Lonquex (lipegfilgrastim): new option for chemotherapy-induced neutropenia

Teva has launched Lonquex (lipegfilgrastim), a sustained-duration granulocyte-colony stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia.

Lipegfilgrastim is a pegylated formulation of G-CSF with an extended duration of action.
Lipegfilgrastim is a pegylated formulation of G-CSF with an extended duration of action.

Lonquex is licensed for the reduction in duration of neutropenia and the incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy (except chronic myeloid leukaemia and myelodysplastic syndromes).1

The recommended dose for Lonquex is 6mg given by subcutaneous injection into the abdomen, upper arm or thigh approximately 24 hours after cytotoxic therapy. A single dose per chemotherapy cycle is recommended.1

Regular monitoring of the platelet count, haematocrit and white blood cell count is recommended during treatment with Lonquex. In patients predisposed to hypokalaemia, serum potassium should also be monitored.1

PHARMACOLOGY

Lipegfilgrastim is a glyco-pegylated G-CSF which binds to the human G-CSF receptor in the same way as filgrastim and pegfilgrastim. The decreased renal clearance of the pegylated formulation confers a sustained duration of action on lipegfilgrastim compared with filgrastim, allowing once-per-cycle administration.1

CLINICAL STUDIES

The efficacy and safety of lipegfilgrastim were compared with pegfilgrastim in a phase III randomised controlled study involving 202 patients with high-risk stage II, III or IV breast cancer receiving myelosuppressive chemotherapy with doxorubicin and docetaxel. Study participants, who had an ECOG performance status >2, an ANC >1.5 x 109/L and a platelet count >100 x 109/L, were randomised to receive a single 6mg subcutaneous injection of lipegfilgrastim or pegfilgrastim approximately 24 hours after chemotherapy for a maximum of four 21-day cycles.2

Non-inferior to pegfilgrastim
The mean duration of severe neutropenia (ANC <0.5 x 109/L) in the first cycle of chemotherapy in the per protocol study population (n=94 in both groups) was similar in both treatment groups (0.8+0.9 days in the pegfilgrastim group versus 0.7+0.9 days in the lipegfilgrastim group) demonstrating non-inferiority of lipegfilgrastim to pegfilgrastim (least squares mean difference -0.218 [95% CI -0.498%, 0.062%], p=0.126).2

Safety profile
The safety profile of lipegfilgrastim was found to be similar to that of pegfilgrastim. Alopecia, nausea, asthenia, neutropenia, bone pain, erythema, leucopenia and diarrhoea were the most commonly reported adverse effects, and may be attributable to myelosuppressive chemotherapy or the primary disease rather than drug treatment.2

References:

  1. Lonquex Summary of Product Characteristics, July 2013.
  2. Bondarenko I et al. BMC Cancer 2013;13:386.

View Lonquex drug record

Further information: Teva UK Ltd

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