Kisunla
Drug name: Kisunla | Dosage form: Injection (intravenous; 350 mg/20 mL [17.5 mg/mL]) | Approval year: 2024 | Company: Eli Lilly and Company., Indianapolis, USA | Class: Amyloid beta-directed antibodies | System:
Indications
- Indicated for the treatment of Alzheimer's disease.
- Treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials.
Document title: Clinically Important Benefits and Harms of Monoclonal Antibodies Targeting Amyloid for the Treatment of Alzheimer Disease: A Systematic Review and Meta-Analysis Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11233076/pdf/0220050.pdf Document source: The Annals of Family Medicine Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Pharmacologic and Nutritional Interventions for Early Alzheimer's Disease: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11191524/pdf/jad-99-jad240161.pdf Document source: Journal of Alzheimer's Disease Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Comparative efficacy, tolerability and acceptability of donanemab, lecanemab, aducanumab and lithium on cognitive function in mild cognitive impairment and Alzheimer's disease: A systematic review and network meta-analysis Document link: https://www.sciencedirect.com/science/article/abs/pii/S1568163724000217?via%3Dihub Document source: Ageing Research Reviews Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Kisunla (donanemab-azbt) Prescribing Information. Document link: https://pi.lilly.com/us/kisunla-uspi.pdf?s=pi Document source: Eli Lilly and Company., Indianapolis, USA Document type: Product Monograph / Prescribing Information Document year: 2024
Document title: Immunotherapies Targeting Amyloid and Tau Protein in Alzheimer's Disease: Should We Move Away from Diseases and Focus on Biological Targets? A Systematic Review and Expert Opinion Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10630258/pdf/40120_2023_Article_541.pdf Document source: Neurology and Therapy Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Comparative Study of Safety and Efficacy of Angiotensin-Receptor Blockers and Anti Amyloid-ss Monoclonal Antibodies for the Treatment of Alzheimer's Disease: A Systematic Review Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10516255/pdf/cureus-0015-00000043984.pdf Document source: Cureus Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Donanemab for Alzheimer's Disease: A Systematic Review of Clinical Trials Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9818878/pdf/healthcare-11-00032.pdf Document source: Healthcare Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: High-clearance anti-amyloid immunotherapies in Alzheimer's disease. Part 1: Meta-analysis and review of efficacy and safety data, and medico-economical aspects Document link: https://www.sciencedirect.com/science/article/pii/S003537872200738X?via%3Dihub Document source: Revue Neurologique Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Leqembi
Drug name: Leqembi | Dosage form: Injection (intravenous; 500 mg/5 mL [100 mg/mL], 200 mg/2 mL [100 mg/mL]) | Approval year: 2023 | Company: Eisai Inc., Nutley, NJ | Class: Amyloid beta-directed antibodies | System:
Indications
- Indicated for the treatment of Alzheimer's disease.
Document title: The efficacy and safety of lecanemab 10 mg/kg biweekly compared to a placebo in patients with Alzheimer's disease: a systematic review and meta-analysis of randomized controlled trials Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11254984/pdf/10072_2024_Article_7477.pdf Document source: Neurological Sciences Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Leqembi (lecanemab-irmb) Prescribing Information. Document link: https://www.leqembi.com/-/media/Files/Leqembi/Prescribing-Information.pdf?hash=3d7bf1a2-5db2-4990-8388-81086f415676 Document source: Eisai Inc., Nutley, NJ Document type: Product Monograph / Prescribing Information Document year: 2023
Document title: The FDA-approved anti-amyloid-beta monoclonal antibodies for the treatment of Alzheimer's disease: a systematic review and meta-analysis of randomized controlled trials Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10683264/pdf/40001_2023_Article_1512.pdf Document source: European Journal of Medical Research Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Aduhelm
Drug name: Aduhelm | Dosage form: Injection (intravenous; 170 mg/1.7 mL [100 mg/mL], 300 mg/3 mL [100 mg/mL]) | Approval year: 2021 | Company: Biogen Inc., Cambridge, MA | Class: Amyloid beta-directed antibodies | System:
Indications
- Indicated for the treatment of Alzheimer's disease.
- Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
- This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM.
- Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
Document title: Clinically Important Benefits and Harms of Monoclonal Antibodies Targeting Amyloid for the Treatment of Alzheimer Disease: A Systematic Review and Meta-Analysis Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11233076/pdf/0220050.pdf Document source: Annals of Family Medicine Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Pharmacologic and Nutritional Interventions for Early Alzheimer's Disease: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11191524/pdf/jad-99-jad240161.pdf Document source: Journal of Alzheimer's Disease Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Comparative Study of Safety and Efficacy of Angiotensin-Receptor Blockers and Anti Amyloid-ss Monoclonal Antibodies for the Treatment of Alzheimer's Disease: A Systematic Review Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10516255/pdf/cureus-0015-00000043984.pdf Document source: Cureus Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Aducanumab for the treatment of Alzheimer's disease: a systematic review Document link: https://onlinelibrary.wiley.com/doi/epdf/10.1111/psyg.12944 Document source: Psychogeriatrics Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Guidelines for pharmacotherapy in Alzheimer's disease - A primer on FDA-approved drugs. Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10696336/?report=printable Document source: Journal of Neurosciences in Rural Practice Document type: Clinical Practice Guidelines Document year: 2023
Document title: Immunotherapies Targeting Amyloid and Tau Protein in Alzheimer's Disease: Should We Move Away from Diseases and Focus on Biological Targets? A Systematic Review and Expert Opinion Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10630258/pdf/40120_2023_Article_541.pdf Document source: Neurology and Therapy Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: The FDA-approved anti-amyloid-beta monoclonal antibodies for the treatment of Alzheimer's disease: a systematic review and meta-analysis of randomized controlled trials Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10683264/pdf/40001_2023_Article_1512.pdf Document source: European Journal of Medical Research Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Aduhelm (aducanumab-avwa) Prescribing Information. Document link: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf Document source: Biogen Inc., Cambridge, MA Document type: Product Monograph / Prescribing Information Document year: 2023
Document title: Aducanumab Use in Symptomatic Alzheimer Disease Evidence in Focus: A Report of the AAN Guidelines Subcommittee. Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9012273/pdf/WNL2021-178593.pdf Document source: Neurology Document type: Clinical Practice Guidelines Document year: 2022
Document title: Aducanumab: Appropriate Use Recommendations. Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8835345/pdf/nihms-1775067.pdf Document source: The Journal of Prevention of Alzheimer's Disease Document type: Clinical Practice Guidelines Document year: 2021
Document title: Effects of monoclonal antibodies against amyloid-beta on clinical and biomarker outcomes and adverse event risks: A systematic review and meta-analysis of phase III RCTs in Alzheimer's disease Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161699/pdf/nihms-1694211.pdf Document source: Ageing Research Reviews Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Tauvid
Drug name: Tauvid | Dosage form: Injection (intravenous; 300 MBq/mL to 3,700 MBq/mL [8.1 mCi/mL to 100 mCi/mL] of flortaucipir F 18 in a multiple-dose vial) | Approval year: 2020 | Company: Avid Radiopharmaceuticals, Philadelphia, PA | Class: Radioactive diagnostic agents | System: Multiple
Indications
- Indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).
Document title: Tauvid (flortaucipir F 18) Prescribing Information. Document link: https://pi.lilly.com/us/tauvid-uspi.pdf Document source: Avid Radiopharmaceuticals, Philadelphia, PA Document type: Product Monograph / Prescribing Information Document year: 2024
Document title: International consensus on the use of tau PET imaging agent 18F-flortaucipir in Alzheimer’s disease Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8803772/pdf/259_2021_Article_5673.pdf Document source: European Journal of Nuclear Medicine and Molecular Imaging Document type: Clinical Practice Guidelines Document year: 2022
Document title: Personality Associations With Amyloid and Tau: Results From the Baltimore Longitudinal Study of Aging and Meta-analysis Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8792161/pdf/nihms-1738041.pdf Document source: Biological Psychiatry Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: What’s the cut-point?: a systematic investigation of tau PET thresholding methods Document link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8985353/pdf/13195_2022_Article_986.pdf Document source: Alzheimer's Research & Therapy Document type: Systematic Reviews / Meta-Analyses Document year: null
Rexulti
Drug name: Rexulti | Dosage form: Tablet (oral; 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg) | Approval year: 2015 | Company: Otsuka America Pharmaceutical, Inc., Princeton, NJ | Class: Atypical antipsychotics | System: Nervous
Indications
- Indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.
