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Mozobil

Prescribing Information
Important Safety Information

Mozobil
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1-877-4MOZOBIL
(1-877-466-9624)

Important Safety Information for Mozobil (plerixafor injection)
Mozobil is contraindicated in patients with a history of hypersensitivity to Mozobil. Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred in patients receiving Mozobil. View additional Important Safety Information.

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.

Study 2 Endpoints

  • Primary endpoint:
    • Number of patients reaching a target of ≥ 6 × 106 CD34+ cells/kg in ≤ 2 days of apheresis
  • Secondary endpoints:
    • Number of patients who achieved a target of > 6 x 106 CD34+ cells/kg in < 4 days of apheresis
    • Number of patients who achieved a minimum of ≥ 2 × 106 CD34+ cells/kg in <4 days of apheresis or less
    • Number of apheresis days required to reach the target of ≥ 6 × 106 CD34+ cells/kg
    • Time to neutrophil and platelet engraftment
    • Graft durability at 100 days, 6 months, and 12 months
    • Safety of Mozobil (0.24 mg/kg) + G-CSF

Patients

Study 2 enrolled 302 patients with MM, 148 to Mozobil + G-CSF and 154 to placebo + G-CSF. Mean age was 58.2 years for Mozobil patients and 58.4 years for placebo patients. As with study 1 most patients were Caucasian (81.1%). Unlike study 1, a similar percentage of patients in both arms had advanced disease (stage III), but more Mozobil patients had stage I MM (19%) compared to G-CSF + placebo patients (12%). This difference is not expected to influence efficacy.

Seven of 154 patients (4.5%) treated with placebo + G-CSF who failed to collect either at least 0.8 x 106 cells/kg after 2 days of apheresis or at least 2 x 106 CD34+ cells/kg in 4 apheresis days, or MM patients who planned for tandem transplant and did not collect at least 4 x 106 CD34+ cells/kg in 4 or fewer apheresis days, entered the rescue protocol and went on to receive open label Mozobil + G-CSF. No patients on the Mozobil arm entered the rescue protocol. All rescue patients collected ≥ 2x 106 CD34+ cells/kg, and 42.9% of patients collected more than 6 x 106 CD34+ cells/kg. All rescue patients proceeded to transplantation, and 4 had tandem transplants.

Study 2 Multiple Myeloma (N = 302)

Study 2 Outcomes

Multiple Myeloma Phase 3 Trial (Study 2): Efficacy

Multiple Myeloma Phase 3 Trial (Study 2): Efficacy

  Mozobil (plerixafor injection) + G-CSF (n=148) Placebo + G-CSF (n=154) P Value a
Primary endpoint1 Proportion of patients achieving > 6 x 106 CD34+ cells/kg in < 2 days of apheresis 71.6% 34.4% < .001
Secondary endpoint1 Proportion of patients achieving ≥ 2 x106 CD34+ cells/kg in ≤ 4 days of apheresis 75.7% 51.3% < .001
Patients proceeding to transplant, n(%)2 142 (96%) 136 (88.3%) < .001

aEstimate of treatment effect: P value assessed by Cochran-Mantel-Haenszel test blocked by study centre and Pearson chi-square with similar results
  • 1. Mozobil (prescribing information). Cambridge, MA: Genzyme Corp: 2013.
  • 2. Dipersio JF, S, et al. Blood. 2009;113(23).:5720-5726.
  • 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).
Median Number of Cells Collected Each Apheresis Day
  • * DiPersio JF, S, et al. Blood. 2009;113(23):5720-5726.

Kaplan-Meier Estimate of Percentage of MM Patients
  • The median number of days to reach target number of CD34+ cells/kg was 1 day with Mozobil + G-CSF vs. 4 days with placebo + G-CSF .
Adverse Reactions in Mozobil Phase 3 Studies
Adverse Reactions in Mozobil Phase 3 Studies

Indication

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).

Important Safety Information for Mozobil (plerixafor injection)

  • Mozobil is contraindicated in patients with a history of hypersensitivity to Mozobil.
  • Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred in patients receiving Mozobil. Observe patients for signs and symptoms of hypersensitivity during and after Mozobil administration for at least 30 minutes and until clinically stable. Only administer Mozobil when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • Mozobil may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Mozobil 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.
  • 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 is teratogenic in animals. There are no adequate and well-controlled studies in pregnant women using Mozobil. Advise women of childbearing potential 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 reactions (34%), headache (22%), arthralgia (13%), dizziness (11%), and vomiting (10%). The majority of these adverse reactions were Grade 1 or 2.

Please see full Prescribing Information

References

  • Mozobil (plerixafor injection) Full Prescribing Information. Genzyme Corporation; 2013.
  • Dipersio JF, Stadtmauer EA, Nademanee A, et al. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009;113(23):5720-5726
Learn More

Mozobil Efficacy in Non-Hodgkin’s Lymphoma (NHL)

Learn more about Mozobil clinical efficacy in a randomized, placebo-controlled phase 3 study of Mozobil + G-CSF in 298 NHL patients.

Mozobil Safety Profile

Find out more about Mozobil Warnings, Precautions, Adverse Events and Use in Specific Populations.

Important Safety Information
Mozobil is contraindicated in patients with a history of hypersensitivity to Mozobil. Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred.

  • Indication

    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).

    Important Safety Information for Mozobil (plerixafor injection)

    • Mozobil is contraindicated in patients with a history of hypersensitivity to Mozobil.
    • Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred in patients receiving Mozobil. Observe patients for signs and symptoms of hypersensitivity during and after Mozobil administration for at least 30 minutes and until clinically stable. Only administer Mozobil when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
    • Mozobil may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Mozobil 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.
    • 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 is teratogenic in animals. There are no adequate and well-controlled studies in pregnant women using Mozobil. Advise women of childbearing potential 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 reactions (34%), headache (22%), arthralgia (13%), dizziness (11%), and vomiting (10%). The majority of these adverse reactions were Grade 1 or 2.

    Please see full Prescribing Information