Recommended Dosage and Administration

Begin treatment with Mozobil after the patient has received G-CSF once daily for 4 days [seeDosage and Administration (2.2)] . Administer Mozobil approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days.

The recommended dose of Mozobil by subcutaneous injection is based on body weight:

• 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing less than or equal to 83 kg. [see Clinical Pharmacology (12.3)]
• 0.24 mg/kg of body weight for patients weighing greater than 83 kg

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 × patient's actual body weight (in kg) = volume to be administered (in mL)

In clinical studies, Mozobil dose has been calculated based on actual body weight in patients up to 175% of ideal body weight. Mozobil dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated.

Based on increasing exposure with increasing body weight, the Mozobil dose should not exceed 40 mg/day [see Clinical Pharmacology (12.3)] .

Vials should be inspected visually for particulate matter and discoloration prior to administration and should not be used if there is particulate matter or if the solution is discolored.

Discard unused portion.

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 [see Clinical Studies (14)] .

Dose Modifications in Renal Impairment

In patients with moderate and severe renal impairment (estimated creatinine clearance (CL CR) less than or equal to 50 mL/min), reduce the dose of Mozobil by one-third based on body weight category as shown in Table 1. If CL CRis less than or equal to 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 [see Clinical Pharmacology (12.3)] . 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 [see Clinical Pharmacology (12.3)] .

The following (Cockcroft-Gault) formula may be used to estimate CL CR:

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

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

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