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Entecavir PK Fact Sheet Reviewed March 2016 Page 1 of 2 for Personal Use Only

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Entecavir PK Fact Sheet Reviewed March 2016 Page 1 of 2 for Personal Use Only www.hep-druginteractions.org Entecavir PK Fact Sheet Reviewed March 2016 Page 1 of 2 For personal use only. Not for distribution. For personal use only. Not for distribution. For personal use only. Not for distribution. Details Generic Name Entecavir Trade Name Baraclude® Class Guanosine nucleoside analogue with selective antiviral activity against HBV polymerase Molecular Weight 295.3 Structure NH2 H2O HO NNH O HO N N CH2 Summary of Key Pharmacokinetic Parameters Entecavir is phosphorylated to the active triphosphate form, which has an intracellular half‐life of 15 hours. Linearity/non‐linearity Dose‐proportionate increases in Cmax and AUC following multiple doses ranging from 0.1‐1 mg. Steady state Achieved between 6‐10 days after once daily dosing with ~2 times accumulation. Plasma half life When peak levels reached, terminal elimination half life is approx. 128‐149 hours. Cmax 4.2 ng/ml (0.5 mg dose) at steady state 8.2 ng/ml (1 mg dose) at steady state Cmin 0.3 ng/ml (0.5 mg dose) at steady state 0.5 ng/ml (1 mg dose) at steady state AUC 27.9 ng.h/ml (1 mg single dose) Bioavailability Absolute bioavailability not determined; estimated to be at least 70%. Absorption Administration with a high fat or light meal results in slight delay in absorption; a 44‐46% decrease in Cmax, and an 18‐20% decrease in AUC. The US Prescribing Information recommends that all patients should take entecavir on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal), but the European SPC only makes this recommendation for lamivudine‐refractory patients. Protein Binding Approximately 13% in vitro Volume of Distribution Estimated to be in excess of total body water CSF:Plasma ratio Data unavailable Semen:Plasma ratio Data unavailable Renal Clearance 75% of dose as unchanged drug, at steady state. Thought to undergo both glomerular filtration and net tubular secretion. Renal Impairment Clearance of entecavir decreases with decreasing creatinine clearance. The manufacturer recommends dose adjustment with creatinine clearance <50 ml/min, including those on haemodialysis or continuous ambulatory peritoneal dialysis. A 4 hour period of haemodialysis removed ~13% of the dose, and 0.3% was removed by CAPD. On haemodialysis days, administer entecavir after haemodialysis. Virological response should be closely monitored. Hepatic Impairment Pharmacokinetics in moderate or severe hepatic impairment are similar to those in normal hepatic function. The European SPC states that dosage adjustments are not necessary. The US Prescribing Information states that the recommended dose in adults with decompensated liver disease is 1 mg once daily. © Liverpool Drug Interactions Group, University of Liverpool, Pharmacology Research Labs, 1st Floor Block H, 70 Pembroke Place, LIVERPOOL, L69 3GF. We aim to ensure that information is accurate and consistent with current knowledge and practice. However, the University of Liverpool and its servants or agents shall not be responsible or in any way liable for the continued currency of information in this publication whether arising from negligence or otherwise howsoever or for any consequences arising therefrom. The University of Liverpool expressly exclude liability for errors, omissions or inaccuracies to the fullest extent permitted by law. www.hep-druginteractions.org Entecavir PK Fact Sheet Reviewed March 2016 Page 2 of 2 For personal use only. Not for distribution. For personal use only. Not for distribution. For personal use only. Not for distribution. Metabolism and Distribution Metabolised by Not a substrate for CYP450. No acetylation or oxidation; minor phase II glucuronidation and sulphate conjugation. Inducer of Not an inducer of CYP450 Inhibitor of Not an inhibitor of CYP450 Transported by Data unavailable References All information is from: Baraclude® Summary of Product Characteristics, Bristol‐Myers Squibb Pharmaceuticals Ltd. Baraclude® US Prescribing Information, Bristol‐Myers Squibb. © Liverpool Drug Interactions Group, University of Liverpool, Pharmacology Research Labs, 1st Floor Block H, 70 Pembroke Place, LIVERPOOL, L69 3GF. We aim to ensure that information is accurate and consistent with current knowledge and practice. However, the University of Liverpool and its servants or agents shall not be responsible or in any way liable for the continued currency of information in this publication whether arising from negligence or otherwise howsoever or for any consequences arising therefrom. The University of Liverpool expressly exclude liability for errors, omissions or inaccuracies to the fullest extent permitted by law. .
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