Peringatan Keamanan

Toxicity information regarding ansuvimab is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as hypotension, tachycardia, tachypnea, pyrexia, chills, diarrhea, vomiting, and hypersensitivity reactions including infusion-related reactions. Symptomatic and supportive measures are recommended.L29560

Ansuvimab

DB16385

biotech approved investigational

Deskripsi

Infection with pathogenic filoviruses, such as Zaire ebolavirus (Ebola virus, EBOV), can cause severe hemorrhagic fever in humans, resulting in frequent outbreaks with case fatality rates as high as 90%.A225933, A225938 Virtually all steps of the EBOV lifecycle have been targeted for therapeutic development. However, to date, the most successful method appears to be the development of monoclonal antibodies (mAbs) against the GP1,2 surface glycoprotein, as evidenced by the previously approved INMAZEB™ (REGN-EB3, a cocktail of atoltivimab, odesivimab, and maftivimab), the now approved ansuvimab, and ZMapp, which remains in clinical trials.A225933 Ansuvimab, formerly mAb114, is a fully human IgG1 mAb derived from a survivor of the 1995 Kikwit EBOV outbreak 11 years after infection, which displays strong glycan-independent binding to a conserved region of the GP1,2 protein that is responsible for interacting with the host NPC1 protein to mediate EBOV endolysosomal escape, a key step in the EBOV lifecycle.A225943, A225948, A226035 A randomized, controlled trial of four investigational therapies for Ebola virus disease (EVD) in the Democratic Republic of Congo during a previous outbreak that began in 2018 compared ansuvimab, REGN-EB3, ZMapp, and remdesivir, a nucleoside analogue designed to inhibit viral replication, showed ansuvimab and REGN-EB3 to be superior, with improved patient survival and faster viral clearance rates.A207646

Ansuvimab received FDA approval on December 21, 2020, and is currently marketed as Ebanga by Ridgeback Biotherapeutics, LP. Ansuvimab is just the second FDA-approved treatment for EVD.L29560

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 half-life of ansuvimab following a single administration of 5 mg/kg, 25 mg/kg, or 50 mg/kg was 20.1 ± 6.9, 26.7 ± 3.8, and 23.6 (no calculated standard deviation available) days, respectively.[A226035]
Volume Distribusi The steady-state volume of distribution in healthy volunteers administered a single dose of 5 mg/kg, 25 mg/kg, or 50 mg/kg ansuvimab was 5.08 ± 0.88, 3.93 ± 0.50, and 4.16 ± 0.74 L, respectively.[A226035]
Klirens (Clearance) The clearance of ansuvimab following a single administration of 5 mg/kg, 25 mg/kg, or 50 mg/kg was 199 ± 45, 108 ± 21, and 115 ± 15 mL/day, respectively.[A226035]

Absorpsi

The absorption of ansuvimab was evaluated in 18 healthy volunteers aged 18-60 years in an open-label phase 1 study. Ansuvimab administered at 5 mg/kg produced a Cmax of 198.45 ± 45.15 ?g/mL, a Tmax of 3.21 ± 1.56 h, and an AUC0-28d of 1480 ± 304 ?g\*day/mL. The corresponding values for 25 mg/kg were: Cmax of 829.38 ± 237.40 ?g/mL, Tmax of 2.99 ± 2.16 h, and AUC0-28d of 8586 ± 900 ?g\*day/mL, while the corresponding values for 50 mg/kg were: Cmax of 1961.21 ± 339.83 ?g/mL, Tmax of 2.75 ± 1.63 h, and AUC0-28d of 18588 ± 3627 ?g\*day/mL.A226035 Overall, the pharmacokinetic profile of ansuvimab is consistent with other IgG1 monoclonal antibodies.L29560

Metabolisme

Ansuvimab is expected to be degraded by various proteolytic and catabolic processes within the body, like other monoclonal antibodies.

