Peringatan Keamanan

Patients experiencing dose-limiting toxicity may present with amyloid-related imaging abnormalities including edema or microhemorrhages of the brain.A235730 Symptoms of dose limiting toxicity were generally transient,A235730 however patients may need to be treated with symptomatic and supportive measures.

Aducanumab

DB12274

biotech approved investigational

Deskripsi

Aducanumab, or BIIB037, is a monoclonal IgG1 antibody that targets extracellular amyloid-? plaques in the brain; similar to gantenerumab, bapineuzumab and solanezumab.A235668,A235730 Aducanumab is a recombinant antibody derived from patients with slow or absent cognitive decline, and phase 1b clinical trial data have shown patients treated with aducanumab show a reduction in amyloid-? plaques.A235668 Based on Mini-Mental State Examination and Clinical Dementia Rating (CDR), patients taking aducanumab showed signs of slowing progression; however, these data were controversial.A235668,A235720 Clinical trials showed a 23% relative difference between the experimental and placebo groups as determined by CDR; however, this is equivalent to an absolute difference of 0.4/18.A235720

Although aducanumab's approval represents the first drug treatment for Alzheimer's disease, the approval is conditional on further results.L34420 Biogen enrolled patients in phase 3 clinical trials in 2015 but increased the size of the trials from 1350 patients to 1650 patients to maintain statistical power in the face of a high standard deviation.A235720 Development of aducanumab was discontinued in March 2019 when two phase 3 clinical trials did not pass futility analysis; however, Biogen sought FDA approval in October 2019 after reanalyzing the data A235720 and aducanumab was granted accelerated FDA approval on 7 June 2021.L34393 In January 2024, Biogen announced that the development and commercialization of aducanumab will be discontinued to prioritize the marketing of lecanemab, another drug approved for the treatment of Alzheimer's disease.L51098

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) The terminal half life of aducanumab is 24.8 days.[L34393]
Volume Distribusi The volume of distribution of aducanumab is 9.63 L.[L34393]
Klirens (Clearance) A 10 mg/kg intravenous dose of aducanumab has a clearance of 0.39 mL/h/kg.[A235730]

Absorpsi

A 10 mg/kg intravenous dose of aducanumab reached a Cmax of 182.7 µg/mL, with a Tmax of 3.0 hours, and an AUCinf of 31,400 h\*µg/mL.A235730

Metabolisme

Aducanumab is expected to be broken down into smaller oligopeptides and amino acids.A40006,L34393

Rute Eliminasi

Monoclonal IgG is predominantly eliminated by catabolism to individual amino acids that are either recycled in the body or metabolized for energy.A40006

