Original GlobalRPh source
- Product / population
- Preserved GlobalRPh source, not a freshly verified product label
- Renal measure
- Use the method specified in the original source
Historical source: not automatically current. Review current official labeling and separately attributed additions before use.
Indication and tropism comments
SELZENTRY is used in combination for adult HIV-1 infection with only CCR5-tropic virus. The source describes two studies in treatment-experienced adults with three-class experience (NRTI, NNRTI, protease inhibitor and/or enfuvirtide) and ongoing replication, and one study in treatment-naive adults.
A highly sensitive validated tropism test is required. Outgrowth of previously undetected low-level CXCR4-tropic or dual/mixed virus can cause failure. The source reports no efficacy in a phase 2 study of dual/mixed or CXCR4 virus. It also describes unestablished pediatric use in that historical labeling and more virologic failure/lamivudine resistance in treatment-naive recipients than with efavirenz.
Usual Dosing (Adults)
Always combine with other antiretrovirals; take with or without food. Dose depends on coadministered drugs:
- Potent CYP3A inhibitors, with or without an inducer: 150 mg twice daily. Examples include protease inhibitors except tipranavir/ritonavir, delavirdine, ketoconazole, itraconazole, clarithromycin, nefazodone and telithromycin.
- Other drugs: 300 mg twice daily. Examples include tipranavir/ritonavir, nevirapine, raltegravir, NRTIs and enfuvirtide.
- Potent CYP3A inducers without a potent inhibitor: 600 mg twice daily. Examples include efavirenz, rifampin, etravirine, carbamazepine, phenobarbital and phenytoin.
Renal Dosing and hemodialysis
For normal (CrCl above 80), mild (above 50 to 80) or moderate (30-50 mL/min) impairment: use the interaction-specific regimens above.
For severe impairment (CrCl below 30) and ESRD receiving hemodialysis:
- With potent CYP3A inhibitors, with or without inducers: not recommended in the source table.
- With drugs in the 'other' group: 300 mg twice daily; reduce to 150 mg twice daily if postural hypotension occurs.
- With potent CYP3A inducers without an inhibitor: not recommended.
The separate hemodialysis heading supplies no additional instruction beyond this table.