Plerixafor parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing plerixafor
Drugs List
Therapeutic Indications
Uses
Mobilisation of haematopoietic stem cells in combination with G-CSF
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.
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 paediatric patients aged 1 to 18 years, with lymphoma or solid malignant tumours, either: Pre-emptively, when circulating stem cell count after mobilization with G-CSF is insufficient or if previously failed to collect sufficient haematopoietic stem cells.
Dosage
Plerixafor therapy should only be given in collaboration with an oncology centre experienced in G-CSF treatment and haematology, with the necessary diagnostic and monitoring facilities.
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 haemopoietic progenitor cells can be correctly performed.
Whilst the doses stated below are those recommended by the manufacturer, local protocols for the relevant indication should be consulted.
Adults
Body weight less than or equal to 83kg
20mg fixed dose or 0.24mg/kg body weight daily.
Body weight greater than 83kg
0.24mg/kg body weight daily.
It should be administered 6 to 11 hours prior to initiation of apheresis following 4 day pre-treatment with G-CSF. Plerixafor has been commonly used for 2 to 4 (up to 7) consecutive days.
The maximum dose should not exceed 40mg/day.
Children
Children aged 1 to 18 years
0.24mg/kg body weight daily.
Patients with Renal Impairment
Patients with creatinine clearance 20ml/minute to 50ml/minute should have their dose of plerixafor reduced by one third to 160micrograms/kg/day.
There is insufficient experience to recommend an alternative dose in patients with creatinine clearance below 20ml/minute or on haemodialysis.
Based on increasing exposure with increasing body weight, the dose should not exceed 27mg/day if the creatinine clearance is lower than 50ml/minute.
Additional Dosage Information
Concomitant G-CSF was administered at a dose of 10micrograms/kg for 4 consecutive days prior to the first dose of plerixafor and on each morning prior to apheresis during clinical studies.
The weight used to calculate dose should be obtained within a week prior to commencement of treatment. In clinical studies the dose has been calculated based on body weight in patients up to 175% of ideal body weight. Patients with a body weight of up to 45kg should use a 1ml syringe for administration. For patients over 45kg, a 1ml or 2ml syringe can be used.
Administration
For subcutaneous injection only
Contraindications
Children under 1 year
Breastfeeding
Pregnancy
Precautions and Warnings
Neutrophil count above 50 x 10 to the power of 9 / L
Haemodialysis
Leukaemia
Renal impairment - creatinine clearance below 50ml/minute
Dose should not exceed 27mg/day if creatinine clearance is below 50ml/min
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Consider splenic rupture if patient has abdominal or shoulder pain
Perform regular white blood cell and platelet counts
Female: Ensure adequate contraception during treatment
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 haemopoietic 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/microlitre, have been identified as predictors of poor mobilisation.
There have been inadequate studies into the effects of the potential re-infusion of tumour cells in patients with lymphoma and multiple myeloma following the administration of plerixafor with granulocyte-colony stimulating factor. Tumour cells may be released from the bone marrow and collect in the leukapheresis product. In the limited studies that have been conducted, tumour cell mobilisation has not been observed in patients with non-Hodgkin's lymphoma and multiple myeloma.
Spleen size should be carefully monitored by clinical examination and ultrasound as splenomegaly and rarely splenic rupture have been observed following administration of granulocyte - colony stimulating factors (G-CSF).
Pregnancy and Lactation
Pregnancy
Plerixafor is contraindicated in pregnancy.
Based on the mechanism of action, plerixafor is suggested to cause congenital malformation when administered in pregnancy. Animal studies have shown teratogenicity.
Lactation
Plerixafor is contraindicated during breastfeeding.
It is unknown whether plerixafor is excreted in human breast milk.
Side Effects
Abdominal distension
Abdominal pain
Allergic reaction
Anaphylactic reaction
Anaphylactic shock
Arthralgia
Constipation
Diarrhoea
Dizziness
Dream abnormalities
Dry mouth
Dyspepsia
Dyspnoea
Erythema
Fatigue
Flatulence
Gastro-intestinal disturbances
Headache
Hyperhidrosis
Hyperleukocytosis
Injection site reactions
Insomnia
Malaise
Musculoskeletal pain
Nausea
Nightmares
Oral hypoaesthesia
Orthostatic hypotension
Periorbital oedema
Shoulder pain
Stomach pain
Syncope
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: May 2015
Reference Sources
Summary of Product Characteristics: Mozobil 20mg/ml solution for injection. Genzyme Therapeutics. Revised May 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 June 2019
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
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