LONQUEX

What it is

Lonquex is the Teva Pharmaceuticals Ltd trademark for lipegfilgrastim (rbe), a long-acting form of recombinant human granulocyte colony-stimulating factor (G-CSF). Lipegfilgrastim is a covalent conjugate of a 19,000 dalton E.Coli produced r-metHuG-CSF and a 20,000 dalton polyethylene glycol (PEG) moiety. Lonquex is a sterile, clear, colourless, preservative-free aqueous liquid for subcutaneous (SC) administration, presented in a 1 mL prefilled syringe.

Approved indications

— Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Dosing overview

The recommended dosage of Lonquex is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. One 6 mg dose of Lonquex (a single pre-filled syringe of Lonquex) is recommended for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.

Key safety warnings

Patients who are hypersensitive to G-CSF or derivatives are also at risk of hypersensitivity reactions to lipegfilgrastim due to possible cross-reactivity, and no lipegfilgrastim therapy should be commenced in these patients because of the risk of cross-reaction. Treatment with lipegfilgrastim does not preclude thrombocytopenia and anaemia caused by myelosuppressive chemotherapy, and lipegfilgrastim may also cause reversible thrombocytopenia. If WBC counts exceed 50 x 109/l after the expected nadir, lipegfilgrastim should be discontinued immediately. The safety and efficacy of Lonquex have not been investigated in patients with chronic myeloid leukaemia, myelodysplastic syndromes or secondary acute myeloid leukaemia; it should therefore not be used in such patients. Patients with breast cancer and patients with lung cancer should be monitored for signs and symptoms of MDS/AML. Frequent but generally asymptomatic cases of splenomegaly and infrequent cases of splenic rupture, including fatal cases, have been reported after administration of G-CSF or derivatives. Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after administration of lipegfilgrastim, and patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk. The onset of pulmonary symptoms such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function together with an increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS), and in such circumstances Lonquex should be discontinued at the discretion of the physician and appropriate treatment given. Capillary leak syndrome, which can be life threatening if treatment is delayed, has been reported mostly in cancer patients undergoing chemotherapy after administration of G-CSF or derivatives.

Contraindications

Lonquex is contraindicated in patients with known hypersensitivity to lipegfilgrastim and any other component of the product or other G-CSF products including lenograstim, pegfilgrastim and filgrastim.

PBS listing

The 6 mg in 0.6 mL single use pre-filled syringe injection is listed on the PBS with 2 items, streamlined restriction, at an ex-manufacturer price of A$1116.25.

Regulatory history

Lonquex lipegfilgrastim (rbe) 6 mg/0.6 mL solution for injection prefilled syringe was first listed on the Australian Register of Therapeutic Goods on 12 November 2015. In March 2016, the PBAC recommended an Authority Required listing of lipegfilgrastim under Section 100 (Highly Specialised Drugs Program) for prophylaxis of chemotherapy induced neutropenia. The recommendation was made on a cost-minimisation basis with filgrastim where the equi-effective doses are lipegfilgrastim 6 mg once per chemotherapy cycle, pegfilgrastim 6 mg once per chemotherapy cycle and filgrastim injection 5 microgram/kg/day for 11.25 days.