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Odefsey
emtricitabine/ rilpivirine/ tenofovir alafenamide
Black Box Warnings .
Hepatitis B Exacerbation
severe acute HBV exacerbations in HBV/HIV co-infected patients when D/C emtricitabine or tenofovir; monitor hepatic function closely for at least several months in HBV/HIV co-infected patients who D/C emtricitabine/rilpivirine/tenofovir; initiate anti-HBV tx if needed
Adult Dosing .
Dosage forms: TAB: 200 mg/25 mg/25 mg
HIV infection
- [tx-naive]
- Dose: 1 tab PO qd; Info: for patients with HIV-1 RNA <100,000 and CD4 >200; give with meals
- [tx-experienced]
- Dose: 1 tab PO qd; Info: for patients with HIV-1 RNA <50; give with meals
- [pregnant patients]
- Dose: 1 tab PO qd; Info: for patients with HIV-1 RNA <50 on stable rilpivirine-containing regimen prior to pregnancy; give with meals
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined, caution advised
- HD: no adjustment, on dialysis days administer after dialysis; supplement not defined; PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: TAB: 200 mg/25 mg/25 mg
HIV infection
- [>25 kg, tx-naive]
- Dose: 1 tab PO qd; Info: for patients with HIV-1 RNA <100,000; give with meals
- [>25 kg, tx-experienced]
- Dose: 1 tab PO qd; Info: for patients with HIV-1 RNA <50; give with meals
- [pregnant patients]
- Dose: 1 tab PO qd; Info: for patients with HIV-1 RNA <50 on stable rilpivirine-containing regimen prior to pregnancy; give with meals
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined, caution advised
- HD: no adjustment, on dialysis days administer after dialysis; supplement not defined; PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined