MOZOBIL
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Package:
VIAL (solution for injection): 1 x 2 ml.
Dosage:
Subcutaneous inject, 6-11 hours prior to initiation of apheresis following 4 day pre-treatment with G-CSF.
0.24 mg/kg body weight/day. See prescribing information for full details.
Prescribing Restrictions: None
Indications:
In combination with G-CSF, to enhance mobilisation of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.
Contra-Indications:
Hypersensitivity to the active substance or to any of the excipients. See prescribing information for full details.
Special Precautions:
Therapy should be initiated and supervised by a physician experienced in oncology and/or hematology.
Renal impairment: Patients with creatinine clearance 20-50 ml/min should have their dose of plerixafor reduced by one-third to 0.16 mg/kg/day. There is insufficient clinical experience to make alternative posology recommendations for patients with a creatinine clearance <20 ml/min, as well as to make posology recommendations for patients on hemodialysis.
Pediatric patients: The experience in pediatric patients is limited. The safety and efficacy have not been established in controlled clinical studies.
Elderly patients (> 65 years old): No dose modifications are necessary in elderly patients with normal renal function. In general, care should be taken in dose selection for elderly patients due to the greater frequency of decreased renal function with advanced age.
The effect of potential re-infusion of tumour cells has not been adequately studied.
White blood cell and platelet counts should be monitored during use and apheresis.
Pregnancy and lactation: There are no adequate data on the use of plerixafor in pregnant women. Should not be used during pregnancy unless the clinical condition of the woman requires treatment. Women of childbearing potential have to use effective contraception during treatment. Breast-feeding should be discontinued during treatment. See prescribing information for full details.
Side Effects:
Very common: Diarrhea, nausea. Injection and infusion site reactions. Common: Insomnia, dizziness, headache. Vomiting, abdominal pain, stomach discomfort, dyspepsia, abdominal distention, constipation, flatulence, oral hypoesthesia, dry mouth. Hyperhidrosis, erythema. Arthralgia, musculoskeletal pain. Fatigue, malaise. See prescribing information for full details.
Drug Interactions:
No interaction studies have been performed. See prescribing information for full details.
