Dosing and Administration

Dosing

The recommended dose of Mozobil is 0.24 mg/kg body weight by subcutaneous (SC) injection. Use the patient’s actual body weight to calculate the volume of Mozobil to be administered. Each vial delivers 1.2 mL of 20 mg/mL solution, and the volume to be administered to patients should be calculated from the following equation:

0.012 x patient’s actually body weight (in kg) = volume to be administered (in mL)

Based on increasing exposure with increasing body weight, the Mozobil dose should not exceed 40 mg/day.

Administration

Administer Mozobil approximately 11 hours prior to initiation of each apheresis session for up to 4 consecutive days.

Recommended Concomitant Medications

Administer daily morning doses of G-CSF (10 micrograms/kg) for 4 days prior to the first evening dose of Mozobil and on each day prior to apheresis.

Pharmacodynamics

In pharmacodynamic studies of Mozobil in healthy volunteers, peak mobilization of CD34+ cells was observed between 6 and 9 hours after administration. In pharmacodynamic studies of Mozobil in conjunction with G-CSF in healthy volunteers, a sustained elevation in the peripheral blood CD34+ count was observed from 4 to 18 hours after Mozobil administration with a peak CD34+ count between 10 and 14 hours.

Dosing in Renal Impairment

In patients with moderate and severe renal impairment (estimated creatinine clearance (CL_CR) ≤ 50 mL/min), reduce the dose of Mozobil by one-third to 0.16 mg/kg as shown in the table below.

Similar systemic exposure is predicted if the dose is reduced by one-third in patients with moderate and severe renal impairment compared with subjects with normal renal function.

If CL_CR is ≤ 50 mL/min the dose should not exceed 27 mg/day, as the mg/kg-based dosage results in increased plerixafor exposure with increasing body weight.

Recommended Dosage of Plerixafor in Patients with Renal Impairment

Estimated Creatinine Clearance (mL/min)	Dose
> 50	0.24 mg/kg once daily (not to exceed 40 mg/day)
≤ 50	0.16 mg/kg once daily (not to exceed 27 mg/day)

The following (Cockroft-Gault) formula may be used to estimate CL_CR:

Males:
Creatinine clearance (mL/min) = weight (kg) x (140 – age in years)
                                                 72 x serum creatinine (mg/dL)

Females:
Creatinine clearance (mL/min) = 0.85 x value calculated for males.

There is insufficient information to make dosage recommendations in patients on hemodialysis.

Read more about the Pharmacodynamics/Pharmakinetics of Mozobil (PDF)