Peringatan Keamanan

There are no reported effects in male or female reproductive organs after an 8- or 13-week repeat-dose toxicity study in animals.FDA label

Emapalumab

DB14724

biotech approved investigational

Deskripsi

Emapalumab, also known as NI-0501, is a fully human monoclonal antibody that targets interferon gamma. Emapalumab development was sponsored by NovImmune SA, further developed by Sobi and FDA approved on November 20, 2018.A38676, L4840 The approval of emapalumab was followed by the designation of orphan drug, priority review and breakthrough therapy.L4840 As well, emapalumab was given the status of PRIME by the EMA.L4845

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) Emapalumab elimination half-life is of approximately 22 days in healthy subjects and it ranges between 2.5-18.9 in HLH patients.[FDA label]
Volume Distribusi The central and peripheral volume of distribution of emapalumab are 4.2 and 5.6 L, respectively.[FDA label]
Klirens (Clearance) Emapalumab clearance is reported to be 0.007 L/h in healthy subjects. This clearance rate can vary in HLH patients depending on the production of interferon-gamma.[FDA label]

Absorpsi

In clinical pharmacokinetic studies, a dose of 1 mg/kg of emapalumab was administered which generated a peak concentration at steady state of 44 mcg/ml and a median steady-state concentration of 25 mcg/ml. The serum concentration of emapalumab increases proportionally between a dose of 1-3 mg/kg and the steady-state is attained by the 7th infusion.FDA label

Metabolisme

Monoclonal antibodies are thought to be internalized in endothelial cells bound to Fc receptor and rescued from metabolism by recycling. Later, they are degraded in the reticuloendothelial system to small peptides and amino acids which can be used for de-novo protein synthesis.A31470

Rute Eliminasi

Emapalumab presents a target-mediated clearance that is dependent on interferon-gamma production.FDA label

