Off-Label Use of Bevacizumab for the Treatment of Age-Related Macular Degeneration

Drugs & Aging ◽  
2009 ◽  
Vol 26 (4) ◽  
pp. 295-320 ◽  
Author(s):  
Focke Ziemssen ◽  
Salvatore Grisanti ◽  
Karl Ulrich Bartz-Schmidt ◽  
Martin S. Spitzer
Keyword(s):  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Off Label Use ◽  
Off Label ◽  
Age Related ◽  
Label Use

scholarly journals Off-label use of bevacizumab for wet age-related macular degeneration in Europe

2019 ◽  
Vol 258 (3) ◽  
pp. 503-511
Author(s):  
Tomas Bro ◽  
Magdalena Derebecka ◽  
Øystein Kalsnes Jørstad ◽  
Andrzej Grzybowski
Keyword(s):  
Macular Degeneration ◽  
European Countries ◽  
Age Related Macular Degeneration ◽  
Off Label Use ◽  
Off Label ◽  
Age Related ◽  
Governmental Institutions ◽  
Very High ◽  
Wet Amd ◽  
Label Use

Abstract Purpose To analyse current off-label use of bevacizumab for wet age-related macular degeneration (AMD) in Europe. Methods The study was conducted as a combined survey and literature review. It included the 22 most populous countries in Europe. In each country, ophthalmologists with particular knowledge about off-label treatment responded to a questionnaire. Results Answers were obtained from twenty European countries. The off-label use of bevacizumab for wet AMD greatly differed between nations; the bevacizumab proportion varied from non-existent (0%) to very high (97%). There were also large disparities within single countries (e.g. 0–80%), which were attributable to differences in regional decision-making. Both governmental institutions and national ophthalmological societies expressed highly diverging opinions on the use of off-label treatment. Intravitreal administration of bevacizumab had been a matter of legal dispute in several countries. The question about responsibility for off-label therapy mainly remained unanswered. Conclusions There was a highly varying utilization of bevacizumab between European countries. Despite an intention of a consistent approach to medical regulations, Europe has not yet reached a professional or political consensus on the ophthalmic off-label use of bevacizumab.

scholarly journals Off-Label Use of Bevacizumab in Age-Related Macular Degeneration: Protocol for a Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
João Estarreja ◽  
Carina Valente ◽  
Carina Silva ◽  
Pedro Camacho ◽  
Vanessa Mateus
Keyword(s):  
Systematic Review ◽  
Macular Degeneration ◽  
Vision Loss ◽  
Meta Analysis ◽  
Age Related Macular Degeneration ◽  
Off Label Use ◽  
Off Label ◽  
Pharmacological Approach ◽  
Age Related ◽  
Label Use

Abstract Background: Age-related macular degeneration (AMD) is considered the leading cause of vision loss in elderly people. Taking into account the phenomenon of aging worldwide, the prevalence of AMD is expected to increase gradually in the future. AMD can be divided into early, intermediate and late stages, where early and intermediate are mainly asymptomatic and, late-stage can be classified in non-vascular AMD and vascular AMD. Current pharmacological treatment in vascular AMD is associated with the administration of anti-VEGF agents, such as ranibizumab, pegaptanib, and aflibercept. Additionally, it has been reported the off-label use of bevacizumab, commonly associated with oncology, in this condition through intravitreal administrations, demonstrating efficacy allied with a lower cost in comparison to other agents used, which makes it a new possible pharmacological approach. In this sense, this review aims to evaluate the off-label use profile of bevacizumab in the treatment of neovascular AMD. Methods/design: To identify and select relevant articles present in current literature, it will be developed a highly sensitive search strategy. To develop this search, it will be used MEDLINE via the Pubmed platform. It will be only considered clinical studies, where it is compared the use of bevacizumab with another pharmacological agent, such as ranibizumab, or even a placebo, in patients aged 50 years and older, diagnosed with vascular AMD.Discussion: This review will provide a synthesis of the current information and underlying evidence, about the influence of the off-label use of bevacizumab in this disease. Altogether, it will allow having a clearer vision on a new possible accepted pharmacological approach for the treatment of vascular AMD.Systematic review registration: The protocol for this review will be submitted and registered with the International Prospective Register of Systematic Reviews (PROSPERO).

scholarly journals Critical evaluation of the off-label indication and of the risks associated to the use of multi-dose vials on the treatment of age-related macular degeneration

2014 ◽  
Vol 50 (1) ◽  
pp. 63-72 ◽  
Author(s):  
Bruna Renata Dutra Barbosa ◽  
Sávio Fujita Barbosa ◽  
Guilherme Diniz Tavares ◽  
Nádia Araci Bou Chacra ◽  
Terezinha de Jesus Andreoli Pinto
Keyword(s):  
Macular Degeneration ◽  
Therapeutic Indication ◽  
Inflammatory Diseases ◽  
Critical Evaluation ◽  
Age Related Macular Degeneration ◽  
Public Consultation ◽  
Off Label ◽  
Age Related ◽  
Ophthalmic Therapy ◽  
Label Indication

