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Prescribing Information
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

Raise your expectations for apheresis success in non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM) patients with Mozobil + granulocyte-colony stimulating factor (G-CSF) compared to G-CSF alone.


Mozobil (plerixafor injection), a hematopoietic stem cell mobilizer, 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).

Mozobil + G-CSF improves mobilization through increased predictability of cell number and timing in patients with NHL or MM compared to G-CSF alone.

The efficacy and safety of Mozobil in conjunction with G-CSF in NHL and MM patients were evaluated in 2 randomized, double-blind, placebo-controlled, multicenter phase 3 studies (study 1 and study 2).

These studies sought to evaluate the safety and efficacy of Mozobil in the two most common indications for autologous stem cell transplant, NHL and MM. These studies were randomized (1:1), double-blind, placebo-controlled studies comparing Mozobil + G-CSF to placebo + G-CSF. The pivotal trials used the same general study design to examine 2 study populations, NHL (study 1) and MM (study 2) patients requiring an autologous HSCT.

Benefits of Mozobil +G-CSF vs G-CSF Alone

  • Mozobil + G-CSF increases the number of patients achieving both the minimum and the target CD34+ cells/kg in fewer apheresis sessions.
  • Mozobil + G-CSF allows for increased predictability of apheresis yield and timing.
  • Mozobil + G+CSF enables more patients to proceed to transplant.

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

Reference

  • Mozobil (plerixafor injection) Full Prescribing Information. Genzyme Corporation; 2013.

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