Plerixafor

Registered South African indications: 

• Lymphoma
• Multiple myeloma

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Moderate to severe renal impairment (CrCl ≤50ml/min)
• Hepatic impairment
• Elderly
• Haematopoietic stem cell mobilisation and harvest in patients with leukaemia
• Peripheral blood neutrophil counts above 50 x 10⁹/L
• Apheresis
• History of vasovagal reactions
• May impair ability to drive or operate machinery

Forms avail. in SA and covered in this monograph: inj

Used for the treatment of

• Lymphoma
• 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 adult patients with lymphoma or multiple myeloma whose cells mobilise poorly

Consult specialist for dosages and regimens

Not established for use in children in South Africa

Used for the treatment of 

• Lymphoma 
• Multiple myeloma
  - In combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haemopoietic 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 G-CSF (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

Consult specialist for dosages and regimens

Pregnancy

• Caution; positive evidence of risk
• There is no adequate data on the use of plerixafor in pregnant women
• Based on the pharmacodynamic mechanism of action, plerixafor is suggested to cause congenital malformations when administered during pregnancy. Studies in animals have shown teratogenicity
• Women of childbearing potential have to use effective contraception during treatment. Plerixafor should not be used during pregnancy unless the clinical condition of the woman requires treatment with plerixafor

Breastfeeding

• Caution, not recommended
• It is unknown whether plerixafor is excreted in human milk. A risk to the suckling child cannot be excluded. Breastfeeding should be discontinued during treatment with plerixafor

Fertility

• The effects of plerixafor on male and female fertility are not known

Renal Impairment

• CrCl >50ml/min: No dose adjustment recommended
• CrCl 20-50ml/min: Caution; dose adjustment recommended
  Reduce dose by 33%. Clinical data with this dose adjustment are limited
• CrCl <20ml/min: Caution; no information available
  There is insufficient clinical experience to make recommendations for this patient group or patients on haemodialysis

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP) 

Central Nervous System Disorders

• Insomnia
• Abnormal dreams
• Nightmares
• Dizziness
• Headache
• Fatigue
• Vasovagal reactions
  - Orthostatic hypotension
  - Syncope
• Paraesthesia

Cardiovascular Disorders

• Myocardial infarction

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Abdominal pain
• Stomach discomfort
• Dyspepsia
• Abdominal distention
• Constipation
• Flatulence
• Oral hypoaesthesia
• Dry mouth

Musculoskeletal Disorders

• Arthralgia
• Musculoskeletal pain

Skin and Subcutaneous Tissue Disorders

• Hyperhidrosis
• Erythema
• Injection and infusion site reactions

Immune, Blood and Lymphatic System Disorders

• Allergic reaction
  - Urticaria
  - Periorbital swelling
  - Dyspnoea
  - Hypoxia
• Anaphylactic reactions including anaphylactic shock
• Splenomegaly
• Splenic rupture
• Hyperleukocytosis

No information available

• Full blood count with differential

Special cases may require:

• Pregnancy test

Plerixafor is a bicyclam derivative, a selective reversible antagonist of the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stromal cell-derived factor-1α (SDF-1α), also known as CXCL12. Plerixafor-induced leukocytosis and elevations in circulating haematopoietic progenitor cell levels are thought to result from a disruption of CXCR4 binding to its cognate ligand, resulting in the appearance of both mature and pluripotent cells in the systemic circulation. CD34+ cells mobilised by plerixafor are functional and capable of engraftment with long-term repopulating capacity.

Injection (per ml) 20mg

• Mozobil (Sanofi) originator
• Heterix 24 (Hetero Drugs)