrombocytopenic Purpura This article was published in the following Dove Press journal: Journal of Blood Medicine Kristin T Ansteatt 1 Abstract: Chronic platelet disorders (CPD), including chronic immune thrombocytopenic Chanel J Unzicker1 purpura (cITP), thrombotic thrombocytopenic purpura (TTP) and platelet function disorders Marsha L Hurn1 are among the most common bleeding disorders and are associated with morbidity and Oluwaseun O Olaiya2 mortality.
    [Show full text]