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Hepatotoxic Medication

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141. Comparative Effectiveness of Analgesics To Reduce Acute Pain in the Prehospital Setting

others—make well-informed decisions and thereby improve the quality of healthcare services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report is made available (...) Administration (NHTSA) requested this report from the EPC Program at AHRQ and provided funding for the report. AHRQ assigned this report to the following EPC: University of Connecticut Evidence- based Practice Center (Contract Number 290-20-1500012-I). The reports and assessments provide organizations with comprehensive, evidence-based information on common medical conditions and new healthcare technologies and strategies. They also identify research gaps in the selected scientific area, identify

2019 Effective Health Care Program (AHRQ)

142. Masitinib mesylate (Alsitek) - Amyotrophic Lateral Sclerosis

disease-specific therapy offers hope that the progression of ALS may one day be slowed by new medications or combinations of drugs. Other treatments for ALS are designed to relieve symptoms and improve the quality of life for individuals with the disorder. This supportive care is best provided by multidisciplinary teams of health care professionals such as physicians; pharmacists; physical, occupational, and speech therapists; nutritionists; and social workers and home care and hospice nurses. Working (...) with patients and caregivers, these teams can design an individualized plan of medical and physical therapy and provide special equipment aimed at keeping patients as mobile and comfortable as possible. Physicians can prescribe medications to help reduce fatigue, ease muscle cramps, control spasticity, and reduce excess saliva and phlegm. Drugs also are available to help patients with pain, depression, sleep disturbances, and constipation. Physical therapy and special equipment can enhance an individual’s

2018 European Medicines Agency - EPARs

143. Plitidepsin (Aplidin) - Multiple Myeloma

Active Substance 133 2.10. Product information 133 Assessment report EMA/249101/2018 Page 4/156 2.10.1. User consultation 133 2.10.2. Additional monitoring 133 3. Benefit-Risk Balance 134 3.1. Therapeutic Context 134 3.1.1. Disease or condition 134 3.1.2. Available therapies and unmet medical need 134 3.1.3. Main clinical studies 134 3.2. Favourable effects 134 3.3. Uncertainties and limitations about favourable effects 135 3.4. Unfavourable effects 135 3.5. Uncertainties and limitations about (...) and unmet medical need 146 6.1.3. Main clinical studies 146 6.2. Favourable effects 146 6.3. Uncertainties and limitations about favourable effects 147 6.4. Unfavourable effects 147 6.5. Uncertainties and limitations about unfavourable effects 147 6.6. Effects Table 148 6.7. Benefit-risk assessment and discussion 149 6.7.1. Importance of favourable and unfavourable effects 149 6.7.2. Balance of benefits and risks 149 6.7.3. Additional considerations on the benefit-risk balance 149 6.8. Conclusions 149 7

2018 European Medicines Agency - EPARs

144. Inotersen sodium (Tegsedi) - Amyloidosis

. Conclusions on the clinical efficacy 86 2.6. Clinical safety 87 2.6.1. Discussion on clinical safety 110 2.6.2. Conclusions on the clinical safety 115 2.7. Risk Management Plan 116 2.8. Pharmacovigilance 121 2.9. New Active Substance 122 Assessment report EMA/411876/2018 Page 3/142 2.10. Product information 122 2.10.1. User consultation 122 2.10.2. Additional monitoring 122 3. Benefit-Risk Balance 122 3.1. Therapeutic Context 122 3.1.1. Disease or condition 122 3.1.2. Available therapies and unmet medical (...) neurological impairment and has also been licensed in Japan and several other countries. Diflunisal is a non- steroidal anti-inflammatory drug (NSAID) that is presently used off-label in subjects with Stage 1 and Stage 2 disease [Adams, 2016]; however, the cardiovascular and renal side effects associated with the NSAID class limit the use of this drug in older patients with hATTR-PN or patients with hATTR CM. Consequently, there continues to be an unmet medical need for effective and well tolerated

