PELGRAZ

What it is

Pelgraz contains pegfilgrastim (rbe), a long-acting form of recombinant human Granulocyte Colony-Stimulating Factor (G-CSF). Pelgraz is a biosimilar medicinal product, a medicine that has been demonstrated to be similar in quality, safety and efficacy to the reference medicinal product, Neulasta®. Pelgraz is a sterile, clear, colourless, preservative-free liquid for subcutaneous administration. Each single-use pre-filled syringe with needle guard of Pelgraz contains 6 mg of pegfilgrastim (based on protein mass only).

Approved indications

— Treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and reduce the incidence of infection, as manifested by febrile neutropenia.

Dosing overview

The recommended dosage of Pelgraz is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. Pelgraz should be administered approximately 24 hours after the administration of cytotoxic chemotherapy.

Key safety warnings

Cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim. Patients who report left upper abdominal pain and/or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture. Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell disease. Clinicians should exercise caution and monitor patients accordingly when administering pegfilgrastim to patients with sickle cell trait or sickle cell disease, and only consider use after careful evaluation of the potential benefits and risks. Pulmonary haemorrhage and haemoptysis requiring hospitalisation have been reported in G-CSF-treated healthy donors undergoing peripheral blood progenitor cell collection mobilisation. Haemoptysis resolved with discontinuation of G-CSF. In patients with sepsis receiving pegfilgrastim, the physician should be alert to the possibility of acute respiratory distress syndrome due to the possible influx of neutrophils at the site of inflammation. Glomerulonephritis has been reported in patients receiving pegfilgrastim. Generally, after withdrawal of pegfilgrastim, events of glomerulonephritis resolved. Monitoring of urinalysis is recommended. In the post-marketing observational study setting, myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in breast and lung cancer patients. Monitor patients for signs and symptoms of MDS/AML in these settings. Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time. Thrombocytopenia has been reported in patients receiving pegfilgrastim. Platelet counts should be monitored closely. Aortitis has been reported in patients receiving pegfilgrastim and may present with generalised signs and symptoms such as fever and increased inflammatory markers. Consider aortitis in patients who develop these signs and symptoms without known aetiology.

Contraindications

Pegfilgrastim is contraindicated in patients with known hypersensitivity to E. coli-derived proteins, pegfilgrastim, filgrastim, or any other component of the product.

PBS listing

Pelgraz was recommended by the PBAC in March 2020 for listing on the Section 100 (Highly Specialised Drugs Program) for all indications for which the reference brand, Neulasta®, is currently PBS-listed.

Regulatory history

Pelgraz pegfilgrastim 6 mg/0.6 mL solution for injection pre-filled syringe was first registered on the Australian Register of Therapeutic Goods on 19 August 2019 (ARTG 308177). In March 2020, the PBAC recommended the listing of the biosimilar brand Pelgraz on the Section 100 (Highly Specialised Drugs Program) for all indications for which the reference brand, Neulasta®, is currently PBS-listed.