Interaksi Obat

373 Data
Diethylstilbestrol Diethylstilbestrol may increase the thrombogenic activities of Aducanumab.
Chlorotrianisene Chlorotrianisene may increase the thrombogenic activities of Aducanumab.
Conjugated estrogens Conjugated estrogens may increase the thrombogenic activities of Aducanumab.
Estrone Estrone may increase the thrombogenic activities of Aducanumab.
Estradiol Estradiol may increase the thrombogenic activities of Aducanumab.
Dienestrol Dienestrol may increase the thrombogenic activities of Aducanumab.
Ethinylestradiol Ethinylestradiol may increase the thrombogenic activities of Aducanumab.
Mestranol Mestranol may increase the thrombogenic activities of Aducanumab.
Estriol Estriol may increase the thrombogenic activities of Aducanumab.
Estrone sulfate Estrone sulfate may increase the thrombogenic activities of Aducanumab.
Quinestrol Quinestrol may increase the thrombogenic activities of Aducanumab.
Hexestrol Hexestrol may increase the thrombogenic activities of Aducanumab.
Tibolone Tibolone may increase the thrombogenic activities of Aducanumab.
Synthetic Conjugated Estrogens, A Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Aducanumab.
Synthetic Conjugated Estrogens, B Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Aducanumab.
Polyestradiol phosphate Polyestradiol phosphate may increase the thrombogenic activities of Aducanumab.
Esterified estrogens Esterified estrogens may increase the thrombogenic activities of Aducanumab.
Zeranol Zeranol may increase the thrombogenic activities of Aducanumab.
Equol Equol may increase the thrombogenic activities of Aducanumab.
Promestriene Promestriene may increase the thrombogenic activities of Aducanumab.
Methallenestril Methallenestril may increase the thrombogenic activities of Aducanumab.
Epimestrol Epimestrol may increase the thrombogenic activities of Aducanumab.
Moxestrol Moxestrol may increase the thrombogenic activities of Aducanumab.
Estradiol acetate Estradiol acetate may increase the thrombogenic activities of Aducanumab.
Estradiol benzoate Estradiol benzoate may increase the thrombogenic activities of Aducanumab.
Estradiol cypionate Estradiol cypionate may increase the thrombogenic activities of Aducanumab.
Estradiol valerate Estradiol valerate may increase the thrombogenic activities of Aducanumab.
Biochanin A Biochanin A may increase the thrombogenic activities of Aducanumab.
Formononetin Formononetin may increase the thrombogenic activities of Aducanumab.
Estetrol Estetrol may increase the thrombogenic activities of Aducanumab.
Cetuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Aducanumab.
Human immunoglobulin G The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Aducanumab.
Omalizumab The risk or severity of adverse effects can be increased when Omalizumab is combined with Aducanumab.
Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Aducanumab.
Abciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Aducanumab.
Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Aducanumab.
Indium In-111 satumomab pendetide The risk or severity of adverse effects can be increased when Indium In-111 satumomab pendetide is combined with Aducanumab.
Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Aducanumab.
Trastuzumab The risk or severity of adverse effects can be increased when Trastuzumab is combined with Aducanumab.
Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Aducanumab.
Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Aducanumab.
Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Aducanumab.
Digoxin Immune Fab (Ovine) The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Aducanumab.
Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Aducanumab.
Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Aducanumab.
Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Aducanumab.
Capromab pendetide The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Aducanumab.
Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Aducanumab.
Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Aducanumab.
Natalizumab The risk or severity of adverse effects can be increased when Natalizumab is combined with Aducanumab.
Palivizumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Aducanumab.
Daclizumab The risk or severity of adverse effects can be increased when Daclizumab is combined with Aducanumab.
Bevacizumab The risk or severity of adverse effects can be increased when Bevacizumab is combined with Aducanumab.
Technetium Tc-99m arcitumomab The risk or severity of adverse effects can be increased when Technetium Tc-99m arcitumomab is combined with Aducanumab.
Eculizumab The risk or severity of adverse effects can be increased when Eculizumab is combined with Aducanumab.
Panitumumab The risk or severity of adverse effects can be increased when Panitumumab is combined with Aducanumab.
Ranibizumab The risk or severity of adverse effects can be increased when Ranibizumab is combined with Aducanumab.
Galiximab The risk or severity of adverse effects can be increased when Galiximab is combined with Aducanumab.
Pexelizumab The risk or severity of adverse effects can be increased when Pexelizumab is combined with Aducanumab.
Afelimomab The risk or severity of adverse effects can be increased when Afelimomab is combined with Aducanumab.
Epratuzumab The risk or severity of adverse effects can be increased when Epratuzumab is combined with Aducanumab.
Bectumomab The risk or severity of adverse effects can be increased when Bectumomab is combined with Aducanumab.
Oregovomab The risk or severity of adverse effects can be increased when Oregovomab is combined with Aducanumab.
IGN311 The risk or severity of adverse effects can be increased when IGN311 is combined with Aducanumab.
Adecatumumab The risk or severity of adverse effects can be increased when Adecatumumab is combined with Aducanumab.
Labetuzumab The risk or severity of adverse effects can be increased when Labetuzumab is combined with Aducanumab.
Matuzumab The risk or severity of adverse effects can be increased when Matuzumab is combined with Aducanumab.
Fontolizumab The risk or severity of adverse effects can be increased when Fontolizumab is combined with Aducanumab.
Bavituximab The risk or severity of adverse effects can be increased when Bavituximab is combined with Aducanumab.
CR002 The risk or severity of adverse effects can be increased when CR002 is combined with Aducanumab.
Rozrolimupab The risk or severity of adverse effects can be increased when Rozrolimupab is combined with Aducanumab.
Girentuximab The risk or severity of adverse effects can be increased when Girentuximab is combined with Aducanumab.
Obiltoxaximab The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Aducanumab.
XTL-001 The risk or severity of adverse effects can be increased when XTL-001 is combined with Aducanumab.
NAV 1800 The risk or severity of adverse effects can be increased when NAV 1800 is combined with Aducanumab.
Briakinumab The risk or severity of adverse effects can be increased when Briakinumab is combined with Aducanumab.
Otelixizumab The risk or severity of adverse effects can be increased when Otelixizumab is combined with Aducanumab.
AMG 108 The risk or severity of adverse effects can be increased when AMG 108 is combined with Aducanumab.
Iratumumab The risk or severity of adverse effects can be increased when Iratumumab is combined with Aducanumab.
Enokizumab The risk or severity of adverse effects can be increased when Enokizumab is combined with Aducanumab.
Ramucirumab The risk or severity of adverse effects can be increased when Ramucirumab is combined with Aducanumab.
Farletuzumab The risk or severity of adverse effects can be increased when Farletuzumab is combined with Aducanumab.
Veltuzumab The risk or severity of adverse effects can be increased when Veltuzumab is combined with Aducanumab.
Ustekinumab The risk or severity of adverse effects can be increased when Ustekinumab is combined with Aducanumab.
Trastuzumab emtansine The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Aducanumab.
PRO-542 The risk or severity of adverse effects can be increased when PRO-542 is combined with Aducanumab.
TNX-901 The risk or severity of adverse effects can be increased when TNX-901 is combined with Aducanumab.
Inotuzumab ozogamicin The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Aducanumab.
RI 624 The risk or severity of adverse effects can be increased when RI 624 is combined with Aducanumab.
Stamulumab The risk or severity of adverse effects can be increased when MYO-029 is combined with Aducanumab.
CT-011 The risk or severity of adverse effects can be increased when CT-011 is combined with Aducanumab.
Leronlimab The risk or severity of adverse effects can be increased when Leronlimab is combined with Aducanumab.
Glembatumumab vedotin The risk or severity of adverse effects can be increased when Glembatumumab vedotin is combined with Aducanumab.
Olaratumab The risk or severity of adverse effects can be increased when Olaratumab is combined with Aducanumab.
IPH 2101 The risk or severity of adverse effects can be increased when IPH 2101 is combined with Aducanumab.
TB-402 The risk or severity of adverse effects can be increased when TB-402 is combined with Aducanumab.
Caplacizumab The risk or severity of adverse effects can be increased when Caplacizumab is combined with Aducanumab.
IMC-1C11 The risk or severity of adverse effects can be increased when IMC-1C11 is combined with Aducanumab.
Eldelumab The risk or severity of adverse effects can be increased when Eldelumab is combined with Aducanumab.
Lumiliximab The risk or severity of adverse effects can be increased when Lumiliximab is combined with Aducanumab.

