Classes
DEA Class; Rx
Common Brand Names; Epivir, Epivir HBV, 3TC
- Hepatitis B/Hepatitis C Agents;
- HIV, NRTIs
Description
Nucleoside reverse transcriptase inhibitor
Used for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents
Lower-dose formulation available for treatment of chronic hepatitis B in patients without HIV
See Also Combos
with zidovudine (Combivir)
with abacavir (Epzicom)
with abacavir/zidovudine
Indications
Indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents.
Contraindications
Hypersensitivity
Adverse Effects
- Cough
- Diarrhea
- Fatigue & malaise
- Fever (peds)
- Headache
- Musculoskeletal pain
- Nausea
- Nervous system neuropathy
- Pancreatitis
- Peripheral neuropathy
- Nasal S/S
- Vomiting
- Abdominal cramps, abdominal pain
- Anorexia &/or decr appetite
- Arthralgia
- Chills
- Depression
- Dizziness
- Dyspepsia
- Insomnia
Warnings
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogues, including lamivudine; a majority of these cases have been in women; female sex and obesity may be risk factors for development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues; suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity, which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations
In pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis, this drug should be used with caution; discontinue immediately if signs or symptoms of pancreatitis occur in patients with history of pancreatitis
In order to reduce risk of resistance in patients receiving monotherapy, consider a switch to alternative regimen if serum HBV DNA remains detectable after 24 weeks of treatment; optimal therapy should be guided by resistance testing
Patients with HIV-1 infection should receive only dosage forms of lamivudine appropriate for treatment of HIV-1
Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens reported
Concomitant administration of emtricitabine with lamivudine-containing products not recommended
Pregnancy and Lactation
Available data from the APR show no difference in the overall risk of birth defects for lamivudine or zidovudine compared with background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population
The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed infants to avoid risking postnatal transmission of HIV-1 infection
Maximum Dosage
300 mg/day PO for HIV and HIV/HBV coinfection; 100 mg/day PO for HBV alone.
300 mg/day PO for HIV and HIV/HBV coinfection; 100 mg/day PO for HBV alone.
300 mg/day PO for HIV and HIV/HBV coinfection; 3 mg/kg/day PO (Max: 100 mg/day) for HBV alone.
2 to 12 years: 10 mg/kg/day PO (Max: 300 mg/day) for HIV; doses up to 8 mg/kg/day PO (Max: 300 mg/day) have been recommended for HIV/HBV coinfection; 3 mg/kg/day PO (Max: 100 mg/day) for HBV alone.
1 year: 10 mg/kg/day PO for HIV; doses up to 8 mg/kg/day PO have been recommended for HIV/HBV coinfection.
3 to 11 months: 10 mg/kg/day PO for HIV; doses up to 8 mg/kg/day PO have been recommended for HIV/HBV coinfection.
1 to 2 months: Safety and efficacy have not been established; doses up to 8 mg/kg/day PO have been used off-label for HIV and HIV/HBV coinfection.
Safety and efficacy have not been established; doses up to 4 mg/kg/day PO have been used off-label for HIV.
How supplied
Lamivudine
tablet
- 100mg (Epivir HBV)
- 150mg (Epivir)
- 300mg (Epivir)
oral solution
- 5mg/mL (Epivir HBV)
- 10mg/mL (Epivir)
