Elderly: there is limited experience in patients >65 years of age, therefore caution should be exercised when administering CELSENTRI in elderly patients (see PHARMACOLOGY, Pharmacokinetics and PRECAUTIONS). Renal impairment: Table 13 provides dosing recommendations for patients based on renal function and concomitant medications Table 13: Recommended dosing regimens based on renal function Concomitant CELSENTRI dose on Renal Function Medications* Normal Mild Moderate Severe End Stage Renal Disease (ESRD) CrCl >80 CrCl >50 CrCl >30 CrCl On Regular ≤ mL/min mL/min and mL/min and Haemodialysis ≤ ≤ 80-mL/min 50-mL/min Potent 150 mg 150 mg twice 150 mg twice NR NR inhibitors (with or twice daily daily daily without CYP3A inducer)* Other concomitant 300 mg 300 mg twice 300 mg twice 300 mg 300 mg medications* twice daily daily daily twice daily# daily# Potent CYP3A 600 mg 600 mg twice 600 mg twice NR NR inducers (without twice daily daily daily CYP3A inhibitor)* NR = not recommended *See Table 7 for list of concomitant medications # The CELSENTRI dose should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension (see PRECAUTIONS, Renal Impariments) Hepatic impairment: limited data in mild and moderately hepatically impaired patients demonstrated increase in the mean Cmax of maraviroc, suggesting no dose adjustment is required. However, CELSENTRI should be used with caution in patients with hepatic impairment (see PHARMACOLOGY, Pharmacokinetics and PRECAUTIONS). Race: no dosage adjustment is necessary on the basis of race (see PHARMACOLOGY, Pharmacokinetics). Gender: no dosage adjustment is necessary on the of gender (see PHARMACOLOGY, Pharmacokinetics). OVERDOSAGE The highest dose administered in clinical studies was 1200 mg. The dose limiting adverse reaction was postural hypotension.
Elderly: there is limited experience in patients >65 years of age, therefore caution should be exercised when administering CELSENTRI in elderly patients (see PHARMACOLOGY, Pharmacokinetics and PRECAUTIONS). Renal impairment: Table 13 provides dosing recommendations for patients based on renal function and concomitant medications Table 13: Recommended dosing regimens based on renal function Concomitant Medications* CELSENTRI dose on Renal Function Normal Mild Moderate Severe End Stage Renal Disease (ESRD) CrCl >80 mL/min CrCl >50 mL/min and ≤ 80-mL/min CrCl >30 mL/min and ≤ 50-mL/min CrCl ≤ On Regular Haemodialysis Potent inhibitors (with or without CYP3A inducer)* 150 mg twice daily 150 mg twice daily 150 mg twice daily NR NR Other concomitant medications* 300 mg twice daily 300 mg twice daily 300 mg twice daily 300 mg twice daily# 300 mg daily# Potent CYP3A inducers (without CYP3A inhibitor)* 600 mg twice daily 600 mg twice daily 600 mg twice daily NR NR NR = not recommended *See Table 7 for list of concomitant medications # The CELSENTRI dose should be reduced to 150 mg twice daily if there are any symptoms of postural hypotension (see PRECAUTIONS, Renal Impariments) Hepatic impairment: limited data in mild and moderately hepatically impaired patients demonstrated increase in the mean Cmax of maraviroc, suggesting no dose adjustment is required. However, CELSENTRI should be used with caution in patients with hepatic impairment (see PHARMACOLOGY, Pharmacokinetics and PRECAUTIONS). Race: no dosage adjustment is necessary on the basis of race (see PHARMACOLOGY, Pharmacokinetics). Gender: no dosage adjustment is necessary on the of gender (see PHARMACOLOGY, Pharmacokinetics). OVERDOSAGE The highest dose administered in clinical studies was 1200 mg. The dose limiting adverse reaction was postural hypotension.
auspar-maraviroc-130512-pi.docx