MOZOBIL

What it is

MOZOBIL contains plerixafor 24 mg per vial supplied as a solution for injection. Plerixafor is a reversible antagonist of the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stromal cell-derived factor-1α (SDF-1α).

Approved indications

— Haematopoietic stem cell mobilisation in combination with granulocyte-colony stimulating factor (G-CSF) for collection and subsequent autologous transplantation in patients with lymphoma. — Haematopoietic stem cell mobilisation in combination with granulocyte-colony stimulating factor (G-CSF) for collection and subsequent autologous transplantation in patients with multiple myeloma.

Dosing overview

The recommended dose of MOZOBIL is 0.24 mg/kg body weight by subcutaneous injection. Treatment should begin after the patient has received G-CSF once daily for 4 days, and MOZOBIL should be administered 6 to 11 hours prior to initiation of apheresis. MOZOBIL has been commonly used for 2 to 4 consecutive days. Patients with moderate and severe renal insufficiency (CrCl 20–50 mL/min) should have their dose reduced by one-third to 0.16 mg/kg.

Key safety warnings

When MOZOBIL is used with G-CSF for haematopoietic stem cell mobilisation in patients with lymphoma or multiple myeloma, tumour cells may be released from the marrow and subsequently collected in the leukapheresis product, and the effect of potential re-infusion of tumour cells has not been well-studied. MOZOBIL is not recommended for haematopoietic stem cell mobilisation in patients with leukaemia. Administration of MOZOBIL with G-CSF increases circulating leukocytes, and white blood cell counts should be monitored during therapy. Thrombocytopenia is a known complication of apheresis and has been observed in patients receiving plerixafor, and platelet counts should be monitored in all patients receiving MOZOBIL and undergoing apheresis. Cases of anaphylactic reactions, including anaphylactic shock, have been reported from post-marketing experience, and patients should be monitored for these adverse reactions following MOZOBIL injection. Cases of splenic enlargement and/or rupture have been reported following administration of MOZOBIL with G-CSF, and individuals receiving MOZOBIL who report left upper abdominal pain and/or scapular or shoulder pain should be evaluated for splenic integrity.

Contraindications

MOZOBIL is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

Regulatory history

MOZOBIL (plerixafor 20 mg/mL solution for injection 1.2 mL vial) was first listed on the ARTG on 31 May 2010. A new product variant, Plerixafor Eugia, was approved on 6 February 2024.