Plerixafor

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.

• Mozobil 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). Mozobil, 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.ICD-10: C85.90, C90.00

• Mozobil is contraindicated in patients with a history of hypersensitivity to plerixafor [see Warnings and Precautions (5.1) ] . Anaphylactic shock has occurred with use of Mozobil.contraindicated

Initiate Mozobil treatment after the patient has received filgrastim once daily for 4 days. ( 2.1 ) Repeat Mozobil dose up to 4 consecutive days. ( 2.1 ) 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. ( 2.1 ) greater than 83 kg: select dose based on 0.24 mg/kg actual body weight. ( 2.1 ) Administer by subcutaneous injection approximately 11 hours prior to initiation of apheresis. ( 2.1 ) Renal impairment: If creatinine clearance is ≤50 mL/min, decrease dose by one-third to 0.16 mg/kg. ( 2.3 ) 2.1 Recommended Dosage and Administration Begin treatment with Mozobil after the patient has received filgrastim once daily for 4 days [see Dosage and Administration (2.2) ] . Administer Mozobil approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days. The recommended dose of Mozobil by subcutaneous injection is based on body weight: 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing less than or equal to 83 kg. [see Clinical Pharmacology (12.3) ] 0.24 mg/kg of body weight for patients weighing greater than 83 kg Use the patient's actual body weight to calculate the volume of Mozobil to be administered. Each vial delivers 1.2 mL of 20 mg/mL solution, and the volume to be administered to patients should be calculated from the following equation: 0.012 × patient's actual body weight (in kg) = volume to be administered (in mL) In clinical studies, Mozobil dose has been calculated based on actual body weight in patients up to 175% of ideal body weight.

Anaphylactic Shock and Serious Hypersensitivity Reactions have occurred. Monitor patients during and after completion of Mozobil administration. ( 5.1 ) Tumor Cell Mobilization in Leukemia Patients: Mozobil may mobilize leukemic cells and should not be used in leukemia patients. ( 5.2 ) Hematologic Effects: Increased circulating leukocytes and decreased platelet counts have been observed. Monitor blood cell counts and platelet counts during Mozobil use. ( 5.3 ) Potential for Tumor Cell Mobilization: Tumor cells may be released from marrow during HSC mobilization with Mozobil and filgrastim. Effect of reinfusion of tumor cells is unknown. ( 5.4 ) Splenic Rupture: Evaluate patients who report left upper abdominal and/or scapular or shoulder pain. ( 5.5 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise women not to become pregnant when taking Mozobil. ( 5.6 , 8.1 ) 5.1 Anaphylactic Shock and Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening with clinically significant hypotension and shock have occurred in patients receiving Mozobil [see Adverse Reactions (6.2) ] . Observe patients for signs and symptoms of hypersensitivity during and after Mozobil administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Mozobil when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Anaphylactic shock and hypersensitivity reactions [see Warnings and Precautions (5.1) ] Potential for tumor cell mobilization in leukemia patients [see Warnings and Precautions (5.2) ] Increased circulating leukocytes and decreased platelet counts [see Warnings and Precautions (5.3) ] Potential for tumor cell mobilization [see Warnings and Precautions (5.4) ] Splenic enlargement [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥10%): diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-877-4MOZOBIL or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥10%) reported in patients who received Mozobil in conjunction with filgrastim regardless of causality and more frequent with Mozobil than placebo during HSC mobilization and apheresis were diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting. Safety data for Mozobil in combination with filgrastim were obtained from two randomized placebo-controlled studies (301 patients) and 10 uncontrolled studies (242 patients).

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Limited available data with Mozobil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, subcutaneous administration of plerixafor to pregnant rats during organogenesis at doses 10-times the maximum recommended human doses resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth [see Data ] . Advise pregnant women of the potential risk to the fetus. Advise women of reproductive potential to avoid becoming pregnant while receiving treatment with Mozobil [see Warnings and Precautions (5.6) ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriages for the indicated population is unknown.

Metabolism

The single-dose pharmacokinetics of plerixafor 0.24 mg/kg were evaluated in patients with NHL and MM following pretreatment with filgrastim (10 mcg/kg once daily for 4 consecutive days). Plerixafor exhibits linear kinetics between the 0.04 mg/kg to 0.24 mg/kg dose range.

