ライフサイエンスコーパス: off-label

1 cations of the package insert is considered 'off-label'.

2 law prohibits companies from marketing drugs off-label.

3 valuated, with 43% of medications being used off-label.

4 testinal illnesses are frequently prescribed off-label.

5 96% to 98%) of 18 311 in-hospital uses were off-label.

6 metal stents and whether use was standard or off-label.

7 pa were more likely to report prescribing it off-label.

8 very are sometimes effective, although given off-label.

9 ients in this study were prescribed riluzole off-label.

10 ly, the pentasaccharide fondaparinux is used off-label.

11 and antipsychotic drugs, often administered off-label.

12 odium dose was typically fixed (10 or 20 mL [off label]).

13 te rates were low (standard, 4.4% [n = 113]; off-label, 7.6% [n = 95]; untested, 6.7% [n = 72]).

14 lled 'stem' cell therapies and, although the off-label administration of intra-articular cell therapi

15 ative capacity has resulted in the extensive off-label administration of this drug by gastroenterolog

16 Monitoring cellular iron levels during "off-label" administration of the FDA-approved iron chela

17 ntibodies (mAbs) are increasingly being used off-label after allo-HCT.

18 ed the assay to produce quantitative titers (off label) against the VaccZyme VZV glycoprotein (VZVgp)

19 matic targeted approach to using a range of 'off-label' agents for specific phenotypes of CU.

20 unted to $12 billion (B; $7.3B on-label, $2B off-label and NCCN supported; $2.5B off-label and NCCN u

21 bel, $2B off-label and NCCN supported; $2.5B off-label and NCCN unsupported).

22 In contemporary US practice, off-label and untested use of drug-eluting stents is com

23 Frequency of off-label and untested use, 1-year repeat target vessel

24 e long-term effectiveness is lower with both off-label and untested use.

25 use of meters in critically ill patients is "off-label" and constitutes "high complexity" testing.

26 Standard, off-label, and untested use was determined in 5541 (95%)

27 The prevalence of off-label anticancer drug use is not well characterized.

28 RI and the iron supplement ferumoxytol, used off-label as a contrast agent.

29 on-deficit/hyperactivity disorder (ADHD) and off-label as a performance-enhancing agent in healthy in

30 onoclonal antibody that is increasingly used off-label as an induction agent in solid organ transplan

31 ications are commonly used in children on an off-label basis due to the life-threatening nature of PA

32 dexamethasone implant (Ozurdex), along with off-label bevacizumab (Avastin) and preservative-free tr

33 oved non-inferior to ranibizumab, use of the off-label bevacizumab could reduce costs enormously with

34 There was bias in recommending off-label bevacizumab for smaller infants with type 1 RO

35 However, the off-label bevacizumab may differentiate the success of b

36 e ranibizumab or aflibercept, as compared to off-label bevacizumab, than those who did not receive an

37 led and screened 1012 FDA-approved drugs for off-label broad-spectrum efficacy against Bacillus anthr

38 cardial perfusion imaging has long been used off label by practitioners attending for children with c

39 ossible explanations for known and potential off-label cancer treatments, suggesting new therapeutic

40 e 3323 patients, 1817 (54.7%) had at least 1 off-label characteristic.

41 groups based on presence of at least 1 of 9 off-label characteristics based on the current US Food a

42 rsistent moderate hypertriglyceridemia), and off-label claim + evidence context (eg, reports on 3 tri

43 antially lower among those randomized to the off-label claim + evidence context scenario (21% [95% CI

44 el indication (severe hypertriglyceridemia), off-label claim + pro forma disclaimers (suggestive but

45 r among those randomized to the on-label and off-label claim + pro forma disclaimers scenarios (35% v

46 vidence context about the data supporting an off-label claim affected physicians' beliefs about drug

47 Supplementing off-label claims with evidence context improved the pres

48 ey questions arise regarding their potential off-label clinical application in pediatric thromboembol

49 We assessed the broadly used, off-label combination of sofosbuvir, daclatasvir, simepr

50 001); point estimates were slightly lower in off-label compared with on-label analyses.

