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Drug-induced Photosensitivity

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41. Maviret (glecaprevir / pibrentasvir) - chronic (long-term) hepatitis C

for appearance, assay, impurities, water content, microbiological quality and polymorphism. The test methods were the same as for release and are stability indicating. No significant changes to any of the measured parameters were observed under long term and accelerated conditions and all remained within specification. Photostability testing on one pilot scale following the ICH guideline Q1B was provided and confirm that the active substance is photosensitive. The results also demonstrate that the primary

2017 European Medicines Agency - EPARs

42. Ribociclib (Kisqali) - breast cancer

units CHMP Committee for Medicinal Products for Human Use CI confidence interval Cmax maximum (peak) plasma drug concentration CTCAE Common Terminology Criteria for Adverse Events CU Content uniformity CYP cytochrome P450 DDI drug-drug interaction DILI drug-induced liver injury EC European Commission ECG electrocardiogram ECOG Eastern Cooperative Oncology Group EORTC QLQ-C30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 EQ-5D-5L EuroQol five (...) parameters was observed, other than an increase in water content. Kisqali is not considered to be photosensitive. A further study examined conditions likely to be experience during transportation, for example, termperature excursions. However, all quality characteristics remained within the proposed specifications indicating no likely issues. Based on available stability data, the proposed shelf-life of 24 months without special storage conditions as stated in the SmPC (section 6.3) is acceptable

2017 European Medicines Agency - EPARs

43. Neonatal jaundice

· Consider: o TSB level o Gestation of baby o Age in hours of baby at time of testing 11 o Individual neurotoxicity risk factors 11,18 [refer to Section 7.2 Bilirubin induced neurologic dysfunction] Contraindications · Congenital erythropoietin porphyria (or family history) 70 o Very rare disorder o Porphyrins are photosensitisers causing injury to tissue (severe blistering and photosensitivity) when exposed to light 72 Side effects/ complications · Separation of mother and baby potentially resulting (...) of no clinical significance) · Blue light phototherapy—potential risk factor for melanocytic nevus development 73 Precautions · Medications: o Refer to Section 6 Medication use o Refer to an Australian pharmacopoeia for complete drug information regarding the use of medications and topical skin preparations during phototherapy o Concomitant use of photosensitising medications: § Usually only of concern after exposure to light in ultraviolet-A(UV-A) (320–400 nm) or UV-B (290–302nm) ranges § Insignificant UV

2018 Queensland Health

44. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Full Text available with Trip Pro

) test, SS-A/Anti-Ro, and SS-B/Anti-La if the rash is predominantly photodistributed or demonstrating photosensitivity. Consider expanding serologic studies or diagnostic work-up if other autoimmune conditions are considered. Skin biopsy, clinical photography may be performed when indicated. Review full list of patient medications to rule out other drug-induced cause for photosensitivity. Recommendation 1.1b – Management. It is recommended that clinicians manage grade 1 toxicities as follows: Should (...) ). Assess for lymphadenopathy, facial or distal extremity swelling (may be signs of drug-induced hypersensitivity syndrome [DIHS]/drug reaction with eosinophilia and systemic symptoms [DRESS]). Assess for pustules or blisters or erosions in addition to areas of “dusky erythema,” which may feel painful to palpation. To assess for a positive Nikolsky sign, place a gloved finger tangentially over erythematous skin and apply friction parallel to the skin surface. Nikolsky sign is positive if this results

2018 American Society of Clinical Oncology Guidelines

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

; both can be delivered at home. Psoralen, a photosensitizing drug, can be used orally or topically, as a bath, to the affected areas. Psoralen is associated with nausea, and PUVA is associated with increased squamous cell cancer and possibly melanoma; as such, UVB by far the most common form of phototherapy delivered in current clinical practice. A final form of phototherapy involves the use of excimer lasers for focused UVB light therapy. Targeted immunomodulators Targeted immunomodulators include

