(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 (10 mcg/kg once daily) for 4 days; 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.
Dosing: Renal Impairment
Note: Creatinine clearance estimate based on Cockcroft-Gault formula:
CrCl >50 mL/minute: No dosage adjustment necessary.
CrCl ≤50 mL/minute:
Patients ≤83 kg: 13 mg fixed dose or 0.16 mg/kg once daily
Patients >83 kg and <160 kg: 0.16 mg/kg once daily; maximum dose: 27 mg daily
Hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
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.
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
Pregnancy Risk Factor
Adverse effects have been observed in animal reproduction studies. May cause fetal harm if administered to pregnant women. Women of childbearing potential should use effective contraceptive measures to avoid becoming pregnant during treatment.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience loss of strength and energy, headache, injection site irritation, nausea, vomiting, abdominal pain, diarrhea, flatulence, or joint pain. Have patient report immediately to prescriber signs of enlarged or ruptured spleen (left upper abdominal pain or left shoulder pain), eye or eyelid edema, severe dizziness, passing out, shortness of breath, bruising, or bleeding (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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- Drug class: hematopoietic stem cell mobilizer
Other brands: Mozobil