"The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Mozobil® (plerixafor injection) is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).
DOSAGE AND ADMINISTRATION
Recommended Dosage And Administration
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.
Begin treatment with Mozobil after the patient has received G-CSF once daily for four days. [see Recommended Concomitant Medications] 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 ≤ 83 kg. [see CLINICAL PHARMACOLOGY]
- 0.24 mg/kg of body weight for patients weighing > 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 x 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]
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]
Dosing In Renal Impairment
In patients with moderate and severe renal impairment (estimated creatinine clearance (CLCR) ≤ 50 mL/min), reduce the dose of Mozobil by one-third based on body weight category as shown in Table 1. If CLCR 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. [see CLINICAL PHARMACOLOGY] 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]
Table 1: Recommended Dosage of Mozobil in Patients
with Renal Impairment
|Estimated Creatinine Clearance (mL/min)||Dose|
|Body Weight ≤ 83 kg||Body Weight > 83 kg and < 160 kg|
|> 50||20 mg or 0.24 mg/kg once daily||0.24 mg/kg once daily (not to exceed 40 mg/day)|
|≤ 50||13 mg or 0.16 mg/kg once daily||0.16 mg/kg once daily (not to exceed 27 mg/day)|
The following (Cockroft-Gault) formula may be used to estimate CLCR:
|Males:||(weight in kg) x (140 – age)|
|(72) x serum creatinine (mg/100 mL)|
|Females||(0.85) x (above value)|
There is insufficient information to make dosage recommendations in patients on hemodialysis.
Dosage Forms And Strengths
Single-use vial containing 1.2 mL of a 20 mg/mL solution.
Storage And Handling
Each single-use vial is filled to deliver 1.2 mL of 20 mg/mL solution containing 24 mg of plerixafor.
NDC Number: 0024-5862-01
- Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [see USP Controlled Room temperature]
- Each vial of Mozobil is intended for single use only. Any unused drug remaining after injection must be discarded.
Manufactured by: Patheon UK Ltd., Swindon, UK. Manufactured for: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 USA. Revised: Aug 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/28/2015
Additional Mozobil Information
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