Plerixafor

Plerixafor is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). Plerixafor, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma.

Plerixafor is an inhibitor of the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stromal cell-derived factor-1α (SDF-1α). SDF-1α and CXCR4 are recognized to play a role in the trafficking and homing of human hematopoietic stem cells (HSCs) to the marrow compartment. Once in the marrow, stem cell CXCR4 can act to help anchor these cells to the marrow matrix, either directly via SDF-1α or through the induction of other adhesion molecules. Treatment with plerixafor resulted in leukocytosis and elevations in circulating hematopoietic progenitor cells in mice, dogs and humans. CD34+ cells mobilized by plerixafor were capable of engraftment with long-term repopulating capacity up to one year in canine transplantation models.

Initiate plerixafor treatment after the patient has received filgrastim once daily for 4 days. Repeat plerixafor dose up to 4 consecutive days. Dose based on patient weight Less than or equal to 83 kg: 20 mg dose or select dose based on 0.24 mg/kg actual body weight. greater than 83 kg: select dose based on 0.24 mg/kg actual body weight. Administer by subcutaneous injection approximately 11 hours prior to initiation of apheresis. Renal impairment: If creatinine clearance is ≤50 mL/min, decrease dose by one-third to 0.16 mg/kg.

Plerixafor is contraindicated in patients with a history of hypersensitivity to plerixafor. Anaphylactic shock has occurred with use of plerixafor. History of hypersensitivity to plerixafor.

Anaphylactic Shock and Serious Hypersensitivity Reactions have occurred. Monitor patients during and after completion of plerixafor administration. Tumor Cell Mobilization in Leukemia Patients: Plerixafor may mobilize leukemic cells and should not be used in leukemia patients. Hematologic Effects: Increased circulating leukocytes and decreased platelet counts have been observed. Monitor blood cell counts and platelet counts during plerixafor use. Potential for Tumor Cell Mobilization: Tumor cells may be released from marrow during HSC mobilization with plerixafor and filgrastim. Effect of reinfusion of tumor cells is unknown. Splenic Rupture: Evaluate patients who report left upper abdominal and/or scapular or shoulder pain. Embryo-Fetal Toxicity: Can cause fetal harm. Advise women not to become pregnant when taking plerixafor.

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Anaphylactic shock and hypersensitivity reactions Potential for tumor cell mobilization in leukemia patients Increased circulating leukocytes and decreased platelet counts Potential for tumor cell mobilization Splenic enlargement Most common adverse reactions (≥10%): diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting.

Store at 25°C (77°F), excursions permitted to 15°C–30°C (59°F–86°F).