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)

INN:

Subtype:

Mantle Cell Lymphoma (MCL)

License:

FDA

Class:

CXCR4 antagonist

Newly Diagnosed

PI: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022311s001lbl.pdf

1. Approved Labelling

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).

2. Treatment Regimen

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. 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)
  • Based on increasing exposure with increasing body weight, the plerixafor dose should not exceed 40 mg/day.
  • Renal impairment: if creatinine clearance is ≤ 50 mL/min, decrease dose by one-third to 0.16 mg/kg.

3. AE/Warnings

Please see section 5 of the PI.

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