Entecavir

BARACLUDE

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Pronunciation: en-TE-ka-veer (BAIR-a-klood)

Entecavir ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Entecavir ballicule

What it isGuanosine analog that inhibits viral reverse transcriptase; chronic hepatitis B.

Why this oneResistance is uncommon unless lamivudine resistance is already present, distinguishing it from older agents.

What limits itTake on an empty stomach. Stopping can trigger a severe hepatitis flare; adjust for renal impairment.

Entecavir molecular structure (skeletal formula) — Molecular structure: Entecavir

FDA-approved for

chronic hepatitis B (2005)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Severe acute HBV exacerbations on discontinuation (monitor hepatic function); HIV resistance risk in untreated HIV/HBV coinfection; lactic acidosis and severe hepatomegaly with steatosis (nucleoside analogues).

FDA dosing	Population	Start	Target	Max
Chronic HBV, nucleoside-naive, compensated liver disease	>=16 yr	0.5 mg QD	0.5 mg QD	0.5 mg QD
Chronic HBV, lamivudine-refractory / known resistance	>=16 yr	1 mg QD	1 mg QD	1 mg QD
Chronic HBV, decompensated liver disease	adult	1 mg QD	1 mg QD	1 mg QD
Chronic HBV (>=2 yr and >=10 kg)	pediatric	Weight-based (oral solution if <30 kg); naive vs lamivudine-experienced	Per Table 1 by weight	0.5 mg (naive) / 1 mg (lamivudine-exp) at >30 kg

Renal CrCl <50 mL/min (incl. hemodialysis/CAPD): reduce dose or extend interval (e.g., 0.25 mg QD or 0.5 mg q48h for the 0.5 mg dose).

Hepatic No adjustment needed

Instructions

Take on an empty stomach (>=2 h after and >=2 h before a meal)
Do not discontinue abruptly; monitor hepatic function for several months if stopped
Offer HIV testing before starting

Available strengths

tab 0.5, 1 mg
sol 0.05 mg/mL

Cautions

Severe acute HBV exacerbation after discontinuation
HIV nucleoside-resistance risk if unrecognized/untreated HIV coinfection
Lactic acidosis and severe hepatomegaly with steatosis

Adverse reactions

Headache
Fatigue
Dizziness
Nausea

Pregnancy Insufficient human data (Antiretroviral Pregnancy Registry); animal studies show no adverse developmental effects at clinically relevant exposures.

Lactation Undefined

Cost

Entecavir (BARACLUDE)

What pharmacies pay · NADAC 9/30/26

Strength		#/mo	generic $	CostPlus
0.5 mg	tab	30 qd	$6.56/mo	offered
1 mg	tab	30 qd	$11.05/mo	offered
0.05 mg/mL	sol	per unit		not offered

Generic entry2014

⚠ BOXED WARNINGS

Severe acute exacerbation of hepatitis B on discontinuation
Lactic acidosis and hepatomegaly

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryUnknown / historical label unavailable

Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.

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