pharmacopeia
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Boxed warning

EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF LAMIVUDINE 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 [see Warnings and Precautions ( 5.1 )]. Important Differences among Lamivudine-Containing Products Lamivudine tablets and oral solution (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 Warnings and Precautions ( 5.1 )]. WARNING: EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF LAMIVUDINE See full prescribing information for complete boxed warning • 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.

Mechanism of action

Sourced from openFDA

Lamivudine is an antiretroviral agent [see Microbiology ( 12.4 )].

Nucleoside Reverse Transcriptase

Indications

Sourced from openFDA
  • & USAGE Lamivudine is nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: • The dosage of this product is for HIV-1 and not for HBV.ICD-10: B20

Contraindications

Sourced from openFDA
  • Lamivudine is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Lamivudine is contraindicated in patients with previous hypersensitivity reaction to lamivudine.contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION • Adults: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily. ( 2.1 ) • Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 300 mg daily. ( 2.2 ) • Patients with Renal Impairment: Doses of lamivudine must be adjusted in accordance with renal function. ( 2.3 ) 2.1 Recommended Dosage for Adult Patients The recommended dosage of lamivudine in HIV-1-infected adults is 300 mg daily, administered as either 150 mg taken orally twice daily or 300 mg taken orally once daily with or without food. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage for Pediatric Patients Lamivudine scored tablet is the preferred formulation for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing lamivudine scored tablets, pediatric patients should be assessed for the ability to swallow tablets.For patients unable to safely and reliably swallow lamivudine tablets, the oral solution formulation may be prescribed [see Warnings and Precautions (5.5)]. The recommended oral dosage of lamivudine for HIV-1-infected pediatric patients is presented in Table 1. Table 1.

Warnings & precautions

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• Co-infected HIV-1/HBV Patients: Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. ( 5.1 ) • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. ( 5.2 ) • Pancreatitis: Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate. ( 5.3 ) • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. ( 5.4 ) • Lower virologic suppression rates and increased risk of viral resistance were observed in pediatric subjects who received EPIVIR oral solution concomitantly with other antiretroviral oral solutions compared with those who received tablets. An all-tablet regimen should be used when possible. ( 5.5 ) 5.1 Patients with Hepatitis B Virus Co-infection Posttreatment Exacerbations of Hepatitis Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine. These exacerbations have been detected primarily by serum ALT elevations in addition to re-emergence of HBV DNA. Although most events appear to have been self-limited, fatalities have been reported in some cases. Similar events have been reported from postmarketing experience after changes from lamivudine-containing HIV-1 treatment regimens to non-lamivudine-containing regimens in patients infected with both HIV-1 and HBV.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in other sections of the labeling: • Exacerbations of hepatitis B [see Boxed Warning, Warnings and Precautions ( 5.1 )]. • Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions ( 5.2 )]. • Pancreatitis [see Warnings and Precautions ( 5.3 )]. • Immune reconstitution syndrome [see Warnings and Precautions ( 5.4 )]. • The most common reported adverse reactions (incidence greater than or equal to 15%) in adults were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. ( 6.1 ) • The most common reported adverse reactions (incidence greater than or equal to 15%) in pediatric subjects were fever and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety profile of lamivudine in adults is primarily based on 3,568 HIV-1-infected subjects in 7 clinical trials. The most common adverse reactions are headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhea, and cough.

Use in specific populations

Sourced from openFDA

• Lactation: Women infected with HIV should be instructed not to breastfeed due to potential for HIV transmission. ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR uses the MACDP as the U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks’ gestation. The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. The background risk for major birth defects and miscarriage for the indicated population is unknown.

Pharmacokinetics

Sourced from openFDA
Metabolism
Pharmacokinetics in Adults The pharmacokinetic properties of lamivudine have been studied in asymptomatic, HIV-1-infected adult subjects after administration of single intravenous (IV) doses ranging from 0.25 to 8 mg per kg, as well as single and multiple (twice-daily regimen) oral doses ranging from 0.25 to 10 mg per kg. The pharmacokinetic properties of lamivudine have also been studied as single and multiple oral doses ranging from 5 mg to 600 mg per day administered to HBV-infected subjects.

Overdosage

Sourced from openFDA

There is no known specific treatment for overdose with lamivudine. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.

Approval history

Sourced from openFDA
  • Nov 17, 1995NDANDA020564Viiv Hlthcare
  • Nov 17, 1995NDANDA020596Viiv Hlthcare
  • Sep 26, 1997NDANDA020857Viiv Hlthcare
  • Aug 22, 2014NDANDA205551Viiv Hlthcare
  • Feb 28, 2018NDANDA022141Mylan Labs Ltd
  • Mar 22, 2018NDANDA022142Mylan Labs Ltd
  • Aug 30, 2018NDANDA210807Msd Merck Co
  • Apr 8, 2019NDANDA211994Viiv Hlthcare

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
46,911 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Foetal Exposure During Pregnancy2,7735.9%
  2. 2Virologic Failure2,1394.6%
  3. 3Pain2,1124.5%
  4. 4Drug Interaction2,0764.4%
  5. 5Drug Resistance2,0404.3%
  6. 6Pathogen Resistance1,9434.1%
  7. 7Anxiety1,9414.1%
  8. 8Product Dose Omission Issue1,9154.1%
  9. 9Viral Mutation Identified1,8584.0%
  10. 10Depression1,7983.8%
  11. 11Drug Exposure During Pregnancy1,7073.6%
  12. 12Pyrexia1,6783.6%
  13. 13Nausea1,6753.6%
  14. 14Emotional Distress1,6183.4%
  15. 15Anaemia1,5453.3%

Literature

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Recent PubMed references pinned to Lamivudine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 822 ClinicalTrials.gov registrations naming Lamivudine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Lamivudine work?
Lamivudine is an antiretroviral agent [see Microbiology ( 12.4 )].
What is Lamivudine used for?
According to FDA labeling, Lamivudine carries indications including: & USAGE Lamivudine is nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: • The dosage of this product is for HIV-1 and not for HBV.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Lamivudine?
Lamivudine is classified as Nucleoside and nucleotide reverse transcriptase inhibitors, Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Nucleoside Reverse Transcriptase Inhibitors, Decreased Reverse Transcription to DNA, Increased Immunologically Active Molecule Activity.
What are the brand names for Lamivudine?
Lamivudine is marketed under brand names including Cimduo, Combivir, Delstrigo, Dovato, Epivir, Epzicom, Symfi, Temixys.
What are the contraindications for Lamivudine?
Lamivudine labeling lists contraindications including: Lamivudine is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Lamivudine is contraindicated in patients with previous hypersensitivity reaction to lamivudine.. Always consult the full prescribing information and a clinician.
Note. Data for lamivudine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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