Peringatan Keamanan

There is no information available regarding the LD50, acute toxicity profile, and overdose of spesolimab.

Spesolimab

DB15626

biotech approved investigational

Deskripsi

Spesolimab is an interleukin-36 (IL-36) receptor antagonist. It is a humanized monoclonal immunoglobulin G1 antibody that was produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. The biosimilar of the drug, spesolimab-sbzo, was first approved by the FDA in September 2022 to treat generalized pustular psoriasis flares. Spesolimab works by inhibiting the inflammatory signaling pathway of IL-36,L43090 which is often overexpressed and aberrantly overactive in generalized pustular psoriasis.A252220, A252225 Spesolimab received recommendations from the EMA's Committee for Medicinal Products for Human Use (CHMP) to be granted marketing authorization in October 2022 and was finally approved in December 2022 for the treatment of flares in adult patients with generalized pustular psoriasis.L43782,L45216

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 is 25.5 (24.4, 26.3) days.[L43090]
Volume Distribusi Based on the population pharmacokinetic analysis, the typical total volume of distribution at steady state was 6.4 L.[L43090]
Klirens (Clearance) In the linear dose range (0.3 to 20 mg/kg), based on the population PK model, spesolimab-sbzo clearance (95% CI) in a typical GPP patient without anti-drug antibodies, weighing 70 kg was 0.184 (0.175, 0.194) L/day.[L43090]

Absorpsi

A population pharmacokinetic model was developed based on data collected from healthy subjects, patients with GPP, and patients with other diseases. After a single intravenous dose of 900 mg of spesolimab, the population PK model-estimated AUC0-? (95% CI) and Cmax (95% CI) in a typical anti-drug antibody (ADA)-negative patient with GPP were 4750 (4510, 4970) mcg x day/mL and 238 (218, 256) mcg/mL, respectively.L43090

Metabolisme

The metabolic pathway of spesolimab-sbzo has not been characterized. As a humanized IgG1 monoclonal antibody, spesolimab-sbzo is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.L43090

Rute Eliminasi

There is no information available.

