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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.

Glossary

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Allogeneic stem cell transplant - transplantation of stem cells from either a relative or an unrelated volunteer donor.

Anemia - a deficiency in red blood cells, leading to tiredness and lack of energy.

Apheresis - the process of collecting blood from a donor, removing one or more blood components (plasma, blood platelets, or white blood cells), and then returning the remaining blood back to the donor through transfusion.

Autologous stem cell transplant - stem cell transplant using a patient’s own stem cells.

Bone marrow - a soft sponge-like tissue in the middle of all your bones that contains lots of blood vessels; red blood cells, most white blood cells and platelets.

Bone marrow harvest – a surgical procedure used to collect bone marrow. The bone marrow harvest takes place in a hospital operating room, usually under general anesthesia. The bone marrow is extracted with a needle and syringe.

Bone marrow transplant (BMT) - infusion of stem cells obtained from the bone marrow.

Central venous catheter (CVC) - a tubular device typically inserted into a large vein in the neck. A CVC can also be inserted into the chest or the groin. A CVC is used to administer multiple medications, intravenous fluids, and to draw blood samples to perform tests.

Central venous line (CVL) – see central venous catheter.

Chemomobilization – a treatment that your doctor may utilize which uses chemotherapy (typically followed by growth factor) as a catalyst to move stem cells from bone marrow to circulating blood.

Conditioning regimen - chemotherapy or radiation that is administered prior to transplant to kill any remaining cancer cells and to make room for new stem cells.

Cryopreservation - the process by which cells or whole tissue are preserved by cooling to subzero temperatures.

Dimethylsulfoxide (DMSO) - a chemical preservative used to protect stem cells during the freezing process preventing the cells from collapsing and dying.

Double autologous transplant -also known as a tandem autologous transplant; a patient undergoing 2 planned autologous stem cell transplants sequentially, using their own stem cells collected before the initial transplant.

Engraftment - the process by which collected stem cells received during transplant start to grow and make new blood cells. The definition of engraftment in transplant is very specific and relates to a neutrophil and platelet count recovery. Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater. Platelet engraftment is defined as 20,000/mm3 (20 x 109/L) unsupported by a platelet transfusion.

General anesthesia - a process induced by drug therapy where a patient’s sensation is blocked. In this situation a patient is not awake (conscious) and will not feel any sensations .

Granulocyte-colony stimulating factor (G-CSFs) - also known as growth factors, are molecules that stimulate cell growth. There are 2 types of G-CSFs – white cell G-CSFs and red cell G-CSFs. White cell G-CSFs stimulate the production of neutrophils and red cell G-CSF stimulate the production of RBCs.

Growth factors - substances that stimulate cell growth.

Hematopoietic stem cell transplant (HSCT) - an infusion of stem cells into a recipient’s bloodstream; in cancer patients, usually performed after high intensity chemotherapy and/or radiation in order to restore healthy levels of blood cells.

Homing - occurs when new, infused stem cells begin traveling through the circulatory system and to the bone marrow.

Leukocytes - also known as white blood cells; these cells fight the bacteria, viruses, fungi, and other substances that cause infection.

Leukocytosis - a condition where the patient has elevated white blood cells in the blood.

Mobilization - the process of stimulating stem cells to move out of the bone marrow and into the bloodstream for collection.

Mucositis - the inflammation of the mucous membranes lining the digestive tract including the mouth, the windpipe, the stomach and the anus.

Neutrophils - the chief white blood cell that consume foreign materials in the body.

Orthostatic hypotension – a sudden fall in blood pressure when a person stands up from the sitting position.

Peripheral blood stem cells (PBSCs) - stem cells that leave the bone marrow and circulate in the bloodstream

Peripheral blood stem cell transplant (PBSCT) -infusion of stem cells obtained from the peripheral blood.

Platelet - a tiny disc-shaped blood fragment that assists in forming blood clots; essential to prevent excessive bleeding.

Preparative regimen - chemotherapy or radiation that is administered prior to transplant to kill any remaining cancer cells and to make a space for your new stem cells.

Remission - a decrease in or disappearance of signs and symptoms of cancer. In partial remission, some, but not all, signs and symptoms of cancer have disappeared. In complete remission, all signs and symptoms of cancer that can be detected with modern technology have disappeared, although cancer still may be in the body.

Remobilization - the process of mobilization following failure of an earlier procedure.

Renal - relating to the kidneys. Your doctor assesses your “renal function” frequently which really is how well your kidneys are working.

Spleen -an oblong-shaped organ situated between the heart and stomach that plays a role in the final destruction of red blood cells, filtration and storage of blood, and production of lymphocytes.

Stem cells - very young cells that mature into the functional components of your bloodstream like red blood cells, white blood cells, and platelets and help you recover from the marrow suppressive effects of high doses of chemotherapy and radiation..

Subcutaneous injection - an injection delivered under the skin.

Syncope – fainting or a loss of consciousness.

Syngeneic stem cell transplant - transplant using stem cells from an identical twin.

Tandem autologous transplant - see double autologous transplant.

Thrombocytopenia - a condition where there are not enough platelets in the blood. Thrombocytopenia is likely to occur following a stem cell transplant and increases your chance of bleeding.

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