2018 California Technology Assessment Forum

48. CRACKCast E118 – SLE and Vasculitides

levels · Direct coombs test positive Table 108.1 is very busy – Remember the only mnemonic from med school SOAP BRAIN MD Serositis Oral Ulcers Arthritis Photosensitivity & Pulmonary Fibrosis Blood cells (pancytopenia) Renal, Raynauds ANA Immunologic (anti-Sm, anti-dsDNA) Neuropsych Malar Rash Discoid Rash [3] List drugs that induce lupus See Box 108.2 from Rosens 8 th Edition – SLE and Vasculitides Drugs Definitively Implicated in Causing Drug-Induced Lupus Procainamide Hydralazine Methyldopa

2017 CandiEM

49. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Gui Full Text available with Trip Pro

Annular VA e242 7.2. Papillary Muscle VA e242 7.3. Interfascicular Reentrant VT (Belhassen Tachycardia) e242 7.4. Idiopathic Polymorphic VT/VF e242 8. PVC-Induced Cardiomyopathy e243 9. VA and SCD Related to Specific Populations e243 9.1. Pregnancy e243 9.2. Older Patients With Comorbidities e243 9.3. Medication-Induced Arrhythmias e243 9.4. Adult Congenital Heart Disease e243 10. Defibrillators Other than Transvenous ICDs e246 10.1. Subcutaneous Implantable Cardioverter-Defibrillator e246 10.2 (...) disease are rare and may be due to a cardiac channelopathy, , medication-induced long QT syndrome, or they may be idiopathic. , 2.2. Sudden Cardiac Death 2.2.1. Incidence of SCD SCA and its most common consequence, SCD, constitute major public health problems, accounting for approximately 50% of all cardiovascular deaths, , with at least 25% being first symptomatic cardiac events. , , In addition, analyses of the magnitude of SCD are limited, in part because of the broad range of estimates of the risk

2017 American Heart Association

50. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Hea Full Text available with Trip Pro

(Belhassen Tachycardia) e335 8.4. Idiopathic Polymorphic VT/VF e336 9. PVC-Induced Cardiomyopathy e337 10. VA and SCD Related to Specific Populations e338 10.1. Athletes e338 10.2. Pregnancy e338 10.3. Older Patients With Comorbidities e339 10.4. Chronic Kidney Disease e340 10.5. Valvular Heart Disease e340 10.6. Sex-Related Differences in the Risk of SCD e340 10.7. Medication-Induced Arrhythmias e341 10.8. Adult Congenital Heart Disease e342 11. Defibrillators Other than Transvenous ICDs e347 11.1 (...) to an automatic focus in a characteristic location, giving rise to typical electrocardiographic appearances. Polymorphic VT and VF occurring in the absence of structural heart disease are rare and may be due to a cardiac channelopathy, , medication-induced long QT syndrome, or they may be idiopathic. , 2.2. Sudden Cardiac Death 2.2.1. Incidence of SCD SCA and its most common consequence, SCD, constitute major public health problems, accounting for approximately 50% of all cardiovascular deaths

2017 American Heart Association

52. Etelcalcetide (Parsabiv) - reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism)

on Photostability Testing of New Drug Substances and Products. Parsabiv is photosensitive and degrades when the vials are exposed to light. It was demonstrated that the outer carton provides adequate protection from light. An additional photostability study was carried out in order to assess the impact of lighting conditions likely to be encountered in a clinical setting. Results indicate that Parsabiv does degrade under such conditions but statistical analysis supports an in-use exposure of up to four hours

2016 European Medicines Agency - EPARs

53. Empagliflozin / linagliptin (Glyxambi) - type 2 diabetes

Attribute(s) CTD Common Technical Document CTR Clinical trial report CV CYP3A4 Cardiovascular Cytochrome P450 3A4 isoform DB Double blind DBP Diastolic blood pressure DILI Drug-induced liver injury DPP-4 Dipeptidyl peptidase-4 eCCR Estimated creatinine clearance eGFR EMA Estimated glomerular filtration rate European medicines agency Empa Empagliflozin ESRD End-stage renal disease FAS Full analysis set FDA FDC Food and drug administration Fixed dose combination FPG GC Fasting plasma glucose Gas (...) , impurities (HPLC), diastereomer (chiral HPLC), assay (HPLC), water content (KF) and particle size (laser diffraction). The analytical methods used were the same as for release and were shown to be stability indicating. No changes to any test parameters were observed under long term or accelerated conditions. Empagliflozin is neither photosensitive, nor affected by high temperature or humidity in the solid state. In solution, it is prone to degradation at low and high pH and in the presence of a strong