2018 European Medicines Agency - EPARs

145. Erenumab (Aimovig) - Migraine

Plan 93 2.7. Pharmacovigilance 95 2.8. New Active Substance 95 2.9. Product information 95 2.9.1. User consultation 95 2.9.2. Additional monitoring 96 3. Benefit-Risk Balance 96 3.1. Therapeutic Context 96 3.1.1. Disease or condition 96 3.1.2. Available therapies and unmet medical need 96 3.1.3. Main clinical studies 97 3.2. Favourable effects 97 3.3. Uncertainties and limitations about favourable effects 98 3.4. Unfavourable effects 99 3.5. Uncertainties and limitations about unfavourable effects (...) liquid chromatography coupled to tandem mass spectrometry LIVCA end of production cells at the limit of in vitro cell age LSM least squares mean MCB master cell bank MEB Medicines Evaluation Board MFI Microflow imaging MHRA Medicines and Healthcare Products Regulatory Agency MID minimal important difference MIDAS Migraine Disability Assessment Questionnaire MMD monthly migraine days MMV mouse minute virus MPA Medical Products Agency MPFID Migraine Physical Function Impact Diary MSQ Migraine-specific

2018 European Medicines Agency - EPARs

146. Neratinib (Nerlynx) - Breast cancer, breast neoplasms

. Available therapies and unmet medical need 143 3.1.3. Main clinical studies 143 3.2. Favourable effects 143 3.3. Uncertainties and limitations about favourable effects 144 3.4. Unfavourable effects 144 3.5. Uncertainties and limitations about unfavourable effects 145 3.6. Effects Table 145 3.7. Benefit-risk assessment and discussion 145 3.7.1. Importance of favourable and unfavourable effects 145 3.7.2. Balance of benefits and risks 146 3.7.3. Additional considerations on the benefit-risk balance 146 (...) 3.8. Conclusions 147 4. Recommendations 147 5. Re-examination of the CHMP opinion of 22 February 2018 148 5.1. Risk Management Plan 155 5.2. Pharmacovigilance 159 5.3. Product information 159 5.3.1. User consultation 159 5.3.2. Additional monitoring 159 6. Benefit-risk balance following re-examination 159 6.1. Therapeutic Context 159 6.1.1. Disease or condition 159 6.1.2. Available therapies and unmet medical need 160 6.1.3. Main clinical studies 160 6.2. Favourable effects 160 6.3. Uncertainties

2018 European Medicines Agency - EPARs

147. Allopurinol / lesinurad (Duzallo) - Gout

on the clinical efficacy 72 2.6. Clinical safety 72 2.6.1. Discussion on clinical safety 89 2.6.2. Conclusions on the clinical safety 92 2.7. Risk Management Plan 92 2.8. Pharmacovigilance 94 2.9. Product information 94 2.9.1. User consultation 94 Assessment report EMA/474026/2018 Page 3/100 2.9.2. Additional monitoring 94 3. Benefit-Risk Balance 94 3.1. Therapeutic Context 94 3.1.1. Disease or condition 94 3.1.2. Available therapies and unmet medical need 95 3.1.3. Main clinical studies 95 3.2. Favourable (...) their limitations regarding safety, and are not overall available in the EU member states e.g. benzbromarone is associated with hepatotoxicity, probenecid causes multiple drug-drug interactions and has to be frequently dosed over the day, whereas sulphinpyrazone has been associated with rash and gastric bleeding. Pegloticase is highly effective; however, its use is limited to last line because of the risk of serious infusion reactions. About the product Duzallo, a fixed dose combination (FDC) of allopurinol

