Posology : מינונים

4.2 Posology and method of administration


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Safety data for Mozobil in conjunction with G-CSF in oncology patients 


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Mozobil therapy should be initiated and supervised by a physician experienced              with lymphoma and multiple myeloma were obtained from 2 placebo- 


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Israel in oncology and/or haematology. The mobilisation and apheresis procedures should           controlled Phase III studies (301 patients) and 10 uncontrolled Phase II studies 


8pt be performed in collaboration with an oncology-haematology centre with acceptable          (242 patients). Patients were primarily treated with daily doses of 0.24 mg/kg 


2 experience in this field and where the monitoring of haematopoietic progenitor cells       plerixafor by subcutaneous injection. The exposure to plerixafor in these studies 


Min. Point Size can be correctly performed.                                                                ranged from 1 to 7 consecutive days (median = 2 days).



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Posology



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In the two Phase III studies in non-Hodgkin’s lymphoma and multiple myeloma 


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The recommended dose of plerixafor is 0.24 mg/kg body weight/day. It should be 


Market patients (AMD3100-3101 and AMD3100-3102, respectively), a total of 301 patients 


Profile administered by subcutaneous injection 6 to 11 hours prior to initiation of each 


Date were treated in the Mozobil and G-CSF group and 292 patients were treated 


Size apheresis following 4 day pre-treatment with granulocyte-colony stimulating factor         in the placebo and G-CSF group. Patients received daily morning doses of G-CSF (G-CSF). In clinical trials, Mozobil has been commonly used for 2 to 4 (and up to 7)       10 μg/kg for 4 days prior to the first dose of plerixafor or placebo and on each 


Clearly mark any amendments on one proof and return to MPS consecutive days.


 in this proof after approval. Whilst we take extreme care
Warning! We cannot accept responsibility for any errors morning prior to apheresis. Adverse reactions that occurred more frequently with 

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at all times to ensure accuracy to our clientʼs brief,
Mozobil and G-CSF than placebo and G-CSF and were reported as related in ≥1% 


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The weight used to calculate the dose of plerixafor should be obtained within 

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1 week before the first dose of plerixafor. In clinical studies, the dose of plerixafor    of the patients who received Mozobil, during haematopoietic stem cell mobilisation 


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has been calculated based on body weight in patients up to 175% of ideal body              and apheresis and prior to chemotherapy/ablative treatment in preparation for weight. Plerixafor dose and treatment of patients weighing more than 175% of ideal         transplantation are shown in Table 1. Adverse reactions are listed by System Organ body weight have not been investigated. Ideal body weight can be determined using          Class and frequency.
the following equations:                                                                   Frequencies are defined according to the following convention: very common male (kg): 50 + 2.3 x ((Height (cm) x 0.394) – 60);                                        (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare female (kg): 45.5 + 2.3 x ((Height (cm) x 0.394) – 60).                                    (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Based on increasing exposure with increasing body weight, the plerixafor dose should not exceed 40 mg/day.                                                               From chemotherapy/ablative treatment in preparation of transplantation through 12 months post-transplantation, no significant differences in the incidence of Recommended concomitant medicinal products                                                 adverse reactions were observed across treatment groups.
In pivotal clinical studies supporting the use of Mozobil, all patients received daily morning doses of 10 μg/kg G-CSF for 4 consecutive days prior to the first dose             Table 1. Adverse reactions occurring more frequently with Mozobil than of plerixafor and on each morning prior to apheresis.                                                   placebo and considered related to Mozobil during mobilisation and apheresis in phase III studies
Special populations
Renal impairment                                                                            Immune system disorders Patients with creatinine clearance 20-50 ml/min should have their dose of plerixafor                                 Uncommon Allergic reaction* reduced by one-third to 0.16 mg/kg/day (see section 5.2). Clinical data with this dose                                          Anaphylactic reactions, including adjustment are limited. There is insufficient clinical experience to make alternative                                           anaphylactic shock (see section 4.4) ** posology recommendations for patients with a creatinine clearance <20 ml/min, Psychiatric disorders as well as to make posology recommendations for patients on haemodialysis.
Common Insomnia
Based on increasing exposure with increasing body weight the dose should not exceed 27 mg/day if the creatinine clearance is lower than 50 ml/min.                                                Uncommon Abnormal dreams, nightmares*** Nervous system disorders
Paediatric population
The experience in paediatric patients is limited. The safety and efficacy of Mozobil                                   Common Dizziness, headache in paediatric patients have not been established in controlled clinical studies.            Gastrointestinal disorders Elderly patients (> 65 years old)                                                                                  Very common Diarrhoea, nausea No dose modifications are necessary in elderly patients with normal renal function.                                    Common Vomiting, abdominal pain, stomach Dose adjustment in elderly patients with creatinine clearance ≤ 50 ml/min                                                       discomfort, dyspepsia, abdominal is recommended (see Renal impairment above). In general, care should be taken                                                   distension, constipation, flatulence, in dose selection for elderly patients due to the greater frequency of decreased renal                                          hypoesthesia oral, dry mouth function with advanced age.                                                                 Skin and subcutaneous tissue disorders Method of administration                                                                                               Common Hyperhidrosis, erythema For subcutaneous injection. Each vial of Mozobil is intended for single use only.           Musculoskeletal and connective tissue disorders Vials should be inspected visually prior to administration and not used if there is particulate matter or discolouration. Since Mozobil is supplied as a sterile,                                       Common Arthralgia, musculoskeletal pain preservative-free formulation, aseptic technique should be followed when transferring       General disorders and administration site conditions the contents of the vial to a suitable syringe for subcutaneous administration                                     Very common Injection and infusion site reactions (see section 6.3).
Common Fatigue, malaise