Lipegfilgrastim
Also known as: glycoPEG-G-CSF, GlycoPEGylated filgrastim, Lipegfilgrastim, Lonquex, XM22
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Summary
Lipegfilgrastim is a long‑acting, glyco‑PEGylated granulocyte colony‑stimulating factor (G‑CSF) approved for prophylaxis of chemotherapy‑induced neutropenia. Administered as a single subcutaneous injection each chemotherapy cycle, it aims to reduce the incidence and duration of severe neutropenia and febrile neutropenia, thereby helping patients maintain planned chemotherapy dosing.
Mechanism of Action
Lipegfilgrastim functions as a G‑CSF analog that binds the granulocyte‑colony stimulating factor receptor on myeloid progenitor cells. This activation drives proliferation, differentiation and maturation of neutrophil precursors, leading to increased circulating neutrophil counts and a shortened period of chemotherapy‑related neutropenia. The PEGylation prolongs its circulating half‑life, allowing once‑per‑cycle dosing.
What the Research Shows
Randomised trials in breast cancer patients demonstrated non‑inferiority to pegfilgrastim for reducing severe neutropenia and febrile neutropenia, with comparable safety. In non‑small‑cell lung cancer, lipegfilgrastim lowered severe neutropenia incidence, shortened its duration, and hastened neutrophil recovery versus placebo. Real‑world data from two European phase IV studies involving 228 urological‑cancer patients reported a 2.6% overall febrile neutropenia rate and low rates of grade 3/4 neutropenia, with bone pain and pyrexia being the most common adverse reactions. A meta‑analysis of 24 studies (5,769 patients) found lipegfilgrastim associated with a statistically significant reduction in severe neutropenia risk in cycles 2‑4 compared with pegfilgrastim or filgrastim, while differences in febrile neutropenia and bone‑pain incidence were not significant. Systematic reviews confirm that primary prophylaxis with lipegfilgrastim reduces febrile neutropenia risk relative to no G‑CSF, though indirect comparisons with pegfilgrastim show mixed results.
Reported Benefits
Clinical evidence indicates that lipegfilgrastim effectively lowers the incidence of severe neutropenia and febrile neutropenia, shortens neutrophil recovery time, and permits patients to receive intended chemotherapy doses with fewer delays or dose reductions. Its long‑acting, once‑per‑cycle subcutaneous administration reduces treatment burden compared with daily filgrastim injections. Safety data from trials and real‑world studies suggest a tolerability profile similar to pegfilgrastim, with bone pain being the most frequently reported adverse event.
Limitations of the Evidence
The evidence base is still modest, with few head‑to‑head randomised trials against filgrastim and reliance on indirect comparisons for many outcomes. Some meta‑analytic findings, such as lower febrile neutropenia risk versus pegfilgrastim, did not reach statistical significance. Real‑world studies involve limited patient numbers and specific cancer types, limiting generalisability. Long‑term safety data beyond the study periods are scarce, and further comparative research is needed to clarify relative benefits.
Safety Considerations
Adverse drug reactions reported in clinical and real‑world settings include bone pain (approximately 2–3% of patients) and pyrexia (around 1%). Overall, the safety profile is comparable to that of pegfilgrastim, with no new safety signals identified in the published studies. Clinicians should monitor patients for typical G‑CSF‑related effects, especially bone pain, and manage symptoms as needed.
How It Is Administered
Lipegfilgrastim is supplied as a sterile solution for subcutaneous injection. It is given once per chemotherapy cycle, typically on the day after chemotherapy administration (e.g., day 2). The product is administered as a single dose (6 mg in the referenced trials) and can be used for primary or secondary prophylaxis of chemotherapy‑induced neutropenia.
Routes of Administration
Goals & Uses
- Prevention of chemotherapy‑induced neutropeniaOncology Supportive CareHigh
- 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
- Patients with known myeloid malignancies (e.g., chronic myeloid leukemia) not in remissionHematologicModerate
- Hypersensitivity to lipegfilgrastim or PEGylated G-CSF productsAllergy/immunologyHigh
- Hypersensitivity to lipegfilgrastim or any excipientAllergyHigh
Adverse Effects
- Acute respiratory distress syndrome (ARDS)PulmonaryRare
- Splenomegaly / splenic ruptureOrgan ToxicityRare
- Bone painMusculoskeletalCommon
- Injection site reactionsLocalCommon
- LeukocytosisHematologicCommon
- ThrombocytopeniaHematologicUncommonLow platelet count
- Splenic ruptureGastrointestinal/HematologicRare
- Injection‑site reactionsLocalCommon
- Bone pain / musculoskeletal painMusculoskeletalCommon
Drug Interactions
- Cytotoxic chemotherapy agentsHigh
- CorticosteroidsLow
- LithiumLow
- Concurrent myelosuppressive chemotherapyModerate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patients (under 18 years)AgeRelative
- Pediatric patientsAgeRelative
- Patients with sickle cell diseaseHematologic DisorderRelative
- Pregnant womenReproductiveRelative
- BreastfeedingReproductiveRelative
Regulatory Status
- European UnionApprovedApproved: Prevention of chemotherapy‑induced neutropeniaMarketed as Lonquex.
