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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)
Mozobil is contraindicated in patients with a history of hypersensitivity to Mozobil. Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred in patients receiving Mozobil. View additional Important Safety Information.

Additional Resources


Mozobil Full Prescribing Information
Includes the highlights of prescribing information and full prescribing information.

Mozobil Billing Guide (PDF)
A detailed guide to help simplify the Mozobil billing process.

Resources for Patients

Patient & Caregiver Education Booklet (PDF)
This booklet is designed to provide your patients with information regarding the use of Mozobil (plerixafor injection) to mobilize stem cells and autologous hematopoietic stem cell transplantation (HSCT) to treat non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).

Potential Questions to Ask Your Doctor (PDF)
Potential questions for patients to bring to their appointments to help stimulate discussion with their doctor about the stem cell transplant process.

Preparing for an Autologous Transplant (PDF)
Help your patients learn more about the autologous stem cell transplant process with a step-by-step guide.

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)

  • Mozobil is contraindicated in patients with a history of hypersensitivity to Mozobil.
  • Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred in patients receiving Mozobil. Observe patients for signs and symptoms of hypersensitivity during and after Mozobil administration for at least 30 minutes and until clinically stable. Only administer Mozobil when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • Mozobil may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Mozobil is not intended for HSC mobilization and harvest in patients with leukemia.
  • Mozobil in conjunction with G-CSF increases circulating leukocytes and HSC populations. White blood cell counts should be monitored during treatment.
  • Thrombocytopenia has been observed in patients receiving Mozobil. Platelet counts should be monitored in patients who receive Mozobil and then undergo apheresis.
  • In patients treated with Mozobil in combination with G-CSF for HSC mobilization‚ tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.
  • The effect of Mozobil on spleen size was not specifically evaluated in clinical studies. Individuals receiving Mozobil in combination with G-CSF who report left upper abdominal pain and/or scapular or shoulder pain should be evaluated for splenic integrity.
  • Mozobil may cause fetal harm when administered to a pregnant woman. Plerixafor is teratogenic in animals. There are no adequate and well-controlled studies in pregnant women using Mozobil. Advise women of childbearing potential to avoid becoming pregnant while receiving treatment with Mozobil.
  • The most common adverse reactions (≥10%) during HSC mobilization and apheresis were: diarrhea (37%), nausea (34%), fatigue (27%), injection site reactions (34%), headache (22%), arthralgia (13%), dizziness (11%), and vomiting (10%). The majority of these adverse reactions were Grade 1 or 2.

Please see full Prescribing Information

Reference

  • Mozobil (plerixafor injection) Full Prescribing Information. Genzyme Corporation; 2013.
Learn More

Mozobil Efficacy in Non-Hodgkin’s Lymphoma (NHL)

Learn more about Mozobil clinical efficacy in a randomized, placebo-controlled phase 3 study of Mozobil + G-CSF in 298 NHL patients.

Mozobil Safety Profile

Find out more about Mozobil Warnings, Precautions, Adverse Events and Use in Specific Populations.

Important Safety Information
Mozobil is contraindicated in patients with a history of hypersensitivity to Mozobil. Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred.

  • 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)

    • Mozobil is contraindicated in patients with a history of hypersensitivity to Mozobil.
    • Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred in patients receiving Mozobil. Observe patients for signs and symptoms of hypersensitivity during and after Mozobil administration for at least 30 minutes and until clinically stable. Only administer Mozobil when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
    • Mozobil may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Mozobil is not intended for HSC mobilization and harvest in patients with leukemia.
    • Mozobil in conjunction with G-CSF increases circulating leukocytes and HSC populations. White blood cell counts should be monitored during treatment.
    • Thrombocytopenia has been observed in patients receiving Mozobil. Platelet counts should be monitored in patients who receive Mozobil and then undergo apheresis.
    • In patients treated with Mozobil in combination with G-CSF for HSC mobilization‚ tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.
    • The effect of Mozobil on spleen size was not specifically evaluated in clinical studies. Individuals receiving Mozobil in combination with G-CSF who report left upper abdominal pain and/or scapular or shoulder pain should be evaluated for splenic integrity.
    • Mozobil may cause fetal harm when administered to a pregnant woman. Plerixafor is teratogenic in animals. There are no adequate and well-controlled studies in pregnant women using Mozobil. Advise women of childbearing potential to avoid becoming pregnant while receiving treatment with Mozobil.
    • The most common adverse reactions (≥10%) during HSC mobilization and apheresis were: diarrhea (37%), nausea (34%), fatigue (27%), injection site reactions (34%), headache (22%), arthralgia (13%), dizziness (11%), and vomiting (10%). The majority of these adverse reactions were Grade 1 or 2.

    Please see full Prescribing Information