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Aspartate Aminotransferase

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221. Gilteritinib (Xospata) - acute myeloid leukaemia (AML)

of chemotherapy. What are the risks associated with Xospata? The most common side effects with Xospata (which may affect more than 1 in 10 people) are increased levels of some enzymes in the blood (creatine phosphokinase, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase), diarrhoea, tiredness, nausea (feeling sick), constipation, cough, peripheral oedema (swelling, especially of the ankles and feet), dyspnoea (shortness of breath), dizziness, hypotension (low blood pressure), pain

2019 European Medicines Agency - EPARs

224. Non-Surgical Management of Advanced Hepatocellular Carcinoma

to 0.87, p 0.999 Post-procedural pain 22 (24.7) 63 (71.6) p=0.001 All other AEs p=ns *Treatment-related SAEs with 30 days of treatment Abbreviations: AE=adverse event; ALT=alanine aminotransferase; AST=aspartate aminotransferase; cTACE = conventional transarterial chemoembolization; DEB-TACE=drug eluting bead transarterial chemoembolization; LVEF=left ventricular ejection fraction; NR=not reported; ORR=objective response rate; OS=overall survival; RCT=randomized controlled trial; SAE=serious adverse

2019 Cancer Care Ontario

225. Acute Treatments for Migraine

for Clinical and Economic Review, 2020 Page vii Evidence Report- Acute Treatments for Migraine Return to Table of Contents List of Acronyms Used in this Report 5-HT 5-hydroxytryptamine 95%CI 95% confidence interval 95%CrI 95% credible interval AAFP American Academy of Family Physicians AAN American Academy of Neurology AE Adverse event ACS Acute coronary syndrome AHRQ Agency for Healthcare Research and Quality AHS American Headache Society ALT Alanine Aminotransferase AST Aspartate Aminotransferase BCBSKC

2020 California Technology Assessment Forum

226. Assessment of liver dysfunction

(breakdown product of the RBC after conjugation in the liver and secretion in biliary system excretion) Alanine aminotransferase (ALT) Alkaline phosphatase (ALP) Serum albumin. The following tests may also be included in this bundle: Aspartate aminotransferase (AST) Gamma-glutamyl transpeptidase (gamma-GT) Lactate dehydrogenase (LDH). Individual tests in these panels are not specific for liver disease. Therefore, pattern recognition is critical. Isolated elevation of liver tests is a less common

2018 BMJ Best Practice

227. Post-exposure HIV prophylaxis

of care (POCT) HIV test renal function tests serum aspartate aminotransferase or alanine aminotransferase hepatitis B serology hepatitis C serology syphilis serology pregnancy test HIV viral load if symptoms of HIV seroconversion Treatment algorithm ACUTE Contributors Authors Genitourinary and HIV Specialist Registrar Department of HIV Harrison Wing Guy’s and St Thomas Hospital NHS Foundation Trust London UK Disclosures MJL declares no competing interests. HIV consultant and Honorary Senior Lecturer

2018 BMJ Best Practice

228. Cytomegalovirus infection

disease acute illness in intensive care setting newborn in CMV infection during pregnancy Diagnostic investigations FBC serum creatinine serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) serum alkaline phosphatase serology pp65 antigenaemia nucleic acid detection CD4 count chest x-ray chest CT scan histopathology of biopsy upper gastrointestinal endoscopy and colonoscopy serial fetal ultrasound examinations (congenital CMV infection) amniocentesis or fetal blood sampling

2018 BMJ Best Practice

229. HELLP syndrome

antithrombin level haptoglobin level maternal upper abdomen ultrasound, CT, or MRI lactate dehydrogenase (LDH)-to-aspartate aminotransferase (AST) ratio Treatment algorithm INITIAL ACUTE Contributors Authors Professor of Obstetrics and Gynecology Vice Chair for Research and Academic Development Director of the Divisions of Maternal-Fetal Medicine and Research University of Mississippi Medical Center Jackson MI Disclosures JNM Jr is a maternal-foetal medicine consultant and obstetrician gynaecologist

