Peringatan Keamanan

No overdose information is available, however, renal toxicity has been seen with the administration of antisense oligomers, sometimes resulting in fatal glomerulonephritis.L10755,L10758 In the case of an overdose, it is advisable to provide supportive care and monitor renal function. LD50 information is currently unavailable for this drug.

Golodirsen

DB15593

biotech approved

Deskripsi

Golodirsen is a morpholino antisense oligomer designed to treat about 8% of patients with Duchenne Muscular Dystrophy (DMD). This is an X-linked condition leading to progressive muscle degeneration that begins in early childhood, rendering many patients wheelchair-bound by age 12. Often, patients succumb to this condition by age 30 or younger due to cardiac and respiratory complications.A188580,T756 A similar drug used in the treatment of other types of DMD is eteplirsen, which targets a different genetic mutation.L10773

Golodirsen was developed by Sarepta Therapeutics and granted accelerated FDA approval on December 12, 2019 due to the urgent need for this drug in patients suffering from a certain form of DMD. Continued approval of this drug will depend on the results of clinical trials that confirm its clinical benefit.L10755,L10758 Golodirsen was initially rejected for FDA approval over concerns about its potential renal toxicity, however, clinical trials did not show significant toxicity.L10755

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) In a pharmacokinetic study, the elimination half-life of golodirsen was 3.4 hours with a standard deviation of 0.6 hours.[L10758]
Volume Distribusi The volume of distribution at steady-state is approximately 668 mL/kg at 30 mL/kg dose of golodirsen.[L10758]
Klirens (Clearance) This drug is rapidly cleared from the systemic circulation, like other members of its drug class.[A188595,A188598] The total clearance of eteplirsen, a drug from the same class, was 339 mL/h/kg after regular doses of 30 mg/kg/week. The clearance of golodirsen is likely similar.[A188598]

Absorpsi

This drug is given by the intravenous route, and is likely rapidly absorbed into the circulation.L10758 Pharmacokinetic studies for eteplirsen determined that Cmax occur within 1.1 to 1.2 hours of infusion initiation, after the administration of doses ranging from 0.5 mg/kg/week to 50 mg/kg/week.A188598

Metabolisme

Golodirsen is not extensively metabolized. There were no metabolites detected in plasma or urine during a pharmacokinetic study.L10758

Rute Eliminasi

Golodirsen is excreted primarily as unchanged drug in the urine.L10758

Interaksi Obat

727 Data
Cyclosporine Cyclosporine may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Icosapent Icosapent may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefotiam Cefotiam may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Mesalazine Mesalazine may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefmenoxime Cefmenoxime may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefmetazole Cefmetazole may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Pamidronic acid Pamidronic acid may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Tenofovir disoproxil Tenofovir disoproxil may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Indomethacin Indomethacin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cidofovir Cidofovir may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefpiramide Cefpiramide may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Ceftazidime Ceftazidime may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Loracarbef Loracarbef may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefalotin Cefalotin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Nabumetone Nabumetone may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Ketorolac Ketorolac may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Tenoxicam Tenoxicam may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Celecoxib Celecoxib may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefotaxime Cefotaxime may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Tolmetin Tolmetin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Foscarnet Foscarnet may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Rofecoxib Rofecoxib may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Piroxicam Piroxicam may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Methotrexate Methotrexate may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cephalexin Cephalexin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Fenoprofen Fenoprofen may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Valaciclovir Valaciclovir may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Valdecoxib Valdecoxib may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Diclofenac Diclofenac may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Sulindac Sulindac may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Bacitracin Bacitracin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Amphotericin B Amphotericin B may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cephaloglycin Cephaloglycin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Flurbiprofen Flurbiprofen may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Adefovir dipivoxil Adefovir dipivoxil may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Pentamidine Pentamidine may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Etodolac Etodolac may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Mefenamic acid Mefenamic acid may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Acyclovir Acyclovir may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Naproxen Naproxen may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Sulfasalazine Sulfasalazine may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Phenylbutazone Phenylbutazone may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Meloxicam Meloxicam may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Carprofen Carprofen may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefaclor Cefaclor may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Diflunisal Diflunisal may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Tacrolimus Tacrolimus may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Ceforanide Ceforanide may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Salicylic acid Salicylic acid may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Meclofenamic acid Meclofenamic acid may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Acetylsalicylic acid Acetylsalicylic acid may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Carboplatin Carboplatin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Oxaprozin Oxaprozin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Ketoprofen Ketoprofen may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Balsalazide Balsalazide may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Ibuprofen Ibuprofen may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefditoren Cefditoren may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Atazanavir Atazanavir may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Colistimethate Colistimethate may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefuroxime Cefuroxime may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefapirin Cefapirin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefadroxil Cefadroxil may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefprozil Cefprozil may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Ceftriaxone Ceftriaxone may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Olsalazine Olsalazine may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Lumiracoxib Lumiracoxib may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefamandole Cefamandole may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefazolin Cefazolin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefonicid Cefonicid may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefoperazone Cefoperazone may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefotetan Cefotetan may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefoxitin Cefoxitin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Ceftizoxime Ceftizoxime may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefradine Cefradine may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Magnesium salicylate Magnesium salicylate may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Salsalate Salsalate may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Choline magnesium trisalicylate Choline magnesium trisalicylate may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefepime Cefepime may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefacetrile Cefacetrile may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Ceftibuten Ceftibuten may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cefpodoxime Cefpodoxime may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Antrafenine Antrafenine may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Aminophenazone Aminophenazone may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Antipyrine Antipyrine may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Phenazopyridine Phenazopyridine may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Tiaprofenic acid Tiaprofenic acid may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Lopinavir Lopinavir may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Etoricoxib Etoricoxib may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Hydrolyzed Cephalothin Hydrolyzed Cephalothin may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cephalothin Group Cephalothin Group may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Oxyphenbutazone Oxyphenbutazone may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Latamoxef Latamoxef may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Nimesulide Nimesulide may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Benoxaprofen Benoxaprofen may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Metamizole Metamizole may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Zomepirac Zomepirac may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Ceftobiprole Ceftobiprole may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Cimicoxib Cimicoxib may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Ceftaroline fosamil Ceftaroline fosamil may decrease the excretion rate of Golodirsen which could result in a higher serum level.
Lornoxicam Lornoxicam may decrease the excretion rate of Golodirsen which could result in a higher serum level.

