Lenograstim
Also known as: G-CSF (CHO-derived), Granocyte, Granulokine, LEN, Lenograstim, rHuG-CSF (glycosylated), rHuG‑CSF
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Summary
Lenograstim is a glycosylated recombinant human granulocyte‑colony stimulating factor (G‑CSF) that is approved as a prescription medication. It is used to prevent or treat neutropenia that occurs after myelosuppressive chemotherapy, stem‑cell transplantation, or certain disease‑related conditions. By accelerating neutrophil recovery, lenograstim lowers infection risk, shortens hospital stays, and facilitates the collection of peripheral‑blood stem cells for autologous or allogeneic transplantation.
Mechanism of Action
Lenograstim binds the G‑CSF receptor (CD114) on hematopoietic progenitor cells in bone marrow, triggering JAK/STAT, PI3K/AKT and MAPK signaling cascades. This promotes proliferation, differentiation and survival of neutrophil precursors and mature neutrophils, leading to a rapid increase in circulating neutrophils. The same signaling expands the CD34⁺ progenitor pool and mobilises these cells into peripheral blood, supporting stem‑cell harvest for transplantation.
What the Research Shows
Clinical data reported in a 2000 review show that lenograstim markedly speeds neutrophil recovery after chemotherapy, reduces laboratory‑confirmed infections and shortens hospitalisation. It also enables higher chemotherapy dose intensity in breast and small‑cell lung cancer, though no improvement in tumour response or survival has been demonstrated. Lenograstim is effective for stem‑cell mobilisation, outperforming filgrastim on a per‑dose basis in some studies, and has been used successfully in autologous and allogeneic transplants. A 2011 European guideline cites lenograstim alongside filgrastim and pegfilgrastim as clinically effective for prophylaxis of febrile neutropenia. A systematic review of 16 comparative trials found no clinically meaningful difference between lenograstim and filgrastim in neutropenia management or peripheral‑blood progenitor cell mobilisation. Reviews highlight its role in reducing morbidity and mortality in patients receiving myelosuppressive therapy, while noting that cost‑effectiveness data remain limited.
Reported Benefits
Lenograstim reduces the incidence of chemotherapy‑induced neutropenia and associated infections, shortens hospital stays, and allows maintenance of planned chemotherapy dose intensity. It facilitates rapid neutrophil recovery, supports peripheral‑blood stem‑cell mobilisation for autologous or allogeneic transplantation, and has not been shown to stimulate malignant blasts in leukemic patients. Overall, it is regarded as a valuable adjunct to mitigate haematological toxicity of myelosuppressive regimens.
Limitations of the Evidence
Evidence does not demonstrate improved tumour response rates or overall survival despite higher chemotherapy dose intensity. Systematic comparisons have not identified a clear superiority of lenograstim over non‑glycosylated filgrastim, and cost‑effectiveness analyses are inconclusive. Data are limited for certain populations such as patients with AIDS, aplastic anaemia, or chronic myeloid leukaemia, and long‑term economic impact remains uncertain.
Safety Considerations
The most frequently reported adverse events are bone pain and injection‑site reactions, occurring in roughly 20% of cancer patients receiving daily G‑CSF therapy, with higher rates reported in healthy stem‑cell donors. Bone pain is thought to result from marrow expansion and nociceptor sensitisation; it is usually managed with acetaminophen, NSAIDs or dose adjustment. Overall, lenograstim is well tolerated, and serious adverse effects are uncommon in the clinical trials reviewed.
How It Is Administered
Lenograstim is supplied for intravenous or subcutaneous injection. In clinical practice it is administered as daily injections during the neutropenic phase of a chemotherapy cycle or prior to stem‑cell harvest. The non‑pegylated formulation requires repeated dosing each cycle, with the route and schedule selected according to the treating physician's judgment.
Routes of Administration
Goals & Uses
- Prevention of chemotherapy‑induced neutropeniaOncology Supportive CareHigh
- Reduction of chemotherapy-induced neutropenia durationHematologic SupportHigh
- Accelerated neutrophil recovery after bone‑marrow transplantHematologyModerate
- Accelerating neutrophil recovery post bone marrow transplantTransplantation SupportHigh
- Treatment of severe chronic neutropeniaHematologic DisorderModerate
- Prevention of infections in neutropenic patientsInfection ProphylaxisHigh
- Mobilization of peripheral blood progenitor cells (PBPC)Stem Cell TransplantationHigh
Contraindications
- Myeloid malignancies (AML, CML) not receiving cytotoxic therapyOncologicHigh
- Hypersensitivity to lenograstim or any excipientAllergyHigh
- Active malignant disease (solid tumors)OncologyModerate
- Hypersensitivity to lenograstim or E. coli-derived proteinsAllergy/ImmunologicHigh
- Concomitant cytotoxic chemotherapy or radiotherapy (within 24 hours)Drug Interaction / TimingHigh
Adverse Effects
- Splenomegaly / splenic ruptureOrgan ToxicityUncommon
- Bone painMusculoskeletalCommon
- Injection site reactionsLocalCommon
- LeukocytosisHematologicCommon
- ThrombocytopeniaHematologicUncommonLow platelet count
- Pulmonary adverse events (ARDS, interstitial pneumonia)RespiratoryRare
- Allergic reaction / anaphylaxisImmuneRare
- Splenic ruptureGastrointestinal/HematologicRare
- Injection‑site reactionLocalCommon
- Bone pain / musculoskeletal painMusculoskeletalCommon
Drug Interactions
- Cytotoxic chemotherapy agentsLow
- BleomycinModerate
- CorticosteroidsLow
- LithiumLow
Population Constraints
- Pediatric patientsAgeRelative
- Patients with sickle cell diseaseHematologic DisorderRelative
- Patients with pre-existing myeloid disordersOncologicRelative
- Pregnant womenReproductiveRelative
- Pediatric patients (<2 years)AgeRelative
Regulatory Status
- European UnionApprovedApproved: Chemotherapy‑induced neutropenia, Neutropenia after bone‑marrow transplantationMarketing authorization holder: Chiesi Farmaceutici.
