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Black Box Warnings .
Hepatitis B Exacerbation
severe acute HBV exacerbations in HBV/HIV co-infected pts when D/C emtricitabine or tenofovir; monitor hepatic fxn closely for at least several months in HBV/HIV co-infected pts who D/C emtricitabine/tenofovir; initiate anti-HBV tx if needed
Drug Resistance Risk In HIV Pre-Exposure Prophylaxis Use
only prescribe for pre-exposure prophylaxis use in HIV-negative pts; confirm HIV status immediately before tx, then q3mo; drug-resistant HIV variants identified w/ use following undetected acute HIV infection; do not start in pts w/ acute HIV infection s/sx unless HIV-negative status confirmed
Adult Dosing .
Dosage forms: TAB: 100 mg/150 mg, 133 mg/200 mg, 167 mg/250 mg, 200 mg/300 mg
HIV infection
- [200 mg/300 mg PO qd]
HIV pre-exposure prophylaxis
- [daily regimen]
- Dose: 200 mg/300 mg PO qd; Info: for at-risk pts; check HIV status before tx start and q3mo or upon diagnosis of other sexually transmitted infections
- [on-demand regimen (off-label)]
- Dose: 400 mg/600 mg PO x1 dose 2-24h prior to sexual activity, then 200 mg/300 mg PO q24h x2 doses or until 48h after last sexual contact; Info: for at-risk HBsAg-negative men who have sex with men; check HIV status before tx start and q3mo or upon diagnosis of other sexually transmitted infections
HIV post-exposure prophylaxis (off-label)
- [200 mg/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, chronic (off-label)
- [200 mg/300 mg PO qd]
renal dosing
- [HIV infection]
- CrCl 30-49: 200 mg/300 mg q48h; CrCl <30: avoid use, dose adjustment not possible w/ fixed-dose combo
- HD: avoid use, dose adjustment not possible w/ fixed-dose combo; PD: not defined
- [HIV pre-exposure prophylaxis, daily regimen]
- CrCl <60: avoid use
- HD/PD: not defined
- [HIV pre-exposure prophylaxis, on-demand regimen]
- renal impairment: not defined
- HD/PD: not defined
- [HIV post-exposure prophylaxis]
- CrCl <60: avoid use
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: TAB: 100 mg/150 mg, 133 mg/200 mg, 167 mg/250 mg, 200 mg/300 mg
HIV infection
- [17-21 kg]
- Dose: 100 mg/150 mg PO qd
- [22-27 kg]
- Dose: 133 mg/200 mg PO qd
- [28-34 kg]
- Dose: 167 mg/250 mg PO qd
- [>35 kg]
- Dose: 200 mg/300 mg PO qd
HIV pre-exposure prophylaxis
- [adolescents, >35 kg]
- Dose: 200 mg/300 mg PO qd; Info: for at-risk pts; check HIV status before tx start and q3mo or upon diagnosis of other sexually transmitted infections
HIV post-exposure prophylaxis, nonoccupational (off-label)
- [13 yo and older]
- Dose: 200 mg/300 mg PO qd; Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
renal dosing
- [HIV infection]
- CrCl 30-49: consider giving usual dose q48h; CrCl <30: avoid use, dose adjustment not possible w/ fixed-dose combo
- HD: avoid use, dose adjustment not possible w/ fixed-dose combo; PD: not defined
- [HIV pre-exposure prophylaxis]
- renal impairment: not defined, consider adult renal dosing for guidance
- HD/PD: not defined
- [HIV post-exposure prophylaxis]
- renal impairment: not defined, consider adult renal dosing for guidance
- HD/PD: not defined
hepatic dosing
- [no adjustment]