Mozobil® (plerixafor injection)
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For more information, please consult the full Prescribing Information. To see the product site go to www.mozobil.com |
Indication:
Mozobil, a hematopoietic stem cell mobilizer, 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 and multiple myeloma.
Key Efficacy Results:
Mozobil Clinical Efficacy in Non-Hodgkin’s Lymphoma
The efficacy and safety of Mozobil in conjunction with granulocyte-colony stimulating factor (G-CSF) in non-Hodgkin’s lymphoma (NHL) patients were evaluated in a randomized, double-blind, placebo-controlled, multicenter phase 3 study (study 1).
Mozobil + G-CSF increased the number of patients achieving both minimum and target CD34+ cells/kg in fewer apheresis sessions compared with placebo + G-CSF.
Kaplan-Meier Estimate of Required Apheresis Days to Collect ≥ 5 x 106 CD34+ Cells/kg in NHL Patients
 | Three times as many patients with NHL reached the primary endpoint of ≥ 5 million CD34+ cells within 4 days of apheresis with Mozobil + G-CSF vs. with G-CSF + placebo. |
| 90% of NHL patients proceeded to transplant when treated with Mozobil + G-CSF vs. 55.4% treated with G-CSF + placebo. |
| 87% of NHL patients collected ≥ 2 x 106 CD34+ cells/kg within 4 apheresis days with Mozobil + G-CSF vs. 47% with G-CSF + placebo. |
Mozobil Clinical Efficacy in Multiple Myeloma
The efficacy and safety of Mozobil in conjunction with granulocyte-colony stimulating factor (G-CSF) in multiple myeloma (MM) patients were evaluated in a randomized, double-blind, placebo-controlled, multicenter phase 3 study (study 2).
Mozobil + G-CSF increased the number of patients achieving both minimum and target CD34+ cells/kg in fewer apheresis sessions compared with placebo + G-CSF.
Kaplan-Meier Estimate of Percentage of MM Patients Who Achieved ≥ 6 x 106 CD34+ cells/kg by Apheresis Day
| More than twice as many patients achieved the primary endpoint of ≥ 6 x 106 CD34+ cells/kg within 2 apheresis days with Mozobil + G-CSF than with placebo + G-CSF. |
| 72% of MM patients who were mobilized with Mozobil + G-CSF collected ≥ 6 x 106 CD34+ cells/kg from the peripheral blood in two or fewer apheresis sessions, compared with 34% of patients who were mobilized with placebo + G-CSF (p < 0.001). |
Important Safety Information:
Mozobil may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Mozobi is not intended for HSC mobilization and harvest in patients with leukemia.
Mozobil in conjunction with G-CSF increases circulating leukocytes and HSC populations. White blood cell counts should be monitored during treatment. Clinical judgment should be exercised when administering Mozobil to patients with peripheral white blood cell counts above 50,000/mcL.
Thrombocytopenia has been observed in patients receiving Mozobil. Platelet counts should be monitored in patients who receive Mozobil and then undergo apheresis.
In patients treated with Mozobil in combination with G-CSF for HSC mobilization‚ tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.
The effect of Mozobil on spleen size was not specifically evaluated in clinical studies. Individuals receiving Mozobil in combination with G-CSF who report left upper abdominal pain and/or scapular or shoulder pain should be evaluated for splenic integrity.
Mozobil may cause fetal harm when administered to a pregnant woman. Plerixafor was teratogenic in animals. There are no adequate and well-controlled studies in pregnant women using Mozobil. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Mozobil.
The most common adverse reactions (≥10%) during HSC mobilization and apheresis were: diarrhea (37%), nausea (34%), fatigue (27%), injection site reaction (34%), headache (22%), arthralgia (13%), dizziness (11%), and vomiting (10%). The majority of these adverse reactions were Grade 1 and 2.
For more information, please consult the Full Prescribing Information (PDF).
To see the product site go to www.mozobil.com.