- United StatesUnapprovedFDA has not approved lenograstim; filgrastim is the approved G‑CSF.
- United KingdomApprovedApproved: Chemotherapy‑induced neutropenia, Post‑transplant neutropeniaApproved via EU pathway post‑Brexit.
Approved for clinical use in the European Union and several other jurisdictions; not approved by the US FDA (filgrastim is the US‑approved counterpart).
Evidence & Sources
- Journal ArticleModerateDunn CJ, Goa KL2000-01-01T00:00:00.000000Z
- Journal ArticleHighAapro MS, et al.2011-01-01T00:00:00.000000Z
- Journal ArticleHighSourgens H, Lefrère F2011-01-01T00:00:00.000000Z
- Journal ArticleModerateWelte K2014-01-01T00:00:00.000000Z
- Journal ArticleModerateLambertini M, et al.2014-01-01T00:00:00.000000Z
Frequently Asked Questions
What clinical situations is lenograstim used for?
Lenograstim is prescribed to prevent or treat neutropenia that follows myelosuppressive chemotherapy, high‑dose chemotherapy before stem‑cell transplantation, and certain disease‑related neutropenia such as in acute leukaemias or severe chronic neutropenia.
How does lenograstim differ from filgrastim?
Lenograstim is a glycosylated form of recombinant G‑CSF, whereas filgrastim is non‑glycosylated. In vitro studies suggested possible potency differences, but systematic clinical reviews have not shown a meaningful superiority of lenograstim over filgrastim in neutropenia management or stem‑cell mobilisation.
What are the most common side effects?
Bone pain and injection‑site reactions are the most frequently reported adverse events, affecting about one‑fifth of cancer patients receiving daily G‑CSF. Pain is usually mild to moderate and can be alleviated with acetaminophen or NSAIDs.
Does lenograstim improve cancer survival?
Current evidence indicates that lenograstim reduces infection‑related complications but has not been shown to improve tumour response rates or overall survival, even when it allows higher chemotherapy dose intensity.
How is lenograstim administered?
The drug is given by subcutaneous or intravenous injection, typically once daily during the neutropenic window of each chemotherapy cycle or before peripheral‑blood stem‑cell collection. The exact schedule is determined by the treating clinician.
What is Lenograstim?
Lenograstim is a glycosylated recombinant human granulocyte‑colony stimulating factor (G‑CSF) that is approved as a prescription medication. It is used to prevent or treat neutropenia that occurs after myelosuppressive chemotherapy, stem‑cell transplantation, or certain disease‑related conditions. By accelerating neutrophil recovery, lenograstim lowers infection risk, shortens hospital stays, and facilitates the collection of peripheral‑blood stem cells for autologous or allogeneic transplantation.
What is Lenograstim used for?
Lenograstim is educationally associated with: Prevention of chemotherapy‑induced neutropenia, Reduction of chemotherapy-induced neutropenia duration, Accelerated neutrophil recovery after bone‑marrow transplant, Accelerating neutrophil recovery post bone marrow transplant, Treatment of severe chronic neutropenia, Prevention of infections in neutropenic patients, Mobilization of peripheral blood progenitor cells (PBPC). Educational only — not medical advice.
How is Lenograstim administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Lenograstim?
Reported adverse effects include: Splenomegaly / splenic rupture, Bone pain, Injection site reactions, Leukocytosis, Thrombocytopenia, Pulmonary adverse events (ARDS, interstitial pneumonia), Allergic reaction / anaphylaxis, Splenic rupture, Injection‑site reaction, Bone pain / musculoskeletal pain. This list is not exhaustive — consult a qualified clinician.
Who should avoid Lenograstim?
Recorded contraindications: Myeloid malignancies (AML, CML) not receiving cytotoxic therapy, Hypersensitivity to lenograstim or any excipient, Active malignant disease (solid tumors), Hypersensitivity to lenograstim or E. coli-derived proteins, Concomitant cytotoxic chemotherapy or radiotherapy (within 24 hours). Consult a qualified clinician before use.