Age-related macular degeneration (AMD) is an ocular inflammatory diseases treated mainly by means of a bevacizumab (Avastin®) or ranibizumab (Lucentis®) intravitreal injection. Among these drugs, only ranibizumab has a specific therapeutic indication for AMD. Considering that, the off-label use on ophthalmic therapy seems to become a rule when it should be an exception. Furthermore, bevacizumab presentation consists of multi-dose vials although it does not contain preservatives in its formula. The current literature review aimed at assessing the risks for the patient related to the use of off-label indication and multi-dose vials on AMD treatment. Considering this, the proposal related to the Brazilian Public Consultation no.10, dated September 12, 2012, which proposes the Clinical Protocol and Therapeutic Guidelines for AMD treatment, was evaluated. This systematic review allowed to conclude that the bevacizumab off-label indication results in increased risks for the patient when compared to the product with specific therapeutic indication for AMD treatment (ranibizumab), especially referring to the significant raise in the adverse events. The risks for the patient related to the multi-dose vial use, referring to the microbiological stability and dose precision, were also made clear.

PD62 Off-Label Use Of Medicines For Public Health Needs

2018 ◽  
Vol 34 (S1) ◽  
pp. 152-153
Author(s):  
Tacila Mega ◽  
Roberta Rabelo ◽  
Juliana Vidal ◽  
Artur Felipe de Brito
Keyword(s):  
Public Health ◽  
Scientific Evidence ◽  
Bipolar Affective Disorder ◽  
Autism Spectrum ◽  
Age Related Macular Degeneration ◽  
Neglected Diseases ◽  
Off Label Use ◽  
Health Technologies ◽  
Off Label ◽  
Label Use

Introduction:The use of drugs for clinical conditions that differ from those approved in prescribing information (product labels) is known as off-label use. In Brazil, the Brazilian Health Regulatory Agency (ANVISA) is the official organization that regulates the use of health technologies. For technologies to be incorporated into the Brazilian public health system, registration with ANVISA is mandatory. However, occasionally, it is necessary to evaluate technologies for off-label use in the interests of public health. This study aimed to identify the health technologies recommended by the National Committee for Health Technology Incorporation (CONITEC) with an off-label indication between January 2012 and October 2017.Methods:A descriptive study was undertaken using data available on the CONITEC website.Results:The study identified seven drugs with a favorable recommendation for off-label use: everolimus, sirolimus, and tacrolimus as immunosuppressants in transplant recipients; clozapine for bipolar affective disorder; pentoxifylline for cutaneous leishmaniosis mucosa; risperidone for adults with autism spectrum disorder, and bevacizumab for age-related macular degeneration and diabetic macular edema. For these decisions the Committee considered the scientific evidence available for the indication proposed, the severity of the disease, and the existence or absence of alternative treatments. This was possible because Brazilian legislation allows ANVISA to authorize the off-label use of health technologies provided that the analysis is supported by scientific evidence regarding effectiveness, accuracy, and safety for the intended purpose.Conclusions:The off-label use of health technologies is a worldwide practice that can favor vulnerable populations and neglected diseases. This practice should be seen as positive when there is evidence supporting off-label use, and such decisions should not be influenced by political, economic, or marketing considerations.

scholarly journals Quantifying the increasing use of anti-vascular endothelial growth factor therapy in ophthalmology

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Jonathan Micieli ◽  
Andrew Micieli
Keyword(s):  
Clinical Trials ◽  
Growth Factor ◽  
Case Reports ◽  
Retinal Pigment ◽  
Phase Iii ◽  
Off Label Use ◽  
Off Label ◽  
Phase Iii Clinical Trials ◽  
Age Related ◽  
Label Use

Introduction: Bevacizumab (Avastin; genetech Inc., South San fran- cisco, CA) and ranibizumab (Lucentis, genetech Inc.) are two anti-Vascular Endo- thelial growth factor (VEgf) agents used in increasing amounts off-label to treat  ocular conditions. To date, no study has quantifed how far reaching these therapies have been in treating eye disease and compared their off-label use to the number of clinical trials performed. Method: A systematic search of Ovid MEdLINE using the keywords bevacizumab and ranibizumab limited to “Case Reports” was used as an index of the number of diseases treated. Each keyword was also limited to “Clinical Trials, All” and “Phase III Clinical Trials” to discern the quality of evidence for these uses.Results: Bevacizumab has been utilized for the treatment of 58 different ocular conditions, but only 14 conditions were studied in a trial, and none were part of a phase III clinical trial. Ranibizumab has been used for 17 different eye conditions,  with only 6 studied in a trial and only 1 disease, “wet” age-related macular degenera- tion reported in 4 phase III trials. In the case reports, there were 21 different adverse  events ascribed to bevacizumab and 2 to ranibizumab with retinal pigment epithelial tears being the most common. Conclusion: Bevacizumab is one of the most far reaching drugs in ophthalmology and even medicine, but it is not yet supported by high quality evidence. The much higher cost of ranibizumab may be responsible for bevacizumab’s popularity among eye specialists. Patients should be fully informed about the off-label use of bevacizumab and the associated risks with its use.

