Posology : מינונים

2        DOSAGE AND ADMINISTRATION
2.1      Testing prior to Initiation of SELZENTRY
Prior to initiation of CELSENTRI for treatment of HIV-1 infection, test all patients for CCR5 tropism using a highly sensitive tropism assay. CELSENTRI is recommended for patients with only CCR5-tropic HIV-1 infection. Outgrowth of pre-existing low-level CXCR4- or dual/mixed-tropic HIV-1 not detected by tropism testing at screening has been associated with virologic failure on CELSENTRI [see Microbiology (12.4), Clinical Studies (14.1)].
Monitor patients for ALT, AST, and bilirubin prior to initiation of CELSENTRI and at other time points during treatment as clinically indicated [see Warnings and Precautions (5.1)].
2.2      General Dosing Recommendations
•     CELSENTRI tablets are taken twice daily by mouth and may be taken with or without food.
•     CELSENTRI must be given in combination with other antiretroviral medications.


•     The recommended dosage of CELSENTRI differs based on concomitant medications due to drug interactions.
2.3       Recommended Dosage in Adult Patients with Normal Renal Function
Table 1 displays oral dosage of CELSENTRI based on different concomitant medications [see Drug Interactions (7.1)].

Table 1. Recommended Dosage in Adults
Concomitant Medications                              Dosage of CELSENTRI Potent cytochrome P450 (CYP)3A inhibitors (with or without a                 150 mg twice daily a potent CYP3A inducer)
Noninteracting concomitant medications b                                     300 mg twice daily c
Potent CYP3A inducers (without a potent CYP3A inhibitor)                     600 mg twice daily a
Potent CYP3A inhibitors (with or without a potent CYP3A inducer) including: clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, protease inhibitors (except tipranavir/ritonavir), telithromycin, telaprevir.
b
Noninteracting concomitant medications include all medications that are not potent CYP3A inhibitors or inducers such as: dolutegravir, enfuvirtide, nevirapine, all nucleoside reverse transcriptase inhibitors (NRTIs), raltegravir, and tipranavir/ritonavir.
c
Potent CYP3A inducers (without a potent CYP3A inhibitor) including: carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin.
2.4          Recommended Dosage in Patients with Renal Impairment
Table 2 provides dosing recommendations for patients based on renal function and concomitant medications.

Table 2. Recommended Dosage in Adults Based on Renal Function
Concomitant Medications                    Dosage of CELSENTRI Based on Renal Function Mild       Moderate                     End-Stage
Normal         (CrCl >50     (CrCl ≥30       Severe      Renal Disease (CrCl >80        and ≤80       and ≤50      (CrCl <30      on Regular mL/min)         mL/min)       mL/min)       mL/min)      Hemodialysis Potent CYP3A inhibitors        150 mg          150 mg        150 mg        Contra-        Contra- (with or without a CYP3A     twice daily     twice daily   twice daily    indicated      indicated inducer) a
Noninteracting concomitant     300 mg          300 mg        300 mg        300 mg      300 mg twice medicationsb                 twice daily     twice daily   twice daily   twice daily       dailyc Potent CYP3A inducers          600 mg          600 mg        600 mg        Contra-        Contra- (without a potent CYP3A      twice daily     twice daily   twice daily    indicated      indicated inhibitor) d a
Potent CYP3A inhibitors (with or without a CYP3A inducer) including: clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, protease inhibitors (except tipranavir/ritonavir), telithromycin, telaprevir.
b
Noninteracting concomitant medications include all medications that are not potent CYP3A inhibitors or inducers such as: dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir.
c
Dosage of CELSENTRI should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension [see Contraindications (4), Warnings and Precautions (5.3)].
d
Potent CYP3A inducers (without a potent CYP3A inhibitor) including: carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin.