Peringatan Keamanan

Overdose from epoetin alfa include signs and symptoms associated with an excessive and/or rapid increase in hemoglobin concentration, including cardiovascular events. Patients with suspected or known overdose should be monitored closely for cardiovascular events and hematologic abnormalities. Polycythemia should be managed acutely with phlebotomy, as clinically indicated. Following resolution of the overdose, reintroduction of epoetin alfa therapy should be accompanied by close monitoring for evidence of rapid increases in hemoglobin concentration (>1 gm/dL per 14 days). In patients with an excessive hematopoietic response, reduce the dose in accordance with the recommendations described in the drug label FDA Label.

Erythropoietin

DB00016

biotech approved

Deskripsi

Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow FDA Label. Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures FDA Label. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market L2784. The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product A7504. Epoetin alfa formulations can be administered intravenously or subcutaneously.

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) **Healthy volunteers:** The half life is approximately 4 hours in healthy volunteers receiving an intravenous injection [F85]. A half-life of approximately 6 hours has been reported in children [F85]. **Adult and paediatric patients with CRF:** The elimination half life following intravenous administration ranges from 4 to 13 hours, which is about 20% longer in CRF patients than that in healthy subjects. The half life is reported to be similar between adult patients receiving or not receiving dialysis [FDA Label]. **Cancer patients receiving cyclic chemotherapy:** Following subcutaneous administration, the average half life is 40 hours with range of 16 to 67 hours [FDA Label].
Volume Distribusi In healthy volunteers, the volume of distribution of intravenous epoetin alfa was generally similar to the plasma volume (range of 40–63.80 mL/kg), indicating limited extravascular distribution [A33080, A33076].
Klirens (Clearance) **Healthy volunteers: ** In male volunteers receiving intravenous epoetin alfa, the total body clearance was approximately 8.12 ± 1.00 mL/h/kg [A33076]. **Cancer patients receiving cyclic chemotherapy:** The average clearance was approximately 20.2 ± 15.9 mL/h/kg after 150 Units/kg three times per week (TIW) subcutaneous (SC) dosing [FDA Label]. The patients receiving a 40,000 Units SC weekly dosing regimen display a lower clearance (9.2 ± 4.7 mL/h/kg) [FDA Label].

Absorpsi

The time to reach peak concentration is slower via the subcutaneous route than the intravenous route which ranges from 20 to 25 hours, and the peak is always well below the peak achieved using the intravenous route (5–10% of those seen with IV administration).A33080 The bioavailability of subcutaneous injectable erythropoietin is much lower than that of the intravenously administered product and is approximately 20-40%.A33080 Adult and paediatric patients with CRF: Following subcutaneous administration, the peak plasma levels are achieved within 5 to 24 hours FDA Label. Cancer patients receiving cyclic chemotherapy: The average time to reach peak plasma concentration was approximately 13.3 ± 12.4 hours after 150 Units/kg three times per week (TIW) subcutaneous (SC) dosing. The Cmax is expected be 3- to 7- fold higher and the Tmax is expected to be 2- to 3-fold longer in patients receiving a 40,000 Units SC weekly dosing regimen FDA Label.

Metabolisme

Binding of erythropoietin and epoetin alfa to EPO-R leads to cellular internalization, which involves the degradation of the ligand. Erythropoietin and epoetin alfa may also be degraded by the reticuloendothelial scavenging pathway or lymphatic system A33080.

Rute Eliminasi

Erythropoietin and epoetin alfa are cleared via uptake and degradation via the EPO-R-expressing cells, and may also involve other cellular pathways in the interstitium, probably via cells in the reticuloendothelial scavenging pathway or lymphatic system A33080. Only a small amount of unchanged epoetin alfa is found in the urine F86.

Interaksi Makanan

1 Data
  • 1. Administer iron supplement. When initiating an erythropoiesis-stimulating agent, evaluate iron stores and start iron supplementation if indicated. Most patients with chronic kidney disease require iron supplementation while taking an erythropoiesis-stimulating agent.