2018 European Medicines Agency - EPARs

148. Vestronidase alfa (Mepsevii) - Mucopolysaccharidosis VII

. Pharmacovigilance 78 2.8. New Active Substance 81 2.9. Product information 81 2.9.1. User consultation 81 2.9.2. Labelling exemption 81 2.9.3. Additional monitoring 81 Assessment report EMA/480950/2018 Page 3/87 3. Benefit-Risk Balance 82 3.1. Therapeutic Context 82 3.1.1. Disease or condition 82 3.1.2. Available therapies and unmet medical need 82 3.1.3. Main clinical studies 82 3.2. Favourable effects 82 3.3. Uncertainties and limitations about favourable effects 83 3.4. Unfavourable effects 83 3.5 (...) 3 study (UX003-CL301). All 12 patients enrolled in the pivotal study had comorbidities and complications in their medical history, as would be expected in this chronic multi-systemic progressive disease. Nearly all patients included in the various studies had cognitive disabilities manifesting as developmental delay, language delay and intellectual impairment. Supportive data are provided by the dose finding study (UX003-CL201) and Study UX003-CL203, an ongoing open-label study of vestronidase

2018 European Medicines Agency - EPARs

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

3.1.2. Available therapies and unmet medical need 131 3.1.3. Main clinical studies 131 3.2. Favourable effects 131 3.3. Uncertainties and limitations about favourable effects 132 3.4. Unfavourable effects 132 3.5. Uncertainties and limitations about unfavourable effects 132 3.6. Effects Table 133 3.7. Benefit-risk assessment and discussion 133 3.7.1. Importance of favourable and unfavourable effects 133 3.7.2. Balance of benefits and risks 134 3.7.3. Additional considerations on the benefit-risk (...) on Harmonisation Ida idarubicin IIR investigator-initiated research IPD individual patient data IR infrared radiation ISS Integrated Summary of Safety IV intravenous IWG International Working Group K Lysine kdes, decay coefficient of the time-dependent clearance LC Light chain LDAC low dose AraC LSC leukaemic stem cell MAA marketing authorisation application mAb monoclonal antibody MAH marketing authorisation holder MDS myelodysplastic syndromes MedDRA Medical Dictionary for Regulatory Activities mITT modified

2018 European Medicines Agency - EPARs

150. Rucaparib camsylate - Ovarian Neoplasms

2.10. Product information 157 2.10.1. User consultation 157 2.10.2. Additional monitoring 158 3. Benefit-Risk Balance 158 3.1. Therapeutic Context 158 3.1.1. Disease or condition 158 3.1.2. Available therapies and unmet medical need 158 3.2. Favourable effects 158 3.3. Uncertainties and limitations about favourable effects 159 3.4. Unfavourable effects 159 3.5. Uncertainties and limitations about unfavourable effects 160 3.6. Effects Table 160 3.7. Benefit-risk assessment and discussion 161 3.7.1 (...) acid DSB double-strand breaks DSC differential scanning calorimetry DVS dynamic vapour sorption EC European Commission ECG(s) electrocardiogram(s) ECOG Eastern Cooperative Oncology Group EMA European Medicines Agency EOC epithelial ovarian cancer ESMO European Society for Medical Oncology EU European Union EU-RMP European Union Risk Management Plan FDA Food and Drug Administration FeSSIF Fed state simulated intestinal fluid Assessment report EMA/CHMP/238139/2018 Page 5/167 FFPE formalin-fixed

2018 European Medicines Agency - EPARs

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

. Conclusions on the clinical efficacy 75 2.6. Clinical safety 75 2.6.1. Discussion on clinical safety 98 2.6.2. Conclusions on the clinical safety 100 2.7. Risk Management Plan 100 2.8. Pharmacovigilance 103 2.9. Product information 103 2.9.1. User consultation 103 Assessment report EMA/243517/2018 Page 3/109 3. Benefit-Risk Balance 103 3.1. Therapeutic Context 103 3.1.1. Disease or condition 103 3.1.2. Available therapies and unmet medical need 104 3.1.3. Main clinical studies 104 3.2. Favourable effects (...) and that the mean duration of use of the ART- regimen at screening was almost 4 years. Moreover, relevant comorbidities, such as CHB-infection and co-medications were excluded. Self-reported adherence to study medications was – with intake of 98% of the doses- unusually high. It is not clear, if outside a study setting and in a less stringently selected population the regimen’s efficacy would be the same. Study 201674 and Study 201676 The data indicate a difference in the relevant PK parameters of RPV

