Medically reviewed by Drugs.com. Last updated on Aug 14, 2020.
(pler IX a fore)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous [preservative free]:
Mozobil: 24 mg/1.2 mL (1.2 mL)
Brand Names: U.S.
- Hematopoietic Agent
- Hematopoietic Stem Cell Mobilizer
Plerixafor reversibly inhibits binding of stromal cell-derived factor-1-alpha (SDF-1α), expressed on bone marrow stromal cells, to the CXC chemokine receptor 4 (CXCR4), resulting in mobilization of hematopoietic stem and progenitor cells from bone marrow into peripheral blood. Plerixafor used in combination with filgrastim results in synergistic increase in CD34+ cell mobilization. Mobilized CD34+ cells are capable of engrafting with extended repopulating capacity.
SubQ: Rapid; exposure using the mg/kg dosing increases with increasing body weight; the fixed dosing (20 mg) results in higher exposure than the mg/kg dose, but the median time to reach the target cell count is the same for both dosing regimens
0.3 L/kg; primarily to extravascular fluid space
Urine (~70%; as parent drug)
Onset of Action
Peak CD34+ mobilization (healthy volunteers): Plerixafor monotherapy: 6 to 9 hours after administration; Plerixafor + filgrastim: 10 to14 hours
Time to Peak
Plasma: SubQ: 30 to 60 minutes
Duration of Action
Sustained elevation in CD34+ cells (healthy volunteers): 4 to 18 hours after administration
Terminal: 3 to 5 hours
Special Populations: Renal Function Impairment
Clearance is reduced in patients with renal impairment. When compared to patients with normal renal function, the mean AUC was increased 7% in patients with mild renal impairment (CrCl 51 to 80 mL/minute), 32% for moderate renal impairment (CrCl 31 to 50 mL/minute), and 39% with severe renal impairment (CrCl <31 mL/minute).
Use: Labeled Indications
Peripheral stem cell mobilization: Mobilization of hematopoietic stem cells (HSCs) for collection and subsequent autologous transplantation (in combination with filgrastim) in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM)
History of hypersensitivity to plerixafor or any component of the formulation (anaphylactic shock has occurred).
Note: Dosing is based on actual body weight. Begin plerixafor after patient has received filgrastim for 4 days (refer to Filgrastim monograph for filgrastim dose); plerixafor, filgrastim, and apheresis should be continued daily until sufficient cell collection up to a maximum of 4 days.
Hematopoietic stem cell mobilization (in non-Hodgkin lymphoma and multiple myeloma): SubQ: Administer ~11 hours prior to apheresis
Patients ≤83 kg: 20 mg fixed dose or 0.24 mg/kg once daily for up to 4 consecutive days
Patients >83 kg: 0.24 mg/kg once daily for up to 4 consecutive days; maximum dose: 40 mg daily
Refer to adult dosing.
The manufacturer recommends calculating the dose based on actual weight for patients weighing up to 175% of ideal body weight (maximum dose: 40 mg daily). Dosing in patients >175% of ideal body weight has not been studied.
SubQ: Administer subcutaneously, ~11 hours prior to initiation of apheresis. In some clinical trials, plerixafor administration began in the evening prior to apheresis; filgrastim was begun on day 1, plerixafor initiated in the evening on day 4 and apheresis in the morning on day 5; with filgrastim, plerixafor, and apheresis then continued daily until sufficient cell collection for autologous transplant (DiPersio 2009a; DiPersio 2009b).
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
There are no known significant interactions.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Adverse reactions reported with filgrastim combination therapy.
Central nervous system: Fatigue (27%), headache (22%), dizziness (11%)
Gastrointestinal: Diarrhea (37%), nausea (34%)
Local: Injection site reaction (34%, including edema, erythema, hematoma, hemorrhage, induration, inflammation, irritation, pain, paresthesia, pruritus, skin rash, urticaria)
Neuromuscular & skeletal: Arthralgia (13%)
1% to 10%:
Central nervous system: Insomnia (7%), malaise (<5%)
Dermatologic: Erythema (<5%), hyperhidrosis (<5%)
Gastrointestinal: Vomiting (10%), flatulence (7%), abdominal distension (<5%), abdominal distress (<5%), abdominal pain (<5%), constipation (<5%), dyspepsia (<5%), oral hypoesthesia (<5%), xerostomia (<5%)
Hematologic & oncologic: Hyperleukocytosis (7%)
Neuromuscular & skeletal: Musculoskeletal pain (<5%)
<1%, postmarketing, and/or case reports: Abnormal dreams, anaphylaxis, diaphoresis, dyspnea, hypersensitivity reaction, hypoxia, leukocytosis, nightmares, orthostatic hypotension, periorbital swelling, syncope, thrombocytopenia
Concerns related to adverse effects:
• Anaphylactic shock/hypersensitivity: Serious hypersensitivity reactions, including anaphylactic-type reactions (may be life-threatening with serious hypotension and shock) have been reported. Observe patients for hypersensitivity symptoms during, for 30 minutes after administration, and until clinically stable. Medication, personnel, and equipment for hypersensitivity management should be immediately available. Mild-to-moderate allergic reactions may also occur, usually within 30 minutes of administration.
• Hematologic effects: Increases circulating leukocytes when used in conjunction with filgrastim; monitor WBC counts. Thrombocytopenia has been observed; monitor platelet counts.
• Splenic enlargement/rupture: Cases of splenomegaly and/or splenic rupture have been reported with plerixafor when used in conjunction with filgrastim; instruct patients to report left upper quadrant pain or scapular/shoulder tip pain; promptly evaluate in any patient who report these symptoms.
• Leukemia: Not intended for mobilization in patients with leukemia; may contaminate apheresis product by mobilizing leukemic cells.
• Renal impairment: Primary route of elimination is renal; dosage reduction is recommended in patients with moderate-to-severe renal impairment (CrCl ≤50 mL/minute).
Concurrent drug therapy issues:
• Nephrotoxic drugs: Medications that may reduce renal function or compete for active tubular secretion may increase serum concentrations of plerixafor.
• Obese patients: Use has not been studied in patients weighing >175% of ideal body weight.
• Tumor cell mobilization: When used in combination with filgrastim, tumor cells released from marrow could be collected in leukapheresis product; potential effect of tumor cell reinfusion is unknown.
CBC with differential and platelets; monitor for signs/symptoms of hypersensitivity (during, for 30 minutes after administration, and until clinically stable) and for signs/symptoms of splenomegaly
Evaluate pregnancy status prior to use in females of reproductive potential.
Evaluate pregnancy status prior to use in females of repro- ductive potential. Pregnancy should be avoided during therapy. Females of reproductive potential should use adequate contraception during treatment and for 1 week after the final plerixafor dose.
Based on data from animal reproduction studies, in utero exposure to plerixafor may cause fetal harm.
What is this drug used for?
• It is used to raise the number of stem cells.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Loss of strength and energy
• Trouble sleeping
• Injection site irritation
• Abdominal pain
• Passing gas
• Joint pain
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Enlarged or ruptured spleen like left upper abdominal pain or left shoulder pain
• Severe dizziness
• Passing out
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
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- Drug class: hematopoietic stem cell mobilizer
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