Adult Dosing
Treatment of HIV infection (Epivir)
- 150 mg PO bid or 300 mg PO qd, in combination with other antiretroviral agents
Treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation (Epivir-HBV)
Pediatric Dosing
Treatment of HIV infection (Epivir)
- Safety and effectiveness in pediatric patients <3 months of age have not been established
- Oral solution
- 3 months-16 years: 4 mg/kg PO bid, in combination with other antiretroviral agents
- Max: 300 mg /day
- Tablets: Children who weigh >14 kg and are able to swallow the tablets
- 14-21 kg (3 months-16 years): 75 mg PO bid, in combination with other antiretroviral agents
- >21 to <30 kg (3 months-16 years): 75 mg PO qam, 150mg PO qpm, in combination with other antiretroviral agents
30 kg (3 months-16 years): 150mg PO bid, in combination with other antiretroviral agents
Treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation (Epivir-HBV)
- Safety and effectiveness in pediatric patients <1 yrs of age have not been established
2-17 yrs
- 3 mg/kg PO qd
- Max: 100 mg/day
[Outline]
Renal Dose Adjustment (Based on CrCl)
Treatment of HIV infection (Epivir)
- 50 mL/min: 150 mg PO bid or 300 mg PO qd
- 30-49 mL/min: 150 mg PO qd
- 15-29 mL/min: 150 mg PO first dose, then 100 mg PO qd
- 5-14 mL/min: 150 mg PO first dose, then 50 mg PO qd
- <5 mL/min: 50 mg PO first dose, then 25 mg PO qd
Treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation (Epivir-HBV)
- 50 mL/min: 100 mg PO qd
- 30-49 mL/min: 100 mg PO first dose, then 50 mg PO qd
- 15-29 mL/min: 100 mg PO first dose, then 25 mg PO qd
- 5-14 mL/min: 35 mg PO first dose, then 15 mg PO qd
- <5 mL/min: 35 mg PO first dose, then 10 mg PO qd
Hepatic Dose Adjustment
- Hepatic impairment: No dose adjustments
- Decompensated liver disease: Dose adjustment not defined
See Supplemental Patient Information
- Lamivudine should be used cautiously 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. Cease therapy immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have occurred with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals. Obesity and prolonged nucleoside exposure may be the risk factors. Consider suspension of therapy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (that may include hepatomegaly and steatosis even in the absence of marked transaminase elevations) occur [US Black Box Warning]
- In patients co-infected with HIV and HBV, stopping lamivudine may lead to a severe acute exacerbation of hepatitis B; closely monitor hepatic function (laboratory and clinical) for at least several months. Initiate anti-hepatitis B therapy if needed [US Black Box Warning]
- Hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin. Closely monitor patients receiving interferon alfa with or without ribavirin and lamivudine for treatment-associated toxicities, especially hepatic decompensation. Discontinue lamivudine therapy if medically appropriate and also consider dose reduction or discontinuation of interferon alfa, ribavirin, or both in case of worsening clinical toxicities
- Lamivudine tablets and oral suspension used for HBV treatment are not appropriate for patients infected with HIV-1 [US Black Box Warning]
- Lamivudine (HBV dosage) can cause HIV-1 resistance when prescribed for chronic hepatitis B treatment in patients with unrecognized or untreated HIV-1 infection [US Black Box Warning]
- Lamivudine-resistant HBV can occur in non-HIV-1-infected patients treated with lamivudine for chronic hepatitis B and also in HIV-1 and hepatitis B co-infected patients after changing from lamivudine-containing antiretroviral treatment regimens to non-lamivudine-containing regimens
- Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy, including lamivudine, which may need further evaluation and treatment
- Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance have occurred in patients receiving antiretroviral therapy
Cautions: Use cautiously in
- Renal impairment
- Female patients
- Diabetes mellitus
Supplemental Patient Information
- Advise patients that lamivudine is not a cure for HIV or hepatitis B and they may continue to experience illnesses associated with HIV and HBV infection, including opportunistic infections
- Instruct patients to promptly report any new symptoms to their physician because emergence of resistant hepatitis B virus and worsening of disease can occur during treatment
- Advise parents or guardians to monitor pediatric patients for signs and symptoms of pancreatitis
- Inform patients that the use of lamivudine does not reduce the risk of transmission of HIV or HBV to others through sexual contact or blood contamination
Pregnancy Category:C
Breastfeeding: HIV-infected mothers generally should not breastfeed their infants. Exclusive breastfeeding for 6 months is recommended for HIV-infected mothers in countries where no acceptable, feasible, sustainable and safe replacement feeding is available to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Lamivudine is generally well tolerated by the breastfed infant and often used as part of a regimen that decreases mother-to-child transmission of HIV. Lamivudine has not been studied in nursing mothers being treated for hepatitis B infection who are HIV negative, but the low doses used would not be expected to cause any serious adverse effects in breastfed infants. In a survey involving US physicians with a practice interest in liver disease, 31% stated that they recommend breastfeeding for their patients with hepatitis B who are taking antiviral therapy, 44% stated that they do not recommend breastfeeding during antiviral therapy and 25% stated that they were unsure. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 2 February 2011). As per manufacturer's data, the Centers for Disease Control and Prevention recommend HIV-1-infected mothers in the US not to breastfeed their infants to avoid the risk of postnatal transmission of HIV-1 infection. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving lamivudine.
US Trade Name(s)
US Availability
lamivudine, 3TC (generic)
Epivir
- TABS: 150, 300 mg
- SOLN: 10 mg/mL
Epivir-HBV
- TABS: 100 mg
- SOLN: 5 mg/mL
Canadian Trade Name(s)
Canadian Availability
3TC
- TABS: 150, 300 mg
- SOLN: 10 mg/mL
Heptovir
- TABS: 100 mg
- SOLN: 5 mg/mL
UK Trade Name(s)
UK Availability
Epivir
- TABS: 150, 300 mg
- SOLN: 10 mg/mL
Zeffix
- TABS: 100 mg
- SOLN: 5 mg/mL
Australian Trade Name(s)
Australian Availability
3TC
- TABS: 150, 300 mg
- SOLN: 10 mg/mL
Zeffix
- TABS: 100 mg
- SOLN: 5 mg/mL
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Epivir 10 MG/ML SOLN [Bottle] (VIIV HEALTHCARE)
240 ml = $109.99
720 ml = $309.96 - Epivir 300 MG TABS [Bottle] (VIIV HEALTHCARE)
30 mg = $443.13
90 mg = $1268.1 - Epivir 150 MG TABS [Bottle] (VIIV HEALTHCARE)
60 mg = $450.01
180 mg = $1277.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.