Lamivudine

EPIVIR

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Pronunciation: la-MI-vyoo-deen (EP-i-veer)

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

What it isCytidine-analog reverse-transcriptase inhibitor; HIV and chronic hepatitis B.

Why this oneIts signature HIV-resistance mutation develops quickly but impairs viral fitness, so the drug may remain useful in a failing regimen.

What limits itStopping can trigger a severe hepatitis B flare; resistance emerges quickly when it is used alone for hepatitis B.

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

FDA-approved for

HIV-1 infection (1995)
chronic hepatitis B

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Severe acute exacerbations of hepatitis B after discontinuation (monitor hepatic function); HIV-1 resistance may emerge if used in unrecognized/untreated HIV-1 (subtherapeutic dose) — offer HIV testing.

FDA dosing	Population	Start	Target	Max
Chronic hepatitis B	Adults	100 mg QD	100 mg QD	100 mg QD
Chronic hepatitis B	Pediatric 2-17 yr	3 mg/kg QD (max 100 mg)	3 mg/kg QD (max 100 mg)	100 mg QD

Renal Adjust by CrCl: 30-49 mL/min 100 mg first dose then 50 mg QD; 15-29 100 mg then 25 mg QD; 5-14 35 mg then 15 mg QD; <5 35 mg then 10 mg QD

Hepatic Undefined

Instructions

May be taken with or without food
Do not use with other lamivudine- or emtricitabine-containing products
Oral solution available for pediatric patients requiring <100 mg or unable to swallow tablets
Monitor hepatic function for several months after discontinuation

Available strengths

tab 100, 150, 300 mg
sol 10 mg/mL

Cautions

Exacerbations of hepatitis after discontinuation
Risk of HIV-1 resistance if unrecognized/untreated HIV-1
Emergence of resistance-associated HBV substitutions
Lactic acidosis and severe hepatomegaly with steatosis (nucleoside analogues)

Adverse reactions

Ear/nose/throat infections
Sore throat
Diarrhea

Pregnancy APR data show no substantial difference in major birth defects vs background; pregnancy registry available

Lactation Present in human milk; weigh benefits of breastfeeding against maternal need

Cost

Lamivudine (EPIVIR)

What pharmacies pay · NADAC 9/30/26

Strength		#/mo	generic $	CostPlus
100 mg	tab	30 qd	$284.29/mo	offered
150 mg	tab	30 qd	$14.66/mo	offered
300 mg	tab	30 qd	$42.04/mo	offered
10 mg/mL	sol	per unit	$0.22/mL	offered

Available combined with: dolutegravir / lamivudine

Generic entry2011

⚠ BOXED WARNING

Severe acute exacerbation of hepatitis B on discontinuation

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger1 / 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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