Lenograstim injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Powder and solvent for solution for injection/infusion formulation of lenograstim (rHuG-CSF).
rHuG-CSF = Recombinant human granulocyte - colony stimulating factor
Drugs List
Therapeutic Indications
Uses
Mobilisation of peripheral blood progenitor cells following chemotherapy
Mobilisation of peripheral blood progenitor cells for autologous infusion
Reduction in the duration of neutropenia following bone marrow transplant
Reduction of neutropenia-related risk of infection with cytotoxic drugs
Dosage
Lenograstim injection 13.4 million unit/ml can be used in patients with body surface area up to 0.7 square metre.
Lenograstim injection 33.6 million unit/ml can be used in patients with body surface area up to 1.8 square metre.
Adults
Peripheral stem cells or bone marrow transplantation
150 micrograms (19.2 million units) per square metre of body surface area per day. This is therapeutically equivalent to 5 micrograms (0.64 million units) per kg per day.
Administer as a 30 minute intravenous infusion diluted in isotonic saline solution, or as a subcutaneous injection starting 24 hours after bone marrow infusion. Treatment should continue until the expected nadir has passed and the neutrophil count stabilises. The maximum duration of treatment is 28 consecutive days.
By day 14 following bone marrow transplantation, it is anticipated that 50% of patients will achieve neutrophil recovery.
Established cytotoxic chemotherapy
150 micrograms (19.2 million units) per square metre of body surface area per day.
Administer as a subcutaneous injection starting 24 hours after chemotherapy completion. Treatment should continue until the expected nadir has passed and the neutrophil count stabilises. The maximum duration of treatment is 28 consecutive days.
A transient increase in neutrophil count may occur within the first 2 days of therapy. If this occurs, treatment should not be stopped as the subsequent nadir usually occurs earlier and recovers more quickly if treatment continues.
Mobilisation of peripheral blood progenitor cells after chemotherapy
150 micrograms (19.2 million units) per square metre of body surface area per day.
Administer as a subcutaneous injection starting 24 hours to 5 days after chemotherapy completion. Treatment should continue until the last leukapheresis.
Leukapheresis should be performed when the post-nadir leucocyte count is rising or after assessment of CD34+ cell count by a validated method. For patients who have not had extensive chemotherapy, one leukapheresis is usually sufficient to obtain the acceptable minimum yield (equal to or greater than 2.0 x 10 to the power of 6 CD34+ cells per kg).
Mobilisation of peripheral blood progenitor cells when used alone
The recommended dose is 10 micrograms (1.28 million units) per kg per day.
Administered as a subcutaneous injection daily for 4 to 6 days, with leukapheresis being performed between days 5 and 7.
In patients who have not had extensive chemotherapy one leukapheresis is often sufficient to obtain the acceptable minimum yield (greater than or equal to 2 x 10 to the power 6 CD34+ cells per kg).
In healthy donors, a 10micrograms/kg daily dose administered subcutaneously for 5 to 6 days is recommended. This allows a CD34+ cell collection of equal to or greater than 3 x 10 to the power of 6 per kg body weight with a single leukapheresis in 83% of patients and with 2 leukapheresis in 97% of patients.
Elderly
Clinical trials with lenograstim have included a small number of patients up to the age of 70. However, special studies have not been performed and so specific dose recommendations cannot be made.
Children
Children over 2 years in bone marrow transplantation and after cytotoxic chemotherapy
(See Dosage; Adults)
Children over 2 years for mobilisation of peripheral blood progenitor cells
Manufacturer advises that there is very limited data at the adult dose.
Alternative sources suggest lenograstim is not licensed for use in children for cytotoxic-induced neutropenia, mobilisation of peripheral blood progenitor cells (monotherapy or adjunctive therapy), or following peripheral stem cell transplantation.
Mobilisation of peripheral blood progenitor cells in children aged 2 to 18 years (unlicensed)
By subcutaneous injection.
Monotherapy: 10 micrograms/kg daily by subcutaneous injection for 4 to 6 days (5 to 6 days in healthy donors).
Following adjunctive myelosuppressive chemotherapy: Administer starting 24 hours to 5 days after chemotherapy completion.
Initial dose: 150 micrograms/square metre per day.
Administration
For intravenous infusion or subcutaneous injection administration.
