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lamivudine
generic
Black Box Warnings .
Lactic Acidosis/Severe Hepatomegaly with Steatosis
lactic acidosis and severe hepatomegaly w/ steatosis, incl. fatal cases, associated w/ nucleoside analog use and other antiretrovirals; incr. risk if female, obese, or long-term nucleoside analog tx; D/C tx if clinical or laboratory findings suggest lactic acidosis or hepatotoxicity
Hepatitis B Exacerbation
severe acute HBV exacerbations in HBV or HBV/HIV co-infected pts upon lamivudine D/C; monitor hepatic fxn closely for at least several months in HBV or HBV/HIV co-infected pts who D/C lamivudine; initiate anti-HBV tx if needed
Non-Interchangeable Forms
lamivudine dosage forms used to treat HIV infection contain higher doses compared to lamivudine dosage forms used to treat chronic HBV infection; ensure pts receive correct dosage form for indicated use
HIV testing
offer HIV counseling and testing before initiating lamivudine tx for HBV and periodically during tx; rapid emergence of HIV resistance may occur if unrecognized or untreated HIV infection due to subtherapeutic dose and inappropriate monotherapy w/ lamivudine tx for HBV
Adult Dosing .
Dosage forms: TAB: 100 mg, 150 mg, 300 mg; SOL: 10 mg per mL
HIV infection
- [300 mg PO qd]
- Alt: 150 mg PO bid
hepatitis B infection, chronic
- [100 mg PO qd]
- Info: higher doses required for pts w/ HIV co-infection
HIV post-exposure prophylaxis (off-label)
- [<50 kg]
- Dose: 4 mg/kg/dose PO bid; Max: 150 mg/dose; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Occupational and HIV Post-Exposure Prophylaxis, Nonoccupational tables
- [>50 kg]
- Dose: 150 mg PO bid; Alt: 300 mg PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Occupational and HIV Post-Exposure Prophylaxis, Nonoccupational tables
hepatitis B infection prophylaxis, perinatal transmission (off-label)
- [100 mg PO qd]
- Start: at 28-32 wk gestation; Info: for pregnant pts w/ HBV DNA >200,000; not 1st-line agent; D/C between birth to 3mo postpartum
renal dosing
- [HIV infection or post-exposure prophylaxis]
- CrCl 30-49: 150 mg qd; CrCl 15-29: 150 mg x1, then 100 mg qd; CrCl 5-14: 150 mg x1, then 50 mg qd; CrCl <5: 50 mg x1, then 25 mg qd
- HD: 50 mg x1, then 25 mg qd, on dialysis days admin. after dialysis; no supplement; PD: 10 mg qd; no supplement
- [hepatitis B infection]
- CrCl 30-49: 100 mg x1, then 50 mg qd; CrCl 15-29: 100 mg x1, then 25 mg qd; CrCl 5-14: 35 mg x1, then 15 mg qd; CrCl <5: 35 mg x1, then 10 mg qd
- HD: 35 mg x1, then 10-15 mg qd; no supplement; PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: no adjustment; decompensated hepatic dz: not defined
Peds Dosing .
- Dosage forms: TAB: 100 mg, 150 mg, 300 mg; SOL: 10 mg per mL
HIV infection
- [>32 wk gestation, <4 wk old (off-label)]
- Dose: 2 mg/kg/dose PO bid
- [4 wk old-3 mo (off-label)]
- Dose: 4 mg/kg/dose PO bid; Max: 300 mg/day
- [3 mo-16 yo, 14-19.9 kg]
- Dose: 150 mg PO qd; Max: 300 mg/day; Alt: 75 mg PO bid; 10 mg/kg/day PO divided qd-bid; Info: tabs preferred over oral solution
- [3 mo-16 yo, 20-24.9 kg]
- Dose: 225 mg PO qd; Max: 300 mg/day; Alt: 75 mg PO qam, 150 mg PO qpm; 10 mg/kg/day PO divided qd-bid; Info: tabs preferred over oral solution
- [3 mo-16 yo, >25 kg]
- Dose: 300 mg PO qd; Max: 300 mg/day; Alt: 150 mg PO bid; 10 mg/kg/day PO divided qd-bid; Info: tabs preferred over oral solution
- [>16 yo]
- Dose: 300 mg PO qd; Alt: 150 mg PO bid
hepatitis B infection, chronic
- [2 yo and older]
- Dose: 3 mg/kg/dose PO qd; Max: 100 mg/day; Info: higher doses required for pts w/ HIV co-infection
HIV infection prevention, high-risk neonates (off-label)
- [>32 wk gestation]
- Dose: 4 mg/kg/day PO divided q12h x4wk, then 8 mg/kg/day PO divided q12h; Start: w/in 12h after birth; Info: give w/ zidovudine and either nevirapine or raltegravir; total duration 2-6wk; refer to DHHS guidelines
HIV post-exposure prophylaxis, nonoccupational (off-label)
- [<4 wk old]
- Dose: 2 mg/kg/dose PO bid; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
- [4 wk old and older]
- Dose: 4 mg/kg/dose PO bid; Max: 150 mg/dose; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
- [<16 yo, 14-19.9 kg]
- Dose: 75 mg PO bid; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
- [<16 yo, 20-24.9 kg]
- Dose: 75 mg PO qam and 150 mg PO qpm; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
- [<16 yo, >25 kg]
- Dose: 150 mg PO bid; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
- [16 yo and older, <50 kg]
- Dose: 4 mg/kg/dose PO bid; Max: 150 mg/dose; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Occupational and HIV Post-Exposure Prophylaxis, Nonoccupational tables
- [16 yo and older, >50 kg]
- Dose: 150 mg PO bid; Alt: 300 mg PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Occupational and HIV Post-Exposure Prophylaxis, Nonoccupational tables
hepatitis B infection prophylaxis, perinatal transmission (off-label)
- [100 mg PO qd]
- Start: at 28-32 wk gestation; Info: for pregnant pts w/ HBV DNA >200,000; not 1st-line agent; D/C between birth to 3mo postpartum
renal dosing
- [HIV infection or post-exposure prophylaxis]
- CrCl 30-49: give usual dose q24h; CrCl 15-29: give usual dose x1, then give 66% usual dose q24h; CrCl 5-14: give usual dose x1, then give 33% usual dose q24h; CrCl <5: give 50% usual dose x1, then give 17% usual dose q24h
- HD: give 17% usual dose q24h, on dialysis days admin. after dialysis; no supplement; PD: give 17% usual dose q24h; no supplement
- [hepatitis B infection]
- renal impairment: not defined, consider adult renal dosing for guidance
- HD/PD: not defined, consider adult renal dosing for guidance
hepatic dosing
- [see below]
- hepatic impairment: no adjustment; decompensated hepatic dz: not defined