2018 European Medicines Agency - EPARs

152. Hepatic steatosis

discomfort pruritus jaundice spider angioma palmar erythema nail changes Dupuytren's contracture bruising petechiae excoriations gynaecomastia parotid gland enlargement testicular atrophy alopecia caput medusae Cruveilhier-Baumgarten murmur peripheral oedema ascites low blood pressure hepatic encephalopathy fetor hepaticus haematemesis melaena obesity insulin resistance or diabetes dyslipidaemia hypertension metabolic syndrome rapid weight loss hepatotoxic medications total parenteral nutrition (TPN (...) abdominal MRI oesophogastroduodenoscopy (OGD) EEG portal venous pressure measurements liver biopsy elastography cytokeratin-18 fragments Treatment algorithm ONGOING Contributors Authors Assistant Professor of Medicine Division of Gastroenterology, Hepatology and Nutrition Associate Program Director Transplant Hepatology Fellowship Program Department of Medicine University of Pittsburgh Medical Center Pittsburgh PA Disclosures SMM declares that he has no competing interests. Professor of Medicine Medical

2017 BMJ Best Practice

153. Kaiser Permanente National Dyslipidemia Clinician Guide

: ? Reinforce medication adherence; ? Reinforce adherence to intensive lifestyle changes; and ? Exclude secondary causes of hyperlipidemia. ? Consider using the following indicators of anticipated therapeutic response to the recommended intensity of statin therapy. Focus is on the intensity of the statin therapy. As an aid to monitoring: ? High-intensity statin therapy generally results in an average LDL–C reduction of = 50% from the untreated baseline. ? Moderate-intensity statin therapy generally results (...) pattern, engage Cardiovascular Risk and Dyslipidemia Management Clinician Guide | SEPTEMBER 2017 ©2017 Kaiser Permanente Care Management Institute 9 in physical activity, achieve and maintain a healthy body weight, cease tobacco use, and continue statin therapy to reduce their risk of ASCVD events. ? For adults taking any dose of statins, consider using caution in those aged >75 years and in those taking concomitant medications that alter drug metabolism, multiple drugs, or drugs for conditions

2017 Kaiser Permanente National Guideline Program

154. Be Careful, Mom and Doc: Hepatotoxicity Associated with Prescribed Medications in Young Infants (PubMed)

Be Careful, Mom and Doc: Hepatotoxicity Associated with Prescribed Medications in Young Infants Accidental poisonings in young infants are relatively uncommon, and the careless caregiver is usually the culprit. We report two cases of hepatotoxicity due to prescribed medications. An infant was given 15 mL instead of 1.5 mL of paracetamol by his mother because she omitted the decimal point on the label of the drug bottle. The infant became symptomatic, and liver enzyme and clotting profile were

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2009 International journal of pediatrics

155. CRACKCast Episode 148 – Acetaminophen

testing Give the antidote = NAC when appropriate. Its all about the nomogram! Don’t forget about the differential diagnosis! In patients with elevated Liver enzymes / abnormal liver function and with or without Renal failure, think: acute tubular necrosis Rhabdomyolysis ischemic hepatitis alcoholic hepatic disease cyclopeptide-containing mushroom toxicity (eg Amanita Phalloides) viral hepatitis Wilson disease, other hepatic toxicities (eg, valproic acid, isoniazid [INH], statins, herbal medications (...) NAC diluted in 200 ml of 5% dextrose IV over 15-60 minutes. Followed by: 50 mg/kg NAC diluted in 500 ml of 5% dextrose IV over 4 hours. Followed by: 100 mg /kg NAC diluted in 1000 ml of 5% dextrose IV over 16 hours. (depending on amount ingested, sometimes the final infusion rate is doubled) If further doses of NAC are required e.g. for late presentations, repeated supra therapeutic ingestion or biochemical evidence of hepatotoxicity then repeat the final dose. For adults this is a: repeat

