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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)
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.

What are Hematopoietic Stem Cells?

Hematopoietic stem cells (referred to as stem cells on this website) are unique cells that are primarily located in the bone marrow. These stem cells mature into a number of blood cell types found in your body.

The Biology of Stem Cells

View a larger image within our patient booklet (PDF)

The Biology of Stem Cells

In adults, the bones of the hip and chest contain the greatest amount of bone marrow and stem cells. Stem cells that leave the bone marrow and circulate into the bloodstream are called peripheral blood stem cells (PBSCs). Although very few PBSCs are found in the blood stream (outside the bone marrow space) their numbers can be increased through administering mobilization agents.

What is a Hematopoietic Stem Cell Transplant?

A hematopoietic stem cell transplant (HSCT) is the infusion of bone marrow or peripheral blood stem cells into a patient’s bloodstream. The stem cells then travel through the blood to the bone marrow, where they take up residence. These cells then grow and divide to produce mature red blood cells, white blood cells and platelets.

If you donate your own stem cells for use in transplant, it is referred to as an autologous stem cell transplant. An autologous stem cell transplant is used to treat forms of blood cancer such as non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).

Why Are Stem Cell Transplants Performed?

The idea behind the autologous stem cell transplant process is to allow administration of higher chemotherapy and/or radiation therapy doses to kill cancerous cells. Although these anticancer treatments are among the most effective available, they do not have a precise aim and can destroy normal cells as well. In an autologous stem cell transplant, a patient’s own stem cells are collected before treatment and are then returned after the high dose chemotherapy or radiation is given. This enables patients to produce new cells destroyed during chemotherapy and/or radiation treatment.

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

Autologous Stem Cell Transplant Resources

Read patient materials and link to further information
Learn more

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