Interaksi Obat

670 Data
Denosumab The risk or severity of adverse effects can be increased when Denosumab is combined with Spesolimab.
Etanercept The risk or severity of adverse effects can be increased when Etanercept is combined with Spesolimab.
Peginterferon alfa-2a The risk or severity of adverse effects can be increased when Peginterferon alfa-2a is combined with Spesolimab.
Interferon alfa-n1 The risk or severity of adverse effects can be increased when Interferon alfa-n1 is combined with Spesolimab.
Interferon alfa-n3 The risk or severity of adverse effects can be increased when Interferon alfa-n3 is combined with Spesolimab.
Peginterferon alfa-2b The risk or severity of adverse effects can be increased when Peginterferon alfa-2b is combined with Spesolimab.
Anakinra The risk or severity of adverse effects can be increased when Anakinra is combined with Spesolimab.
Interferon gamma-1b The risk or severity of adverse effects can be increased when Interferon gamma-1b is combined with Spesolimab.
Interferon alfa-2a The risk or severity of adverse effects can be increased when Interferon alfa-2a is combined with Spesolimab.
Aldesleukin The risk or severity of adverse effects can be increased when Aldesleukin is combined with Spesolimab.
Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Spesolimab.
Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Spesolimab.
Pegaspargase The risk or severity of adverse effects can be increased when Pegaspargase is combined with Spesolimab.
Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Spesolimab.
Interferon beta-1b The risk or severity of adverse effects can be increased when Interferon beta-1b is combined with Spesolimab.
Interferon alfacon-1 The risk or severity of adverse effects can be increased when Interferon alfacon-1 is combined with Spesolimab.
Trastuzumab The risk or severity of neutropenia can be increased when Trastuzumab is combined with Spesolimab.
Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Spesolimab.
Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Spesolimab.
Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Spesolimab.
Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Spesolimab.
Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Spesolimab.
Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Spesolimab.
Cyclosporine Spesolimab may increase the immunosuppressive activities of Cyclosporine.
Alefacept The risk or severity of adverse effects can be increased when Alefacept is combined with Spesolimab.
Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Spesolimab.
Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Spesolimab.
Interferon alfa-2b The risk or severity of adverse effects can be increased when Interferon alfa-2b is combined with Spesolimab.
Natalizumab The risk or severity of immunosuppression can be increased when Spesolimab is combined with Natalizumab.
Daclizumab The risk or severity of adverse effects can be increased when Daclizumab is combined with Spesolimab.
Phenylalanine The risk or severity of adverse effects can be increased when Phenylalanine is combined with Spesolimab.
Flunisolide The risk or severity of adverse effects can be increased when Flunisolide is combined with Spesolimab.
Bortezomib The risk or severity of adverse effects can be increased when Bortezomib is combined with Spesolimab.
Cladribine Spesolimab may increase the immunosuppressive activities of Cladribine.
Carmustine The risk or severity of adverse effects can be increased when Carmustine is combined with Spesolimab.
Amsacrine The risk or severity of adverse effects can be increased when Amsacrine is combined with Spesolimab.
Bleomycin The risk or severity of adverse effects can be increased when Bleomycin is combined with Spesolimab.
Chlorambucil The risk or severity of adverse effects can be increased when Chlorambucil is combined with Spesolimab.
Raltitrexed The risk or severity of adverse effects can be increased when Raltitrexed is combined with Spesolimab.
Mitomycin The risk or severity of adverse effects can be increased when Mitomycin is combined with Spesolimab.
Bexarotene The risk or severity of adverse effects can be increased when Bexarotene is combined with Spesolimab.
Vindesine The risk or severity of adverse effects can be increased when Vindesine is combined with Spesolimab.
Floxuridine The risk or severity of adverse effects can be increased when Floxuridine is combined with Spesolimab.
Fluorometholone The risk or severity of adverse effects can be increased when Fluorometholone is combined with Spesolimab.
Indomethacin The risk or severity of adverse effects can be increased when Indomethacin is combined with Spesolimab.
Tioguanine The risk or severity of adverse effects can be increased when Tioguanine is combined with Spesolimab.
Vinorelbine The risk or severity of adverse effects can be increased when Vinorelbine is combined with Spesolimab.
Dexrazoxane The risk or severity of adverse effects can be increased when Dexrazoxane is combined with Spesolimab.
Beclomethasone dipropionate The risk or severity of adverse effects can be increased when Beclomethasone dipropionate is combined with Spesolimab.
Sorafenib The risk or severity of adverse effects can be increased when Sorafenib is combined with Spesolimab.
Streptozocin The risk or severity of adverse effects can be increased when Streptozocin is combined with Spesolimab.
Trifluridine The risk or severity of adverse effects can be increased when Trifluridine is combined with Spesolimab.
Gemcitabine The risk or severity of adverse effects can be increased when Gemcitabine is combined with Spesolimab.
Betamethasone The risk or severity of adverse effects can be increased when Betamethasone is combined with Spesolimab.
Teniposide The risk or severity of adverse effects can be increased when Teniposide is combined with Spesolimab.
Epirubicin The risk or severity of adverse effects can be increased when Epirubicin is combined with Spesolimab.
Chloramphenicol The risk or severity of adverse effects can be increased when Chloramphenicol is combined with Spesolimab.
Lenalidomide The risk or severity of adverse effects can be increased when Lenalidomide is combined with Spesolimab.
Altretamine The risk or severity of adverse effects can be increased when Altretamine is combined with Spesolimab.
Zidovudine The risk or severity of adverse effects can be increased when Zidovudine is combined with Spesolimab.
Cisplatin The risk or severity of adverse effects can be increased when Cisplatin is combined with Spesolimab.
Oxaliplatin The risk or severity of adverse effects can be increased when Oxaliplatin is combined with Spesolimab.
Cyclophosphamide The risk or severity of adverse effects can be increased when Cyclophosphamide is combined with Spesolimab.
Vincristine The risk or severity of adverse effects can be increased when Vincristine is combined with Spesolimab.
Fluorouracil The risk or severity of adverse effects can be increased when Fluorouracil is combined with Spesolimab.
Desoximetasone The risk or severity of adverse effects can be increased when Desoximetasone is combined with Spesolimab.
Propylthiouracil The risk or severity of adverse effects can be increased when Propylthiouracil is combined with Spesolimab.
Pentostatin The risk or severity of adverse effects can be increased when Pentostatin is combined with Spesolimab.
Methotrexate The risk or severity of adverse effects can be increased when Methotrexate is combined with Spesolimab.
Carbamazepine The risk or severity of adverse effects can be increased when Carbamazepine is combined with Spesolimab.
Vinblastine The risk or severity of adverse effects can be increased when Vinblastine is combined with Spesolimab.
Fluticasone propionate The risk or severity of adverse effects can be increased when Fluticasone propionate is combined with Spesolimab.
Fluocinolone acetonide The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with Spesolimab.
Linezolid The risk or severity of adverse effects can be increased when Linezolid is combined with Spesolimab.
Imatinib The risk or severity of adverse effects can be increased when Imatinib is combined with Spesolimab.
Triamcinolone The risk or severity of adverse effects can be increased when Triamcinolone is combined with Spesolimab.
Clofarabine The risk or severity of adverse effects can be increased when Clofarabine is combined with Spesolimab.
Prednisone The risk or severity of adverse effects can be increased when Prednisone is combined with Spesolimab.
Pemetrexed The risk or severity of adverse effects can be increased when Pemetrexed is combined with Spesolimab.
Fludrocortisone The risk or severity of adverse effects can be increased when Fludrocortisone is combined with Spesolimab.
Mycophenolate mofetil The risk or severity of adverse effects can be increased when Mycophenolate mofetil is combined with Spesolimab.
Daunorubicin The risk or severity of adverse effects can be increased when Daunorubicin is combined with Spesolimab.
Irinotecan The risk or severity of adverse effects can be increased when Irinotecan is combined with Spesolimab.
Methimazole The risk or severity of adverse effects can be increased when Methimazole is combined with Spesolimab.
Mometasone The risk or severity of adverse effects can be increased when Mometasone is combined with Spesolimab.
Etoposide The risk or severity of adverse effects can be increased when Etoposide is combined with Spesolimab.
Sulfasalazine The risk or severity of adverse effects can be increased when Sulfasalazine is combined with Spesolimab.
Dacarbazine The risk or severity of adverse effects can be increased when Dacarbazine is combined with Spesolimab.
Temozolomide The risk or severity of adverse effects can be increased when Temozolomide is combined with Spesolimab.
Penicillamine The risk or severity of adverse effects can be increased when Penicillamine is combined with Spesolimab.
Prednisolone The risk or severity of adverse effects can be increased when Prednisolone is combined with Spesolimab.
Tacrolimus Tacrolimus may increase the immunosuppressive activities of Spesolimab.
Sirolimus The risk or severity of adverse effects can be increased when Sirolimus is combined with Spesolimab.
Mechlorethamine The risk or severity of adverse effects can be increased when Mechlorethamine is combined with Spesolimab.
Azacitidine The risk or severity of adverse effects can be increased when Azacitidine is combined with Spesolimab.
Carboplatin The risk or severity of adverse effects can be increased when Carboplatin is combined with Spesolimab.
Methylprednisolone The risk or severity of adverse effects can be increased when Methylprednisolone is combined with Spesolimab.
Dactinomycin The risk or severity of adverse effects can be increased when Dactinomycin is combined with Spesolimab.
Cytarabine The risk or severity of adverse effects can be increased when Cytarabine is combined with Spesolimab.
Azathioprine The risk or severity of adverse effects can be increased when Azathioprine is combined with Spesolimab.