51 ipsychotic medications are commonly used for off-label conditions such as agitation in dementia, anxi

52 dication, or other pharmacotherapy for adult off-label conditions were included.

53 Because SOF/SMV is currently used off-label, debate exists among physicians and payers abo

54 urpose To report multicenter safety data for off-label diagnostic ferumoxytol use.

55 Fixed off-label dose (10 or 20 mL) of gadoxetate disodium is a

56 ong AF patients and the associations between off-label dose therapy and clinical outcomes in communit

57 e recommended dose, those who were receiving off-label doses were older (median: 79 and 80 years of a

58 nd human in vivo pharmacodynamics, safety of off-label doses, and treatment outcomes.

59 ID-19 to compassionate use of remdesivir, or off-label drug use of hydroxychloroquine or other therap

60 rred predominantly in patients who underwent off-label drug-eluting stent implantation.

61 ivity reactions due to current and candidate off-label drugs and highlights relevant recommendations.

62 failure of multiple clinically-approved and off-label drugs in individual NSCLC patient samples.

63 A possible means of controlling the use of off-label drugs is to focus on medications used off-labe

64 Off-label, EoE is currently treated by using the 3 Ds: d

65 The off-label extension of the Melody TPV to patients with n

66 t was instituted in 13 patients utilising on/off label FDA approved drugs (n = 9), clinical trials (n

67 coronary syndromes were present in 52% and "off-label" feature in 77% of patients.

68 osis was increased among patients considered off label for drug-eluting stent use (P=0.024).

69 leeding disorders, but it is also prescribed off-label for patients with nocturia.

70 in adult PAH, sildenafil is used extensively off-label for the treatment of neonates, infants, and ch

71 the manufacturer, and 16% had prescribed it off-label for this purpose.

72 It has also been used "off-label" for Enterococcal infections.

73 r, some US physicians use aqueous allergens, off-label, for sublingual desensitization.

74 ns consider alternative treatment options to off-label gabapentin for the management of chronic pelvi

75 Adjusted 30-day mortality was higher in the off-label group (hazard ratio, 1.27; 95% CI, 1.04-1.55;

76 e occurred in 198 (10.9%) of patients in the off-label group and 76 (5.0%) of patients in the on-labe

77 clinical outcome occurred more often in the off-label group compared with the on-label group; 309 (1

78 curred more frequently among patients in the off-label group during the initial hospitalization (8 [0

79 s were noted in AEs occurring in on-label vs off-label icatibant users.

80 Off-label implantation of non-PFO closure devices in tri

81 We defined "off-label" implants as those in which the ejection fract

82 replacement therapy (CRRT) machines are used off label in infants smaller than 15 kg and are not desi

83 otherapies are more often used on-label than off-label in contemporary practice.

84 In addition, both drugs are currently used off-label in hospitals worldwide and in numerous clinica

85 Medications are widely used off-label in pediatrics, including medications intended

86 Cremophor micellar paclitaxel solution used off-label in previous IP studies.

87 ies are types of medications frequently used off-label in the pediatric gastroenterology arena.

88 ugs in 2006, updated literature related to 1 off-label indication between 2006 and 2008, and complete

89 dge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.

90 ercent of use conformed to an NCCN-supported off-label indication, and 10% of off-label use was assoc

91 etic valves (BPV) is currently considered an off-label indication.

92 the United States have received TAVR for an off-label indication.

93 r referred to as Pfizer and Parke-Davis) for off-label indications (prophylaxis against migraine and

94 Only off-label indications for cancer drugs were included, an

95 ients with a majority of complex lesions and off-label indications for drug-eluting stents.

