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Life-Threatening Drug-Induced Rashes

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65. Zykadia - ceritinib

response CrCL Calculated creatinine clearance CRF Case Report/Record Form CRO Contract Research Organization EMA/170114/2015 Page 6/105 CSR Clinical study report CT Computerized tomography CTCAE Common terminology criteria for adverse events CTD Common Technical Document DBP Diastolic blood pressure DDS Dose determining set DILI Drug induced liver injury DLT Dose limiting toxicity DMC Data monitoring committee DoE Design of Experiment DOR Duration of response DSC Differential Scanning Calorimetry EAS (...) bradycardia or to a heart rate of 60 bpm or above. If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, reinitiate Zykadia with dose reduced by one EMA/170114/2015 Page 16/105 decrement upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above. Bradycardia a (life-threatening consequences, urgent intervention indicated) Permanently discontinue Zykadia if no contributing concomitant

2015 European Medicines Agency - EPARs

68. Daclatasvir (DCV) (Daklinza)

. The Warnings and Precautions section of the package insert will include a recently identified drug-drug interaction (DDI) describing the risk of severe, life-threatening bradycardia associated with use of amiodarone co-administered with sofosbuvir in combination with another HCV direct acting antiviral, including DCV. This DDI was not identified in the clinical trials (where amiodarone use was prohibited) but was observed in the large expanded access program where DCV was used in combination with SOF (...) anti-HCV drugs in the pivotal and supportive clinical trials for the original and resubmission DCV NDAs. The most significant safety issue recently identified is a potential drug-drug interaction leading to life-threatening bradycardia with use of amiodarone in combination with sofosbuvir and another DAA, including DCV. This safety signal was identified in the DCV compassionate use population and investigated during the review cycle of this resubmission NDA. Warnings and Precautions language

2015 FDA - Drug Approval Package

70. Corluxin - mifepristone

consistent with hypertensive retinopathy, results of these exams showed no abnormal findings beyond a scattering of mild changes due to aging that would be expected in this cohort of patients. There was no evidence to suggest that any of these changes are related to treatment with mifepristone. Skin Rashes Findings of skin rash on physical examination were common and might not be unexpected in subjects with Cushing’s syndrome. Ten subjects experienced a TEAE of rash, three of which were related to study (...) drug. The rash in one subject was an exacerbation of a lupus rash, but was considered related to study drug. Rashes were mild to moderate in severity, were most often described as papular or erythematous and tended to be localised and not generally distributed. There were no reports of exfoliation or associated systemic signs or symptoms. Five subjects received no treatment for their rashes, four subjects were treated with medication for their rashes, and one subject had the dose of mifepristone

2015 European Medicines Agency - EPARs

71. Induction of labour in late intrauterine fetal death: vaginal misoprostol (after oral mifepristone)

of misoprostol. Regulatory status of misoprostol Misoprostol is not currently licensed in the UK for the induction of labour in women with late IUFD. Misoprostol 200 microgram oral tablets (Cytotec, Pharmacia Limited) are licensed in the UK for treating duodenal and gastric ulcers and preventing non-steroidal anti-inflammatory drug-induced ulcers in adults. Medabon (Sun Pharmaceutical Industries Europe) is a combination pack containing 1 oral mifepristone 200 mg tablet and 4 vaginal misoprostol 200 microgram (...) -inflammatory drug-induced ulcers in adults. Medabon (Sun Pharmaceutical Industries Europe) is a combination pack containing 1 oral mifepristone 200 mg tablet and 4 vaginal misoprostol 200 microgram tablets. It received UK Induction of labour in late intrauterine fetal death: vaginal misoprostol (after oral mifepristone) (ESUOM11) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 13 of 29marketing authorisation in May 2012

2013 National Institute for Health and Clinical Excellence - Advice

72. Prostatitis - acute

Prostatitis - acute Prostatitis - acute - NICE CKS Share Prostatitis - acute: Summary Acute bacterial prostatitis is a severe, potentially life-threatening bacterial infection of the prostate. Urinary infection with pathogens may be caused by urethral instrumentation, trauma, bladder outflow obstruction, or dissemination of infection from outside the urinary tract. Most men treated appropriately for acute prostatitis will recover completely within 2 weeks. Acute prostatitis should be suspected (...) for Quality and Innovation (CQUIN) and the Quality Premium schemes. Promote the antibiotic guardian call to action and the keep antibiotics working campaign. [ ; ] NICE quality standards NICE quality standards No NICE quality standards were found during the review of this topic. Background information Background information Definition What is it? Acute bacterial prostatitis is a severe, potentially life-threatening bacterial infection of the prostate. Acute bacterial prostatitis is accompanied

