MOZOBIL Solution for injection Ref.[9696] Active ingredients: Plerixafor

Mozobil therapy should be initiated and supervised by a physician experienced in oncology and/or haematology. The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.

Age over 60 and/or prior myelosuppressive chemotherapy and/or extensive prior chemotherapy and/or a peak circulating stem cell count of less than 20 stem cells/microliter, have been identified as predictors of poor mobilisation.

Posology

Adult

The recommended daily dose of plerixafor by subcutaneous injection (SC) is:

• 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing ≤ 83 kg (see section 5.2).
• 0.24 mg/kg of body weight for patients weighing >83 kg.

Paediatric (1 to less than 18 years)

The recommended daily dose of plerixafor by subcutaneous injection (SC) is:

• 0.24 mg/kg of body weight (see section 5.1).

Each vial of plerixafor is filled to deliver 1.2 ml of 20 mg/ml plerixafor aqueous solution for injection containing 24 mg of plerixafor.

Plerixafor has to be drawn up into a syringe size type which should be selected according to the weight of the patient.

For low weight patients, up to 45 kg of body weight, 1 ml syringes for use in infant patients can be used. This type of syringe has major graduations for 0.1 ml and minor graduations for 0.01 ml and therefore is suitable to administer plerixafor, at a dose of 240 µg/kg, to paediatric patients of at least 9 kg body weight.

For patients of more than 45 kg, a1 ml or 2 ml syringe with graduations that allow a volume to 0.1 ml to be measured can be used.

It should be administered by subcutaneous injection 6 to 11 hours prior to initiation of each apheresis following 4 day pre-treatment with G-CSF. In clinical trials, Mozobil has been commonly used for 2 to 4 (and up to 7) consecutive days.

The weight used to calculate the dose of plerixafor should be obtained within 1 week before the first dose of plerixafor. In clinical studies, the dose of plerixafor has been calculated based on body weight in patients up to 175% of ideal body weight. Plerixafor dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated. Ideal body weight can be determined using the following equations:

• male (kg): 50 + 2.3 x ((Height (cm) x 0.394) – 60);
• female (kg): 45.5 + 2.3 x ((Height (cm) x 0.394) – 60).

Based on increasing exposure with increasing body weight, the plerixafor dose should not exceed 40 mg/day.

Recommended concomitant medicinal products

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 of plerixafor and on each morning prior to apheresis.

Special populations

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 (see section 5.2). Clinical data with this dose adjustment are limited. 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 haemodialysis.

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.

Paediatric population

The safety and efficacy of Mozobil in children (1 to less than 18 years) were studied in an open label, multicenter, controlled study (see sections 4.8, 5.1, and 5.2).

Elderly patients (>65 years old)

No dose modifications are necessary in elderly patients with normal renal function. Dose adjustment in elderly patients with creatinine clearance ≤ 50 ml/min is recommended (see Renal impairment above). In general, care should be taken in dose selection for elderly patients due to the greater frequency of decreased renal function with advanced age.

Method of administration

Mozobil is for subcutaneous injection. Each vial is intended for single use only.

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, preservative-free formulation, aseptic technique should be followed when transferring the contents of the vial to a suitable syringe for subcutaneous administration (see section 6.3).

No case of overdose has been reported. Based on limited data at doses above the recommended dose and up to 0.48 mg/kg the frequency of gastrointestinal disorders, vasovagal reactions, orthostatic hypotension, and/or syncope may be higher.

Unopened vial: 3 years.

After opening: From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

This medicinal product does not require any special storage conditions.

Clear type I glass 2 ml vial with a chlorobutyl/butyl rubber stopper and aluminium seal with a plastic flip-off cap. Each vial contains 1.2 ml solution.

Pack size of 1 vial.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.