Off-label prescriptions of quetiapine for sleep disturbances

2017 ◽  
Vol 41 (S1) ◽  
pp. S749-S750
Author(s):  
M. Arts ◽  
S. Petrykiv ◽  
J. Fennema ◽  
L. De Jonge
Keyword(s):  
Sleep Disturbances ◽  
Dose Range ◽  
Metabolic Effects ◽  
Cochrane Library ◽  
Anti Psychotic ◽  
Off Label Use ◽  
Off Label ◽  
Age Related ◽  
Increased Risk ◽  
Label Use

IntroductionQuetiapine, a short-acting atypical anti-psychotic drug for the treatment of bipolar I disorder and schizophrenia, is increasingly used off-label for the treatment of sleep disturbances or insomnia. However, data supporting this off-label prescription of quetiapine are limited.Objectives and aimsTo report and discuss the effects of “off-label” use of quetiapine for the treatment of sleep disturbances.MethodsAn English-language literature search was conducted using Pubmed, EMBASE and Cochrane library (December 1980–December 2015) using the search terms quetiapine, insomnia, sleep disorders, sleep disturbances, and sleeplessness.ResultsDuring the last decade, there is an enormous increase in prescribing quetiapine. This anti-psychotic drug is among the best selling drugs worldwide. For the approved indications, the usual therapeutic dose range is 400–800 mg/day. However, off-label use of quetiapine was most evident for the 25 mg/day to 100 mg/day. In some countries, off-label uses are promoted to non-psychiatrists for the treatment of insomnia, dementia, agitation, and aggression. Inappropriate anti-psychotic use may lead to serious health problems, including metabolic effects, increased sudden cardiac death, and age-related side effects with increased risk for orthostatic hypotension, fractures, pneumonia, cognitive impairment, and stroke.ConclusionThere is growing concern regarding the potential harm from off-label prescription of anti-psychotics, particularly quetiapine. There is little evidence supporting the enormous off-label uses of quetiapine. In addition, prescribing quetiapine for indications that are not evidence based has ethical, financial, and safety implications, especially in the older population.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Age-related off-label use of nasal corticosteroids for allergies is relatively common in Finnish children with asthma

2017 ◽  
Vol 106 (11) ◽  
pp. 1830-1836
Author(s):  
Katja Sonninen ◽  
Johanna Jyrkkä ◽  
Jaana E. Martikainen ◽  
Kristiina Malmström ◽  
Mika J. Mäkelä ◽  
...  
Keyword(s):  
Off Label Use ◽  
Off Label ◽  
Age Related ◽  
Children With Asthma ◽  
Label Use

scholarly journals Contextualising Single-Arm Ophthalmology Trials With Real-World Data: An Emulated Target Trial Comparing The Efficacy Of Interventions For Neovascular Age-Related Macular Degeneration

2020 ◽  
Author(s):  
Darren S Thomas ◽  
Aaron Y. Lee ◽  
Philipp L. Muller ◽  
Roy Schwartz ◽  
Abraham Olvera-Barrios ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
Target Trial ◽  
Real World Data ◽  
World Data ◽  
Off Label ◽  
Age Related ◽  
Randomised Controlled

Methods of causal inference have shown promise in replicating randomised trials using real-world data recorded by Electronic Health Records (EHRs). We herein emulated a target trial on the intention-to-treat efficacy of off-label bevacizumab (q6w) pro re nata relative to fixed-interval aflibercept (q8w) for improving week-54 visual acuity of eyes affected by neovascular age-related macular degeneration. The bevacizumab arm (n 65) was taken from the ABC randomised controlled trial. A total of 4,471 aflibercept-treated eyes aligning with the ABC trial eligibility were identified from EHRs and synthetic control arms were created by emulating randomisation conditional on age, sex, and baseline visual read via exact matching and propensity score methods. We undertook an inferiority analysis on mean difference at 54 weeks; outcomes regression on achieving a change in visual acuity of ≥ 15, ≥ 10, and ≤ -15 Early Treatment Diabetic Retinopathy Letters (ETDRS) letters at week 54; and a time-to-event analysis on achieving a change in visual acuity of ≥ 15, ≥ 10, and ≤ -15 ETDRS letters by week 54. Our findings suggest off-label bevacizumab to be neither non-inferior nor superior to licensed aflibercept. While being no substitute for randomised controlled trials, emulated target trials could aid the interpretation of single-armed trials.

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