Peringatan Keamanan

In clinical studies, single doses of up to 12 times (and multiple doses of up to 5 times) the recommended dosage of difelikefalin were administered in subjects undergoing hemodialysis.L36395 These patients experienced a dose-dependent increase in adverse reactions, including gastrointestinal effects and CNS depressant effects. In the event of overdosage, difelikefalin is dialyzable - 4 hours of high-flux hemodialysis effectively clears approximately 70-80% of the drug from plasma, and levels are likely to be undetectable following a second cycle.L36395

Difelikefalin

DB11938

small molecule approved investigational

Deskripsi

Difelikefalin (CR845) is an agonist of kappa opioid receptors (KORs) useful in the treatment of pruritus secondary to chronic kidney disease. KORs were first associated with itching in 1984.A237610 Further investigations revealed that dynorphins, endogenous agonists of KORs, work to inhibit the itching sensation at the spinal cord level, and scratching could be elicited in mouse models with the administration of KOR antagonists.A237610 These revelations led to the study of KOR agonists as a potential treatment option in patients suffering from pruritic conditions.

Pruritus associated with chronic kidney disease (also called uremic pruritus) affects 50-60% of all patients on dialysis and 25% of non-dialysis patients with chronic kidney disease.A237615,A237620 The clinical burden of uremic pruritus in this patient population is being increasingly recognized as contributing to a significant reduction in patient quality of life, poor outcomes, and even mortality.A237620 Options for therapy are limited - with no FDA-approved treatments, off-label gabapentin was the most evidence-based and widely available treatment.A237620

Difelikefalin received FDA approval in August 2021 (under the brand name Korsuva), becoming the first FDA-approved therapy for patients with chronic kidney disease suffering from uremic pruritus.L36420,L36395 Difelikefalin was later approved by the EMA in April 2022 for the same indication.L41665

Struktur Molekul 2D

Berat 679.863
Wujud solid

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

Profil Farmakokinetik

Waktu Paruh (Half-Life) The half-life of difelikefalin in hemodialysis patients prior to dialysis ranges between 23 and 31 hours.[L36395]
Volume Distribusi The mean volume of distribution of difelikefalin is approximately 238 mL/kg.[L36395]
Klirens (Clearance) One cycle of hemodialysis reduces difelikefalin plasma concentrations by 70-80% and no detectable drug remains after two cycles.[L36395]

Absorpsi

Difelikefalin is administered via bolus intravenous injection with each hemodialysis treatmentL36395 - for this reason, each dose is effectively 100% bioavailable.

Metabolisme

Difelikefalin is not metabolized to any appreciable extent and is not a substrate for cytochrome P450 enzymes.L36395

Rute Eliminasi

Following intravenous difelikefalin administration to hemodialysis patients, approximately 11% of the dose was excreted in the urine, 59% in the feces, and 20% in the dialysate.L36395

Interaksi Makanan

1 Data
  • 1. Avoid excessive or chronic alcohol consumption. Difelikefalin can cause dizziness and somnolence that may be exacerbated by the CNS depressant effects of alcohol.

Interaksi Obat

0 Data
Tidak ada data.

Target Protein

Kappa-type opioid receptor OPRK1

Referensi & Sumber

Artikel (PubMed)
  • PMID: 33296031
    Inan S, Cowan A: Antipruritic Effects of Kappa Opioid Receptor Agonists: Evidence from Rodents to Humans. Handb Exp Pharmacol. 2020 Dec 10. doi: 10.1007/1642020420.
  • PMID: 33190563
    Lipman ZM, Yosipovitch G: An evaluation of difelikefalin as a treatment option for moderate-to-severe pruritus in end stage renal disease. Expert Opin Pharmacother. 2021 Apr;22(5):549-555. doi: 10.1080/14656566.2020.1849142. Epub 2020 Dec 14.
  • PMID: 32740217
    Trachtenberg AJ, Collister D, Rigatto C: Recent advances in the treatment of uremic pruritus. Curr Opin Nephrol Hypertens. 2020 Sep;29(5):465-470. doi: 10.1097/MNH.0000000000000625.

Contoh Produk & Brand

Produk: 4 • International brands: 1
Produk
  • Kapruvia
    Injection, solution • 50 ?g/ml • Intravenous • EU • Approved
  • Kapruvia
    Injection, solution • 50 ?g/ml • Intravenous • EU • Approved
  • Korsuva
    Injection, solution • 50 ug/1mL • Intravenous • US • Approved
  • Korsuva
    Solution • 50 mcg / mL • Intravenous • Canada • Approved
International Brands
  • Korsuva — Cara Therapeutics, Inc.

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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