PLERISTEM SOLUTION FOR INJECTION 20MG/ML [SIN16879P]

Product Info

PLERISTEM SOLUTION FOR INJECTION 20MG/ML

[SIN16879P]

4.1 Therapeutic indications
Adult patients
Plerixafor 20 mg/mL Solution for Injection is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2).

Paediatric patients (1 to less than 18 years)
Plerixafor 20 mg/mL Solution for Injection is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:

• pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with GCSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or

• who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).

4.2 Posology and method of administration
Plerixafor 20 mg/mL Solution for Injection 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 mcg/kg, to paediatric patients of at least 9 kg body weight.

For patients of more than 45 kg, 1 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, Plerixafor 20 mg/mL Solution for Injection 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 Plerixafor 20 mg/mL Solution for Injection, all patients received daily morning doses of 10 mcg/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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 Plerixafor 20 mg/mL Solution for Injection 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

Plerixafor 20 mg/mL Solution for Injection 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 Plerixafor 20 mg/mL Solution for Injection 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.