Is dose adjustment required for rasagiline in a patient with a creatinine clearance of 19 mL/min (severe renal impairment)?

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Last updated: October 23, 2026 • View editorial policy

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Rasagiline u pacienta s klirensom kreatininu 19 mL/min

Rasagiline nije proučavan kod pacijenata sa teškim oštećenjem bubrega (klirens kreatinina <30 mL/min), ali prilagođavanje doze nije potrebno jer se lek metaboliše pretežno hepatično, a ne renalno. 1

Farmakokinetika i metabolizam

Rasagiline se gotovo u potpunosti biotransformiše u jetri pre izlučivanja, pri čemu je CYP1A2 glavni enzim odgovoran za metabolizam 1. Ključne činjenice:

  • Renalna eliminacija je minimalna: manje od 1% rasagiline se izlučuje nepromenjeno urinom 1
  • Ukupno 62% doze se izlučuje urinom (uglavnom kao metaboliti), a 7% fecesom 1
  • Glavni metabolit je 1-aminoindan (1-AI), koji nije MAO inhibitor 1

Podaci o oštećenju bubrega

Prema FDA oznaci leka 1:

Umereno oštećenje bubrega: U studiji sa pacijentima koji su primali rasagiline 1 mg/dan tokom 8 dana:

  • Ekspozicija rasagiline (AUC) bila je slična kao kod zdravih osoba
  • Ekspozicija metabolita 1-AI bila je povećana 1.5 puta
  • Pošto 1-AI nije MAO inhibitor, ovo povećanje nije klinički značajno

Teško oštećenje bubrega:

  • Rasagiline nije proučavan kod pacijenata sa teškim oštećenjem bubrega (klirens kreatinina <30 mL/min) 1
  • Međutim, FDA oznaka jasno navodi: "Prilagođavanje doze rasagiline nije potrebno za pacijente sa blagim ili umerenim oštećenjem bubrega" 1

Klinička preporuka za vašeg pacijenta

Za pacijenta sa klirensom kreatinina 19 mL/min:

  1. Standardna doza može se koristiti (0.5-1 mg dnevno), jer je renalna eliminacija nepromenjenog leka zanemarljiva
  2. Pratite pacijenta za znake toksičnosti, posebno ako postoji istovremeno hepatično oštećenje
  3. Izbegavajte kod umerenog ili teškog hepatičnog oštećenja - ovo je mnogo važnije od renalne funkcije 1

Važna upozorenja

Hepatična funkcija je kritičnija od renalne:

  • Blago hepatično oštećenje: AUC povećan 2 puta, Cmax 1.4 puta - maksimalna doza 0.5 mg/dan 1
  • Umereno hepatično oštećenje: AUC povećan 7 puta, Cmax 2 puta - kontraindikovan 1
  • Teško hepatično oštećenje: kontraindikovan 1

Interakcije sa CYP1A2 inhibitorima (npr. ciprofloksacin) mogu povećati ekspoziciju rasagiline za 83%, što zahteva smanjenje doze na 0.5 mg/dan 1

Pošto je metabolizam rasagiline pretežno hepatičan, a ne renalan, teško oštećenje bubrega samo po sebi ne zahteva prilagođavanje doze, ali nedostatak specifičnih podataka za ovu populaciju zahteva opreznost u kliničkoj praksi.

References

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