- RUApprovedApproved: Prevention of chemotherapy‑induced neutropeniaApproved under local brand names.
- United StatesUnapprovedNot submitted for FDA approval; pegfilgrastim is the FDA‑approved counterpart.
- 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 in the European Union (brand Lonquex) and several other jurisdictions; not approved by the US FDA.
Evidence & Sources
- Journal ArticleModerateGuariglia R, et al.2016-01-01T00:00:00.000000Z
- Journal ArticleHighMerseburger AS, et al.2021-01-01T00:00:00.000000Z
- Journal ArticleModerateRatti M, Tomasello G2015-01-01T00:00:00.000000Z
- Journal ArticleHighBond TC, et al.2018-01-01T00:00:00.000000Z
- Journal ArticleHighWang L, et al.2015-01-01T00:00:00.000000Z
- Journal ArticleModerateGladkov OA, et al.2016-01-01T00:00:00.000000Z
Frequently Asked Questions
How does lipegfilgrastim differ from pegfilgrastim?
Both are long‑acting G‑CSF agents given as a single subcutaneous injection per cycle. Lipegfilgrastim is a glyco‑PEGylated analog, whereas pegfilgrastim is a PEGylated form of filgrastim. Clinical trials suggest similar efficacy and safety, with some analyses showing a modest advantage in reducing severe neutropenia in later chemotherapy cycles.
In which cancers has lipegfilgrastim been studied?
Randomised trials have evaluated lipegfilgrastim in breast cancer and non‑small‑cell lung cancer. Real‑world phase IV studies have included patients with prostate, testicular, bladder and other urological malignancies. The drug is intended for any solid tumour or lymphoma where myelosuppressive chemotherapy poses a high risk of neutropenia.
What are the most common side effects?
The most frequently reported adverse events are bone pain (about 2–3% of patients) and pyrexia (roughly 1%). These are consistent with the known safety profile of G‑CSF agents. Most side effects are mild to moderate and manageable with standard symptomatic treatment.
Can lipegfilgrastim be used after a patient develops febrile neutropenia?
Yes. Studies report both primary prophylaxis (before any neutropenic episode) and secondary prophylaxis (after an episode) using lipegfilgrastim. In the pooled real‑world analysis, about 13% of administrations were for secondary prophylaxis, with low rates of subsequent febrile neutropenia.
Is dose adjustment needed for renal or hepatic impairment?
The published abstracts do not provide specific dosing guidance for renal or hepatic dysfunction. Current prescribing information recommends using the standard dose unless otherwise indicated by the product label, and clinicians should follow local guidelines and consider individual patient factors.
What is Lipegfilgrastim?
Lipegfilgrastim is a long‑acting, glyco‑PEGylated granulocyte colony‑stimulating factor (G‑CSF) approved for prophylaxis of chemotherapy‑induced neutropenia. Administered as a single subcutaneous injection each chemotherapy cycle, it aims to reduce the incidence and duration of severe neutropenia and febrile neutropenia, thereby helping patients maintain planned chemotherapy dosing.
What is Lipegfilgrastim used for?
Lipegfilgrastim is educationally associated with: Prevention of chemotherapy‑induced neutropenia, Reduction of febrile neutropenia duration, Reduction of infection risk during myelosuppressive chemotherapy, Prevention of chemotherapy-induced neutropenia. Educational only — not medical advice.
How is Lipegfilgrastim administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Lipegfilgrastim?
Reported adverse effects include: Acute respiratory distress syndrome (ARDS), Splenomegaly / splenic rupture, Bone pain, Injection site reactions, Leukocytosis, Thrombocytopenia, Splenic rupture, Injection‑site reactions, Bone pain / musculoskeletal pain. This list is not exhaustive — consult a qualified clinician.
Who should avoid Lipegfilgrastim?
Recorded contraindications: Use in patients with chronic myeloid leukemia or myelodysplastic syndrome, Patients with known myeloid malignancies (e.g., chronic myeloid leukemia) not in remission, Hypersensitivity to lipegfilgrastim or PEGylated G-CSF products, Hypersensitivity to lipegfilgrastim or any excipient. Consult a qualified clinician before use.