Contraindications
Children under 2 years
Breastfeeding
Chronic myeloid leukaemia
Myelodysplastic syndrome
Myeloid malignancy (other than new onset acute myeloid leukaemia)
New onset acute myeloid leukaemia in patients below 55 years
New onset acute myeloid leukaemia in patients with good cytogenetics
Phenylketonuria
Pregnancy
Secondary acute myeloid leukaemia
Precautions and Warnings
Children aged 2 to 18 years
Patients over 70 years
History of pulmonary infiltrates
Impaired haemostasis
Malignancy with myeloid characteristics
Myelosuppression
Premalignant myeloid disorder
Recent history of pneumonia
Severe hepatic impairment
Severe renal impairment
Sickle cell disease
Sickle cell trait
Do not perform leukapheresis on anticoagulated/haemostasis-defective donors
Treatment to be initiated and supervised by a specialist
Contains phenylalanine
Do not administer during or within 24 hours before or after chemotherapy
Record name and batch number of administered product
Consider splenic rupture if patient has abdominal or shoulder pain
Monitor long-term safety of normal donors
Monitor patients at risk for signs & symptoms of thromboembolism
Monitor spleen size
Perform regular urinalysis
Perform regular white blood cell and platelet counts
Advise patient to report breathlessness or cough immediately
Advise patient to seek medical advice if signs/symptoms of aortitis occur
Consider discontinuing if pulmonary adverse events suspected/confirmed
Discontinue if adult respiratory distress syndrome occurs
Discontinue if patient shows signs of capillary leak syndrome
Discontinue or reduce dose if glomerulonephritis occurs
Not licensed for all indications in all age groups
Some tumours with non-specific characteristics can express a G-CSF receptor, which can lead to unexpected tumour regrowth with lenograstim therapy.
In patients receiving lenograstim following bone marrow transplant or cytotoxic chemotherapy, lenograstim should be discontinued immediately if leucocyte levels exceed 50 x 10 to the power of 9 per litre after the expected nadir.
In patients receiving lenograstim for mobilisation of peripheral blood progenitor cells, lenograstim should be discontinued immediately if leucocyte levels exceed 70 x 10 to the power of 9 per litre.
Spleen size should be carefully monitored by clinical examination and ultrasound as splenomegaly and splenic rupture has been observed following administration of granulocyte - colony stimulating factors (G-CSF). If patients present with left upper abdominal pain or shoulder tip pain, splenic rupture should be considered.
The safety of lenograstim has not been established in patients with substantially reduced myeloid progenitor cells due to prior intensive radiotherapy/chemotherapy. Neutrophil response is sometimes diminished in these patients.
Lenograstim should not be used to decrease the interval between chemotherapy courses or to increase the dose. Non-myeloid toxicities were limiting factors in a clinical trail of chemotherapy intensification.
Patients, who have undergone extensive prior myelosuppressive therapy and/or radiotherapy, may not show sufficient peripheral blood progenitor cell mobilisation to achieve the acceptable minimum yield (equal or greater than 2 x 10 to the power of 6 CD34+ cells per kg).
Leukapheresis should not be performed in healthy donors who are anticoagulated or who have known defects in haemostasis. If more than one leukapheresis is required particular attention should be paid to donors with platelets less than 100 x 10 to the power of 9 per litre prior to apheresis. In general apheresis should not be performed if platelets are less than 75 x 10 to the power of 9 per litre.
If aortitis is suspected it can usually be diagnosed by CT scan and generally resolves after withdrawal of lenograstim.
Monitor donors and patients with known risk factors for thrombosis.
Pregnancy and Lactation
Pregnancy
Lenograstim is contraindicated during pregnancy.
The manufacturer advises that lenograstim should only be used during pregnancy if treatment is clearly necessary. Animal studies have shown reproductive toxicity. At the time of writing there is limited human data available. The potential risk for humans is unknown.
Lactation
Lenograstim is contraindicated during breastfeeding.
The manufacturer recommends that breastfeeding is discontinued during treatment with lenograstim. It is unknown whether lenograstim is excreted in human milk.
Side Effects
Abdominal pain
Acute febrile dermatosis (Sweet's syndrome)
Adult respiratory distress syndrome
Alopecia
Anaphylactic shock
Anorexia
Aortitis
Arterial thrombosis
Asthenia
Back pain
Bone pain
Buccal irritation
Capillary leak syndrome
Chest pain
Cutaneous vasculitis
Diarrhoea
Dyspnoea
Erythema nodosum
Fever
Gastro-intestinal disturbances
Glomerulonephritis
Haemoptysis
Headache
Hypersensitivity reactions
Hypoxia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in serum ALT/AST
Infections
Injection site reactions
Interstitial pneumonia
Leucocytosis
Lyell's syndrome
Mucositis
Musculoskeletal pain
Nausea
Pain - generalised
Pulmonary fibrosis
Pulmonary haemorrhage
Pulmonary infiltrates
Pulmonary oedema
Pyoderma gangrenosum
Raised C-reactive protein
Rash
Respiratory failure
Sepsis
Splenic rupture
Splenomegaly
Thrombocytopenia
Toxic epidermal necrolysis
Venous thrombosis
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: March 2021
Reference Sources
Summary of Product Characteristics: Granocyte 13 million IU/mL, powder and solvent for solution for injection/infusion. Chugai Pharma UK Limited. Revised November 2020.
Summary of Product Characteristics: Granocyte 13 million IU/mL, powder and solvent for solution for injection/infusion in a pre-filled syringe. Chugai Pharma UK Limited. Revised November 2020.
Summary of Product Characteristics: Granocyte 34 million IU/mL, powder and solvent for solution for injection/infusion. Chugai Pharma UK Limited. Revised November 2020.
Summary of Product Characteristics: Granocyte 34 million IU/mL, powder and solvent for solution for injection/infusion in a pre-filled syringe. Chugai Pharma UK Limited. Revised November 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 5 March 2021
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