FULPHILA

What it is

Fulphila contains pegfilgrastim (rbe), a long-acting form of recombinant human Granulocyte Colony-Stimulating Factor (G-CSF). Fulphila 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. Fulphila is a sterile, clear, colourless, preservative-free liquid for subcutaneous (SC) administration.

Approved indications

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

Dosing overview

The recommended dosage of Fulphila is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. Fulphila 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, 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. 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

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

PBS listing

Fulphila is listed on the PBS with a streamlined Authority Required restriction for chemotherapy-induced neutropenia for all indications for which the reference biologic is currently PBS listed.

Regulatory history

Fulphila (pegfilgrastim 6 mg/0.6 mL pre-filled syringe) was first listed on the ARTG on 17 August 2018. In November 2018, the PBAC recommended Fulphila as a new listing for chemotherapy-induced neutropenia with a streamlined Authority Required restriction under Section 100 (Highly Specialised Drug).