2019 NICE Clinical Knowledge Summaries

74. Erectile dysfunction

Erectile dysfunction Erectile dysfunction - NICE CKS Share Erectile dysfunction: Summary Erectile dysfunction is the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance. It is a complicated disorder with several possible organic and/or psychogenic causes. It can also be drug induced. Organic causes may be vasculogenic (for example cardiovascular disease [CVD], hypertension, hyperlipidaemia, diabetes mellitus); neurogenic (for example (...) in at least 15–20% of younger men [ ]. Prognosis What is the prognosis? Generally, most cases of erectile dysfunction can be treated successfully but not cured. However: Psychogenic erectile dysfunction, post-traumatic arteriogenic erectile dysfunction in young men, and erectile dysfunction with hormonal causes (for example hypogonadism and hyperprolactinaemia) can be cured with specific treatment. Drug-induced erectile dysfunction can be cured if a clear temporal relationship is established between

2019 NICE Clinical Knowledge Summaries

76. GORD in children

mouth, constipation, dizziness, insomnia, and skin rashes. Very infrequent cases of subacute cutaneous lupus erythematosus (SCLE) have been reported in people taking proton pump inhibitors (PPIs). Drug-induced SCLE can occur weeks, months, or years after exposure to the drug [ ]. If a child being treated with a PPI develops lesions, especially in sun-exposed areas of the skin, which are accompanied by arthralgia: Advise the parents and/or carers to avoid exposing the skin to sunlight. Consider SCLE (...) -oesophageal reflux disease include: Reflux oesophagitis. Recurrent aspiration pneumonia. Recurrent acute otitis media (more than three episodes in 6 months). Dental erosion in a child with neurodisability (for example cerebral palsy). Rarely, apnoea or apparent life-threatening events (episodes of combinations of apnoea, colour change, change in muscle tone, choking, and gagging that are sometimes considered 'missed' sudden infant death syndrome). Most children with regurgitation do not develop

2019 NICE Clinical Knowledge Summaries

77. Hyperthyroidism

[ ]. Thyroid storm (thyrotoxic crisis), which is rare and potentially life-threatening, and may occur after trauma, childbirth, surgery, infection, or stroke, for example (in people with untreated or suboptimally treated hyperthyroidism) [ ]. Clinical features include tachycardia, fever, atrial fibrillation, heart failure, fever, diarrhoea, vomiting, dehydration, jaundice, agitation, delirium, and coma [ ; ]. Atrial fibrillation — the risk of developing atrial fibrillation increases with decreasing levels (...) or intravenous contrast media [ ]. Amiodarone-induced hyperthyroidism is more common in iodine-deficient areas, such as Denmark, and in people with underlying thyroid disease. The long half-life of amiodarone may cause drug-induced hyperthyroidism for up to one year after it is discontinued. Lithium rarely causes hyperthyroidism, and this usually occurs only after long-term use [ ; ]. Interferon alfa (for example used in the specialist treatment of hepatitis C infection) can rarely cause hyperthyroidism

2019 NICE Clinical Knowledge Summaries

79. Autoimmune Hepatitis

(PBC) or primary sclerosing cholangitis (PSC), but also with drug-induced liver injury (DILI), alcoholic or non-alcoholic steatohepatitis (NASH) or viral hepatitis. Each condition provides specialdiagnosticandtherapeuticchallenges.Despitethesechal- lengesandcomplexities,diagnosisandtreatmentofAIHhasseen strikingprogress,andnowpatientsinspecialisedcentreshavean excellent prognosis, both in respect to survival and to quality of life. The aim of the present Clinical Practice Guideline (CPG (...) -cadidiasis ectodermal dystrophy; AS, acute severe autoimmune; CNI, Calcineurin inhibitor; CPG, Clinical Practice Guideline; DEXA, Dual energy x-ray absorptiometry; DILI, Drug-induced liver injury; HAI, Hepatitis activity index; HBV, Hepatitis B virus; HLA, Human leukocyte antigens; HRQoL, Health related quality of life; IBD, In?ammatory bowel disease; IgG, Immunoglobulin G; LBR, Live birth rate; LT, Liver transplantation; MMF, Mycophenolate mofetil; MRCP, Magnetic resonance cholangiopancreatography

2015 European Association for the Study of the Liver

80. Treatment of Hepatitis C

) is de?ned as undetectable HCV RNA 12weeks (SVR12) or 24weeks (SVR24)after treatment completion. The infection is cured in more than 99% of patients who achieve an SVR. The SVR is generally associated with res- olution of liver disease in patients without cirrhosis. Patients with cirrhosis remain at risk of life-threatening complications; however hepatic ?brosis may regress and the risk of com- plications such as hepatic failure and portal hypertension is reduced. Recent data suggest that the risk (...) be tested for other hepatotropic viruses, particularly hepatitis B virus (HBV), and for human immunode?ciency virus (HIV). Alcohol consumption should be assessed and quanti?ed, and speci?c counselling to stop any use of alcohol should be given. Possible comorbidities, including alcoholism, autoimmunity, genetic or metabolic liver diseases (for instance genetic hemochromatosis, diabetes or obesity) and the possibility of drug-induced hep- atotoxicity should be assessed. Assessment of liver disease

2015 European Association for the Study of the Liver

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