Peringatan Keamanan

There is limited information about the overdose profile and LD50 of durvalumab. In case of overdose, the patient should be closely monitored for drug-related adverse events, and appropriate symptomatic treatment should be immediately initiated.L12627 Based on the findings of clinical studies, durvalumab had a risk of causing immune-mediated reactions, such as pneumonitis, hepatitis, and other serious infections. In animal reproductive studies, durvalumab caused fetal harm and this fetal toxicity may be possible in humans.L12621

Durvalumab

DB11714

biotech approved investigational

Deskripsi

Durvalumab is a human immunoglobulin G1 kappa (IgG1?) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment.A192789 Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture,L12621 durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells.L12621,L12627

Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 A192807 for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma.L12621 In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ? 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy.A192789,L12627 On March 27, 2020, durvalumab was approved by the FDA for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).L12624

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) Based on baseline clearance rate, the geometric mean terminal half-life is 18 days.[L12621,L12627]
Volume Distribusi In patients receiving the dose range of ? 10 mg/kg every 2 weeks, the mean steady state volume of distribution (Vss) was 5.64 L.[L12621,L12627]
Klirens (Clearance) Clearance of durvalumab decreases over time, resulting in a mean steady-state clearance (CLss) of 8.2 mL/h following 365 days of initial drug administration. However, the decrease in CLss is not considered clinically relevant.[L12621,L12627]

Absorpsi

Durvalumab exhibits a dose-proportional pharmacokinetic profile that is non-linear at doses <3 mg/kg and linear at doses ?3 mg/kg. Following intravenous administration in patients with solid tumours, the steady-state plasma concentrations were reached at approximately 16 weeks.L12621

Metabolisme

Durvalumab is subject to protein catabolism via reticuloedothelial system or target-mediated disposition.L12627

Rute Eliminasi

Durvalumab is primarily eliminated by protein catabolism.L12627

Interaksi Obat

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

Target Protein

Programmed cell death 1 ligand 1 CD274
Programmed cell death protein 1 PDCD1

Referensi & Sumber

Artikel (PubMed)
  • PMID: 20608753
    Keizer RJ, Huitema AD, Schellens JH, Beijnen JH: Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010 Aug;49(8):493-507. doi: 10.2165/11531280-000000000-00000.
  • PMID: 31686616
    Botticella A, Mezquita L, Le Pechoux C, Planchard D: Durvalumab for stage III non-small-cell lung cancer patients: clinical evidence and real-world experience. Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619885530. doi: 10.1177/1753466619885530.
  • PMID: 28717238
    Lee HT, Lee JY, Lim H, Lee SH, Moon YJ, Pyo HJ, Ryu SE, Shin W, Heo YS: Molecular mechanism of PD-1/PD-L1 blockade via anti-PD-L1 antibodies atezolizumab and durvalumab. Sci Rep. 2017 Jul 17;7(1):5532. doi: 10.1038/s41598-017-06002-8.
  • PMID: 29416316
    Faiena I, Cummings AL, Crosetti AM, Pantuck AJ, Chamie K, Drakaki A: Durvalumab: an investigational anti-PD-L1 monoclonal antibody for the treatment of urothelial carcinoma. Drug Des Devel Ther. 2018 Jan 23;12:209-215. doi: 10.2147/DDDT.S141491. eCollection 2018.
  • PMID: 28643244
    Syed YY: Durvalumab: First Global Approval. Drugs. 2017 Aug;77(12):1369-1376. doi: 10.1007/s40265-017-0782-5.
  • PMID: 28414296
    Ni X, Song Q, Cassady K, Deng R, Jin H, Zhang M, Dong H, Forman S, Martin PJ, Chen YZ, Wang J, Zeng D: PD-L1 interacts with CD80 to regulate graft-versus-leukemia activity of donor CD8+ T cells. J Clin Invest. 2017 May 1;127(5):1960-1977. doi: 10.1172/JCI91138. Epub 2017 Apr 17.

Contoh Produk & Brand

Produk: 5 • International brands: 0
Produk
  • Imfinzi
    Injection, solution, concentrate • 50 mg/ml • Intravenous • EU • Approved
  • Imfinzi
    Injection, solution, concentrate • 50 mg/ml • Intravenous • EU • Approved
  • Imfinzi
    Solution • 50 mg / mL • Intravenous • Canada • Approved
  • Imfinzi
    Injection, solution • 120 mg/2.4mL • Intravenous • US • Approved
  • Imfinzi
    Injection, solution • 500 mg/10mL • Intravenous • US • Approved

Sekuens Gen/Protein (FASTA)

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