96 Use of TAVR for off-label indications has not been previously reported.

97 ndia's stated methods, literature related to off-label indications of 14 cancer drugs in 2006, update

98 label use, the majority of stents placed for off-label indications remained unhealed after 12 months

99 For the 14 off-label indications studied, the compendia differed in

100 Limited available evidence for 5 off-label indications suggests no mortality reduction wi

101 Services limit coverage of cancer drugs for off-label indications to indications listed in specified

102 Food and Drug Administration approvals, new off-label indications, and new competitors did not influ

103 Among patients with off-label indications, the use of drug-eluting stents wa

104 of atrial fibrillation, but increasingly for off-label indications.

105 ved for hemophilia, is increasingly used for off-label indications.

106 tors but has been applied to a wide range of off-label indications.

107 ealing was further delayed in DES placed for off-label indications.

108 o evidence and reimbursement information for off-label indications.

109 are needed to confirm its efficacy for these off-label indications.

110 s support the use of drug-eluting stents for off-label indications.

111 The 2006 analysis was limited to 14 off-label indications; the 2008 update examined 1 indica

112 with a vast majority of complex lesions and "off-label" indications for drug-eluting stents, which we

113 ine clinical use of drug-eluting stents for "off-label" indications was associated with lower nonfata

114 es higher among physicians who received such off-label information (38% versus 7%, P<0.001).

115 (48% response rate), 29% reported receiving off-label information about Vascepa (ie, use as an add-o

116 alidity of evidence for the effectiveness of off-label interventions.

117 nd analysis of the ethical considerations in off-label ketamine use for severe, treatment-resistant d

118 d in whistleblower complaints as involved in off-label marketing activities adequately disclosed thei

119 whistleblower testimony have alleged complex off-label marketing campaigns that remain concealed to c

120 ed whistleblower complaints alleging illegal off-label marketing from the US Department of Justice an

121 nalysed the apparent strategic goals of each off-label marketing scheme and the practices consistent

122 ases, it may offer a partial view of exposed off-label marketing.

123 With its benefit/risk ratio, rituximab used off-label may remain a valid option for treating persist

124 ons increases by 8% for every one additional off-label medication (hazard ratio = 1.08; 95% CI, 1.018

125 To provide current information on off-label medication use in pediatric gastroenterology,

126 reaction risk increases with each additional off-label medication used.

127 , number of high-risk medications, number of off-label medications, and severity of illness score wer

128 Among medications used off-label, moderate evidence supports an association wit

129 fore any recommendation regarding the use of off-label NAC to treat IPF.

130 This study assessed the frequency of off-label NOAC doses among AF patients and the associati

131 s while not actively receiving chemotherapy (off label) occurred in 2,876 patients (13.6%).

132 All other use was "off-label." Off-label use was divided by whether it conf

133 sulted in more than $11 billion in fines for off-label or deceptive marketing practices.

134 l infarction after DES or BMS use for either off-label or on-label indications.

135 uting stents, 2588 (47%) received stents for off-label or untested indications.

136 ombosis was not statistically different with off-label or untested vs standard use.

137 subjects were randomized to use netarsudil (off-label) or placebo once daily for 9 months after Desc

138 e are limited data comparing DES and BMS in "off-label" patients.

139 We conducted a nonrandomized, off-label, pilot, phase I/II study of alemtuzumab monoth

140 , biopsy-proved DLE were prescribed a novel, off-label preparation of tacrolimus lotion, 0.3%, in an

141 Off-label prescribing may lead to innovative new uses of

142 y and potentially increase the likelihood of off-label prescribing of psychotropic medication.

143 Off-label prescribing was 5 times higher among physician

144 ide some relevant background information for off-label prescription in AD.

145 t also provides a clinical algorithm for the off-label prescription of systemic immunosuppressants in

146 cal rules to be considered in the context of off-label prescription.

147 ficant unmet medical need and are subject to off-label prescriptions.

148 potential risks and benefits of prescribing off-label products to pediatric patients.

149 and Drug Administration specially permitted off-label promotion after a manufacturer lawsuit.

