Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma whose cells mobilise poorly

INN:

Subtype:

Marginal Zone Lymphoma (MZL)

License:

EMA

Class:

CXCR4 antagonist

Newly Diagnosed

SmPC: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001030/WC500030686.pdf

1. Approved Labelling

Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma whose cells mobilize poorly.

2. Treatment Regimen

Mozobil therapy should be initiated and supervised by a physician experienced in oncology and/or hematology. The mobilization and apheresis procedures should be performed in collaboration with an oncology-hematology centre with acceptable experience in this field and where the monitoring of hematopoietic progenitor cells can be correctly performed.

Age over 60 and/or prior myelosuppressive chemotherapy and/or extensive prior chemotherapy and/or a peak circulating stem cell count of less than 20 stem cells/microliter, have been identified as predictors of poor mobilization.

The recommended dose of plerixafor is 0.24 mg/kg body weight/day. It should be administered by subcutaneous injection 6 to 11 hours prior to initiation of each apheresis following 4 day pre-treatment with G-CSF. In clinical trials, Mozobil has been commonly used for 2 to 4 (and up to 7) consecutive days.

The weight used to calculate the dose of plerixafor should be obtained within 1 week before the first dose of plerixafor. In clinical studies, the dose of plerixafor has been calculated based on body weight in patients up to 175% of ideal body weight. Plerixafor dose and treatment of patients weighing more than 175% of ideal body weight have no been investigated.

Ideal body weight can be determined using the following equations:

  • Male (kg): 50 + 2.3 ((Height (cm) x 0.394) - 60)
  • Female (kg): 45.5 + 2.3 x ((Height (cm) x 0.394) - 60)

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

3. AE/Warnings

Please see section 4.4 of the SmPC.

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