Rx Item-Mozobil 24Mg 1.2Ml Vial By Aventis Pharma

MOZOBIL- plerixafor solution
Genzyme Corporation

1 INDICATIONS AND USAGE

Mozobil� (plerixafor injection) is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).

2 DOSAGE AND ADMINISTRATION

2.1 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 Dosage 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 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 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 plerixafor dose should not exceed 40 mg/day. [see Clinical Pharmacology (12.3)]

2.2 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)] DOSAGE FORMS AND STRENGTHS

Single-use vial containing 1.2 mL of a 20 mg/mL solution. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Plerixafor is an inhibitor of the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stromal cell-derived factor-1α (SDF-1α). SDF-1α and CXCR4 are recognized to play a role in the trafficking and homing of human hematopoietic stem cells (HSCs) to the marrow compartment. Once in the marrow, stem cell CXCR4 can act to help anchor these cells to the marrow matrix, either directly via SDF-1α or through the induction of other adhesion molecules. Treatment with plerixafor resulted in leukocytosis and elevations in circulating hematopoietic progenitor cells in mice, dogs and humans. CD34+ cells mobilized by plerixafor were capable of engraftment with long-term repopulating capacity up to one year in canine transplantation models.

RX ITEM-Mozobil 24Mg 1.2Ml Vial By Avent
item No.:RX257451 NDC No.24586201 00024-5862-01 0024586201 0024-5862-01 00024586201 UPC No.:300245862013 NDC No.00024-5862-01 UPC/GTIN No.3-00245-86201-3 3-00245-862013 300245-862013 MPN 586201 vial

Mozobil 24Mg 1.2Ml Vial By Aventis Pharm
BRAND: MOZOBIL NDC: 00024-5862-01,24586201 UPC: 3-00245-86201-3,300245862013 Aventis Pharmaceuticals/Ds

PLERIXAFOR SUB-Q VIAL 24M
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