150 tives of this study were to (1) characterize off-label promotion rulings in the UK compared to the wh

151 There were 74 off-label promotion rulings involving 43 companies and 6

152 ompany outsiders, which may explain why most off-label promotion rulings relate to plainly visible pr

153 ngs cited prescribers as the prime target of off-label promotion, competing companies lodged the majo

154 ld be attentive to, and increasingly report, off-label promotion.

155 sm for detecting, deterring, and sanctioning off-label promotion.

156 UNICORN was the first study of an off-label protocol using whole blood finger-prick sample

157 patients (operable and nonoperable) receive off-label pulmonary arterial hypertension-targeted treat

158 take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial.

159 and effectiveness of drug-eluting stents for off-label (restenosis, bypass graft lesion, long lesions

160 Off-label rituximab as an add-on therapy in patients wit

161 th rapid improvement after administration of off-label, single-dose tocilizumab.

162 in B2 receptor antagonist, or to the current off-label standard therapy consisting of intravenous pre

163 olled trial to compare the immunogenicity of off-label standard-dose (15 microg) ID vs standard-dose

164 For "off-label" stent procedures, the hazard ratio for DES co

165 d with lower risk of MI, death, and ST than "off-label" stent procedures.

166 It performed well in off-label studies but failed to demonstrate efficacy in

167 Alemtuzumab has been used in off-label studies of solid organ transplantation.

168 ortality was higher among patients receiving off-label TAVR than those receiving on-label TAVR (6.3%

169 Frequency of off-label TAVR use and the association with in-hospital,

170 The median rate of off-label TAVR use per hospital was 6.8% (range, 0%-34.7

171 d for additional research on the efficacy of off-label TAVR use.

172 Off-label TAVR was defined as TAVR in patients with know

173 4 years [interquartile range, 78-88 years]), off-label TAVR was used in 2272 patients (9.5%).

174 -label drugs is to focus on medications used off-label that are both expensive and potentially risky.

175 patients with HNFS angiosarcoma had received off-label therapeutic use of antibody to the programmed

176 ment for vitiligo repigmentation and current off-label therapies have limited efficacy, emphasising t

177 Off-label therapy is recognised as an alternative, notab

178 mplantation have been raised about DES used "off-label." There are limited data comparing DES and BMS

179 he REMS to address evidence of high rates of off-label TIRF use, and, although the REMS program had a

180 g Administration for cancer therapy and used off label to treat neovascular age-related macular degen

181 phodiesterase-5 inhibitors (PDE5i), are used off-label to reduce RV afterload before LVAD implantatio

182 Low dose ketamine is increasingly used off-label to treat conditions such as depression.

183 Memantine has been used off-label to treat frontotemporal lobar degeneration (FT

184 It is used off-label to treat gastroesophageal, endometrial, cervic

185 ll membrane of enterococci and is often used off-label to treat patients infected with vancomycin-res

186 Bevacizumab is used off-label to treat this condition despite the absence of

187 s suggest that ferumoxytol could be applied 'off label' to protect the liver from metastatic seeds an

188 Off-label tocilizumab use in COVID-19 patients reflects

189 potentially important issues related to the off-label treatment approach that should be considered t

190 have led to increased use of ketamine as an off-label treatment for mood and other psychiatric disor

191 MMC, although still off-label treatment for ophthalmic surgical uses, is now

192 as been increasingly adopted as a first-line off-label treatment for patients with NMOSDs.

193 abis use, when selecting a medication in the off-label treatment of CUD or cannabis withdrawal.

194 philia patients with inhibitors, as well for off-label treatment of severe bleeding in trauma and sur

195 patients possible candidates for on-label or off-label treatment with an FDA-approved drug.

196 d upper arms were performed before and after off-label treatment with hyaluronidase injections.

197 Off-label treatment with tocilizumab restored the cytoto

198 ern regarding risk of late thrombosis after "off-label" treatment with drug-eluting stents has prompt

199 Krauel and colleagues identify two potential off-label treatments(rivaroxaban, dabigatran) for hepari

200 bortezomib demonstrated clinical efficacy in off-label trials of Systemic Lupus Erythematosus.