- Indicated for the treatment of schizophrenia in adults and pediatric patients ages 13 years and older.
- Indicated for the treatment of agitation associated with dementia due to Alzheimer's disease.
Document title: Rexulti (brexpiprazole) Prescribing Information. Document link: https://www.otsuka-us.com/media/document/Rexulti-PI.pdf Document source: Otsuka America Pharmaceutical, Inc., Princeton, NJ Document type: Product Monograph / Prescribing Information Document year: 2024
Document title: Canadian Clinical Practice Guidelines for Assessing and Managing Behavioural and Psychological Symptoms of Dementia (BPSD) Document link: https://ccsmh.ca/wp-content/uploads/2024/03/V4-CCSMH-BPSD-Clinical-Guidelines_Final-for-webinar.pdf Document source: Canadian Coalition for Seniors' Mental Health Document type: Clinical Practice Guidelines Document year: 2024
Document title: Comparison of brexpiprazole, aripiprazole, and placebo for Japanese major depressive disorder: A systematic review and network meta-analysis Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10932760/pdf/NPR2-44-165.pdf Document source: Neuropsychopharmacology Reports Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Efficacy and safety of brexpiprazole for the treatment of agitation in Alzheimer's disease: a meta-analysis of randomized controlled trials Document link: https://link.springer.com/article/10.1007/s10072-024-07576-8 Document source: Neurological Sciences Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Efficacy, acceptability and tolerability of second-generation antipsychotics for behavioural and psychological symptoms of dementia: a systematic review and network meta-analysis Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC11293415/pdf/bmjment-27-1.pdf Document source: BMJ Mental Health Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Real-World Effectiveness, Economic, and Humanistic Outcomes of Selected Oral Antipsychotics in Patients with Schizophrenia: A Systematic Review Evaluating Global Evidence Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC11385900/pdf/ceor-16-621.pdf Document source: ClinicoEconomics and Outcomes Research Document type: Systematic Reviews / Meta-Analyses Document year: 2024
Document title: Comparison of antipsychotic dose equivalents for acute bipolar mania and schizophrenia Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10035777/pdf/bmjment-2022-300546.pdf Document source: BMJ Mental Health Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Efficacy and safety/tolerability of antipsychotics in the treatment of adult patients with major depressive disorder: a systematic review and meta-analysis Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10317805/pdf/S0033291722000745a.pdf Document source: Psychological Medicine Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Comparative efficacy and safety of 4 atypical antipsychotics augmentation treatment for major depressive disorder in adults: A systematic review and network meta-analysis Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10519518/pdf/medi-102-e34670.pdf Document source: Medicine Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Optimal dose of brexpiprazole for augmentation therapy of antidepressant-refractory depression: A systematic review and dose-effect meta-analysis Document link: https://onlinelibrary.wiley.com/doi/epdf/10.1111/pcn.13438 Document source: Psychiatry and Clinical Neurosciences Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: Antipsychotic-Induced Weight Gain: Dose-Response Meta-Analysis of Randomized Controlled Trials Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC9077426/pdf/sbac001.pdf Document source: Schizophrenia Bulletin Document type: Systematic Reviews / Meta-Analyses Document year: 2022
Document title: Efficacy and Tolerability of Combination Treatments for Major Depression: Antidepressants plus Second-Generation Antipsychotics vs. Esketamine vs. Lithium Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC8358538/pdf/10.1177_02698811211013579.pdf Document source: Journal of Psychopharmacology (Oxford, England) Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Document title: Efficacy and safety of antipsychotic treatments for schizophrenia: A systematic review and network meta-analysis of randomized trials in Japan Document link: https://www.sciencedirect.com/science/article/abs/pii/S0022395621002594?via%3Dihub Document source: Journal of Psychiatric Research Document type: Systematic Reviews / Meta-Analyses Document year: 2021
Document title: Aripiprazole vs. brexpiprazole for acute schizophrenia: a systematic review and network meta-analysis Document link: https://link.springer.com/article/10.1007/s00213-020-05472-5 Document source: Psychopharmacology Document type: Systematic Reviews / Meta-Analyses Document year: 2020
