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Aspartate Aminotransferase

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281. Guidance on Primary Biliary Cholangitis

of Hepatology, Vol. 0, No. 0, 2018 l i Ndor et al. 5 aminotransferase (alanine aminotransferase or aspar- tate aminotransferase) activity, and increased levels of immunoglobulins (mainly IgM). Some patients with PBC may have high alanine aminotransferase or aspartate aminotransferase activities associated with hyper-?-globulinemia (elevated IgG). The magnitude of biochemical test elevations is loosely related to the severity of the disease. (70,82-83) In patients without cirrhosis, the degree of elevation (...) ) TB 1× LLN Toronto (151) ALP 1.67× ULN Paris II (152) ALP 1.5× ULN; AST 1.5× ULN; and TB 1 mg/dL Rochester II (79) ALP 2× ULN Global (77) ALP 2× ULN ALP, alkaline phosphatase; AST, aspartate aminotransferase; TB, total bilirubin, ULN, upper limit of normal.l i Ndor et al. Hepatology , Month 2018 12 randomized to placebo, 10 mg/day OCA, or a titra- tion arm, in which subjects were started at 5 mg/day OCA and could increase to 10 mg/day after 6 months if they were tolerating the medication well

2018 American Association for the Study of Liver Diseases

283. Esmya (ulipristal acetate) and risk of serious liver injury: new restrictions to use and requirements for liver function monitoring before, during, and after treatment

is contraindicated in women with underlying liver disorders Liver function monitoring before initiation of each treatment course: perform liver function tests; do not initiate Esmya in women with baseline alanine transaminase (ALT) or aspartate aminotransferase (AST) more than 2-times the upper limit of normal [ULN] during the first 2 treatment courses: perform liver function tests every month for further treatment courses: perform liver function tests once before each new course and when clinically indicated

2018 MHRA Drug Safety Update

284. Hepatocellular carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

versus 8.0 months). Response rate was 4% with cabozantinib based upon RECIST v1.1. The most common grade 3/4 AEs with cabozantinib versus placebo were palmar– plantar erythrodysesthaesia (17% versus 0%), hypertension (16% versus 2%), increased aspartate aminotransferase (AST) (12% versus 7%), fatigue (10% versus 4%) and diarrhoea (10% versus 2%) and led to 62% dose reductions and 16% treatment discontinuation. Ramucirumab: RAM is a human immunoglobulin G1 (IgG1) monoclonal antibody (mAb

2018 British Society of Gastroenterology

285. Sarilumab (Kevzara) - for treating adults with moderate to severe rheumatoid arthritis

of Rheumatology 50% improvement ACR70 American College of Rheumatology 70% improvement ADA anti-drug antibody, anti-drug antibody ALT alanine aminotransferase ANA antinuclear antibodies ANC absolute neutrophil count Assessment report EMA/292840/2017 Page 5/189 AUC0 14 days area under the serum concentration versus time curve at steady state CDAI Clinical Disease Activity Index CRP C-reactive protein CV cardiovascular DAS28-CRP Disease Activity Score for 28 Joints using C-reactive protein DMARD disease

2017 European Medicines Agency - EPARs

286. Dimethyl fumarate (Skilarence) - plaque psoriasis

Analysis of covariance AST Aspartate aminotransferase ATC Anatomical Therapeutic Chemical AUC0-8 Area under the plasma concentration-time curve from time zero to infinity AUC0-t Area under the plasma concentration-time curve from time zero to time t, where t is the time of the last concentration measured BfArM Bundesinstitut für Arzneimittel und Medizinprodukte (the German Federal Institute for Drugs and Medical Devices) BID Twice Daily BSA Body surface area CHMP Committee for Medicinal Products (...) favourable effects 99 3.4. Unfavourable effects 100 3.5. Uncertainties and limitations about unfavourable effects 101 3.6. Effects Table 102 3.7. Benefit-risk assessment and discussion 103 3.7.1. Importance of favourable and unfavourable effects 103 3.7.2. Balance of benefits and risks 105 3.8. Conclusions 106 4. Recommendations 106 Assessment report EMA/412737/2017 Page 4/108 List of abbreviations a.a. After administration AE Adverse event ALP Alkaline phosphatase ALT Alanine aminotransferase ANCOVA

2017 European Medicines Agency - EPARs

287. Avelumab (Bavencio) - Neuroendocrine Tumors

AE adverse event AESI adverse event of special interest AEX anion exchange chromatography ALT alanine aminotransferase AST aspartate aminotransferase AUCss area under the serum concentration-time curve at steady state BOR best overall response CEOI concentration at the end of the infusion CHO chinese hamster ovary cells CL total systemic clearance CLL chronic lymphocytic leukemia CMA conditional marketing authorization Cmax maximum plasma concentration observed postdose CPI Relative Cluster pI