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

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

Target Protein

Envelope glycoprotein GP

Referensi & Sumber

Synthesis reference: Corti D, Misasi J, Mulangu S, Stanley DA, Kanekiyo M, Wollen S, Ploquin A, Doria-Rose NA, Staupe RP, Bailey M, Shi W, Choe M, Marcus H, Thompson EA, Cagigi A, Silacci C, Fernandez-Rodriguez B, Perez L, Sallusto F, Vanzetta F, Agatic G, Cameroni E, Kisalu N, Gordon I, Ledgerwood JE, Mascola JR, Graham BS, Muyembe-Tamfun JJ, Trefry JC, Lanzavecchia A, Sullivan NJ: Protective monotherapy against lethal Ebola virus infection by a potently neutralizing antibody. Science. 2016 Mar 18;351(6279):1339-42. doi: 10.1126/science.aad5224.
Artikel (PubMed)
  • PMID: 31341272
    Hoenen T, Groseth A, Feldmann H: Therapeutic strategies to target the Ebola virus life cycle. Nat Rev Microbiol. 2019 Oct;17(10):593-606. doi: 10.1038/s41579-019-0233-2. Epub 2019 Jul 24.
  • PMID: 31909070
    Inungu J, Iheduru-Anderson K, Odio OJ: Recurrent Ebolavirus disease in the Democratic Republic of Congo: update and challenges. AIMS Public Health. 2019 Nov 20;6(4):502-513. doi: 10.3934/publichealth.2019.4.502. eCollection 2019.
  • PMID: 26917592
    Misasi J, Gilman MS, Kanekiyo M, Gui M, Cagigi A, Mulangu S, Corti D, Ledgerwood JE, Lanzavecchia A, Cunningham J, Muyembe-Tamfun JJ, Baxa U, Graham BS, Xiang Y, Sullivan NJ, McLellan JS: Structural and molecular basis for Ebola virus neutralization by protective human antibodies. Science. 2016 Mar 18;351(6279):1343-6. doi: 10.1126/science.aad6117. Epub 2016 Feb 25.
  • PMID: 26917593
    Corti D, Misasi J, Mulangu S, Stanley DA, Kanekiyo M, Wollen S, Ploquin A, Doria-Rose NA, Staupe RP, Bailey M, Shi W, Choe M, Marcus H, Thompson EA, Cagigi A, Silacci C, Fernandez-Rodriguez B, Perez L, Sallusto F, Vanzetta F, Agatic G, Cameroni E, Kisalu N, Gordon I, Ledgerwood JE, Mascola JR, Graham BS, Muyembe-Tamfun JJ, Trefry JC, Lanzavecchia A, Sullivan NJ: Protective monotherapy against lethal Ebola virus infection by a potently neutralizing antibody. Science. 2016 Mar 18;351(6279):1339-42. doi: 10.1126/science.aad5224. Epub 2016 Feb 25.
  • PMID: 30686586
    Gaudinski MR, Coates EE, Novik L, Widge A, Houser KV, Burch E, Holman LA, Gordon IJ, Chen GL, Carter C, Nason M, Sitar S, Yamshchikov G, Berkowitz N, Andrews C, Vazquez S, Laurencot C, Misasi J, Arnold F, Carlton K, Lawlor H, Gall J, Bailer RT, McDermott A, Capparelli E, Koup RA, Mascola JR, Graham BS, Sullivan NJ, Ledgerwood JE: Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): an open-label phase 1 study. Lancet. 2019 Mar 2;393(10174):889-898. doi: 10.1016/S0140-6736(19)30036-4. Epub 2019 Jan 24.
  • PMID: 31774950
    Mulangu S, Dodd LE, Davey RT Jr, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, Nzolo D, Tshomba Oloma A, Ibanda A, Ali R, Coulibaly S, Levine AC, Grais R, Diaz J, Lane HC, Muyembe-Tamfum JJ, Sivahera B, Camara M, Kojan R, Walker R, Dighero-Kemp B, Cao H, Mukumbayi P, Mbala-Kingebeni P, Ahuka S, Albert S, Bonnett T, Crozier I, Duvenhage M, Proffitt C, Teitelbaum M, Moench T, Aboulhab J, Barrett K, Cahill K, Cone K, Eckes R, Hensley L, Herpin B, Higgs E, Ledgerwood J, Pierson J, Smolskis M, Sow Y, Tierney J, Sivapalasingam S, Holman W, Gettinger N, Vallee D, Nordwall J: A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics. N Engl J Med. 2019 Dec 12;381(24):2293-2303. doi: 10.1056/NEJMoa1910993. Epub 2019 Nov 27.

Contoh Produk & Brand

Produk: 1 • International brands: 1
Produk
  • Ebanga
    Injection, powder, lyophilized, for solution; Kit • 400 mg/8mL • Intravenous • US • Approved
International Brands
  • Ebanga

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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