201 for Food and Drug Administration-approved or off-label use (0.74% vs 0.67%; p = 0.336; 33 vs 31 event

202 site end point was significantly higher with off-label use (adjusted hazard ratio [HR], 2.08; 95% con

203 s end point was not different at 1 year with off-label use (adjusted HR, 1.10; 95% CI, 0.79-1.54; P =

204 essel revascularization were associated with off-label use (adjusted HR, 1.49; 95% CI, 1.13-1.98; P =

205 gle intravitreal injection of bevacizumab in off-label use (n = 33 eyes) or peripheral laser ablation

206 On-label use amounted to 70%, and off-label use amounted to 30%.

207 ce of adverse drug reactions associated with off-label use and evaluate off-label use as a risk facto

208 Excluding off-label use and pregnancy, 438 patients (78.6%) did no

209 s associated with off-label use and evaluate off-label use as a risk factor for the development of ad

210 ibed promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US

211 %), with hospitals in the highest tertile of off-label use associated with increased 30-day adverse c

212 re safe and efficacious in both on-label and off-label use but highlight differences between RCT and

213 rials in children, which might reduce unsafe off-label use by promoting more quickly proper labeling

214 agonists should not be offered routinely but off-label use can be considered in selected children.

215 re not approved for use in the forehead, but off-label use for enhancement in this region is common.

216 EDTA chelation therapy has been in off-label use for the treatment of atherosclerosis.

217 Off-label use has been promoted because of the paucity o

218 is common in the ICU; however, the safety of off-label use has not been assessed.

219 ations, their unanticipated side effects and off-label use have contributed significantly to our unde

220 in Europe for olodaterol or indacaterol for off-label use in asthma or for pediatric use.

221 rol in clinical practice and to quantify the off-label use in asthma.

222 disclosures made in articles related to the off-label use in question, determined the frequency of a

223 The extent of off-label use is a policy concern because the clinical b

224 tor medication in the United States, but its off-label use is associated with risks associated with t

225 Prior research indicates that off-label use is common in the ICU; however, the safety

226 Off-label use is composed of a roughly equal mix of chem

227 Off-label use occurred in 54.7% of all patients with bar

228 Caution is thus required with the off-label use of a perioperative intravenous n-3 PUFA em

229 In addition, off-label use of a third anti-VEGF agent, bevacizumab, a

230 MLV-related viruses, including XMRV, and the off-label use of antiretrovirals for the treatment of CF

231 It could be argued that all off-label use of any agent should be deemed illegal.

232 While investigating the off-label use of BDQ as salvage therapy, seven of 13 pat

233 pares annulus measurements from 3D-TEE using off-label use of commercially available software with MD

234 eosinophilic esophagitis (EoE) is limited to off-label use of corticosteroids not optimized for esoph

235 eosinophilic esophagitis (EoE) is limited to off-label use of corticosteroids not optimized for esoph

236 yrin production, we treated the patient with off-label use of deferasirox to maintain iron deficiency

237 Recent reports suggest that off-label use of drug-eluting stents is associated with

238 Compared with on-label use, off-label use of drug-eluting stents is associated with

239 , highlighting the risks associated with the off-label use of drugs in newborn infants before safety

240 because of access to clinical trials and/or off-label use of drugs.

241 Off-label use of empagliflozin in 4 GSD-Ib patients with

242 D-19 are limited to supportive therapies and off-label use of FDA-approved drugs.

243 Studies in the literature suggest that the off-label use of fibrin glue to close limbal conjunctiva

244 ed selective outcome reporting for trials of off-label use of gabapentin.

245 ugs and substantial medical need justify the off-label use of HCV PIs in select HIV/HCV-coinfected pe

246 We also discuss off-label use of medications studied for obesity and pro

247 ar use of nonsedating antihistamines and the off-label use of omalizumab.