2017 European Medicines Agency - EPARs

288. Dupilumab (Dupixent) - Atopic Dermatitis

-drug antibody AE Adverse event AESI Adverse event of special interest AKC Atopic keratoconjunctivitis ALT Alanine Aminotransferase ANA Anti-nuclear antibody ANCOVA Analysis of covariance anti-dsDNA Anti-nuclear antibody against double-stranded DNA anti-TPO Anti-thyroid peroxidase ARGUS A Pharmacovigilance and Risk Management Safety Software System AST Aspartate Aminotransferase ATC Anatomical Therapeutic Chemical BMI Body mass index BSA Body surface area CI Confidence interval CMH Cochran-Mantel

2017 European Medicines Agency - EPARs

289. Darunavir / cobicistat / emtricitabine / tenofovir alafenamide (Symtuza) - HIV Infections

. Conclusions 105 4. Recommendations 106 Assessment report EMA/496527/2017 Page 4/106 List of abbreviations AAG a1-acid glycoprotein ADR adverse drug reaction AE adverse event aGFR actual glomerular filtration rate AhR aryl hydrocarbon receptor AIDS acquired immunodeficiency syndrome APV amprenavir ARV antiretroviral ART antiretroviral therapy AST aspartate aminotransferase ATV atazanavir AUC area under the curve AUC 24h area under the plasma concentration-time curve over 24 hours AUClast area under

2017 European Medicines Agency - EPARs

290. Atezolizumab (Tecentriq) - Non-Small-Cell Lung Carcinoma or Transitional Cell Carcinoma

Page 4/205 List of abbreviations 1L first-line treatment 2L second-line treatment 2L+ = second-line treatment AC acceptance criterion AE adverse event AESI adverse event of special interest ADCC antibody-dependent cell-mediated cytotoxicity ADE acceptable daily exposure AST aspartate aminotransferase ATA/ATAG anti-therapeutic antibody AUC area under the curve BCG Bacillus Calmette-Guerin BSC best supportive care BOR best overall response CL clearance Cmax maximum observed serum concentration Cmin

2017 European Medicines Agency - EPARs

291. Dinutuximab beta Apeiron - neuroblastoma

function: absolute neutrophil count = 500/µL, platelet count = 20.000/µL, haemoglobin > 8.0 g/dL - adequate liver function: alanine aminotransferase (ALT)/ aspartate amino transferase (AST) 60 mL/min/1.73 m 2 . Type of Application and aspects on development This application has been submitted under Article 8.3 of Directive 2001/83/EC - complete and independent application. During the evaluation of the application, the CHMP considered that the data provided in support of this application (...) cell-mediated cytotoxicity ADR Adverse drug reaction AE Adverse event ALT Alanine transaminase ANR Advances in Neuroblastoma Research ASCO American Society of Clinical Oncology ASCR/T autologous stem cell rescue/transplantation AST Aspartate transaminase BuMel busulfan and melphalan CD Circular dichroism CD16 Fc? receptor CDC complement-dependent cytotoxicity CDR Complementarity determining regions CEM carboplatin, etoposide and melphalan CFU Colony forming unit CHMP Committee for Medicinal

2017 European Medicines Agency - EPARs

292. Chenodeoxycholic acid sigma-tau - cerebrotendinous xanthomatosis

40 2.6. Pharmacovigilance 40 2.7. Product information 42 2.7.1. User consultation 42 2.7.2. Additional monitoring 42 3. Benefit-risk balance 43 4. Recommendation 46 Assessment report EMA/650359/2016 Page 3/47 List of abbreviations ADR Adverse Drug Reaction AE Adverse Event ALT Alanine Aminotransferase AST Aspartate Aminotransferase ATC Anatomic Therapeutic Chemical classification system BUN Blood Urea Nitrogen CA Cholic acid CBC Complete Blood Count CDCA Chenodeoxycholic acid CI Confidence

2017 European Medicines Agency - EPARs

294. Adalimumab (Imraldi) - psoriasis, psoriatic arthritis, axial spondyloarthritis, Crohn?s disease, ulcerative colitis

of the ACR response ADA Anti-drug antibody ADCC Antibody dependent cell-mediated cytotoxicity AE Adverse effect AlphaScreen Amplified Luminescent Proximity Homogeneous Assay Screen ALT Alanine transaminase ANCOVA Analysis of covariance API Active Pharmaceutical Ingredient Apoptosis Programmed Cell Death Asn Asparagine AST Aspartate transaminase ANOVA Analysis of variance AS Ankylosing spondylitis AU Absorbance Unit AUC Area under the concentration-time curve AUC inf Area under the concentration-time

2017 European Medicines Agency - EPARs

295. Ribociclib (Kisqali) - breast cancer

AESI adverse event of special interest AI aromatase inhibitor ALT alanine aminotransferase ANC absolute neutrophil count AST aspartate aminotransferase AUC area under the plasma concentration-time curve BCRP breast cancer resistance protein BCS Biopharmaceutics classification system BIRC Blinded Independent Review Committee BR23 breast cancer specific module of the EORTC QLQ-C30 BSEP bile salt export pump BU Blend uniformity CBR clinical benefit rate CDK cyclin-dependent kinase CFU Colony forming