Document title: Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia Document link: https://psychiatryonline.org/doi/epdf/10.1176/appi.ajp.2019.19010034 Document source: The American Journal of Psychiatry Document type: Systematic Reviews / Meta-Analyses Document year: 2020
Document title: Blonanserin patch vs. Other Antipsychotics for Acute Schizophrenia: A Systematic Review of Double-blind, Randomized, Placebo-controlled, Phase 3 Trials in Japan Document link: https://www.thieme-connect.com/products/ejournals/abstract/10.1055/a-1096-1266 Document source: Pharmacopsychiatry Document type: Systematic Reviews / Meta-Analyses Document year: 2020
Document title: Efficacy and safety of brexpiprazole in acute management of psychiatric disorders: a meta-analysis of randomized controlled trials Document link: https://journals.lww.com/intclinpsychopharm/abstract/2020/05000/efficacy_and_safety_of_brexpiprazole_in_acute.1.aspx Document source: international Clinical Psychopharmacology Document type: Systematic Reviews / Meta-Analyses Document year: 2020
Document title: Brexpiprazole as Adjunctive Treatment for Major Depressive Disorder Following Treatment Failure With at Least One Antidepressant in the Current Episode: a Systematic Review and Meta-Analysis Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC6872963/pdf/pyz040.pdf Document source: The international Journal of Neuropsychopharmacology Document type: Systematic Reviews / Meta-Analyses Document year: 2019
Neuraceq
Drug name: Neuraceq | Dosage form: Injection (intravenous: 50 to 5000 MBq/mL [1.4 to135 mCi/mL]) | Approval year: 2014 | Company: Life Molecular Imaging Ltd., Warwick, United Kingdom | Class: Radioactive diagnostic agents | System: Nervous
Indications
- Indicated for Positron Emission Tomography (PET) imaging of the brain to estimate -amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.
Document title: Neuraceq (florbetaben F18) Prescribing Information. Document link: https://neuraceq.com/wp-content/uploads/PRESCRIBING-INFORMATION.pdf Document source: Life Molecular Imaging Ltd., Warwick, United Kingdom Document type: Product Monograph / Prescribing Information Document year: 2024
Document title: Positron emission tomography in the diagnosis and follow-up of transthyretin amyloid cardiomyopathy patients: A systematic review Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10684414/pdf/259_2023_Article_6381.pdf Document source: European Journal of Nuclear Medicine and Molecular Imaging Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Amyvid
Drug name: Amyvid | Dosage form: Injection (intravenous; 500-1900 MBq/mL [13.5-51 mCi/mL]) | Approval year: 2012 | Company: Eli Lilly and Company, Indianapolis, IN | Class: Radioactive diagnostic agents | System: Nervous
Indications
- Indicated for Positron Emission Tomography (PET) imaging of the brain to estimate -amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline.
- A negative Amyvid scan indicates sparse to no neuritic plaques, and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patients cognitive impairment is due to AD.
- A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition.
- Amyvid is an adjunct to other diagnostic evaluations.
Document title: Amyvid (florbetapir F 18) Prescribing Information. Document link: https://pi.lilly.com/us/amyvid-uspi.pdf Document source: Eli Lilly and Company, Indianapolis, IN Document type: Product Monograph / Prescribing Information Document year: 2023
Document title: Amyloid-beta PET in Alzheimer's disease: A systematic review and Bayesian meta-analysis Document link: https://onlinelibrary.wiley.com/doi/10.1002/brb3.2850 Document source: Brain and Behavior Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: Positron emission tomography in the diagnosis and follow-up of transthyretin amyloid cardiomyopathy patients: A systematic review Document link: https://link.springer.com/article/10.1007/s00259-023-06381-3 Document source: European Journal of Nuclear Medicine and Molecular Imaging Document type: Systematic Reviews / Meta-Analyses Document year: 2023
Document title: International Nuclear Medicine consensus on the clinical use of amyloid positron emission tomography in Alzheimer’s disease. Document link: https://pmc.ncbi.nlm.nih.gov/articles/PMC10425321/pdf/43657_2022_Article_68.pdf Document source: Phenomics Document type: Clinical Practice Guidelines Document year: 2022
Document title: ACR Appropriateness Criteria® Dementia Document link: https://www.jacr.org/action/showPdf?pii=S1546-1440%2820%2930128-9 Document source: Journal of the American College of Radiology Document type: Clinical Practice Guidelines Document year: 2020