Target Protein

Dystrophin DMD

Referensi & Sumber

Artikel (PubMed)
  • PMID: 30171533
    Rodrigues M, Yokota T: An Overview of Recent Advances and Clinical Applications of Exon Skipping and Splice Modulation for Muscular Dystrophy and Various Genetic Diseases. Methods Mol Biol. 2018;1828:31-55. doi: 10.1007/978-1-4939-8651-4_2.
  • PMID: 29301272
    Aslesh T, Maruyama R, Yokota T: Skipping Multiple Exons to Treat DMD-Promises and Challenges. Biomedicines. 2018 Jan 2;6(1). pii: biomedicines6010001. doi: 10.3390/biomedicines6010001.
  • PMID: 18974549
    Yiu EM, Kornberg AJ: Duchenne muscular dystrophy. Neurol India. 2008 Jul-Sep;56(3):236-47. doi: 10.4103/0028-3886.43441.
  • PMID: 26140716
    Gao QQ, McNally EM: The Dystrophin Complex: Structure, Function, and Implications for Therapy. Compr Physiol. 2015 Jul 1;5(3):1223-39. doi: 10.1002/cphy.c140048.
  • PMID: 15544491
    Arora V, Devi GR, Iversen PL: Neutrally charged phosphorodiamidate morpholino antisense oligomers: uptake, efficacy and pharmacokinetics. Curr Pharm Biotechnol. 2004 Oct;5(5):431-9. doi: 10.2174/1389201043376706.
  • PMID: 31257147
    Tsoumpra MK, Fukumoto S, Matsumoto T, Takeda S, Wood MJA, Aoki Y: Peptide-conjugate antisense based splice-correction for Duchenne muscular dystrophy and other neuromuscular diseases. EBioMedicine. 2019 Jul;45:630-645. doi: 10.1016/j.ebiom.2019.06.036. Epub 2019 Jun 27.
  • PMID: 28515510
    Baker DE: Eteplirsen. Hosp Pharm. 2017 Apr;52(4):302-305. doi: 10.1310/hpj5204-302.
  • PMID: 24554202
    Kinter J, Sinnreich M: Molecular targets to treat muscular dystrophies. Swiss Med Wkly. 2014 Feb 19;144:w13916. doi: 10.4414/smw.2014.13916.
Menampilkan 8 dari 11 artikel.
Textbook
  • Vijay Venugopal; Steven Pavlakis (2019). Duchenne Muscular Dystrophy. StatPearls Publishing.

Contoh Produk & Brand

Produk: 1 • International brands: 1
Produk
  • Vyondys 53
    Injection • 50 mg/1mL • Intravenous • US • Approved
International Brands
  • Vyondys 53

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