.Pharmacolibrary.Drugs.ATC.L.L01EA03

Information

Nilotinib is a second-generation oral tyrosine kinase inhibitor targeting BCR-ABL and is used primarily in the treatment of Philadelphia chromosome-positive chronic myelogenous leukemia (CML). It is currently approved and widely used in clinical practice for this indication.

Pharmacokinetics

Pharmacokinetic parameters derived from adult patients with chronic myeloid leukemia following oral administration under fasting conditions.

References

1. Li, CH, et al., & Bies, RR (2015). Clinical trial simulation to evaluate population pharmacokinetics and food effect: capturing abiraterone and nilotinib exposures. Journal of clinical pharmacology 55(5) 556–562. DOI:10.1002/jcph.449 PUBMED:https://pubmed.ncbi.nlm.nih.gov/25511575

2. Heimbach, T, et al., & He, H (2019). Physiologically Based Pharmacokinetic Modeling to Supplement Nilotinib Pharmacokinetics and Confirm Dose Selection in Pediatric Patients. Journal of pharmaceutical sciences 108(6) 2191–2198. DOI:10.1016/j.xphs.2019.01.028 PUBMED:https://pubmed.ncbi.nlm.nih.gov/30721710

3. Yin, OQ, et al., & Schran, H (2009). Effects of hepatic impairment on the pharmacokinetics of nilotinib: an open-label, single-dose, parallel-group study. Clinical therapeutics 31 Pt 2 2459–2469. DOI:10.1016/j.clinthera.2009.11.015 PUBMED:https://pubmed.ncbi.nlm.nih.gov/20110053

Revisions

• 06/2025 Tomas Kulhanek, generated model from data extracted from PUBMED, DrugBank and LLM(GPT4.1)