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 testinal illnesses are frequently prescribed off-label.

3 96% to 98%) of 18 311 in-hospital uses were off-label.

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

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

6 and antipsychotic drugs, often administered off-label.

7 law prohibits companies from marketing drugs off-label.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

27 Much of pediatric drug use is off-label because appropriate pediatric studies have not

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

58 nt literature from the past year related to "off-label" immune-based treatment of skin disease, using

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

80 acy of SES has led to their expanded use for off-label indications, including LMCA disease.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

104 In some settings pediatricians will use "off-label" medications if the benefit-to-risk ratio is f

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

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

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

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

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

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

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

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

113 of maximum hybridization intensity as a cut-off, labeled P450 genes exhibited essentially no cross-h

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

115 tment in adults, has also been examined for "off-label" pediatric use in nongenital warts, molluscum

116 cals, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products.

117 tamins and supplements, and 10% investigated off-label pharmaceuticals.

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

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

120 use has been increasing and their widespread off-label prescribing by practitioners has raised some i

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

150 4 years [interquartile range, 78-88 years]), off-label TAVR was used in 2272 patients (9.5%).

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

152 antiepileptic drug use in children is often "off label." The present review of newer antiepileptic dr

153 onal experience when assessing any role for "off label" therapy.

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

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

156 declined to reimburse the cost of drugs used off-label to treat cancer on the ground that these uses

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

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

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

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

161 ter its introduction, it has also been used "off-label" to enhance hemostasis in nonhemophilic patien

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

163 ed factor VII is increasingly being used for off-label treatment and prophylaxis of bleeding in non-h

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

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

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

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

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

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

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

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

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

173 The predominance of medications with off-label (unlabeled) indications calls for prospective

174 Published experience that may report "off-label" usage can be helpful in decision making, alth

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

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

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

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

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

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

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

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

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

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

185 %), with hospitals in the highest tertile of off-label use associated with increased 30-day adverse c

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

211 rend continued until the mid-1990s, when the off-label use of fenfluramine plus phentermine (fen-phen

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

227 Off-label use of TAVR.

228 art failure code was evaluated for potential off-label use of the drug.

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

230 Off-label use of transcatheter aortic and pulmonary valv

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

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

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

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

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

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

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

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

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

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

241 seven ADRs lacking PI changes occurred with off-label use, for which PI change is not recommended by

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

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

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

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

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

247 among atypical antipsychotic medications for off-label use.

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

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

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

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

252 Finally, "off-label" use of intravenous Ig has been evaluated for

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

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

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

256 cally appropriate cancer therapies including off-label uses recognized by established drug compendia

257 ontin, Pfizer, Inc., New York, New York) for off-label uses.

258 Novel "off-label" uses in children for interleukin-1 receptor a

259 ld collaborate to develop local policies for off-label utilization of recombinant activated factor VI

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

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

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