Based on limited data at doses above the recommended dose of 0.24 mg/kg SC, the frequency of gastrointestinal disorders, vasovagal reactions, orthostatic hypotension, and/or syncope may be higher.

• Dec 15, 2008NDANDA022311Genzyme
• Jul 24, 2023ANDAANDA211901Msn
• Jul 24, 2023ANDAANDA205182Dr Reddys
• Jul 24, 2023ANDAANDA215698Meitheal
• Jul 24, 2023ANDAANDA215334Amneal
• Jul 24, 2023ANDAANDA213672Eugia Pharma
• Jul 26, 2023ANDAANDA208980Zydus Pharms
• May 3, 2024ANDAANDA206644Gland

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Plerixafor, Injection, 24 mg per 1.2 mL (20 mg per mL) (NDC 65219-284-12)To be discontinued
  Sponsor: Fresenius Kabi USA, LLC
  Updated Mar 13, 2026

1. 1Febrile Neutropenia1429.8%
2. 2Off Label Use1208.3%
3. 3Diarrhoea1006.9%
4. 4Pyrexia855.9%
5. 5Mucosal Inflammation835.7%
6. 6Thrombocytopenia815.6%
7. 7Nausea805.5%
8. 8Death604.1%
9. 9Plasma Cell Myeloma604.1%
10. 10Pneumonia563.9%
11. 11Vomiting553.8%
12. 12Dyspnoea543.7%
13. 13Neutropenia543.7%
14. 14Drug Ineffective493.4%
15. 15Infection453.1%

The 10 most recently updated of 189 ClinicalTrials.gov registrations naming Plerixafor as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
  Recruiting · Phase 2 · Interventional · 40 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT02015013updated 2026-06-12
• Protocol Title: Safety and Feasibility of Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis in Participants With RUNX1 Familial Platelet Disorder
  Recruiting · Phase 1 · Interventional · 4 enrolled · M.D. Anderson Cancer Center
  NCT06414889updated 2026-06-11
• Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease
  Recruiting · Phase 1 · Phase 2 · Interventional · 10 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06325709updated 2026-06-11
• Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
  Recruiting · Phase 1 · Phase 2 · Interventional · 265 enrolled · National Cancer Institute (NCI)
  NCT05470491updated 2026-06-08
• Allo HSCT for High Risk Hemoglobinopathies
  Recruiting · Phase 2 · Interventional · 62 enrolled · Masonic Cancer Center, University of Minnesota
  NCT06872333updated 2026-06-04
• Base-Edited Hematopoietic Stem/Progenitor Cell X-Linked Severe Combined Immunodeficiency Gene Therapy
  Enrolling by invitation · Phase 1 · Phase 2 · Interventional · 18 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06851767updated 2026-06-01
• Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial
  Not yet recruiting · Phase 2 · Interventional · 74 enrolled · National Cancer Institute (NCI)
  NCT07605416updated 2026-05-26
• A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
  Recruiting · Phase 1 · Phase 2 · Interventional · 20 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT00967785updated 2026-05-22
• Stem Cell Mobilization and Apheresis for Life-threatening Blood Disorders
  Not yet recruiting · Phase 1 · Interventional · 12 enrolled · St. Jude Children's Research Hospital
  NCT07585136updated 2026-05-22
• Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
  Active not recruiting · Phase 1 · Interventional · 66 enrolled · Stanford University
  NCT05088356updated 2026-05-12

Frequently asked questions

How does Plerixafor work?

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.

What is Plerixafor used for?

According to FDA labeling, Plerixafor carries indications including: Mozobil 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). Mozobil, 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Plerixafor?

Plerixafor is classified as Other immunostimulants, Hematopoietic Stem Cell Mobilizer, Unknown Cellular or Molecular Interaction, Increased Hematopoietic Stem Cell Mobilization.

What are the brand names for Plerixafor?

Plerixafor is marketed under brand names including Mozobil.

What are the contraindications for Plerixafor?

Plerixafor labeling lists contraindications including: Mozobil is contraindicated in patients with a history of hypersensitivity to plerixafor [see Warnings and Precautions (5.1) ] . Anaphylactic shock has occurred with use of Mozobil.. Always consult the full prescribing information and a clinician.