248 the design of future prospective trials for off-label use of oncology drugs across four areas: trial

249 For now, decisions about off-label use of recombinant factor VIIa remain at the p

250 From 2000 to 2008, off-label use of rFVIIa in hospitals increased more than

251 Off-label use of rFVIIa in the hospital setting far exce

252 rent antiarenaviral therapy is limited to an off-label use of ribavirin that is only partially effect

253 antiarenaviral therapy being limited to the off-label use of ribavirin that is only partially effect

254 rent antiarenaviral therapy is limited to an off-label use of ribavirin that is only partially effect

255 ile antiarenaviral therapy is limited to the off-label use of ribavirin, which is only partially effe

256 and antiarenaviral therapy is limited to the off-label use of ribavirin, which is only partially effe

257 mammarenavirus infections is limited to the off-label use of ribavirin, which is partially effective

258 To evaluate patterns and adverse outcomes of off-label use of TAVR in US clinical practice.

259 Off-label use of TAVR.

260 resources to perform a validation study for off-label use of the breakpoints on their systems.

261 ts (n = 20) with baricitinib according to an off-label use of the drug.

262 t therapeutic intervention is limited to the off-label use of the wide-spectrum antiviral ribavirin.

263 To better assess the safety and efficacy of off-label use of Tpo-RAs during pregnancy, a multicenter

264 sis of these preliminary findings, temporary off-label use of Tpo-RAs for severe and/or refractory IT

265 Off-label use of transcatheter aortic and pulmonary valv

266 rm prophylactic treatment relies on lithium, off-label use of valproate, and growing use of modern an

267 Off-label use of vemurafenib (VMF) to treat BRAF(V600E)

268 Off-label use of VPA and other HDAC inhibitors for the t

269 Prevalence of off-label use ranged from 3.5% for both drugs to 12.4% f

270 N-supported off-label indication, and 10% of off-label use was associated with an FDA-approved cancer

271 Potential off-label use was defined as no recorded diagnosis of ei

272 Off-label use was defined as use among adults with a rec

273 Off-label use was defined as use in restenotic lesions,

274 All other use was "off-label." Off-label use was divided by whether it conformed to Nat

275 rventions were excluded, however, risk after off-label use was not significantly increased (P=0.23).

276 physician, and hospital characteristics with off-label use were explored with multivariable hierarchi

277 Delays in evaluation may result in off-label use without dosing information as the only acc

278 eterization laboratory-only eptifibatide (an off-label use) as procedural pharmacotherapy for patient

279 reactions do not occur more frequently with off-label use, adverse drug reaction risk increases with

280 ard use, relative early safety is lower with off-label use, and the long-term effectiveness is lower

281 However, it is an off-label use, and the potential side effects of dexmede

282 position) and articles (type, connection to off-label use, journal impact factor, citation count/yea

283 th Food and Drug Administration-approved and off-label use, respectively.

284 ependently associated with increased odds of off-label use, whereas diabetes mellitus, increasing age

285 ved crizotinib therapy through an individual off-label use.

286 for Food and Drug Administration-approved or off-label use.

287 BDQ and DLM are extended beyond 24 weeks as off-label use.

288 , with concomitant increases in dabigatran's off-label use.

289 e and duration of treatment as well as their off-label use.

290 among atypical antipsychotic medications for off-label use.

291 ere weakly associated with the likelihood of off-label use.

292 treatment in the concept of repurposing and off-label use.

293 rent antiarenaviral therapy is limited to an off-labeled use of the nucleoside analog ribavirin, whic

294 and indacaterol were classified as potential off-label users, with prevalence ranging from 17.3% to 4

295 The CMS would pay only for off-label uses for which there is adequate evidence in i

296 Trials were for off-label uses of gabapentin sponsored by Pfizer and Par

297 al companies have paid physicians to promote off-label uses of their products through a number of dif

298 Indeed, many devices remain off-label with a best-fit approach often required, spurn

299 tine use of drug-eluting stents (DES) (>75% "off-label") with a comparable group treated with bare-me

300 chotomously (Food and Drug Administration or off-label), with 56% and 44% being associated with Food