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Long-acting recombinant G-CSF Pregnancy: Section 4.6 verbatim: 'Pregnancy There are very limited data (less than 300 pregnancy outcomes) on the use of lipegfilgrastim in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Lonquex during pregnancy. Breast-feeding It is unknown whether lipegfilgrastim/metabolites are excreted in human milk. A risk to the breast-fed child cannot be excluded. Breast-feeding should be discontinued during treatment with Lonquex. Fertility No data are available. Animal studies with G-CSF and derivatives do not indicate harmful effects with respect to fertility.'

Lipegfilgrastim

Brand names: Lonquex

Lipegfilgrastim is a long-acting (pegylated, glycopegylated) recombinant granulocyte colony-stimulating factor (G-CSF) used to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving cytotoxic chemotherapy.

Adult dose

Dose: 6 mg lipegfilgrastim - one single pre-filled syringe - per chemotherapy cycle
Route: Subcutaneous injection. The injections should be given into the abdomen, upper arm or thigh.
Frequency: One 6 mg dose for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy
Max: 6 mg per chemotherapy cycle - one single pre-filled syringe, one dose per cycle
UK SPC (Lonquex 6 mg solution for injection in pre-filled syringe) section 4.2, verbatim: 'One 6 mg dose of lipegfilgrastim (a single pre-filled syringe of Lonquex) is recommended for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.' SPECIALIST SUPERVISION: 'Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology.' ELDERLY: 'In clinical studies with a limited number of elderly patients, there was no relevant age-related difference with regard to the efficacy or safety profiles of lipegfilgrastim. Therefore, no adjustment of the dose is necessary for elderly patients.' RENAL IMPAIRMENT and HEPATIC IMPAIRMENT: for both, 'Currently available data are described in section 5.2, but no recommendation on a posology can be made' - no adjusted regimen exists in this source, so none is stated here. SELF-ADMINISTRATION: 'Self-administration of Lonquex should only be performed by patients who are well motivated, adequately trained and have access to expert advice. The first injection should be performed under direct medical supervision.' LIMITS OF USE (section 4.4): 'The safety and efficacy of Lonquex have not been investigated in patients receiving high dose chemotherapy. Lonquex should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens.' It should not be used in patients with chronic myeloid leukaemia, myelodysplastic syndromes or secondary acute myeloid leukaemia, in whom safety and efficacy have not been investigated. STOPPING RULE: 'If WBC counts exceed 50 x 10 9 /l after the expected nadir, lipegfilgrastim should be discontinued immediately.' TRUNCATION CAVEAT: sections 4.2, 4.3 and 4.6 were captured complete; section 4.4 was cut at the source-fetch limit part-way through the myelodysplastic-syndrome/AML post-marketing paragraph and section 4.8 was cut part-way through the description of musculoskeletal pain, so the warnings and side-effect lists below are NOT complete.

Paediatric dose

NO PAEDIATRIC DOSE EXISTS IN THIS SOURCE, so dosePerKg is null and the weight calculator is deliberately unset. Section 4.2 verbatim: 'Paediatric population The safety and efficacy of Lonquex in children and adolescents aged up to 17 years have not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2.' The adult dose is a fixed 6 mg per cycle and is not weight-based; do not scale it down for children. Verify against a children's formulary.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (section 4.3)
  • Do not commence lipegfilgrastim in patients who are hypersensitive to G-CSF or derivatives, because of the risk of cross-reaction (section 4.4 special warning)
  • Should not be used in patients with chronic myeloid leukaemia, myelodysplastic syndromes or secondary acute myeloid leukaemia - safety and efficacy have not been investigated in these patients (section 4.4)

Side effects

  • Very common: musculoskeletal pains (bone pain and myalgia - the most frequent adverse reaction) and nausea
  • Common: thrombocytopenia, hypokalaemia, headache, haemoptysis, skin reactions (erythema and rash), chest pain
  • Uncommon: leukocytosis, splenomegaly (generally asymptomatic), hypersensitivity reactions (allergic skin reactions, urticaria, angioedema and serious allergic reactions), pulmonary adverse reactions (in particular interstitial pneumonia, and also pulmonary oedema, pulmonary infiltrates, pulmonary fibrosis, respiratory failure or ARDS), pulmonary haemorrhage, injection site reactions (induration and pain), blood alkaline phosphatase increased, blood lactate dehydrogenase increased
  • Not known: capillary leak syndrome - which can be life-threatening if treatment is delayed and has been reported mostly in cancer patients undergoing chemotherapy after administration of G-CSF or derivatives; aortitis
  • Treatment does not preclude thrombocytopenia and anaemia caused by myelosuppressive chemotherapy (section 4.4)
  • Increased haematopoietic activity of the bone marrow has been associated with transient positive bone-imaging findings, which should be considered when interpreting bone-imaging results (section 4.4)
  • INCOMPLETE: section 4.8 was cut at the source-fetch limit part-way through the description of musculoskeletal pain - consult the full SPC

Monitoring

  • Full blood count - regular monitoring of the platelet count and haematocrit is recommended, with special care when giving single or combination chemotherapeutic products known to cause severe thrombocytopenia
  • White cell count at regular intervals during therapy, because of the potential for leukocytosis - discontinue lipegfilgrastim immediately if WBC counts exceed 50 x 10^9/l after the expected nadir
  • Watch for capillary leak syndrome, which can be life-threatening if treatment is delayed
  • Traceability - record the trade name and batch number of the administered product clearly in the patient file
  • If a patient fails to respond to treatment, undergo further evaluation - anti-drug antibody responses can lead to undesirable effects or loss of efficacy
  • If a serious allergic reaction occurs, administer appropriate therapy with close patient follow-up over several days
  • Particular care to distinguish blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia

Clinical monograph

How it works

It binds to G-CSF receptors on myeloid progenitor cells, stimulating proliferation, differentiation and functional activation of neutrophils, with pegylation prolonging its half-life to allow once-per-cycle dosing.

Prescribing in practice

  • Rare but serious splenic rupture, capillary leak syndrome and acute respiratory distress syndrome have been reported; advise patients to report upper-left abdominal or shoulder-tip pain urgently.
  • It should not be given in the period spanning the days immediately before and after cytotoxic chemotherapy; follow the SPC for timing relative to the chemotherapy cycle.
  • Sickle cell crises have been reported in patients with sickle cell disease or trait, so use with caution in this group.

Monitoring

Monitor the full blood count regularly during therapy, watching in particular for leucocytosis and the platelet count.

Counselling the patient

  • Bone pain is a common side effect and can usually be managed with simple analgesia.
  • Report sudden severe upper abdominal or left shoulder pain, breathlessness or signs of allergy promptly.

Evidence & guidelines

Use of G-CSF for chemotherapy-induced neutropenia is supported by NICE cancer guidance and established oncology practice.

Reference: NICE CG151; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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