Peringatan Keamanan

No studies in animals have been conducted to evaluate the carcinogenic potential of hexaminolevulinate hydrochloride.

Hexaminolevulinate hydrochloride was not mutagenic in in-vitro reverse mutation tests in bacteria, or in chromosome aberration tests in human peripheral blood lymphocytes, and was negative in an in-vivo micronucleus test in mice after intravenous injection of doses up to 45 mg/kg in the absence of light activation.

Adequate studies have not been performed to evaluate the genetic toxicity of hexaminolevulinate hydrochloride in the presence of light activation.

Adequate reproductive and developmental toxicity studies in animals have not been performed to evaluate the effects of hexaminolevulinate hydrochloride on fertility.

Hexaminolevulinate

DB06261

small molecule approved

Deskripsi

Hexaminolevulinate is an optical imaging drug. In solution form it is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. On May 28, 2010, the U.S. Food and Drug Administration (FDA) granted approval for hexaminolevulinate hydrochloride (Cysview for Intravesical Solution, Photocure ASA), as an optical imaging agent for use in combination with the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Hexaminolevulinate is manufactured under the brand Cysview® by Photocure ASA. In Europe, Hexaminolevulinate is marketed under the brand Hexvix®.

Struktur Molekul 2D

Berat 215.293
Wujud solid

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

Profil Farmakokinetik

Waktu Paruh (Half-Life) Biphasic elimination, with an initial elimination half-life of 39 minutes, followed by a terminal half-life of approximately 76 hours.
Volume Distribusi -
Klirens (Clearance) -

Absorpsi

Absolute bioavailability 7% (90% confidence interval CI: 5%-10%)

Metabolisme

Rapid metabolism in human blood.

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

5 Data
Porfimer sodium Hexaminolevulinate may increase the photosensitizing activities of Porfimer sodium.
Verteporfin Hexaminolevulinate may increase the photosensitizing activities of Verteporfin.
BCG vaccine BCG vaccine may decrease effectiveness of Hexaminolevulinate as a diagnostic agent.
Tretinoin The risk or severity of adverse effects can be increased when Tretinoin is combined with Hexaminolevulinate.
Padeliporfin Hexaminolevulinate may increase the photosensitizing activities of Padeliporfin.

Referensi & Sumber

Artikel (PubMed)
  • PMID: 24248555
    Yang LP: Hexaminolevulinate blue light cystoscopy: a review of its use in the diagnosis of bladder cancer. Mol Diagn Ther. 2014 Feb;18(1):105-16. doi: 10.1007/s40291-013-0068-x.
  • PMID: 21068759
    O'Brien T, Thomas K: Bladder cancer: Photodynamic diagnosis can improve surgical outcome. Nat Rev Urol. 2010 Nov;7(11):598-9. doi: 10.1038/nrurol.2010.183.
  • PMID: 18177838
    Hillemanns P, Wang X, Hertel H, Andikyan V, Hillemanns M, Stepp H, Soergel P: Pharmacokinetics and selectivity of porphyrin synthesis after topical application of hexaminolevulinate in patients with cervical intraepithelial neoplasia. Am J Obstet Gynecol. 2008 Mar;198(3):300.e1-7. doi: 10.1016/j.ajog.2007.07.045. Epub 2008 Feb 21.

Contoh Produk & Brand

Produk: 3 • International brands: 1
Produk
  • Cysview
    Kit • 100 mg/50mL • Intravesical • US • Approved
  • Cysview
    Kit; Powder, for solution • 100 mg/50mL • Intravesical • US • Approved
  • Cysview
    Kit; Powder, for solution • 100 mg / vial • Intravesical • Canada • Approved
International Brands
  • Hexvix — GE Healthcare

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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