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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.

Frequently Asked Questions for Caregivers and Patients

Commonly asked questions about treatment with Mozobil include the following:

What is Mozobil (plerixafor injection)?
How does Mozobil work?
Why would my doctor prescribe Mozobil?
How will my doctor or healthcare provider give me Mozobil?
When will I receive Mozobil and for how long?
Where will I receive Mozobil?
Is there any patient group who should not receive Mozobil?
What are some of the potential side effects of Mozobil?
Are there any potentially serious side effects of Mozobil?

What is Mozobil (plerixafor injection)?

Mozobil is a drug that when used in combination with granulocyte-colony stimulating factor (G-CSF) may help increase the hematopoetic stem cells in the blood that can be collected for autologous stem cell transplant in patients with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM).

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How does Mozobil work?

Mozobil, in combination with G-CSF, works by releasing stem cells from the bone marrow, making them available for collection from your bloodstream. Normally, these cells are present in the bloodstream in very low levels, since they are more likely to stay in the bone marrow. Mozobil in combination with G-CSF increases the number of stem cells in the blood by preventing them from remaining anchored inside the bone marrow space.

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Why would my doctor prescribe Mozobil?

Your doctor may prescribe Mozobil because you have been diagnosed with NHL or MM and are expected to eventually undergo an autologous stem cell transplant. As your own cells will be used for your stem cell transplant, your transplant team must collect them before you receive treatment for your cancer. Mozobil plus G-CSF may help to release your stem cells from the bone marrow into the bloodstream so they can be collected for transplant. Infusing your collected stem cells may help your blood counts rebound after receiving high-dose chemotherapy with or without radiation.

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How will my doctor or healthcare provider give me Mozobil?

Mozobil is administered as an injection under your skin, known as a subcutaneous injection. Some patients may experience itching, burning, swelling or redness around the site of the Mozobil injection. Let your healthcare provider know if you notice any of these symptoms.

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When will I receive Mozobil and for how long?

Mozobil will be administered approximately 11 hours prior to each apheresis session, up to a total of 4 days.

Mozobil Administration and Timing

In addition to receiving Mozobil, you will receive G-CSF for 4 days prior to the start of Mozobil and on each morning of apheresis.

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Where will I receive Mozobil?

You are most likely to receive Mozobil at your transplant center or hospital or as directed by your physician.

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Is there any patient group who should not receive Mozobil?

The following patients should not receive Mozobil:

  • Patients with a history of allergy to Mozobil.
  • Patients who have leukemia.
  • Patients who are pregnant. Women of childbearing potential should not become pregnant while receiving treatment with Mozobil.
  • Patients who are nursing mothers.
  • Patients who are under the age of 18.
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What are some of the potential side effects of Mozobil?

While being treated with Mozobil some of the most common side effects you may experience include diarrhea, nausea, vomiting, fatigue, redness and swelling at the injection site, pain in your joints, headache and dizziness.

Less common side effects that were reported in some patients who have taken Mozobil include abdominal pain and swelling, excessive sweating, dry mouth, redness of the skin, stomach discomfort, constipation, indigestion, muscle or bone pain, a reduced sensation to stimuli such as touch or generally not feeling well.

You should let your doctor know if you have difficulty breathing, eye swelling or hives shortly after your Mozobil injection as these could be signs of allergic reactions to Mozobil. You should also let your doctor know if you feel lightheaded. Some patients have experienced a sudden drop in their blood pressure when standing from a lying or sitting position (orthostatic hypotension). Do not stand up abruptly from a lying or sitting position on days when you are taking Mozobil. Allergic reactions and low blood pressure usually occur within 1 hour of Mozobil administration.

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Are there any potentially serious side effects of Mozobil?

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.

Patients taking Mozobil may experience increases in leukocytes (leukocytosis), an increased number of white blood cells; or a decrease in the number of platelets circulating in their blood (thrombocytopenia). While you are receiving Mozobil injections, your doctors and healthcare providers will monitor your blood cell counts closely to manage these side effects.

The size of your spleen may increase while you are taking Mozobil. Spleen enlargement can result in the spleen bursting (rupture), which may cause death. Signs of an enlarging spleen include pain in the upper left-hand region of your stomach or near the tip of your shoulder. Let your doctor know immediately if you have any of these symptoms.

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 has not been well studied.

Tell your doctor or healthcare provider immediately if you develop any side effects.

To report SUSPECTED ADVERSE REACTIONS, contact Sanofi US at
1-800-633-1610 Option 2 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/MedWatch.

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 Process

Autologous Stem Cell Transplant Process

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

Questions to ask Your Doctor

Questions to Ask Your Doctor

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

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