2016 European Medicines Agency - EPARs

55. Briviact - brivaracetam

were observed. Photostability testing following the ICH guideline Q1B was performed on one batch and the active substance shown not to be photosensitive. Solid state stress testing was carried out at a range of temperatures and humidities. Brivaracetam is stable to heat exposure but degrades and picks up water when exposed to both high temperature and humidity. Forced degradation was carried out in aqueous solution at a variety of pHs from 1 to 11 and in aqueous hydrogen peroxide. Brivaracetam (...) tablets are not considered to be photosensitive. Thermal cycling studies were also carried out over three weeks between -20 o C and 40 o C / 75% RH. No changes to any of the tested parameters were observed. Finally, bulk stability studies were carried out on one 10 mg batch and one 25 mg batch. The 25 mg tablet is considered the worst case scenario as it has the highest surface area to weight ratio. No changes to any of the tested parameters were observed over the twelve month study and thus, a bulk

2016 European Medicines Agency - EPARs

56. Zerbaxa - ceftolozane / tazobactam

Deductive Estimation of Risk from Existing Knowledge DSMB Data Safety Monitoring Board ECF Extracellular fluid (volume) ECG Electrocardiogram ESBL Enterobacteriaceae eDISH Evaluation of drug-induced serious hepatotoxicity EMA European Medicines Agency EOT End of treatment FCA Freund’s complete adjuvant FDA GC Food and Drug Administration Gas chromatography GLP GTIs Good laboratory practice Genotoxic impurities hERG Human ether-à go-go related gene HIV HPLC IAI ICH Human immunodeficiency virus High (...) were presented. A hydrolysis product typically found in cephalosporin products is the main solution degradant. Degradation was more prominent under conditions of base hydrolysis. Based upon known photosensitivity of the ceftolozane the omission of photostability testing on the active substance was accepted. It is noted that the secondary container of the active substance includes an aluminium layer that protects the substance from light during storage at -20 °C. Based on the overall data

2015 European Medicines Agency - EPARs

58. Treatment of Hepatitis C

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 (...) removal of simeprevir. Adverse reactions with at least 3% higher frequency in patients receiving simeprevir in combination with PegIFN-a and ribavirin were rash (including photosensitivity), pruritus and nausea. Because simeprevir is an inhibitor of the hepatic transporters OATP1B1 and MRP2 [23], mild, transient hyper- bilirubinaemia not accompanied by changes in other liver parameters was observed in approximately 10% of cases. Because the primary enzyme involved in the metabolism of simeprevir

2015 European Association for the Study of the Liver

59. Acne vulgaris: Oral antibiotics

with an increased risk of adverse effects such as drug-induced lupus, skin pigmentation and hepatitis. Macrolide antibiotics (such as erythromycin) should generally be avoided due to high levels of P. acnes resistance but can be used if tetracyclines are contraindicated (for example in pregnancy). A topical retinoid (if not contraindicated) or benzoyl peroxide should always be co-prescribed with oral antibiotics to reduce the risk of antibiotic resistance developing. Do not use topical and oral antibiotics (...) ), hepatic and renal impairment. For erythromycin — avoid in acute porphyria, caution is advised in renal impairment. Adverse effects For all tetracyclines — anorexia, anaphylaxis; angioedema; blood disorders; exfoliative dermatitis; hepatotoxicity and liver failure; hypersensitivity reactions; pancreatitis; pericarditis; photosensitivity; rash; Stevens-Johnson syndrome; urticaria, antibiotic-associated colitis; benign intracranial hypertension; diarrhoea; dysphagia; headache; nausea; oesophageal

2019 NICE Clinical Knowledge Summaries

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