Target Protein

Interleukin-1 receptor-like 2 IL1RL2

Referensi & Sumber

Artikel (PubMed)
  • PMID: 33919434
    Iznardo H, Puig L: Exploring the Role of IL-36 Cytokines as a New Target in Psoriatic Disease. Int J Mol Sci. 2021 Apr 21;22(9). pii: ijms22094344. doi: 10.3390/ijms22094344.
  • PMID: 33661508
    Mrowietz U, Burden AD, Pinter A, Reich K, Schakel K, Baum P, Datsenko Y, Deng H, Padula SJ, Thoma C, Bissonnette R: Spesolimab, an Anti-Interleukin-36 Receptor Antibody, in Patients with Palmoplantar Pustulosis: Results of a Phase IIa, Multicenter, Double-Blind, Randomized, Placebo-Controlled Pilot Study. Dermatol Ther (Heidelb). 2021 Apr;11(2):571-585. doi: 10.1007/s13555-021-00504-0. Epub 2021 Mar 4.
  • PMID: 34626330
    Menter A, Van Voorhees AS, Hsu S: Pustular Psoriasis: A Narrative Review of Recent Developments in Pathophysiology and Therapeutic Options. Dermatol Ther (Heidelb). 2021 Dec;11(6):1917-1929. doi: 10.1007/s13555-021-00612-x. Epub 2021 Oct 9.

Contoh Produk & Brand

Produk: 6 • International brands: 0
Produk
  • Spevigo
    Injection • 150 mg/1mL • Intravenous • US • Approved
  • Spevigo
    Solution • 150 mg / mL • Subcutaneous • Canada • Approved
  • Spevigo
    Injection • 60 mg/1mL • Intravenous • US • Approved
  • Spevigo
    Solution • 60 mg / mL • Intravenous • Canada • Approved
  • Spevigo
    Injection, solution, concentrate • 450 mg • Intravenous • EU • Approved
  • Spevigo
    Injection, solution • 150 mg • Subcutaneous • EU • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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