2018 CandiEM

156. Erectile Dysfunction

Erectile Dysfunction Erectile Dysfunction (ED) Guideline - American Urological Association advertisement Toggle navigation About Us About the AUA Membership AUA Governance Industry Relations Education AUAUniversity Education Products & Resources Normal Histology and Important Histo-anatomic Structures Urinary Bladder Prostate Kidney Renovascular Diseases Andrenal Gland Testis Paratesticular Tumors Penis Retroperitoneum Cytology Online Learning For Medical Students Exams/LLL/Certifications Exam (...) is the cornerstone of the treatment and management of ED, a model that relies on the concepts of autonomy and respect for persons in the clinical encounter. It is also a process in which the patient and the clinician together determine the best course of therapy based on a discussion of the risks, benefits and desired outcome. Using this approach, all men should be informed of all treatment options that are not medically contraindicated to determine the appropriate treatment. Although many men may choose

2018 American Urological Association

157. BSG and UKPBC primary biliary cholangitis treatment and management guidelines

of several pathways 13 Hirschfield GM, et al. Gut 2018;0:1–27. doi:10.1136/gutjnl-2017-315259 Guidelines leading to bile acid synthesis. 162 It is important for practising clinicians to take clinical note that, while there is long-standing interest regarding these agents in cholestatic liver disease, in the UK drug labelling has documented contraindication to their use in PBC because of concerns over reported hepatotoxicity. Fibrates at high dose inhibit some CYP enzymes, in particular CYP2C9

2018 British Society of Gastroenterology

158. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy

, TX; Jeffrey M. Caterino, The Ohio State University Wexner Medical Center, Columbus, OH; Ian Chau, The Royal Marsden Hospital and Institute of Cancer Research, London and Surrey, United Kingdom; Marc S. Ernstoff and Igor Puzanov, Roswell Park Cancer Institute, Buffalo; Bianca D. Santomasso and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center; Jeffrey S. Weber, New York University Langone Medical Center, New York, NY; Pamela Ginex, Oncology Nursing Society, Pittsburgh, PA; Jennifer M (...) . Gardner, Seattle Cancer Care Alliance and University of Washington, Seattle, WA; Sigrun Hallmeyer, Oncology Specialists SC, Park Ridge, IL; Jennifer Holter Chakrabarty, University of Oklahoma, Stephenson Cancer Center, Oklahoma City, OK; Natasha B. Leighl, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; David F. McDermott, Beth Israel Deaconess Medical Center; Carole Seigel, Massachusetts General Hospital Cancer Center, Boston, MA; John A. Thompson, Seattle Cancer Care Alliance, University

2018 American Society of Clinical Oncology Guidelines

159. Erectile Dysfunction

treatment options that are not medically contraindicated to determine the appropriate treatment. Although many men may choose to begin with the least invasive option, the Panel notes that it is valid for men to begin with any type of treatment, regardless of invasiveness or reversibility. Men also may choose to forego treatment. In each scenario, the clinician’s role is to ensure that the man and his partner have a full understanding of the benefits and risks/burdens of the various management strategies (...) ) Copyright © 2018 American Urological Association Education and Research, Inc.® Guideline Statements: Evaluation and Diagnosis: 1. Men presenting with symptoms of ED should undergo a thorough medical, sexual, and psychosocial history; a physical examination; and selective laboratory testing. (Clinical Principle) 2. For the man with ED, validated questionnaires are recommended to assess the severity of ED, to measure treat- ment effectiveness, and to guide future management. (Expert Opinion) 3. Men should

2018 American Urological Association

160. Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value

Immunomodulators for Plaque Psoriasis | Condition Update About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. The funding for this report comes from government grants and non-profit foundations, with the largest single funder being the Laura and John Arnold Foundation. No funding (...) . New England CEPAC seeks to help patients, clinicians, insurers, and policymakers interpret and use evidence to improve the quality and value of health care. The New England CEPAC is an independent committee of medical evidence experts from across New England, with a mix of practicing clinicians, methodologists, and leaders in patient engagement and advocacy. All Council members meet strict conflict of interest guidelines and are convened to discuss the evidence summarized in ICER reports and vote

2018 California Technology Assessment Forum

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