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Drug-induced Photosensitivity

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63. 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

64. Systematic Review: Monoclonal Antibody-Induced Subacute Cutaneous Lupus Erythematosus Full Text available with Trip Pro

and a dermatohistopathologist (Table ). The agreed criteria incorporated morphological features specified by the European Society of Cutaneous Lupus Erythematosus (EUSCLE) [ ] and previously published features of the disease [ , , ]. To avoid ambiguity, the presence of lesions in sun-exposed regions was used to define ‘photosensitivity’. A conservative boundary of 2 years post-initiation of therapy was used for inclusion as a drug-induced case [ ]. Reports lacking sufficient detail to confirm inclusion criteria from three (...) . Sixteen percent of patients (8/49) were treated with biologic cessation alone as first-line. One of these patients started the DMARD hydroxychloroquine, however the rash had already started to improve [ ]. Some patients did not initially stop their mAb therapy until the drug-induced nature of the rash was suggested; two of three patients did not see improvement until cessation of the drug despite starting topical corticosteroid creams at rash onset [ , ]. For 38 of the remaining patients, mAbs were

2020 Drugs in R&D

65. Cutaneous Adverse Events in Newly Approved FDA Non-cancer Drugs: A Systematic Review Full Text available with Trip Pro

reactions, which were seen in 10% of patients taking dupilumab compared with 6% of patients taking placebo [ ], a recent case series describes a paradoxical head and neck erythema in seven patients after taking dupilumab for 10–39 weeks [ ]. Both clinical and histopathological findings suggested that these were drug-induced skin reactions. A multi-institution retrospective medical record review revealed that dupilumab-induced facial redness was seen in approximately 10% of patients treated (...) , Mehta RD. Cutaneous adverse reactions of chemotherapy in cancer patients: a clinicoepidemiological study. Indian J Dermatol. 2018;63(1):41–6. . 2. Ng CY, Chen C-B, Wu M-Y, et al. Anticancer drugs induced severe adverse cutaneous drug reactions: an updated review on the risks associated with anticancer targeted therapy or immunotherapies. J Immunol Res. 2018;17(2018):5376476. 3. Rosen AC, Balagula Y, Raisch DW, et al. Life-threatening dermatologic adverse events in oncology. Anticancer Drugs. 2014;25

2020 Drugs in R&D

66. Jardiance - empagliflozin

) oxidants, and under UV irradiation. The following parameters were tested: appearance, impurities (HPLC), diaseteromer (chiral HPLC), assay (HPLC), water content (KF) and particle size (laser diffraction). The analytical methods used were the same as for release. 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, empagliflozin is prone

2014 European Medicines Agency - EPARs

67. Evolocumab (Repatha)

ULN or INR > 1.5: one case occurred 3 days after the participant admitted himself to rehabilitation for alcohol detoxification; one case had a normal bilirubin but an elevated INR due to warfarin and the transaminases declined despite continuation of evolocumab treatment; and in the last case, the participant was being treated for a urinary tract infection with nitrofurantoin and was also on simvastatin. Liver biopsy in this participant was consistent with drug-induced hepatitis. LFTs eventually

2014 FDA - Drug Approval Package

70. Tasimelteon (Hetlioz)

period ( t) that governs circadian rhythms is typically a little over 24 hours and ranges between 23.5 and 24.7 hours in healthy sighted individuals. These rhythms are synchronized (entrained) to the 24-hour day by exposure to environmental time cues, the strongest of which is the daily light-dark cycle, detected primarily by the photosensitive ganglion cells of the retina. In the absence of light input, synchronization with the 24-hour day is lost; consequently the circadian rhythms follow

2013 FDA - Drug Approval Package

72. Antibody-Mediated Rejection in Cardiac Transplantation: Emerging Knowledge in Diagnosis and Management Full Text available with Trip Pro

antibodiesBleeding diathesisHypotensionAllergic reactionTransmission of blood-borne pathogens 1–7 Sessions/wk, 1–4 weekly cyclesExchange 1–2 times the blood volume with FFP or albumin as replacement 1–7 Sessions Variable $$$ Photopheresis Upregulation of costimulatory molecules, downregulation of T cells, immunoregulation via T-regulatory cells Vascular access complications, skin erythema, pruritus, nausea, rare drug-induced lupus or scleroderma-like syndrome Oral: 0.6 mg/kg (target level ≥50 ng/mL 2 h after

