Benefits and risks of Mozobil

Mozobil is a mobilization agent for those who have been diagnosed with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM) and are expected to eventually undergo an autologous stem cell transplant (ASCT).

As a person’s own cells will be used in autologous SCT, a transplant team must collect them prior to treatment for cancer and keep them until transplant. Mozobil helps to release stem cells from the bone marrow into the bloodstream so they can be collected for transplant through a process called stem cell mobilization.

How could Mozobil help?

In clinical studies, Mozobil + [growth factors] demonstrated several benefits for the mobilization of stem cells compared to G-CSF alone.

Mozobil + G-CSF was found to significantly reduce mobilization failures vs G-CSF alone in two well-controlled trials evaluating safety and efficacy

MM
Mozobil
+ G-CSF
71.6%
vs
Placebo
+ G-CSF
34.4%

Percentage of patients with MM who achieved the target stem cell collection goal* in 2 or fewer days of apheresis with Mozobil + G-CSF vs placebo + G-CSF, respectively

NHL
Mozobil
+ G-CSF
59.3%
vs
Placebo
+ G-CSF
19.6%

Percentage of patients with NHL who achieved the target stem cell collection goal in 4 or fewer days of apheresis with Mozobil + G-CSF vs placebo + G-CSF, respectively

*Target=6 million CD34+ cells/kg
Target=5 million CD34+ cells/kg

Significantly higher success rates for mobilizing stem cells was seen with Mozobil + G-CSF compared to placebo + G-CSF

  • - More patients achieved the minimum and target number of stem cells for a transplant
  • - More patients collected stem cells and went on to stem cell transplant

Potential for fewer apheresis procedures

  • - More patients needed only 1 day to collect the target number of stem cells with Mozobil + G-CSF compared to placebo + G-CSF
    • - MM: 54.2% collected in 1 day for Mozobil + G-CSF arm vs 17.3% in placebo + G-CSF arm
    • - NHL: 27.9% collected in 1 day for Mozobil + G-CSF arm vs 4.2% in placebo + G-CSF arm

Who shouldn’t receive Mozobil?

Talk to a doctor or healthcare provider about whether or not Mozobil should be taken while:

  • You are pregnant or trying to become pregnant
  • You are a nursing mother
  • You are under the age of 18

People who have leukemia should not receive Mozobil. Taking Mozobil to increase stem cells while you have leukemia may increase the number of leukemic cells in the bloodstream.

Mozobil may cause harm to an unborn child when administered to pregnant women. Women of childbearing potential should not become pregnant while receiving treatment with Mozobil.

What are some of the potential side effects of Mozobil?

  • While being treated with Mozobil, some of the most common side effects a person may experience include diarrhea, nausea, vomiting, fatigue, redness and swelling at the injection site, pain in your joints, headache, and dizziness. Most of these side effects may improve or disappear after you finish receiving Mozobil injections.
  • Less common side effects that were reported in some people 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 a general feeling of being unwell.
  • Let a doctor know if you feel lightheaded or have difficulty breathing shortly after your Mozobil injection as these could be signs of allergic reactions to Mozobil. Some patients have experienced a sudden drop in their blood pressure when standing from a sitting position (orthostatic hypotension). Do not stand up abruptly on days when you are taking Mozobil. This usually occurs within 1 hour of Mozobil administration.
  • Patients taking Mozobil may experience increases in leukocytes (leukocytosis), an increased number of white blood cells (WBCs); 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 if you develop any other potential side effects.

What does Mozobil actually do?

Mozobil works by releasing stem cells from the bone marrow, making them available to collect from your bloodstream. Specifically, Mozobil binds to a protein on the surface of stem cells called CXCR4. Normally, these stem cells are present in the bloodstream in very low numbers since they are more likely to stay in the bone marrow. Mozobil increases the levels of stem cells in the blood by preventing them from remaining anchored inside the bone marrow space. This enables your healthcare team to collect more stem cells during apheresis.

Diagram showing stem cells anchored in the bone marrow through the CXCR4/SDF‐1a interaction

Stem cells anchored in the bone marrow through the CXCR4/SDF-1α interaction

Diagram showing Mozobil disrupting the CXCR4/SDF‐1a interaction.

Mozobil disrupts the CXCR4/SDF-1α interaction

Diagram showing stem cells moving into the bloodstream.

Stem cells moving into the bloodstream

What is mobilization?

Stem cell mobilization is a process whereby stem cells are stimulated out of the bone marrow space (eg, the hip bones and the chest bone) into the bloodstream so they are available for collection for future reinfusion. Learn what happens during stem cell mobilization.

How is Mozobil administered?

Mozobil is to be administered as a subcutaneous injection approximately 11 hours prior to the start of each apheresis session for up to 4 consecutive days.

Chart showing how Mozobil is administered.

For patients taking Mozobil with G-CSF, the median number of days required to reach the target number of stem cells was 1 for patients with MM and 3 for patients with NHL.

You are most likely to receive Mozobil at your transplant center or hospital depending on hours of operation.

Mozobil is to be used in combination with G-CSF. G-CSF is administered in the morning daily for 4 days prior to the first dose of Mozobil and on each morning prior to apheresis.