Interaksi Obat

612 Data
Cyclophosphamide The risk or severity of pulmonary toxicity can be increased when Erythropoietin is combined with Cyclophosphamide.
Nandrolone phenpropionate The therapeutic efficacy of Erythropoietin can be increased when used in combination with Nandrolone phenpropionate.
Nandrolone decanoate The therapeutic efficacy of Erythropoietin can be increased when used in combination with Nandrolone decanoate.
Nandrolone The therapeutic efficacy of Erythropoietin can be increased when used in combination with Nandrolone.
Ramipril The serum concentration of Erythropoietin can be decreased when it is combined with Ramipril.
Fosinopril The serum concentration of Erythropoietin can be decreased when it is combined with Fosinopril.
Trandolapril The serum concentration of Erythropoietin can be decreased when it is combined with Trandolapril.
Benazepril The serum concentration of Erythropoietin can be decreased when it is combined with Benazepril.
Enalapril The serum concentration of Erythropoietin can be decreased when it is combined with Enalapril.
Moexipril The serum concentration of Erythropoietin can be decreased when it is combined with Moexipril.
Lisinopril The serum concentration of Erythropoietin can be decreased when it is combined with Lisinopril.
Perindopril The serum concentration of Erythropoietin can be decreased when it is combined with Perindopril.
Quinapril The serum concentration of Erythropoietin can be decreased when it is combined with Quinapril.
Omapatrilat The serum concentration of Erythropoietin can be decreased when it is combined with Omapatrilat.
Rescinnamine The serum concentration of Erythropoietin can be decreased when it is combined with Rescinnamine.
Captopril The serum concentration of Erythropoietin can be decreased when it is combined with Captopril.
Cilazapril The serum concentration of Erythropoietin can be decreased when it is combined with Cilazapril.
Spirapril The serum concentration of Erythropoietin can be decreased when it is combined with Spirapril.
Temocapril The serum concentration of Erythropoietin can be decreased when it is combined with Temocapril.
Enalaprilat The serum concentration of Erythropoietin can be decreased when it is combined with Enalaprilat.
Imidapril The serum concentration of Erythropoietin can be decreased when it is combined with Imidapril.
Zofenopril The serum concentration of Erythropoietin can be decreased when it is combined with Zofenopril.
Delapril The serum concentration of Erythropoietin can be decreased when it is combined with Delapril.
Benazeprilat The serum concentration of Erythropoietin can be decreased when it is combined with Benazeprilat.
Fosinoprilat The serum concentration of Erythropoietin can be decreased when it is combined with Fosinoprilat.
Ramiprilat The serum concentration of Erythropoietin can be decreased when it is combined with Ramiprilat.
Trandolaprilat The serum concentration of Erythropoietin can be decreased when it is combined with Trandolaprilat.
Moexiprilat The serum concentration of Erythropoietin can be decreased when it is combined with Moexiprilat.
Perindoprilat The serum concentration of Erythropoietin can be decreased when it is combined with Perindoprilat.
Quinaprilat The serum concentration of Erythropoietin can be decreased when it is combined with Quinaprilat.
Cilazaprilat The serum concentration of Erythropoietin can be decreased when it is combined with Cilazaprilat.
Vindesine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Vindesine.
Vinorelbine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Vinorelbine.
Vincristine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Vincristine.
Vinblastine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Vinblastine.
Vintafolide The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Vintafolide.
Vinflunine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Vinflunine.
Vincamine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Vincamine.
Lenalidomide The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Lenalidomide.
Thalidomide The risk or severity of thromboembolism can be increased when Thalidomide is combined with Erythropoietin.
Pomalidomide The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Pomalidomide.
Cetuximab The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Cetuximab.
Denileukin diftitox The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Denileukin diftitox.
Leuprolide The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Leuprolide.
Peginterferon alfa-2a The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Peginterferon alfa-2a.
Goserelin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Goserelin.
Asparaginase Escherichia coli The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Asparaginase Escherichia coli.
Aldesleukin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Aldesleukin.
Gemtuzumab ozogamicin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Gemtuzumab ozogamicin.
Pegaspargase The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Pegaspargase.
Trastuzumab The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Trastuzumab.
Rituximab The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Rituximab.
Tositumomab The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Tositumomab.
Alemtuzumab The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Alemtuzumab.
Octreotide The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Octreotide.
Interferon alfa-2b The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Interferon alfa-2b.
Bevacizumab The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Bevacizumab.
Masoprocol The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Masoprocol.
Bortezomib The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Bortezomib.
Pipobroman The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Pipobroman.
Cladribine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Cladribine.
Cabergoline The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Cabergoline.
Anagrelide The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Anagrelide.
Carmustine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Carmustine.
Chlorotrianisene The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Chlorotrianisene.
Amsacrine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Amsacrine.
Pamidronic acid The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Pamidronic acid.
Bleomycin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Bleomycin.
Chlorambucil The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Chlorambucil.
Raltitrexed The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Raltitrexed.
Mitomycin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Mitomycin.
Bexarotene The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Bexarotene.
Valproic acid The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Valproic acid.
Gefitinib The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Gefitinib.
Floxuridine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Floxuridine.
Megestrol acetate The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Megestrol acetate.
Tioguanine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Tioguanine.
Aminoglutethimide The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Aminoglutethimide.
Valrubicin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Valrubicin.
Sorafenib The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Sorafenib.
Streptozocin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Streptozocin.
Trifluridine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Trifluridine.
Gemcitabine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Gemcitabine.
Teniposide The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Teniposide.
Epirubicin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Epirubicin.
Altretamine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Altretamine.
Flutamide The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Flutamide.
Cisplatin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Cisplatin.
Alitretinoin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Alitretinoin.
Oxaliplatin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Oxaliplatin.
Erlotinib The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Erlotinib.
Toremifene The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Toremifene.
Fluorouracil The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Fluorouracil.
Pentostatin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Pentostatin.
Methotrexate The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Methotrexate.
Medroxyprogesterone acetate The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Medroxyprogesterone acetate.
Imatinib The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Imatinib.
Clofarabine The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Clofarabine.
Prednisone The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Prednisone.
Pemetrexed The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Pemetrexed.

