Dosing and uses of Mozobil (plerixafor)
Adult dosage forms and strengths
single use injection
- 20mg/mL (24mg vial)
Stem Cell Transplantation
Mobilization of Hematopoietic Stem Cells to Peripheral Blood for Collection and Subsequent Autoloqous Transplantation in Patients with Non-Hodgkin's Lymphoma (NHL) & Multiple Myeloma
Initiate treatment after patient has received granulocyte-colony stimulating factor (G-CSF) qDay for 4 days
Recommended dose: 0.24 mg/kg SC qDay; repeat up to 4 consecutive days; not to exceed 40 mg/day
Start treatment approximately 11 hr prior to apheresis initiation
Acute Myeloid Leukemia (Orphan)
Orphan indication sponsor
- Genzyme Corporation; 500 Kendall Street, Cambridge, MA 02142
Renal Impairment
CrCl >50 mL: Dose adjustment not necessary
CrCl <50 mL/min: Reduce Dose by 1/3 to 0.16 mg/kg; not to exceed 27 mg/day
Pediatric dosage forms and strengths
Safety and efficacy not established
Mozobil (plerixafor) adverse (side) effects
>10%
Diarrhea (37%)
Injection site reaction (34%)
Nausea (34%)
Fatigue (27%)
Headache (22%)
Arthralgia (13%)
Dizziness (11%)
Vomiting (10%)
1-10%
Insomnia (7%)
Flatulence (7%)
Vomiting (10%)
Postmarketing Reports
Immune System Disorders: Anaphylactic reactions, including anaphylactic shock
Abnormal dreams and nightmares
Warnings
Contraindications
None listed in the manufacturer's labeling
History of hypersensitivity; anaphylaxis reported
Cautions
Not intended for HSC mobilization and harvest in patients with leukemia
When used in combination with filgrastim tumor cells may be released from the bond marrow and subsequently collected in the leukapheresis product. Effects of potential reinfusion of tumor cells not studied
Dose reduction recommended in patients with moderate-severe renal impairment
Leukocytosis; use in conjunction with G-CSF increases circulating leukocytes as well as HSC populations
Risk of thrombocytopenia; monitor platelet counts in all patients receiving treatment and then undergo apheresis
Risk of splenic enlargement and rupture
Optimal effective dose in patients wighing >175% of ideal body weight not studied
Splenomegaly and splenic rupture reported
Medications that reduce renal function or compete for active tubular secretion may increase serum concentrations of plerixafor
Pregnancy and lactation
Pregnancy category: d
Lactation: Not known if excreted in breast milk; not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Mozobil (plerixafor)
Mechanism of action
A hematopoeitic stem cell mobilizer. Blocks binding of stromal cell-derived factor-1-alpha, found on bond marrow stromal cells, to the CXC chemokine receptor 4 (CXCR4). The inhibition results in the mobilization of progenitor and hematopoietic stem cells from the bone marrow into peripheral blood.
Absorption
Peak Plasma Time: 30-60 min (SC)
Distribution
Protein Bound: 58%
Vd: 0.3 L/kg
Metabolism
None
Elimination
Half-Life: 3-6 hr
Excretion: Urine 70%
