Peringatan Keamanan

There are no available human data on Asfotase Alfa use in pregnant women to inform a drug associated risk. In animal reproduction studies, Asfotase Alfa administered intravenously to pregnant rats and rabbits during the period of organogenesis showed no evidence of fetotoxicity, embryolethality or teratogenicity at doses causing plasma exposures up to 21 and 24 times, respectively, the exposure at the recommended human dose.

Asfotase alfa

DB09105

biotech approved investigational

Deskripsi

Asfotase alfa is a first-in-class bone-targeted enzyme replacement therapy designed to address the underlying cause of hypophosphatasia (HPP)—deficient alkaline phosphatase (ALP). Hypophosphatasia is almost always fatal when severe skeletal disease is obvious at birth. By replacing deficient ALP, treatment with Asfotase Alfa aims to improve the elevated enzyme substrate levels and improve the body's ability to mineralize bone, thereby preventing serious skeletal and systemic patient morbidity and premature death. Asfotase alfa was first approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on July 3, 2015, then approved by the European Medicine Agency (EMA) on August 28, 2015, and was approved by the U.S. Food and Drug Administration (FDA) on October 23, 2015. Asfotase Alfa is marketed under the brand name Strensiq® by Alexion Pharmaceuticals, Inc. The annual average price of Asfotase Alfa treatment is $285,000.

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) Approximately 5 days.
Volume Distribusi -
Klirens (Clearance) -

Absorpsi

Data absorpsi tidak tersedia.

Metabolisme

Data metabolisme tidak tersedia.

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

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

Target Protein

Pyrophosphate

Referensi & Sumber

Artikel (PubMed)
  • PMID: 26893260
    Whyte MP: Hypophosphatasia - aetiology, nosology, pathogenesis, diagnosis and treatment. Nat Rev Endocrinol. 2016 Apr;12(4):233-46. doi: 10.1038/nrendo.2016.14. Epub 2016 Feb 19.
  • PMID: 26529632
    Whyte MP, Rockman-Greenberg C, Ozono K, Riese R, Moseley S, Melian A, Thompson DD, Bishop N, Hofmann C: Asfotase Alfa Treatment Improves Survival for Perinatal and Infantile Hypophosphatasia. J Clin Endocrinol Metab. 2016 Jan;101(1):334-42. doi: 10.1210/jc.2015-3462. Epub 2015 Nov 3.
  • PMID: 22397652
    Whyte MP, Greenberg CR, Salman NJ, Bober MB, McAlister WH, Wenkert D, Van Sickle BJ, Simmons JH, Edgar TS, Bauer ML, Hamdan MA, Bishop N, Lutz RE, McGinn M, Craig S, Moore JN, Taylor JW, Cleveland RH, Cranley WR, Lim R, Thacher TD, Mayhew JE, Downs M, Millan JL, Skrinar AM, Crine P, Landy H: Enzyme-replacement therapy in life-threatening hypophosphatasia. N Engl J Med. 2012 Mar 8;366(10):904-13. doi: 10.1056/NEJMoa1106173.

Contoh Produk & Brand

Produk: 19 • International brands: 0
Produk
  • Strensiq
    Solution • 18 mg/0.45mL • Subcutaneous • US • Approved
  • Strensiq
    Solution • 28 mg/0.7mL • Subcutaneous • US • Approved
  • Strensiq
    Solution • 40 mg/1mL • Subcutaneous • US • Approved
  • Strensiq
    Solution • 80 mg/0.8mL • Subcutaneous • US • Approved
  • Strensiq
    Solution • 40 mg / mL • Subcutaneous • Canada • Approved
  • Strensiq
    Solution • 100 mg / mL • Subcutaneous • Canada • Approved
  • Strensiq
    Solution • 40 mg / mL • Subcutaneous • Canada • Approved
  • Strensiq
    Solution • 40 mg / mL • Subcutaneous • Canada • Approved
Menampilkan 8 dari 19 produk.

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