Peringatan Keamanan

There is no information regarding the acute toxicity (LD50) of sotatercept. In healthy volunteers, a dose of 1 mg/kg resulted in cases of increased Hgb associated with hypertension, which improved with phlebotomy. In the event of an overdosage, monitor closely for increases in Hgb and blood pressure, and provide supportive care as appropriate. Sotatercept is not dialyzable and there is no known antidote for this drug.L50351

Sotatercept

DB12118

biotech approved investigational

Deskripsi

Sotatercept is an activin signalling inhibitor. It is a homodimeric recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA (ActRIIA) linked to the human IgG1 Fc domain.L50351

On March 26, 2024, sotatercept was approved by the FDA for the treatment of pulmonary arterial hypertension (PAH).L50361 Sotatercept works to resolve the imbalance in activin–growth differentiation factor and BMP pathway signalling observed in PAH.A263481 Sotatercept was approved by the European Commission on August 26, 2024.L51549

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 effective half-life is approximately 24 days.[L50351]
Volume Distribusi The population PK model estimated volume of distribution (%CV) of sotatercept at steady state is approximately 5.3 L (27.3%) in patients with PAH.[L50351]
Klirens (Clearance) Clearance is approximately 0.18 L/day.[L50351]

Absorpsi

Following subcutaneous administration, the absolute bioavailability of sotatercept is approximately 66%. The Tmax is approximately seven days (range: 2-8 days) following multiple subcutaneous administration every four weeks.L50351 Following subcutaneous administration of 0.7 mg/kg sotatercept every three weeks to PAH patients, the steady state geometric mean (%CV) area under the time concentration curve (AUC) is 172 mcg × d/mL (34.2%), and peak concentration (Cmax) is 9.7 mcg/mL (30%). The AUC and Cmax increased proportionally with dose. Steady-state is achieved after approximately 15 weeks following initiation of multiple dosing. The accumulation ratio of sotatercept AUC is approximately 2.2.L50351

Metabolisme

Sotatercept is expected to be metabolized into small peptides by catabolic pathways.L50351

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

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

Target Protein

Activin receptor type-2A ACVR2A
Activin receptor type-1B ACVR1B
Growth/differentiation factor 8 MSTN
Growth/differentiation factor 11 GDF11

Referensi & Sumber

Artikel (PubMed)
  • PMID: 33789009
    Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman A, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, Barnes J, Linde PG, de Oliveira Pena J, Badesch DB: Sotatercept for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2021 Apr 1;384(13):1204-1215. doi: 10.1056/NEJMoa2024277.
  • PMID: 36877098
    Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, McLaughlin VV, Preston IR, Souza R, Waxman AB, Grunig E, Kopec G, Meyer G, Olsson KM, Rosenkranz S, Xu Y, Miller B, Fowler M, Butler J, Koglin J, de Oliveira Pena J, Humbert M: Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2023 Apr 20;388(16):1478-1490. doi: 10.1056/NEJMoa2213558. Epub 2023 Mar 6.
  • PMID: 36041750
    Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman AB, Ghofrani HA, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, de Oliveira Pena J, Badesch DB: Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension. Eur Respir J. 2023 Jan 6;61(1):2201347. doi: 10.1183/13993003.01347-2022. Print 2023 Jan.
  • PMID: 35551212
    Joshi SR, Liu J, Bloom T, Karaca Atabay E, Kuo TH, Lee M, Belcheva E, Spaits M, Grenha R, Maguire MC, Frost JL, Wang K, Briscoe SD, Alexander MJ, Herrin BR, Castonguay R, Pearsall RS, Andre P, Yu PB, Kumar R, Li G: Sotatercept analog suppresses inflammation to reverse experimental pulmonary arterial hypertension. Sci Rep. 2022 May 12;12(1):7803. doi: 10.1038/s41598-022-11435-x.

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