2018 BMJ Best Practice

230. Acute pancreatitis

Sjogren's syndrome pancreas divisum pancreatic cancer sphincter of Oddi dysfunction family history of pancreatitis Diagnostic investigations serum lipase or amylase aspartate aminotransferase/alanine aminotransferase FBC and differential CRP haematocrit arterial blood gas abdominal plain film CXR trans-abdominal ultrasound ratio of serum lipase:amylase abdominal CT scan magnetic resonance cholangiopancreatography (MRCP) endoscopic ultrasound (EUS) urinary trypsinogen-2 serum interleukin-6 serum

2018 BMJ Best Practice

231. Alcohol-use disorder

behaviour (pre-morbid) high trait anxiety level lack of facial flushing on exposure to alcohol low responsivity to the effects of alcohol history of gastric bypass Diagnostic investigations diagnostic interview alcohol level (breath and blood) Clinical Institute Withdrawal Assessment for Alcohol--revised (CIWA-Ar) carbohydrate-deficient transferrin (CDT) gamma glutamyl transpeptidase (gamma-GT), alanine aminotransferase (ALT), aspartate aminotransferase (AST) FBC urinary ethyl glucuronide Treatment

2018 BMJ Best Practice

232. Rucaparib camsylate - Ovarian Neoplasms

aspartate aminotransferase AUC area under the plasma concentration-time curve AUC 0–12 area under the concentration versus time curve from time zero to 12 hours postdose AUC 0–24 area under the concentration versus time curve from time zero to 24 hours postdose AUC 0–24.5 area under the concentration versus time curve from time zero to 24.5 hours postdose AUC ss dose-averaged model-predicted steady-state area under the concentration-time curve AUC ss,avg further adjusted AUC ss,avg AUC last area under (...) . Importance of favourable and unfavourable effects 161 3.7.2. Balance of benefits and risks 161 3.7.3. Additional considerations on the benefit-risk balance 162 3.8. Conclusions 163 4. Recommendations 164 DIVERGENT POSITION DATED 22.03.2018 167 Assessment report EMA/CHMP/238139/2018 Page 4/167 List of abbreviations AE adverse event AEMPS Agencia Española de Medicamentos y Productos Sanitarios AESI(s) adverse event(s) of special interest ALT alanine aminotransferase AML acute myeloid leukaemia AST

2018 European Medicines Agency - EPARs

233. Peramivir (Alpivab) - Influenza, Human

aminotransferase AP Alkaline phosphatase ARDS Acute respiratory distress syndrome AST Aspartate aminotransferase AUC Area under the time concentration curve BID Twice daily BMI Body mass index CDC Centers for Disease Control and Prevention CFB Change from baseline CI Confidence interval CL Clearance CLcr Creatinine clearance Cmax Maximum concentration CSR Clinical study report CK / CPK Creatine phosphokinase COPD Chronic obstructive pulmonary disease CYP Cytochrome ECDC European Centre for Disease Prevention

2018 European Medicines Agency - EPARs

234. Beclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium (Riarify - (previously CHF 5993 Chiesi Farmaceutici S.p.A.)) - Chronic Obstructive Pulmonary Disease

and risk benefit assessment 12 4. Recommendations 12 Assessment report EMA/155339/2018 Page 3/13 List of abbreviations ADME absorption, distribution, metabolism, and excretion ADR Adverse Drug Reaction AE adverse event AESI adverse event of special interest ALT alanine aminotransferase APSD aerodynamic particle size distribution AST aspartate aminotransferase ATS American Thoracic Society BMI body mass index BUD budesonide CAT COPD Assessment Test CDLM Capacity of Daily Living during the Morning CEC

2018 European Medicines Agency - EPARs

235. Beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium (Trydonis) - COPD, Chronic Obstructive Pulmonary Disease

12 Assessment report EMA/155337/2018 Page 3/13 List of abbreviations ADME absorption, distribution, metabolism, and excretion ADR Adverse Drug Reaction AE adverse event AESI adverse event of special interest ALT alanine aminotransferase APSD aerodynamic particle size distribution AST aspartate aminotransferase ATS American Thoracic Society BMI body mass index BUD budesonide CAT COPD Assessment Test CDLM Capacity of Daily Living during the Morning CEC Clinical Endpoint Committee CHMP Committee

