Peringatan Keamanan

The toxicity of Crysvita can be classified into several categories L2347:

Ectopic mineralisation: Clinically manifested by nephrocalcinosis, has been seen in patients with XLH treated with oral phosphorous and vitamin D analogues. These drugs should be stopped at least 1 week before starting burosumab treatment L2347.

Monitoring for signs and symptoms of nephrocalcinosis, e.g. by renal ultrasonography, is recommended at the beginning of treatment and at intervals of every 6 months for the first 12 months of treatment, and yearly thereafter. Regular monitoring of plasma alkaline phosphatases, Calcium, PTH, and creatinine is advised at 6 months intervals(every 3 months for children 1- 2 years) or as indicated L2347.

Monitoring of urine calcium and phosphate is suggested every 3 months.

Hyperphosphatemia

Fasting serum phosphate level must be followed due to the risk of hyperphosphatemia while taking this drug. To decrease the risk for ectopic mineralization, it is advised that fasting serum phosphate is aimed to be in the lower end of the normal reference range for any given age. Dose interruption and/or dose reduction may be required. Regular measurement of postprandial serum phosphate is advised L2347.

Serum parathyroid hormone increases

Increases in serum parathyroid hormone have been measured in some XLH patients while undergoing treatment with burosumab. Regular measurement of serum parathyroid hormone is recommended L2347.

Injection site reactions

Administration of burosumab, like other injections, can lead to local injection site reactions. Administration of this drug should cease in any patient experiencing severe injection site reactions and appropriate medical therapy administered L2347.

Hypersensitivity

Burosumab should be discontinued if serious hypersensitivity reactions occur and appropriate medical treatment should be provided L2347.

Reproductive toxicity/pregnancy

There are no or limited amount of data available from the use of burosumab in pregnant women. Studies in animals have demonstrated reproductive toxicity. Burosumab use is not advised during pregnancy and in women of childbearing potential/age currently not using contraception L2347.

Burosumab

DB14012

biotech approved investigational

Deskripsi

Burosumab (KRN23) is an entirely human monoclonal IgG1 antibody that binds excess fibroblast growth factor 23 (FGF23) and has been successfully tested in clinical trials in children with X-linked hypophosphatemic rickets A32593.

The U.S. Food and Drug Administration approved Crysvita (burosumab) in April 2018. This is the first drug approved to treat adults and children ages 1 year and older with X-linked hypophosphatemia (XLH), which is a rare, inherited form of rickets. X-linked hypophosphatemia causes low circulating levels of phosphorus in the blood. It causes impaired bone growth and development in children and adolescents and issues with bone mineralization throughout a patient’s life L2346.

XLH is a serious disease which affects about 3,000 children and 12,000 adults in the United States. Most children with XLH suffer from bowed or bent legs, short stature, bone pain and severe dental pain. Some adults with this condition suffer from persistent, unrelenting discomfort and complications, such as joint pain, impaired mobility, tooth abscesses and hearing loss L2346.

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) About 19 days [L2347].
Volume Distribusi Burosumab is comprised solely of amino acids and carbohydrates as a native immunoglobulin and is not likeluy to be eliminated by hepatic metabolic mechanisms. The metabolism of burosumab and elimination are expected to follow the immunoglobulin clearance pathways, which results in its degradation to smaller peptides and amino acids [L2347].
Klirens (Clearance) The clearance of burosumab depends on weight and is estimated to be 0.290 L/day and 0.136 L/day in a typical adult (70 kg) and pediatric (30 kg) XLH patient, respectively [L2347].

Absorpsi

Burosumab absorption after subcutaneous injection sites into to the blood circulation is nearly complete. Following the subcutaneous route of administration, the time to reach maximum serum concentrations (Tmax) of burosumab is estimated at 5-10 days. The peak serum concentration (Cmax) and area under the concentration-time curve (AUC) of serum burosumab is proportional to the dose, over the dose range of 0.1-2.0 mg/kg L2347.

Metabolisme

Burosumab is composed solely of amino acids and carbohydrates as a native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms. Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids L2347.

Rute Eliminasi

Because of its molecular size, burosumab is not likely to be directly excreted L2347.

Interaksi Obat

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

Target Protein

Fibroblast growth factor 23 FGF23

Referensi & Sumber

Artikel (PubMed)
  • PMID: 29545670
    Kutilek S: Burosumab: A new drug to treat hypophosphatemic rickets. Sudan J Paediatr. 2017;17(2):71-73. doi: 10.24911/SJP.2017.2.11.
  • PMID: 29381780
    Kinoshita Y, Fukumoto S: X-linked hypophosphatemia and FGF23-related hypophosphatemic diseases -Prospect for new treatment. Endocr Rev. 2018 Jan 26. pii: 4825438. doi: 10.1210/er.2017-00220.

Contoh Produk & Brand

Produk: 12 • International brands: 0
Produk
  • Crysvita
    Injection • 10 mg/1mL • Subcutaneous • US • Approved
  • Crysvita
    Injection • 20 mg/1mL • Subcutaneous • US • Approved
  • Crysvita
    Injection • 30 mg/1mL • Subcutaneous • US • Approved
  • Crysvita
    Injection, solution • 10 mg/ml • Subcutaneous • EU • Approved
  • Crysvita
    Injection, solution • 20 mg/ml • Subcutaneous • EU • Approved
  • Crysvita
    Injection, solution • 30 mg/ml • Subcutaneous • EU • Approved
  • Crysvita
    Injection • 10 mg/1mL • Subcutaneous • US • Approved
  • Crysvita
    Injection • 30 mg/1mL • Subcutaneous • US • Approved
Menampilkan 8 dari 12 produk.

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