Peringatan Keamanan

Ropeginterferon alfa-2b overdose may present with influenza-like symptoms or other adverse reactions. As there is no known antidote, symptomatic and supportive care should be administered in the result of an overdose. Ropeginterferon alfa-2b is not mutagenic in standard assays but has not been tested for carcinogenic potential.L39170

Ropeginterferon alfa-2b

DB15119

biotech approved investigational

Deskripsi

Polycythemia vera (PV) is the most common Philadelphia chromosome-negative myeloproliferative neoplasm (MPN), characterized by increased hematocrit and platelet/leukocyte counts, an increased risk for hemorrhage and thromboembolic events, and a long-term propensity for myelofibrosis and leukemia.A242000, A242005 Interferon alfa-2b has been used for decades to treat PV but requires frequent dosing and is not tolerated by all patients.A242005 Ropeginterferon alfa-2b is a next-generation mono-pegylated type I interferon produced from proline-IFN-?-2b in Escherichia coli that has high tolerability and a long half-life.A242015, L39170 Ropeginterferon alfa-2b has shown efficacy in PV in in vitro and in vivo models and clinical trials.A242010, A242015

Ropeginterferon alfa-2b was approved by the FDA on November 12, 2021, and is currently marketed under the trademark BESREMi by PharmaEssentia Corporation.L39170

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) Ropeginterferon alfa-2b administered to polycythemia vera patients over a dose range of 100-500 ?g has a half-life of approximately seven days.[L39170]
Volume Distribusi Ropeginterferon alfa-2b has an estimated geometric mean apparent volume of distribution (%CV) of 4.8 L (21%) in polycythemia vera patients.[L39170]
Klirens (Clearance) Ropeginterferon alfa-2b administered to polycythemia vera patients over a dose range of 100-500 ?g has a clearance of 1.7-2.5 L/h.[L39170]

Absorpsi

In patients with polycythemia vera on a two-week dosing interval, the estimated steady-state Cmin was 1.4-12 ng/mL, Cmax was 4.4-31 ng/mL, and AUC was 1011-7809 ng\*h/mL. The estimated geometric mean (%CV) of the absorption rate constant if 0.12 day-1 (27%) and the estimated steady-state Cmax occurs between 2-5 days.L39170

Metabolisme

Ropeginterferon alfa-2b is expected to be catabolized by various proteolytic enzymes.L15811

Rute Eliminasi

Ropeginterferon alfa-2b is expected to be eliminated predominantly by hepatic metabolism.L15811