Target Protein

Amyloid-beta precursor protein APP

Referensi & Sumber

Artikel (PubMed)
  • PMID: 29686315
    Arndt JW, Qian F, Smith BA, Quan C, Kilambi KP, Bush MW, Walz T, Pepinsky RB, Bussiere T, Hamann S, Cameron TO, Weinreb PH: Structural and kinetic basis for the selectivity of aducanumab for aggregated forms of amyloid-beta. Sci Rep. 2018 Apr 23;8(1):6412. doi: 10.1038/s41598-018-24501-0.
  • PMID: 33971962
    Cummings J, Aisen P, Lemere C, Atri A, Sabbagh M, Salloway S: Aducanumab produced a clinically meaningful benefit in association with amyloid lowering. Alzheimers Res Ther. 2021 May 10;13(1):98. doi: 10.1186/s13195-021-00838-z.
  • PMID: 31978357
    Schneider L: A resurrection of aducanumab for Alzheimer's disease. Lancet Neurol. 2020 Feb;19(2):111-112. doi: 10.1016/S1474-4422(19)30480-6. Epub 2019 Dec 4.
  • PMID: 29067304
    Ferrero J, Williams L, Stella H, Leitermann K, Mikulskis A, O'Gorman J, Sevigny J: First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2016 Jun 20;2(3):169-176. doi: 10.1016/j.trci.2016.06.002. eCollection 2016 Sep.
  • PMID: 28653357
    Ryman JT, Meibohm B: Pharmacokinetics of Monoclonal Antibodies. CPT Pharmacometrics Syst Pharmacol. 2017 Sep;6(9):576-588. doi: 10.1002/psp4.12224. Epub 2017 Jul 29.

Contoh Produk & Brand

Produk: 2 • International brands: 1
Produk
  • Aduhelm
    Injection, solution • 100 mg/1mL • Intravenous • US • Approved
  • Aduhelm
    Injection, solution • 100 mg/1mL • Intravenous • US • Approved
International Brands
  • Aduhelm — Biogen

Sekuens Gen/Protein (FASTA)

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