Target Protein

Erythropoietin receptor EPOR

Referensi & Sumber

Artikel (PubMed)
  • PMID: 20886265
    Brinks V, Hawe A, Basmeleh AH, Joachin-Rodriguez L, Haselberg R, Somsen GW, Jiskoot W, Schellekens H: Quality of original and biosimilar epoetin products. Pharm Res. 2011 Feb;28(2):386-93. doi: 10.1007/s11095-010-0288-2. Epub 2010 Oct 1.
  • PMID: 1752115
    Halstenson CE, Macres M, Katz SA, Schnieders JR, Watanabe M, Sobota JT, Abraham PA: Comparative pharmacokinetics and pharmacodynamics of epoetin alfa and epoetin beta. Clin Pharmacol Ther. 1991 Dec;50(6):702-12.
  • PMID: 14671225
    Weiss MJ: New insights into erythropoietin and epoetin alfa: mechanisms of action, target tissues, and clinical applications. Oncologist. 2003;8 Suppl 3:18-29.
  • PMID: 18922615
    Elliott S, Pham E, Macdougall IC: Erythropoietins: a common mechanism of action. Exp Hematol. 2008 Dec;36(12):1573-84. doi: 10.1016/j.exphem.2008.08.003. Epub 2008 Oct 14.

Contoh Produk & Brand

Produk: 438 • International brands: 6
Produk
  • Abseamed
    Injection, solution • 1000 IU/0.5ml • Intravenous; Subcutaneous • EU • Approved
  • Abseamed
    Injection, solution • 1000 IU/0.5ml • Intravenous; Subcutaneous • EU • Approved
  • Abseamed
    Injection, solution • 2000 IU/1.0ml • Intravenous; Subcutaneous • EU • Approved
  • Abseamed
    Injection, solution • 2000 IU/1.0ml • Intravenous; Subcutaneous • EU • Approved
  • Abseamed
    Injection, solution • 3000 IU/0.3ml • Intravenous; Subcutaneous • EU • Approved
  • Abseamed
    Injection, solution • 3000 IU/0.3ml • Intravenous; Subcutaneous • EU • Approved
  • Abseamed
    Injection, solution • 4000 IU/0.4ml • Intravenous; Subcutaneous • EU • Approved
  • Abseamed
    Injection, solution • 4000 IU/0.4ml • Intravenous; Subcutaneous • EU • Approved
Menampilkan 8 dari 438 produk.
International Brands
  • Epobel — Nobel Ilac Pazarlama ve Sanayii Ltd. STI., Turkey
  • Epocept — Lupin pharma
  • Epofit — Intas pharma
  • Epogin — Chugai
  • Eqralys — Hemofarm AD
  • Nanokine — Nanogen Pharmaceutical biotechnology, Vietnam)

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
© 2025 Digital Pharmacy Research - Universitas Esa Unggul