Recombinant G-CSF Pregnancy: There are no adequate data from use in pregnant women and animal studies have shown reproductive toxicity; the potential risk for humans is unknown, so lenograstim should not be used during pregnancy unless clearly necessary. It is unknown whether lenograstim is excreted in human milk and excretion in milk has not been studied in animals — breast-feeding should be discontinued during therapy (SPC section 4.6).

Lenograstim

Brand names: Granocyte

Lenograstim is a recombinant granulocyte colony-stimulating factor (G-CSF) used to reduce the duration of neutropenia after chemotherapy or bone marrow transplantation and to mobilise peripheral blood stem cells.

Adult dose

Dose: 19.2 million IU (150 micrograms) per m2 per day — therapeutically equivalent to 0.64 million IU (5 micrograms) per kg per day

Route: Subcutaneous injection, or 30-minute intravenous infusion diluted in isotonic saline solution (the intravenous route is described for peripheral stem cell or bone marrow transplantation)

Frequency: Once daily

Max: If necessary, a maximum of 28 consecutive days of treatment

SPC section 4.2. Therapy should only be given in collaboration with an experienced oncology and/or haematology centre. THE 19.2 MIU (150 micrograms)/m2/day DOSE APPLIES TO: peripheral stem cell or bone marrow transplantation; established cytotoxic chemotherapy; and PBPC mobilisation after chemotherapy. PERIPHERAL STEM CELL OR BONE MARROW TRANSPLANTATION: administer daily as a 30-minute intravenous infusion diluted in isotonic saline solution or as a subcutaneous injection; the first dose should not be given within 24 hours of the bone marrow infusion. Continue until the expected nadir has passed and the neutrophil count returns to a stable level compatible with treatment discontinuation, with a maximum of 28 consecutive days if necessary; by day 14 after bone marrow transplantation 50% of patients are anticipated to achieve neutrophil recovery. ESTABLISHED CYTOTOXIC CHEMOTHERAPY: administer daily as a subcutaneous injection, with the first dose not less than 24 hours after cytotoxic chemotherapy; continue until the expected nadir has passed and the neutrophil count is stable, maximum 28 consecutive days. A transient increase in neutrophil count may occur within the first 2 days but treatment should not be stopped, since the subsequent nadir usually occurs earlier and recovers more quickly if treatment continues. PBPC MOBILISATION AFTER CHEMOTHERAPY: administer daily as a subcutaneous injection starting within 1 to 5 days after completion of chemotherapy according to the mobilising regimen, and maintain until the last leukapheresis; perform leukapheresis when the post-nadir leukocyte count is rising or after assessment of blood CD34+ cells. PBPC MOBILISATION WITH LENOGRASTIM ALONE: the recommended dose is 1.28 million IU (10 micrograms) per kg per day by subcutaneous injection for 4 to 6 days, with leukapheresis performed between day 5 and day 7; in healthy donors 10 micrograms/kg/day subcutaneously for 5-6 days allows a CD34+ collection of at least 3 x 10^6/kg body weight with a single leukapheresis in 83% of subjects and with 2 leukaphereses in 97%. PRESENTATIONS BY BODY SURFACE AREA: the 13 million IU/mL strength can be used in patients with body surface area up to 0.7 m2; the 34 million IU/mL strength can be used in patients with body surface area up to 1.8 m2. ELDERLY: clinical trials included a small number of patients up to the age of 70 years but special studies have not been performed, so specific dosage recommendations cannot be made. PAEDIATRIC: the SPC states that the dose in children older than 2 years and adolescents is the same as in adults when used to reduce the duration of neutropenia after myeloablative therapy followed by bone marrow transplantation or after cytotoxic chemotherapy; very limited data are available for mobilisation of peripheral blood progenitor cells at the adult dose; safety and efficacy in children aged less than 2 years have not been established. No separate numeric paediatric regimen is stated, so no structured paediatric dose is given here — verify against a children's formulary before prescribing, noting the SPC warning that in children with ALL an increased risk of secondary myeloid leukaemia or myelodysplastic syndrome has been reported with colony-stimulating factors. SOURCE NOTE: the US openFDA record retrieved in this bundle is an unrelated homeopathic pellet product and was not used; the dose above is from the UK SPC.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — 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
Must not be used to increase the dose intensity of cytotoxic chemotherapy beyond established doses and dosage regimens, since it could reduce myelotoxicity but not the overall toxicity of cytotoxic drugs
Must not be administered concurrently with cytotoxic chemotherapy
Myeloid malignancy other than de novo acute myeloid leukaemia
De novo acute myeloid leukaemia in patients aged below 55 years
De novo acute myeloid leukaemia with good cytogenetics, i.e. t(8;21), t(15;17) and inv(16)

Side effects

Leukocytosis and thrombocytopenia — a white blood cell count should be performed at regular intervals; discontinue immediately if leukocytes exceed 50 x 10^9/L after the expected nadir, or exceed 70 x 10^9/L during PBPC mobilisation
Bone pain, back pain, headache and asthenia (most frequent in healthy donors undergoing PBPC mobilisation, transient and mild to moderate)
Fever, and infection or inflammatory disorder of the buccal cavity, sepsis and infection (transplantation and chemotherapy-induced neutropenia settings)
Gastrointestinal — diarrhoea, abdominal pain, nausea, vomiting
Rash, alopecia and cutaneous vasculitis
Splenomegaly (common but generally asymptomatic) with very rare splenic rupture; raised ALT, AST, alkaline phosphatase and LDH
Capillary leak syndrome (uncommon, post-marketing) which can be life-threatening if treatment is delayed; rare interstitial pneumonia and pulmonary infiltrates; very rare allergic reactions including anaphylaxis after the first subcutaneous administration

Clinical monograph

How it works

It is a glycosylated recombinant human G-CSF that stimulates proliferation and differentiation of neutrophil progenitors and enhances the function and release of mature neutrophils.

Prescribing in practice

Splenic enlargement and rare splenic rupture can occur, so investigate left upper abdominal or shoulder-tip pain promptly.
It should not be given in the period immediately surrounding cytotoxic chemotherapy administration, in line with the SPC.
Bone pain is common and pulmonary adverse effects have been reported, warranting clinical vigilance.

Monitoring

Monitor full blood count regularly to guide therapy and detect excessive leucocytosis, and review for splenic and pulmonary adverse effects.

Counselling the patient

Bone or muscle aches are common and can usually be managed with simple analgesia.
Report severe pain in the upper left abdomen or tip of the shoulder promptly.
Attend for the blood tests needed to monitor your treatment.

Evidence & guidelines

Lenograstim use is supported by established evidence that G-CSF shortens the duration of chemotherapy-induced neutropenia and aids stem-cell mobilisation.

Reference: NICE; 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).

Curated clinical cross-links plus same-class fallbacks.

Pathways