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Black Box Warnings .
Hypersensitivity Rxn
serious or fatal hypersensitivity rxn have occurred w/ abacavir-containing products; abacavir hypersensitivity is a multi-organ clinical syndrome; HLA-B*57:01 allele carriers at higher risk of hypersensitivity rxns; abacavir/dolutegravir/lamivudine contraindicated in HLA-B*57:01-positive pts or in pts w/ prior hypersensitivity rxn to abacavir; permanently D/C if hypersensitivity rxn suspected or cannot be ruled out, regardless of HLA-B*57:01 status; NEVER restart any abacavir-containing products after hypersensitivity rxn
Hepatitis B Exacerbation
all pts w/ HIV infection should be tested for HBV before starting abacavir/dolutegravir/lamivudine; lamividine-resistant HBV variants assoc. w/ lamivudine-containing regimens reported; consider additional tx for chronic HBV tx if abacavir/dolutegravir/lamivudine used in HBV/HIV co-infected pts, or consider alternative regimen; severe acute HBV exacerbations in HBV/HIV co-infected pts upon lamivudine D/C; monitor hepatic fxn closely for at least several months in HBV/HIV co-infected pts who D/C abacavir/dolutegravir/lamivudine; initiate anti-HBV tx if needed
Adult Dosing .
Dosage forms: TAB: 600 mg/50 mg/300 mg
HIV infection
- [1 tab PO qd]
- Info: D/C drug and do not restart if hypersensitivity rxn suspected; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl 30-49: avoid use if lamivudine-related toxicities, dose adjustment not possible w/ fixed-dose combo, otherwise no adjustment; CrCl <30: avoid use, dose adjustment not possible w/ fixed-dose combo
- HD/PD: avoid use, dose adjustment not possible w/ fixed-dose combo
hepatic dosing
- [see below]
- Child-Pugh Class A: avoid use, dose adjustment not possible w/ fixed-dose combo; Child-Pugh Class B or C: contraindicated
Peds Dosing .
- Dosage forms: TAB: 600 mg/50 mg/300 mg
Special Note
- [formulation clarification]
- Info: not interchangeable w/ abacavir/dolutegravir/lamivudine dispersable tabs; do not substitute on a mg to mg basis
HIV infection
- [>25 kg]
- Dose: 1 tab PO qd; Info: D/C drug and do not restart if hypersensitivity rxn suspected; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl 30-49: avoid use if lamivudine-related toxicities, dose adjustment not possible w/ fixed-dose combo, otherwise no adjustment; CrCl <30: avoid use, dose adjustment not possible w/ fixed-dose combo
- HD/PD: avoid use, dose adjustment not possible w/ fixed-dose combo
hepatic dosing
- [see below]
- Child-Pugh Class A: avoid use, dose adjustment not possible w/ fixed-dose combo; Child-Pugh Class B or C: contraindicated