Exposure to fentanyl after transdermal patch administration for cancer pain management
Author(s)
Bista, Sudeep R
Haywood, Alison
Hardy, Janet
Norris, Ross
Hennig, Stefanie
Griffith University Author(s)
Year published
2016
Metadata
Show full item recordAbstract
This study aimed to describe exposure after fentanyl transdermal patch administration in patients with advanced cancer to quantify variability around the exposure. Patients (n = 56) with advanced cancer who received transdermal fentanyl (Durogesic®; median dose, 50 μg/h; range, 12–200 μg/h) provided venous blood samples (n = 163) at various times (0.5–72 hours) during several patch application intervals. Plasma fentanyl concentration was determined (median, 0.9 μg/L; range, 0.04–9.7 μg/L) by high‐performance liquid chromatography coupled to tandem mass spectrometry. Pharmacokinetic analysis was performed using nonlinear ...
View more >This study aimed to describe exposure after fentanyl transdermal patch administration in patients with advanced cancer to quantify variability around the exposure. Patients (n = 56) with advanced cancer who received transdermal fentanyl (Durogesic®; median dose, 50 μg/h; range, 12–200 μg/h) provided venous blood samples (n = 163) at various times (0.5–72 hours) during several patch application intervals. Plasma fentanyl concentration was determined (median, 0.9 μg/L; range, 0.04–9.7 μg/L) by high‐performance liquid chromatography coupled to tandem mass spectrometry. Pharmacokinetic analysis was performed using nonlinear mixed‐effects modeling with NONMEM. A 1‐compartment distribution model with first‐order absorption and elimination described fentanyl exposure after transdermal patch administration. Fentanyl apparent clearance (between‐subject variability [BSV], %) was estimated at 122 L/h/70 kg and 38.5%, respectively. The absorption rate constant was 0.013 h−1. Between‐occasion variability on apparent clearance was 22.0%, which was lower than BSV, suggesting predictable exposure within the same patient and justifying therapeutic drug monitoring. Except for weight‐based dosing, no other patient characteristic could be identified to guide initial fentanyl dose selection in patients with advanced cancer.
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View more >This study aimed to describe exposure after fentanyl transdermal patch administration in patients with advanced cancer to quantify variability around the exposure. Patients (n = 56) with advanced cancer who received transdermal fentanyl (Durogesic®; median dose, 50 μg/h; range, 12–200 μg/h) provided venous blood samples (n = 163) at various times (0.5–72 hours) during several patch application intervals. Plasma fentanyl concentration was determined (median, 0.9 μg/L; range, 0.04–9.7 μg/L) by high‐performance liquid chromatography coupled to tandem mass spectrometry. Pharmacokinetic analysis was performed using nonlinear mixed‐effects modeling with NONMEM. A 1‐compartment distribution model with first‐order absorption and elimination described fentanyl exposure after transdermal patch administration. Fentanyl apparent clearance (between‐subject variability [BSV], %) was estimated at 122 L/h/70 kg and 38.5%, respectively. The absorption rate constant was 0.013 h−1. Between‐occasion variability on apparent clearance was 22.0%, which was lower than BSV, suggesting predictable exposure within the same patient and justifying therapeutic drug monitoring. Except for weight‐based dosing, no other patient characteristic could be identified to guide initial fentanyl dose selection in patients with advanced cancer.
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Journal Title
Journal of Clinical Pharmacology
Note
This publication has been entered into Griffith Research Online as an Advanced Online Version.
Subject
Pharmacology and pharmaceutical sciences
Pharmaceutical sciences