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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.

About Mozobil


Solution for subcutaneous use.

Mozobil + G-CSF has been shown to improve mobilization compared to G-CSF alone by increasing predictability of cell number and timing in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).

Indications and Usage

Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with NHL and MM.

Mozobil is a first in class CXCR4 receptor antagonist.

Dosage Forms and Strengths

Mozobil (plerixafor injection) (NDC Number 0024-5862-01) is provided as a 20 mg/mL solution in a single use vial. Each vial is filled to deliver a volume of 1.2 mL and contains 24 mg of drug and 5.9 mg sodium chloride dissolved in water for injection adjusted to a pH of 6.0-7.5 with hydrochloric acid and with sodium hydroxide, if required.

Store at room temperature (25°C) / (77°F).

The recommended dose of Mozobil is 0.24 mg/kg of actual body weight, administered by subcutaneous (SC) injection. Granulocyte-colony stimulating factor (G-CSF) (10 micrograms/kg) should be administered daily for 4 days prior to the first evening dose of Mozobil and on each day prior to apheresis.

Mechanism of Action

Mozobil is an inhibitor of the CXCR4 chemokine receptor and blocks binding of its cognate ligand stromal cell derived factor-1 (SDF-1α). SDF-1α and CXCR4 are recognized to play a role in the trafficking and homing of hematopoietic stem cells (HSC) to the marrow compartment.



Mozobil Mechanism of Action

Chemical Description

The chemical name of plerixafor is 1, 1’-[1,4-phenylenebis (methylene)]-bis-1,4,8,11-tetraazacyclotetradecane. It has the molecular formula C28H54N8. The molecular weight of plerixafor is 502.9 g/mol.

Structural Forumula of Mozobile (plerixafor injection)

Physical Description

Plerixafor is a white to off-white crystalline solid. It is supplied as a clear, colorless to pale yellow, sterile, preservative-free, isotonic solution for subcutaneous injection. It is hygroscopic and has a typical melting point of 131.5˚C.

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

References

  • Mozobil (plerixafor injection) Full Prescribing Information. Genzyme Corporation; 2013.
  • Lapidot T, Petit I. Current understanding of stem cell mobilization: the roles of chemokines, proteolytic enzymes, adhesion molecules, cytokines, and stromal cells. Exp Hematol. 2002;30(9):973-981.
  • Martin C, Bridger GJ, Rankin SM. Structural analogues of AMD3100 mobilise haematopoietic progenitor cells from bone marrow in vivo according to their ability to inhibit CXCL12 binding to CXCR4 in vitro. Br J Haematol. 2006;134(3):326-329.
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 Efficacy in Multiple Myeloma (MM)

Learn more about Mozobil clinical efficacy in a randomized, placebo-controlled phase 3 study of Mozobil + G-CSF in 302 MM patients.

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