Interaksi Obat

1334 Data
Denosumab The risk or severity of adverse effects can be increased when Denosumab is combined with Emapalumab.
Etanercept The risk or severity of adverse effects can be increased when Etanercept is combined with Emapalumab.
Peginterferon alfa-2a The risk or severity of adverse effects can be increased when Peginterferon alfa-2a is combined with Emapalumab.
Interferon alfa-n1 The risk or severity of adverse effects can be increased when Interferon alfa-n1 is combined with Emapalumab.
Interferon alfa-n3 The risk or severity of adverse effects can be increased when Interferon alfa-n3 is combined with Emapalumab.
Peginterferon alfa-2b The risk or severity of adverse effects can be increased when Peginterferon alfa-2b is combined with Emapalumab.
Anakinra The risk or severity of adverse effects can be increased when Anakinra is combined with Emapalumab.
Interferon gamma-1b The risk or severity of adverse effects can be increased when Interferon gamma-1b is combined with Emapalumab.
Interferon alfa-2a The risk or severity of adverse effects can be increased when Interferon alfa-2a is combined with Emapalumab.
Aldesleukin The risk or severity of adverse effects can be increased when Aldesleukin is combined with Emapalumab.
Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Emapalumab.
Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Emapalumab.
Pegaspargase The risk or severity of adverse effects can be increased when Pegaspargase is combined with Emapalumab.
Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Emapalumab.
Interferon beta-1b The risk or severity of adverse effects can be increased when Interferon beta-1b is combined with Emapalumab.
Interferon alfacon-1 The risk or severity of adverse effects can be increased when Interferon alfacon-1 is combined with Emapalumab.
Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Emapalumab.
Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Emapalumab.
Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Emapalumab.
Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Emapalumab.
Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Emapalumab.
Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Emapalumab.
Alefacept The risk or severity of adverse effects can be increased when Alefacept is combined with Emapalumab.
Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Emapalumab.
Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Emapalumab.
Interferon alfa-2b The risk or severity of adverse effects can be increased when Interferon alfa-2b is combined with Emapalumab.
Daclizumab The risk or severity of adverse effects can be increased when Daclizumab is combined with Emapalumab.
Phenylalanine The risk or severity of adverse effects can be increased when Phenylalanine is combined with Emapalumab.
Cladribine Emapalumab may increase the immunosuppressive activities of Cladribine.
Amsacrine The risk or severity of adverse effects can be increased when Amsacrine is combined with Emapalumab.
Bleomycin The risk or severity of adverse effects can be increased when Bleomycin is combined with Emapalumab.
Chlorambucil The risk or severity of adverse effects can be increased when Chlorambucil is combined with Emapalumab.
Raltitrexed The risk or severity of adverse effects can be increased when Raltitrexed is combined with Emapalumab.
Mitomycin The risk or severity of adverse effects can be increased when Mitomycin is combined with Emapalumab.
Floxuridine The risk or severity of adverse effects can be increased when Floxuridine is combined with Emapalumab.
Tioguanine The risk or severity of adverse effects can be increased when Tioguanine is combined with Emapalumab.
Dexrazoxane The risk or severity of adverse effects can be increased when Dexrazoxane is combined with Emapalumab.
Streptozocin The risk or severity of adverse effects can be increased when Streptozocin is combined with Emapalumab.
Trifluridine The risk or severity of adverse effects can be increased when Trifluridine is combined with Emapalumab.
Gemcitabine The risk or severity of adverse effects can be increased when Gemcitabine is combined with Emapalumab.
Epirubicin The risk or severity of adverse effects can be increased when Epirubicin is combined with Emapalumab.
Chloramphenicol The risk or severity of adverse effects can be increased when Chloramphenicol is combined with Emapalumab.
Lenalidomide The risk or severity of adverse effects can be increased when Lenalidomide is combined with Emapalumab.
Altretamine The risk or severity of adverse effects can be increased when Altretamine is combined with Emapalumab.
Cisplatin The risk or severity of adverse effects can be increased when Cisplatin is combined with Emapalumab.
Oxaliplatin The risk or severity of adverse effects can be increased when Oxaliplatin is combined with Emapalumab.
Propylthiouracil The risk or severity of adverse effects can be increased when Propylthiouracil is combined with Emapalumab.
Pentostatin The risk or severity of adverse effects can be increased when Pentostatin is combined with Emapalumab.
Linezolid The risk or severity of adverse effects can be increased when Linezolid is combined with Emapalumab.
Clofarabine The risk or severity of adverse effects can be increased when Clofarabine is combined with Emapalumab.
Methimazole The risk or severity of adverse effects can be increased when Methimazole is combined with Emapalumab.
Sulfasalazine The risk or severity of adverse effects can be increased when Sulfasalazine is combined with Emapalumab.
Temozolomide The risk or severity of adverse effects can be increased when Temozolomide is combined with Emapalumab.
Penicillamine The risk or severity of adverse effects can be increased when Penicillamine is combined with Emapalumab.
Mechlorethamine The risk or severity of adverse effects can be increased when Mechlorethamine is combined with Emapalumab.
Azacitidine The risk or severity of adverse effects can be increased when Azacitidine is combined with Emapalumab.
Carboplatin The risk or severity of adverse effects can be increased when Carboplatin is combined with Emapalumab.
Dactinomycin The risk or severity of adverse effects can be increased when Dactinomycin is combined with Emapalumab.
Hydroxyurea The risk or severity of adverse effects can be increased when Hydroxyurea is combined with Emapalumab.
Mycophenolic acid The risk or severity of adverse effects can be increased when Mycophenolic acid is combined with Emapalumab.
Topotecan The risk or severity of adverse effects can be increased when Topotecan is combined with Emapalumab.
Mercaptopurine The risk or severity of adverse effects can be increased when Mercaptopurine is combined with Emapalumab.
Melphalan The risk or severity of adverse effects can be increased when Melphalan is combined with Emapalumab.
Fludarabine The risk or severity of adverse effects can be increased when Fludarabine is combined with Emapalumab.
Flucytosine The risk or severity of adverse effects can be increased when Flucytosine is combined with Emapalumab.
Procarbazine The risk or severity of adverse effects can be increased when Procarbazine is combined with Emapalumab.
Arsenic trioxide The risk or severity of adverse effects can be increased when Arsenic trioxide is combined with Emapalumab.
Mitoxantrone The risk or severity of adverse effects can be increased when Mitoxantrone is combined with Emapalumab.
Lomustine The risk or severity of adverse effects can be increased when Lomustine is combined with Emapalumab.
Eculizumab The risk or severity of adverse effects can be increased when Eculizumab is combined with Emapalumab.
Decitabine The risk or severity of adverse effects can be increased when Decitabine is combined with Emapalumab.
Nelarabine The risk or severity of adverse effects can be increased when Nelarabine is combined with Emapalumab.
Abatacept The risk or severity of adverse effects can be increased when Abatacept is combined with Emapalumab.
Stepronin The risk or severity of adverse effects can be increased when Stepronin is combined with Emapalumab.
Castanospermine The risk or severity of adverse effects can be increased when Castanospermine is combined with Emapalumab.
Vorinostat The risk or severity of adverse effects can be increased when Vorinostat is combined with Emapalumab.
2-Methoxyethanol The risk or severity of adverse effects can be increased when 2-Methoxyethanol is combined with Emapalumab.
Brequinar The risk or severity of adverse effects can be increased when Brequinar is combined with Emapalumab.
Afelimomab The risk or severity of adverse effects can be increased when Afelimomab is combined with Emapalumab.
Interferon alfa The risk or severity of adverse effects can be increased when Interferon alfa is combined with Emapalumab.
Glatiramer The risk or severity of adverse effects can be increased when Glatiramer is combined with Emapalumab.
Briakinumab The risk or severity of adverse effects can be increased when Briakinumab is combined with Emapalumab.
Human interferon omega-1 The risk or severity of adverse effects can be increased when Human interferon omega-1 is combined with Emapalumab.
Canakinumab The risk or severity of adverse effects can be increased when Canakinumab is combined with Emapalumab.
Tocilizumab The risk or severity of adverse effects can be increased when Tocilizumab is combined with Emapalumab.
Rilonacept The risk or severity of adverse effects can be increased when Rilonacept is combined with Emapalumab.
Mepolizumab The risk or severity of adverse effects can be increased when Mepolizumab is combined with Emapalumab.
Abetimus The risk or severity of adverse effects can be increased when Abetimus is combined with Emapalumab.
Golimumab The risk or severity of adverse effects can be increased when Golimumab is combined with Emapalumab.
Belatacept The risk or severity of adverse effects can be increased when Belatacept is combined with Emapalumab.
Pralatrexate The risk or severity of adverse effects can be increased when Pralatrexate is combined with Emapalumab.
Wortmannin The risk or severity of adverse effects can be increased when Wortmannin is combined with Emapalumab.
Eribulin The risk or severity of adverse effects can be increased when Eribulin is combined with Emapalumab.
Belimumab The risk or severity of adverse effects can be increased when Belimumab is combined with Emapalumab.
Teriflunomide The risk or severity of adverse effects can be increased when Teriflunomide is combined with Emapalumab.
Carfilzomib The risk or severity of adverse effects can be increased when Carfilzomib is combined with Emapalumab.
Certolizumab pegol The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Emapalumab.
Dimethyl fumarate The risk or severity of adverse effects can be increased when Dimethyl fumarate is combined with Emapalumab.
Obinutuzumab The risk or severity of adverse effects can be increased when Obinutuzumab is combined with Emapalumab.
Secukinumab The risk or severity of adverse effects can be increased when Secukinumab is combined with Emapalumab.