Interaksi Obat

1356 Data
Zolmitriptan The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Zolmitriptan.
Caffeine The metabolism of Caffeine can be decreased when combined with Ropeginterferon alfa-2b.
Dyphylline The metabolism of Dyphylline can be decreased when combined with Ropeginterferon alfa-2b.
Pentoxifylline The metabolism of Pentoxifylline can be decreased when combined with Ropeginterferon alfa-2b.
Mercaptopurine The risk or severity of adverse effects can be increased when Mercaptopurine is combined with Ropeginterferon alfa-2b.
Oxtriphylline The metabolism of Oxtriphylline can be decreased when combined with Ropeginterferon alfa-2b.
Theobromine The metabolism of Theobromine can be decreased when combined with Ropeginterferon alfa-2b.
Fenethylline The metabolism of Fenethylline can be decreased when combined with Ropeginterferon alfa-2b.
8-azaguanine The metabolism of 8-azaguanine can be decreased when combined with Ropeginterferon alfa-2b.
7,9-Dimethylguanine The metabolism of 7,9-Dimethylguanine can be decreased when combined with Ropeginterferon alfa-2b.
Xanthine The metabolism of Xanthine can be decreased when combined with Ropeginterferon alfa-2b.
7-Deazaguanine The metabolism of 7-Deazaguanine can be decreased when combined with Ropeginterferon alfa-2b.
Guanine The metabolism of Guanine can be decreased when combined with Ropeginterferon alfa-2b.
9-Methylguanine The metabolism of 9-Methylguanine can be decreased when combined with Ropeginterferon alfa-2b.
Peldesine The metabolism of Peldesine can be decreased when combined with Ropeginterferon alfa-2b.
Hypoxanthine The metabolism of Hypoxanthine can be decreased when combined with Ropeginterferon alfa-2b.
9-Deazaguanine The metabolism of 9-Deazaguanine can be decreased when combined with Ropeginterferon alfa-2b.
Propentofylline The metabolism of Propentofylline can be decreased when combined with Ropeginterferon alfa-2b.
Valomaciclovir The metabolism of Valomaciclovir can be decreased when combined with Ropeginterferon alfa-2b.
3-isobutyl-1-methyl-7H-xanthine The metabolism of 3-isobutyl-1-methyl-7H-xanthine can be decreased when combined with Ropeginterferon alfa-2b.
Uric acid The metabolism of Uric acid can be decreased when combined with Ropeginterferon alfa-2b.
Doxofylline The metabolism of Doxofylline can be decreased when combined with Ropeginterferon alfa-2b.
6-O-benzylguanine The metabolism of 6-O-benzylguanine can be decreased when combined with Ropeginterferon alfa-2b.
Lisofylline The metabolism of Lisofylline can be decreased when combined with Ropeginterferon alfa-2b.
Lobucavir The metabolism of Lobucavir can be decreased when combined with Ropeginterferon alfa-2b.
Cafedrine The metabolism of Cafedrine can be decreased when combined with Ropeginterferon alfa-2b.
Theodrenaline The metabolism of Theodrenaline can be decreased when combined with Ropeginterferon alfa-2b.
Bamifylline The metabolism of Bamifylline can be decreased when combined with Ropeginterferon alfa-2b.
Proxyphylline The metabolism of Proxyphylline can be decreased when combined with Ropeginterferon alfa-2b.
Acefylline The metabolism of Acefylline can be decreased when combined with Ropeginterferon alfa-2b.
Etamiphylline The metabolism of Etamiphylline can be decreased when combined with Ropeginterferon alfa-2b.
Pentifylline The metabolism of Pentifylline can be decreased when combined with Ropeginterferon alfa-2b.
Bufylline The metabolism of Bufylline can be decreased when combined with Ropeginterferon alfa-2b.
Bromotheophylline The metabolism of Bromotheophylline can be decreased when combined with Ropeginterferon alfa-2b.
Furafylline The metabolism of Furafylline can be decreased when combined with Ropeginterferon alfa-2b.
8-chlorotheophylline The metabolism of 8-chlorotheophylline can be decreased when combined with Ropeginterferon alfa-2b.
PCS-499 The metabolism of PCS-499 can be decreased when combined with Ropeginterferon alfa-2b.
Amphetamine The metabolism of Amphetamine can be decreased when combined with Ropeginterferon alfa-2b.
Cevimeline The metabolism of Cevimeline can be decreased when combined with Ropeginterferon alfa-2b.
Esmolol The metabolism of Esmolol can be decreased when combined with Ropeginterferon alfa-2b.
Tramadol The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Tramadol.
Sildenafil The metabolism of Sildenafil can be decreased when combined with Ropeginterferon alfa-2b.
Ticlopidine The metabolism of Ticlopidine can be decreased when combined with Ropeginterferon alfa-2b.
Citalopram The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Citalopram.
Eletriptan The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Eletriptan.
Nevirapine The metabolism of Nevirapine can be decreased when combined with Ropeginterferon alfa-2b.
Ranolazine The metabolism of Ranolazine can be decreased when combined with Ropeginterferon alfa-2b.
Benzatropine The metabolism of Benzatropine can be decreased when combined with Ropeginterferon alfa-2b.
Phenytoin The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Phenytoin.
Metoprolol The metabolism of Metoprolol can be decreased when combined with Ropeginterferon alfa-2b.
Venlafaxine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Venlafaxine.
Atomoxetine The metabolism of Atomoxetine can be decreased when combined with Ropeginterferon alfa-2b.
Bupivacaine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Bupivacaine.
Gefitinib The metabolism of Gefitinib can be decreased when combined with Ropeginterferon alfa-2b.
Codeine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Codeine.
Methadone The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Methadone.
Atenolol The metabolism of Atenolol can be decreased when combined with Ropeginterferon alfa-2b.
Terfenadine The metabolism of Terfenadine can be decreased when combined with Ropeginterferon alfa-2b.
Diltiazem The metabolism of Diltiazem can be decreased when combined with Ropeginterferon alfa-2b.
Timolol The metabolism of Timolol can be decreased when combined with Ropeginterferon alfa-2b.
Palonosetron The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Palonosetron.
Progesterone The metabolism of Progesterone can be decreased when combined with Ropeginterferon alfa-2b.
Remoxipride The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Remoxipride.
Prochlorperazine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Prochlorperazine.
Duloxetine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Duloxetine.
Celecoxib The metabolism of Celecoxib can be decreased when combined with Ropeginterferon alfa-2b.
Buspirone The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Buspirone.
Darifenacin The metabolism of Darifenacin can be decreased when combined with Ropeginterferon alfa-2b.
Oxycodone The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Oxycodone.
Ritonavir The metabolism of Ritonavir can be decreased when combined with Ropeginterferon alfa-2b.
Dextromethorphan The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Dextromethorphan.
Lisuride The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Lisuride.
Doxazosin The metabolism of Doxazosin can be decreased when combined with Ropeginterferon alfa-2b.
Piperazine The metabolism of Piperazine can be decreased when combined with Ropeginterferon alfa-2b.
Labetalol The metabolism of Labetalol can be decreased when combined with Ropeginterferon alfa-2b.
Chloroquine The metabolism of Chloroquine can be decreased when combined with Ropeginterferon alfa-2b.
Simvastatin The metabolism of Simvastatin can be decreased when combined with Ropeginterferon alfa-2b.
Dextropropoxyphene The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Dextropropoxyphene.
Trazodone The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Trazodone.
Galantamine The metabolism of Galantamine can be decreased when combined with Ropeginterferon alfa-2b.
Thioridazine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Thioridazine.
Nicergoline The metabolism of Nicergoline can be decreased when combined with Ropeginterferon alfa-2b.
Amprenavir The metabolism of Amprenavir can be decreased when combined with Ropeginterferon alfa-2b.
Delavirdine The metabolism of Delavirdine can be decreased when combined with Ropeginterferon alfa-2b.
Tamsulosin The metabolism of Tamsulosin can be decreased when combined with Ropeginterferon alfa-2b.
Nateglinide The metabolism of Nateglinide can be decreased when combined with Ropeginterferon alfa-2b.
Risperidone The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Risperidone.
Meclizine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Meclizine.
Pentamidine The metabolism of Pentamidine can be decreased when combined with Ropeginterferon alfa-2b.
Epinastine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Epinastine.
Dolasetron The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Dolasetron.
Minaprine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Minaprine.
Donepezil The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Donepezil.
Alprenolol The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Alprenolol.
Phenformin The metabolism of Phenformin can be decreased when combined with Ropeginterferon alfa-2b.
Almotriptan The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Almotriptan.
Buprenorphine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Buprenorphine.
Tipranavir The metabolism of Tipranavir can be decreased when combined with Ropeginterferon alfa-2b.
Mesoridazine The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Mesoridazine.
Hydrocodone The risk or severity of neuropsychiatric effects can be increased when Ropeginterferon alfa-2b is combined with Hydrocodone.

