Lamivudine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]
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Black Box Warning
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WARNING: RISK OF LACTIC ACIDOSIS, EXACERBATIONS OF HEPATITIS B IN CO-INFECTED PATIENTS UPON DISCONTINUATION OF LAMIVUDINE, DIFFERENT FORMULATIONS OF LAMIVUDINE.
Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. Exacerbations of Hepatitis B: Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted. Important Differences Among Lamivudine-Containing Products: Lamivudine tablets (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV® tablets and oral solution (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1.See full prescribing information for complete Boxed Warning.
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Overview
Lamivudine is a nucleoside analogue reverse transcriptase inhibitor that is FDA approved for the treatment of HIV-1 infection. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Lamivudine FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lamivudine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Lamivudine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Lamivudine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lamivudine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Lamivudine in pediatric patients.
Contraindications
There is limited information regarding Lamivudine Contraindications in the drug label.
Warnings
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WARNING: RISK OF LACTIC ACIDOSIS, EXACERBATIONS OF HEPATITIS B IN CO-INFECTED PATIENTS UPON DISCONTINUATION OF LAMIVUDINE, DIFFERENT FORMULATIONS OF LAMIVUDINE.
Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. Exacerbations of Hepatitis B: Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted. Important Differences Among Lamivudine-Containing Products: Lamivudine tablets (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV® tablets and oral solution (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1.See full prescribing information for complete Boxed Warning.
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There is limited information regarding Lamivudine Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Lamivudine Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Lamivudine Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Lamivudine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Lamivudine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lamivudine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Lamivudine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Lamivudine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Lamivudine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Lamivudine in geriatric settings.
Gender
There is no FDA guidance on the use of Lamivudine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Lamivudine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Lamivudine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Lamivudine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lamivudine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Lamivudine in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Lamivudine Administration in the drug label.
Monitoring
There is limited information regarding Lamivudine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Lamivudine and IV administrations.
Overdosage
There is limited information regarding Lamivudine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Lamivudine Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Lamivudine Mechanism of Action in the drug label.
Structure
There is limited information regarding Lamivudine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Lamivudine Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Lamivudine Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Lamivudine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Lamivudine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Lamivudine How Supplied in the drug label.
Storage
There is limited information regarding Lamivudine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Lamivudine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Lamivudine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Lamivudine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Lamivudine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
For patient information, click here.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]
Overview
Lamivudine (2',3'-dideoxy-3'-thiacytidine, commonly called 3TC) is a potent nucleoside analog reverse transcriptase inhibitor (nRTI).
It is marketed by GlaxoSmithKline with the brand names Epivir and Epivir-HBV.
Lamivudine has been used for treatment of chronic hepatitis B at a lower dose than for treatment of HIV. It improves the seroconversion of e-antigen positive hepatitis B and also improves histology staging of the liver. Long term use of lamivudine unfortunately leads to emergence of a resistant hepatitis B virus (YMDD) mutant. Despite this, lamivudine is still used widely as it is well tolerated.
Category
Antiretroviral
US Brand Names
EPIVIR®
FDA Package Insert
Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages
Mechanism of Action
Intracellularly, lamivudine is phosphorylated to its active 5′-triphosphate metabolite, lamivudine triphosphate (3TC-TP). The principal mode of action of 3TC-TP is the inhibition of HIV-1 reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide analogue into viral DNA. 3TC-TP is a weak inhibitor of mammalian DNA polymerases α, β, and γ.