Lipegfilgrastim

Summary

Lipegfilgrastim (brand name Lonquex) is a glycoPEGylated recombinant human G-CSF approved in the EU for reducing the duration of neutropenia and incidence of febrile neutropenia in adults receiving cytotoxic chemotherapy for malignancies. It is administered as a single subcutaneous injection per chemotherapy cycle, similar to pegfilgrastim, but uses a novel glycoPEGylation technology.

Mechanism of Action

Binds to and activates the G-CSF receptor on neutrophil precursors and mature neutrophils, stimulating proliferation, differentiation, and activation. The glycoPEGylation (polyethylene glycol attached via a glycan linker) extends the half-life by reducing renal clearance, allowing once-per-cycle dosing.

Routes of Administration

Goals & Uses

• Reduction of febrile neutropenia durationOncology Supportive CareHigh
• Reduction of infection risk during myelosuppressive chemotherapyOncology Supportive CareHigh
• Prevention of chemotherapy-induced neutropeniaOncology Supportive CareHigh

Contraindications

• Use in patients with chronic myeloid leukemia or myelodysplastic syndromeOncologyHigh
• Hypersensitivity to lipegfilgrastim or PEGylated G-CSF productsAllergy/immunologyHigh

Adverse Effects

• Acute respiratory distress syndrome (ARDS)PulmonaryRare
• Splenomegaly / splenic ruptureOrgan ToxicityRare
• Injection site reactionsLocalCommon
• LeukocytosisHematologicCommon
• ThrombocytopeniaHematologicUncommonLow platelet count
• Bone pain / musculoskeletal painMusculoskeletalCommon

Drug Interactions

• Cytotoxic chemotherapy agentsHigh
• LithiumLow

Population Constraints

• PregnancyReproductive SafetyRelative
• Pediatric patients (under 18 years)AgeRelative
• Patients with sickle cell diseaseHematologic DisorderRelative
• BreastfeedingReproductiveRelative

Regulatory Status

• European UnionApprovedApproved: Reduction in duration of severe neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (excluding chronic myeloid leukemia and myelodysplastic syndromes)Approved by EMA in July 2013 under the brand name Lonquex; marketed by Teva
• United StatesUnapprovedNot approved by FDA; pegfilgrastim (Neulasta) is the standard long-acting G-CSF in the US
• United KingdomApprovedApproved: Reduction in duration of severe neutropenia and incidence of febrile neutropenia in adult cancer patients receiving cytotoxic chemotherapyApproved via EMA decision prior to Brexit; status maintained post-Brexit through MHRA

Approved by the European Medicines Agency (EMA) in 2013. Not approved by the US FDA; pegfilgrastim (Neulasta) is the dominant long-acting G-CSF in the US market. Lonquex is marketed in Europe by Teva Pharmaceuticals.

Evidence & Sources

No sources recorded yet.