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Mozobil

Prescribing Information
Important Safety Information

Mozobil
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1-877-4MOZOBIL
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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 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.

Study 1 Endpoints

  • Primary endpoint:
    • Number of patients reaching a target of ≥ 5 × 106 CD34+ cells/kg in ≤ 4 days of apheresis
  • Secondary endpoints:
    • Number of patients who achieved a minimum of ≥ 2 × 106 CD34+ cells/kg in ≤ 4 days of apheresis
    • Number of apheresis days required to reach the target of ≥ 5 × 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 1 randomized 298 patients with NHL, 150 Mozobil + G-CSF and 148 placebo + G-CSF. Mean age was 55.1 years for Mozobil patients and 57.5 years for placebo patients. Most (92.6%) subjects were Caucasian. More patients in the Mozobil group had late stage disease (stage IV), 48% versus 35%, respectively.

Ten patients treated with Mozobil + G-CSF and 52 patients treated with placebo + G-CSF failed to collect either at least 0.8 x 106 cells/kg after 2 apheresis days or at least 2 x 106 CD34+ cell/kg in 4 apheresis days. These patients entered the rescue protocol and went on to receive open label Mozobil + G-CSF. Among these rescue patients 37/62 (59.7%), 4/10 from the Mozobil group and 33/52 from the placebo group, achieved ≥ 2 x 106 CD34+ cells/kg in 4 or fewer days of apheresis after a course of Mozobil + G-CSF; 84% proceeded to transplant.

Study 1 Non-Hodgkin’s Lymphoma (N = 298)

Study 1 Outcomes

NHL Phase 3 Trial (Study 1): Efficacy

NHL Phase 3 Trial (Study 1): Efficacy

  Mozobil (plerixafor injection) + G-CSF (n=150) Placebo + G-CSF (n=148) P Value a
Primary endpoint1 Proportion of patients achieving > 5 x 106 CD34+ cells/kg in < 4 days of apheresis 59.3% 19.6% < .001
Secondary endpoint1 Proportion of patients achieving ≥ 2 x106 CD34+ cells/kg in ≤ 4 days of apheresis 86.7% 47.3% < .001
Patients proceeding to transplant, n(%)2 135 (90%) 82 (55.4%) < .001

NHL non-Hodgkin’s lymphoma 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. J Clin Oncol. 2009;27(28):4767-4773.
  • 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.

Kaplan-Meier Estimate of Required Apheresis Days to Collect ≥ 5 x 106 CD34+ Cells/kg in NHL Patients

Kaplan-Meier Estimate of Required Apheresis Days to Collect
  • NHL patients receiving Mozobil + G-CSF had a greater day 1 collection of CD34+ cells/kg than patients receiving placebo + G-CSF.

Kaplan-Meier Estimate of Percentage of NHL Patients Who Achieved ≥ 2 x 106 CD34+ Cells/kg by Apheresis Day

Kaplan-Meier Estimate of Percentage of NHL Patients
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, Micallef IN, Stiff PJ, et al. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009;27(28):4767-4773.
  • Micallef IN, Stiff PJ, DiPersio JF, et al. Successful stem cell remobilization using plerixafor (Mozobil) plus granulocyte colonystimulating factor in patients with non-Hodgkin lymphoma: results from the plerixafor NHL phase 3 study rescue protocol. Biol Blood Marrow Transplant. 2009;15(12):1578-1586.
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Mozobil Efficacy in Multiple Myeloma (MM)

Learn more about Mozobil clinical efficacy in a randomized, placebo-controlled phase 3 study of Mozobil + G-CSF in 302 MM patients.

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