2018 European Medicines Agency - EPARs

236. Infliximab (Zessly) - Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Psoriasis, Ankylosing Spondylitis

of favourable and unfavourable effects 103 3.6.2. Balance of benefits and risks 103 3.7. Conclusions 104 4. Recommendations 104 CHMP assessment report EMA/223369/2018 Page 3/106 List of abbreviations %CV Percent coefficient of variation %RE Percent relative error Ab Antibody Abs Absolute ACR American College of Rheumatology ADA Anti-drug antibody ADCC Antibody-Dependent Cell-Mediated Cytotoxicity ADR Adverse drug reaction AE Adverse event ALT Alanine aminotransferase AST Aspartate aminotransferase AUC-SE

2018 European Medicines Agency - EPARs

237. Gemtuzumab ozogamicin (Mylotarg) - Leukemia, Myeloid, Acute

leukaemia AraC cytarabine AST aspartate aminotransferase AT As Treated AUC area under the plasma concentration-time curve BCRP breast cancer resistance protein BMA bone marrow aspirate BSA bovine serum albumin CD Cluster of Differentiation CDR Complementarity determining region CFU Colony Forming Units CHMP Committee for Medicinal Products for Human Use CI confidence interval CL Clearance CLL1 C-type lectin-like molecule-1 Cmax Maximum Serum Concentration CNS central nervous system COG Children's (...) balance 134 3.8. Conclusions 135 4. Recommendations 135 Assessment report EMA/155284/2018 Page 4/138 List of abbreviations Term Definition AAS Amino Acid Substitution AcBut (4-(4'acetylphenoxy)butanoic acid) ADA anti-drug antibody ADC antibody-drug conjugate ADE AraC/DNR/etoposide ADR adverse drug reaction AE adverse event ALFA Acute Leukemia French Association ALP alkaline phosphatase ALT alanine aminotransferase AML acute myeloid leukaemia ANC absolute neutrophil count APL acute promyelocytic

2018 European Medicines Agency - EPARs

238. Dolutegravir sodium rilpivirine hydrochloride (Juluca) - HIV Infections

Abacavir AE Adverse event ALAG Absorption lag time ALT Alanine aminotransferase ART Antiretroviral therapy ARV Antiretroviral ASMF Active substance master file AST Aspartate aminotransferase ATV Atazanavir AUC Area under the concentration-time curve AUC(0-t) Area under the concentration-time curve over the dosing interval AZT Zidovudine BA Bioavailability BCS Biopharmaceutics classification system BE Bioequivalence c/mL copies/milliliter C 0avg Average pre-dose concentration C 0h Observed plasma (...) in aminotransferases are known and very common side effects of both, DTG and RPV. Altogether, no new risk with regard to the liver chemistries and no increased risk of hepatic toxicity for DTG + RPV compared with CAR could be detected. Renal Function Renal disorders AEs in the Early Switch Phase are discussed already above in section ‘Adverse events of special interest (AESIs)’. Ten (2%) subjects in the DTG + RPV group had Grade 1 maximum post-baseline emergent elevations in creatinine; there were no Grade 2

2018 European Medicines Agency - EPARs

239. Esmya: new measures to minimise risk of rare but serious liver injury

each treatment course, monthly during the first 2 treatment courses, and thereafter as clinically indicated. Liver testing also to be performed again 2-4 weeks after stopping treatment. Esmya should not be started if levels of alanine transaminase (ALT) or aspartate aminotransferase (AST) are more than 2 times the upper limit of normal (ULN). Treatment should be stopped in patients with ALT or AST levels more than 3 times ULN. Healthcare professionals should advise their patients about the signs

2018 European Medicines Agency - EPARs

240. Axicabtagene ciloleucel (Yescarta) - diffuse large B-cell lymphoma (DLBCL); primary mediastinal large B-cell lymphoma (PMBCL)

Vomiting Constipation Abdominal pain Dry mouth Skin and subcutaneous tissue disorders Common Rash Musculoskeletal and connective tissue disorders Very common Motor dysfunction Pain in extremity Back pain Arthralgia Muscle pain Renal and urinary disorders Common Renal insufficiency General disorders and administration site conditions Very common Fatigue Pyrexia Oedema Chills Investigations Very common Alanine aminotransferase increased Aspartate aminotransferase increased Common Bilirubin increased

2018 European Medicines Agency - EPARs

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