Target Protein

Interferon gamma IFNG

Referensi & Sumber

Artikel (PubMed)
  • PMID: 29300693
    Kaplon H, Reichert JM: Antibodies to watch in 2018. MAbs. 2018 Feb/Mar;10(2):183-203. doi: 10.1080/19420862.2018.1415671. Epub 2018 Jan 16.
  • PMID: 26610523
    Avau A, Matthys P: Therapeutic Potential of Interferon-gamma and Its Antagonists in Autoinflammation: Lessons from Murine Models of Systemic Juvenile Idiopathic Arthritis and Macrophage Activation Syndrome. Pharmaceuticals (Basel). 2015 Nov 25;8(4):793-815. doi: 10.3390/ph8040793.
  • PMID: 27336613
    Zuber B, Rudstrom K, Ehrnfelt C, Ahlborg N: Epitope Mapping of Neutralizing Monoclonal Antibodies to Human Interferon-gamma Using Human-Bovine Interferon-gamma Chimeras. J Interferon Cytokine Res. 2016 Sep;36(9):542-51. doi: 10.1089/jir.2016.0017. Epub 2016 Jun 23.
  • PMID: 16478695
    Tabrizi MA, Tseng CM, Roskos LK: Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today. 2006 Jan;11(1-2):81-8. doi: 10.1016/S1359-6446(05)03638-X.

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