Peringatan Keamanan

There are no significant differences in pharmacokinetics cross age, sex, race, progression of osteoporosis, past history of alendronic acid prescribing, and all stages of renal impairmentL9554. However, patients with severe renal impairment or who are on dialysis are at an increased risk of hypocalcemiaL9554. A patient's weight will affect their level of romosozumab exposureL9554.

Romosozumab has not been shown to be associated with carcinogenicity or impairment of fertility, and is not expected to be mutagenicL9554.

Romosozumab is not indicated in pregnancy, lactation, or pedatric patientsL9554. Romosozumab is associated with skeletal defects in the offspring of rats given romosozumab and is detected in the excreted milkL9554.

Romosozumab is currently undergoing post marketing surveillance to ensure the risk of major adverse cardiac events is not being underestimatedL5924. There is currently an expected hazard ratio of 1.30 compared to current treatments for osteoporosis, though hip and vertebral fractures may have an equal impact on overall quality of lifeL5924.

Romosozumab

DB11866

biotech approved investigational

Deskripsi

Romosozumab is a humanized monoclonal antibody indicated for the treatment of osteoperosis in postmenopausal women at high risk of fracture and patients who have failed in other treatments or are intolerant to other osteoperosis therapiesL9554. Romosozumab prevents bone resorption and induces the formation of bone though it is associated with an increased risk of cardiac death, heart attack, and stroke in one studyL5921,L5924. In a comparison study of post menopausal women with osteoporosis and a past fracture, romosozumab for 12 months followed by alendronic acid for 12 months was superior to alendronic acid alone for 24 monthsA177071. Romosozumab also demonstrates a faster and larger increase in bone density than teriparatideA177050. Romosozumab is marketed in the United States by Amgen under the brand name EvinityL5921. Romosozumab was granted FDA approval on April 9,2019L5921.

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) 12.8 days[L9554].
Volume Distribusi 3.92L[L9554].
Klirens (Clearance) 0.38mL/hr/kg[L9554].

Absorpsi

Romosozumab reaches peak concentration within 2 to 7 days with a median time of 5 daysL9554. Subcutaneous bioavailability is 50 to 70%A177056,A177062.

Metabolisme

The metabolism of romosozumab has not been clarified, however it is expected to be degraded into small peptides and amino acids like other protein drugsL9554.

Rute Eliminasi

Monoclonal antibodies are eventually phagocytosed and broken down to smaller peptides and amino acidsL9554 which are eliminated in a similar fashion to other proteinsA31470,A177074.

Interaksi Makanan

2 Data
  • 1. Administer calcium supplement. Ensure adequate calcium supplementation.
  • 2. Administer vitamin supplements. Ensure adequate vitamin D supplementation.

Interaksi Obat

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

Target Protein

Sclerostin SOST

Referensi & Sumber

Artikel (PubMed)
  • PMID: 20593411
    Padhi D, Jang G, Stouch B, Fang L, Posvar E: Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody. J Bone Miner Res. 2011 Jan;26(1):19-26. doi: 10.1002/jbmr.173.
  • PMID: 29942362
    Solling ASK, Harslof T, Langdahl B: The clinical potential of romosozumab for the prevention of fractures in postmenopausal women with osteoporosis. Ther Adv Musculoskelet Dis. 2018 Jun;10(5-6):105-115. doi: 10.1177/1759720X18775936. Epub 2018 Jun 7.
  • PMID: 28892457
    Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A: Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
  • PMID: 28755782
    Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP, Daizadeh NS, Dokoupilova E, Engelke K, Finkelstein JS, Genant HK, Goemaere S, Hyldstrup L, Jodar-Gimeno E, Keaveny TM, Kendler D, Lakatos P, Maddox J, Malouf J, Massari FE, Molina JF, Ulla MR, Grauer A: Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017 Sep 30;390(10102):1585-1594. doi: 10.1016/S0140-6736(17)31613-6. Epub 2017 Jul 26.
  • 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.
  • PMID: 15389672
    Lobo ED, Hansen RJ, Balthasar JP: Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004 Nov;93(11):2645-68. doi: 10.1002/jps.20178.

Contoh Produk & Brand

Produk: 7 • International brands: 0
Produk
  • Evenity
    Injection, solution • 105 mg • Subcutaneous • EU • Approved
  • Evenity
    Solution • 105 mg / 1.17 mL • Subcutaneous • Canada • Approved
  • Evenity
    Injection, solution • 105 mg/1.17mL • Subcutaneous • US • Approved
  • Evenity
    Injection, solution • 105 mg/1.17mL • Subcutaneous • US • Approved
  • Evenity
    Injection, solution • 105 mg • Subcutaneous • EU • Approved
  • Evenity
    Injection, solution • 105 mg • Subcutaneous • EU • Approved
  • Evenity
    Injection, solution • 105 mg • Subcutaneous • EU • Approved

Sekuens Gen/Protein (FASTA)

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