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Prescribing Information
Mozobil

Prescribing Information
Important Safety Information

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

Important Safety Information for Mozobil (plerixafor injection)
Severe, life-threatening allergic reactions (anaphylaxis) can happen in people who take Mozobil. Tell your doctor right away if you experience hives (itchy raised bumps), eye swelling, or trouble breathing. View additional Important Safety Information.

Why Mozobil?

Mozobil (plerixafor injection) is approved by the United States Food and Drug Administration (FDA) to be used with another agent, granulocyte-colony stimulating factor (G-CSF), to mobilize hematopoietic stem cells into the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM).

The safety and efficacy of Mozobil in children has not been established in clinical studies.

How Mozobil Works

Mozobil, in combination with G-CSF, releases hematopoietic stem cells from the bone marrow into the bloodstream by disrupting a bond that normally keeps stem cells anchored to the bone marrow. This enables your healthcare team to collect more stem cells during apheresis.

View a larger image within our patient booklet (PDF)

How Mozobil Works

Benefits of Mozobil

Clinical studies demonstrated that using Mozobil with G-CSF, had several benefits as compared to using G-CSF alone for the mobilization of stem cells in patients with NHL or MM.

These included:

  • More patients were able to proceed to an autologous transplant
  • More stem cells were collected per apheresis session
  • Fewer apheresis sessions were needed to collect the target number of stem cells to proceed to transplant
  • Nearly all NHL and MM patients receiving cells mobilized by either Mozobil in combination with G-CSF or by G-CSF alone had successful regrowth of stem cells (engraftment)

Patients taking Mozobil may experience certain side effects. The most common side effects (adverse reactions), occurring in greater than 10% of patients during HSC mobilization were: diarrhea, nausea, tiredness (fatigue), injection site reaction, headache, pain in your joints (arthralgia), dizziness and vomiting.

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)

  • Severe, life-threatening allergic reactions (anaphylaxis) can happen in people who take Mozobil. Tell your doctor right away if you experience hives (itchy raised bumps), eye swelling, or trouble breathing.
  • Mozobil is not intended for hematopoietic stem cell transplantation (HSCT) mobilization and collection in patients with leukemia.
  • Mozobil in combination with G-CSF increases circulating white blood cells (WBCs). Your WBC counts will be monitored.
  • Thrombocytopenia (a decrease in the number of platelets circulating in the blood) has been observed in patients receiving Mozobil. Your platelet counts will be monitored.
  • Cancer cells may be released from the bone marrow and subsequently collected along with your stem cells during apheresis. The potential effects of infusing cancer cells during your transplant have not been well-studied.
  • Your spleen may be examined if you experience pain in the left upper stomach area or left shoulder area as these may be signs of an enlarged or burst (ruptured) spleen.
  • Mozobil may harm the unborn child when administered to a pregnant woman. Scientific studies have shown that Mozobil causes harm to unborn animals. The safety of Mozobil in pregnant women has not been established in clinical trials. If you are of childbearing potential you should be advised to avoid becoming pregnant while receiving treatment with Mozobil. If this drug is used during pregnancy, or if you become pregnant while taking this drug, you should be apprised of the potential hazard to the unborn child.
  • The most common adverse reactions (occurring in greater than or equal to 10% of patients) during HSC mobilization and apheresis were: diarrhea (37%), nausea (34%), tiredness (fatigue) (27%), injection site reactions (34%), headache (22%), pain in your joints (arthralgia) (13%), dizziness (11%), and vomiting (10%).

Please see full Prescribing Information

Questions to ask Your Doctor

Questions to Ask Your Doctor

Prepare for your next appointment with our list of questions to ask your doctor.

Autologous Stem Cell Transplant Process

Autologous Stem Cell Transplant Process

View our guide to learn more about the autologous stem cell transplant process.
Download guide

Important Safety Information
Severe, life-threatening allergic reactions (anaphylaxis) can happen in people who take Mozobil. Tell your doctor right away if you experience hives (itchy raised bumps), eye swelling, or trouble breathing.

  • 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)

    • Severe, life-threatening allergic reactions (anaphylaxis) can happen in people who take Mozobil. Tell your doctor right away if you experience hives (itchy raised bumps), eye swelling, or trouble breathing.
    • Mozobil is not intended for hematopoietic stem cell transplantation (HSCT) mobilization and collection in patients with leukemia.
    • Mozobil in combination with G-CSF increases circulating white blood cells (WBCs). Your WBC counts will be monitored.
    • Thrombocytopenia (a decrease in the number of platelets circulating in the blood) has been observed in patients receiving Mozobil. Your platelet counts will be monitored.
    • Cancer cells may be released from the bone marrow and subsequently collected along with your stem cells during apheresis. The potential effects of infusing cancer cells during your transplant have not been well-studied.
    • Your spleen may be examined if you experience pain in the left upper stomach area or left shoulder area as these may be signs of an enlarged or burst (ruptured) spleen.
    • Mozobil may harm the unborn child when administered to a pregnant woman. Scientific studies have shown that Mozobil causes harm to unborn animals. The safety of Mozobil in pregnant women has not been established in clinical trials. If you are of childbearing potential you should be advised to avoid becoming pregnant while receiving treatment with Mozobil. If this drug is used during pregnancy, or if you become pregnant while taking this drug, you should be apprised of the potential hazard to the unborn child.
    • The most common adverse reactions (occurring in greater than or equal to 10% of patients) during HSC mobilization and apheresis were: diarrhea (37%), nausea (34%), tiredness (fatigue) (27%), injection site reactions (34%), headache (22%), pain in your joints (arthralgia) (13%), dizziness (11%), and vomiting (10%).

    Please see full Prescribing Information