Target Protein

Interferon alpha/beta receptor (IFNAR) IFNAR1

Referensi & Sumber

Artikel (PubMed)
  • PMID: 32366208
    Bartalucci N, Guglielmelli P, Vannucchi AM: Polycythemia vera: the current status of preclinical models and therapeutic targets. Expert Opin Ther Targets. 2020 Jul;24(7):615-628. doi: 10.1080/14728222.2020.1762176. Epub 2020 May 18.
  • PMID: 32708474
    How J, Hobbs G: Use of Interferon Alfa in the Treatment of Myeloproliferative Neoplasms: Perspectives and Review of the Literature. Cancers (Basel). 2020 Jul 18;12(7). pii: cancers12071954. doi: 10.3390/cancers12071954.
  • PMID: 30287855
    Verger E, Soret-Dulphy J, Maslah N, Roy L, Rey J, Ghrieb Z, Kralovics R, Gisslinger H, Grohmann-Izay B, Klade C, Chomienne C, Giraudier S, Cassinat B, Kiladjian JJ: Ropeginterferon alpha-2b targets JAK2V617F-positive polycythemia vera cells in vitro and in vivo. Blood Cancer J. 2018 Oct 4;8(10):94. doi: 10.1038/s41408-018-0133-0.
  • PMID: 26261238
    Gisslinger H, Zagrijtschuk O, Buxhofer-Ausch V, Thaler J, Schloegl E, Gastl GA, Wolf D, Kralovics R, Gisslinger B, Strecker K, Egle A, Melchardt T, Burgstaller S, Willenbacher E, Schalling M, Them NC, Kadlecova P, Klade C, Greil R: Ropeginterferon alfa-2b, a novel IFNalpha-2b, induces high response rates with low toxicity in patients with polycythemia vera. Blood. 2015 Oct 8;126(15):1762-9. doi: 10.1182/blood-2015-04-637280. Epub 2015 Aug 10.

Contoh Produk & Brand

Produk: 4 • International brands: 0
Produk
  • BESREMi
    Injection • 500 ug/1mL • Subcutaneous • US • Approved
  • Besremi
    Injection, solution • 250 ?g/0.5ml • Subcutaneous • EU • Approved
  • Besremi
    Injection, solution • 500 ?g/0.5ml • Subcutaneous • EU • Approved
  • Besremi
    Injection, solution • 250 ?g/0.5ml • Subcutaneous • EU • Approved

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