2015 American Heart Association

75. Salazopyrine (A07EC01 (intestinal anti-inflammatory agents)) - Ulcerative colitis, Crohn's disease in the colon, Rheumatoid arthritis

in the colon. Rheumatology: Rheumatoid arthritis". 1 Akobeng et al. Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn’s Disease, the Cochrane library 2005, Issue 2. 2 Travis et al. European evidence based consensus on the diagnosis and management of Crohn’s disease: current management, Gut 2006; 55; 16-35 HAS - Medical, Economic and Public Health Assessment Division 3/15 03.2 Dosage "For oral use. The tablets must be swallowed with water, preferably after meals and must (...) ), pancreatitis. Skin and subcutaneous tissue disorders Exanthema, urticaria, skin colouration and more rarely: cyanosis, epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, exfoliative dermatitis, photosensitivity, alopecia, lichen planus. Musculoskeletal and connective tissue disorders Rare: systemic lupus erythematosus, arthralgia, myalgia. Systemic Symptoms (DRESS) syndrome. This syndrome includes a severe skin rash, fever, eosinophilia above 1500/mm3 and/or atypical lymphocytosis

2015 Haute Autorite de sante

77. Systemic lupus erythematosus

a flare of systemic disease. Sometimes a more generalised form over the body is present. DLE are characterised by slightly raised, scaly lesions that have a potential to scar. They can be found commonly on the scalp and face, and less commonly over the limbs and trunk. Only 5% of people with DLE have SLE, but conversely among individuals with SLE, 20% will have DLE. 17 Subacute cutaneous lupus erythematosus is another lupus-specific rash. It is a common skin manifestation in drug-induced lupus (...) , NO. 10 OCTOBER 2013 697 Cutaneous manifestations The spectrum of cutaneous manifestations of lupus erythematosus (LE) is broad, but the most classical forms associated with systemic LE are the acute malar and chronic discoid lupus erythematosus (DLE) rash. Both can be quite photosensitive in nature. 15,16 Acute malar rash is a slightly raised erythematous rash of the face, particularly cheeks and nose, with nasolabial sparing, known as the ‘butterfly’ rash. A worsening of the rash usually accompanies

2014 Clinical Practice Guidelines Portal

78. Lipanthyl (fenofibrate) - hypertriglyceridaemia or hyperlipidaemia

the ACCORD study in women treated by lipid-lowering combinations. As HAS - Medical, Economic and Public Health Assessment Division 9/11 regards the Abbot products, the analysis was extended to include other risks (hypercholesterolaemia, cholelithiasis, pancreatitis, myopathy/rhabdomyolysis, drug-induced hepatitis, increase in CPK, photosensitivity, venous thromboembolic disease, risk of developing diabetes and hyperglycaemia with statins in addition to the potential risk of major cardiovascular events

2014 Haute Autorite de sante

80. Cutaneous Lupus Erythematosus (CLE), Diagnosis and Monitoring

(for further information on drugs inducing CLE, please see Table 1 in the “S2k Guideline for Treatment of Cutaneous Lupus Erythematosus” [3]). SCLE is associated with SLE in 10-15% of SCLE patients [18]. Chronic cutaneous lupus erythematosus (CCLE) CCLE includes three different forms of disease: discoid LE (DLE), LE profundus/panniculitis (LEP), and chilblain LE (CHLE). Discoid lupus erythematosus (DLE) DLE is the most common form of CCLE. The lesions of this subtype are sharply bordered and present (...) be performed even in CLE patients. Usually, the ANA titer in CLE patients are low (= 1:320), varying in frequency and depending on the particular subtype (Table 6) [5, 39]. Anti-Ro/SS-A and – in less 18 cases – anti-La/SSB antibodies are characteristic for SCLE. Anti-histone antibodies are usually found in drug-induced LE, but they may also occur in conjunction with anti-dsDNA antibodies in idiopathic SLE (24–95%) [56]. Autoantibodies against ds- DNA and Sm are in the majority of cases associated with SLE

2013 European Dermatology Forum

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