lenograstim: clinical use

Prescribing considerations

• Use only with an experienced oncology or haematology centre.
• Assess previous myelosuppressive treatment, pulmonary history, thrombosis risk, sickle-cell disease or trait, and severe renal or hepatic impairment.
• For healthy donors, confirm standard donation eligibility and arrange appropriate long-term donor records and follow-up.
• Record the product name and batch number for biological traceability.

Contraindications and cautions

• Hypersensitivity to lenograstim or an excipient.
• Concurrent cytotoxic chemotherapy.
• Myeloid malignancy other than the specifically permitted de novo acute myeloid leukaemia population.
• De novo acute myeloid leukaemia in people below the licensed age restriction or with favourable cytogenetic abnormalities specified in the SmPC.

Monitoring

• Full blood count with differential and platelets.
• Clinical assessment of spleen size and urgent investigation of compatible pain.
• Respiratory symptoms and signs, particularly with previous pulmonary infiltrates or pneumonia.
• Urinalysis for evidence of glomerulonephritis.
• Symptoms of capillary leak, thrombosis, sickle-cell crisis or aortitis.
• Stem-cell yield and donor platelet recovery where used for mobilisation.

Clinical pharmacology

Lenograstim is glycosylated recombinant human G-CSF produced in Chinese hamster ovary cells. It stimulates neutrophil-lineage precursors and produces neutrophils with normal chemotactic and phagocytic function; its pharmacokinetics and neutrophil response are related to exposure.

Formulation and product differences

• Available as a single-use vial of powder with water for injections supplied in an ampoule or pre-filled syringe.
• The reconstituted product can be administered subcutaneously or diluted appropriately for intravenous infusion.
• It contains phenylalanine and is essentially sodium-free; it must not be frozen.