2017 European Medicines Agency - EPARs

296. Tadalafil - Pulmonary Hypertension

phosphatase ALT Alanine aminotransferase ANSM National Agency for the Safety of Medicine and Health Products AP Applicant's Part of ASMF API Active Pharmaceutical Ingredient APPM Association of Paediatric Palliative Medicine Master Formulary AR Assessment Report ASM Active Substance Manufacturer ASMF Active Substance Master File = Drug Master File AST Aspartate aminotransferase AUC Area Under the plasma Concentration AUC0-inf Area Under the plasma Concentration-time curve from time zero to infinity AUC0-t

2017 European Medicines Agency - EPARs

297. Insulin glargine (Lusduna) - Diabetes Mellitus

3.6.3. Additional considerations on the benefit-risk balance 75 3.7. Conclusions 75 4. Recommendation 75 Medicinal product no longer authorised Assessment report EMA/813309/2016 Page 4/76 List of abbreviations 14C-2DG 2-deoxy-D-glucose labeled with 14C A1C Hemoglobin A1c A660 Absorbance at 660 nm AAS Atomic absorption spectrometry ADME Absorption, distribution, metabolism, excretion AE Adverse event AEX Anion Exchange Chromatography AIA Anti-insulin antibodies ALP Aspartate aminotransferase ALT (...) Alanine transaminase ANCOVA Analysis of covariance API Active Pharmaceutical Ingredient approx Approximately ASaT All Subjects as Treated ASR All subjects randomized AST Aspartate transaminase AU absorbance units AUC Area under the concentration-time curve AUC0-24h Area under the concentration-time curve from time 0 to 24 hours AUC0-6h Area under the concentration-time curve from time 0 to 6 hours Avg Average BLQ Below the Limit of Quantitation BMI Body mass index bp base pairs BP Blood pressure Ca

2017 European Medicines Agency - EPARs

298. Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia

time ASO PCR allele specific oligonucleotide polymerase chain reaction AST aspartate aminotransferase Bcl B cell lymphoma BCRi B Cell receptor inhibitor BMI body mass index BR bendamustine rituximab CD cluster of differentiation CI confidence interval CLL chronic lymphocytic leukaemia CPP Critical process parameter CQA Critical Quality Attribute CR complete remission CRi complete remission with incomplete bone marrow recovery CSR clinical study report CT computed tomography CTLS clinical tumour (...) Management Plan 114 2.8. Pharmacovigilance 124 2.9. Product information 124 2.9.1. User consultation 124 2.9.2. Additional monitoring 124 3. Benefit-Risk Balance 124 4. Recommendations 130 Assessment report EMA/725631/2016 Page 3/132 List of abbreviations AE adverse event AIHA autoimmune hemolytic anaemia ALC absolute lymphocyte count ALT alanine aminotransferase ANC absolute neutrophil count anti HBc hepatitis B core antibody anti HBs hepatitis B surface antibody aPTT activated partial thromboplastin

2017 European Medicines Agency - EPARs

299. Obeticholic acid (Ocaliva) - Liver Cirrhosis, Biliary

/2016 Page 5/129 List of abbreviations AASLD American Association for the Study of Liver Diseases AE adverse event AMA antimitochondrial antibody ALT alanine aminotransferase ALP alkaline phosphatase AMA antimitochondrial antibodies ANCOVA analysis of covariance aPTT activated partial thromboplastin time AST aspartate aminotransferase ATC Anatomical/Therapeutic/Chemical AUC area under the curve BA bioavailability BAS bile acid sequestrants BE bioequivalence BMD bone mineral density BMI body mass (...) ). ALP is the predominant biochemical marker used in the diagnosis and treatment for cholestatic conditions. Gamma-glutamyl transferase (GGT) lacks specificity as it is seen in many clinical conditions; however, elevation of this enzyme in the presence of elevated ALP levels is confirmatory of a hepatic etiology and in particular cholestatic condition such as PBC (Giannini 2005). In the later stage of PBC, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) may also be elevated due

2017 European Medicines Agency - EPARs

300. Alcoholic Liver Disease

of steatohepatitis and/or liver fi brosis. Alcoholic fatty liver disease is diagnosed in a patient with AUD with hepatic steatosis on ultrasound and/or elevation in liver enzymes (aspartate aminotransferase (AST)>alanine ami- notransferase (ALT)), serum bilirubin 8 Abnormal liver test (elevation GOT and GGT) Refer to GI specialist/hepatology Refer to alcohol addiction specialist Counseling/anticraving drugs (i.e., Baclofen) Follow-up by primary practitioner No/mild fibrosis Advanced fibrosis/cirrhosis Consider

2018 American College of Gastroenterology

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