Lenograstim interacts in the following cases:
Granulocyte colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
The safety and efficacy of lenograstim administration in patients with myelodysplasia or secondary AML or chronic myelogenous leukaemia have not been established. Therefore, it should not be used in these indications. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Clinical trials have not established whether lenograstim influences the progression of myelodysplastic syndrome to acute myeloid leukaemia. Caution should be exercised in using it in any pre-malignant myeloid condition. As some tumours with non-specific characteristics can exceptionally express a G-CSF receptor, caution should be exerted in the event of unexpected tumour regrowth concomitantly observed with rHuG-CSF therapy.
A leukocyte count greater than 50 × 109/L has not been observed in any of the 174 clinical trials patients treated with 5 µg/kg/day (0.64 million units/kg/day) following bone marrow transplantation. White blood cell counts of 70 × 109/L or greater have been observed in less than 5% of patients who received cytotoxic chemotherapy and were treated by lenograstim at 5 µg/kg/day (0.64 million units/kg/day). No adverse events directly attributable to this degree of leukocytosis have been reported. In view of the potential risks associated with severe leukocytosis, a white blood cell count should, however, be performed at regular intervals during lenograstim therapy.
If leukocyte counts exceed 50 × 109/L after the expected nadir, lenograstim should be discontinued immediately.
During PBPC mobilisation, lenograstim should be discontinued if the leukocyte counts rise to >70 × 109/L.
Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in either healthy donors or patients following administration of Granulocyte-colony stimulating factors (G-CSFs). Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered when left upper abdominal pain or shoulder tip pain is reported.
Glomerulonephritis has been reported in patients and donors receiving lenograstim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of G-CSF. Urinalysis monitoring is recommended.
Sickle cell crisis may be potentially associated with the use of lenograstim in patients with sickle cell trait or sickle cell disease. Therefore, physicians should use caution when prescribing Granocyte in patients with sickle cell trait or sickle cell disease.
Rare (>0.01% and <0.1%) pulmonary adverse effects, in particular interstitial pneumonia, have been reported after G-CSFs administration.
Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
The onset of pulmonary symptoms or signs, such as cough, fever and dyspnoea, in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of acute respiratory distress syndrome (ARDS).
Lenograstim should be immediately discontinued and appropriate treatment given.
In donors and patients, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, lung infiltrates, dyspnoea and hypoxia) have been reported in post marketing experience. In case of suspected or confirmed pulmonary adverse events, discontinuation of treatment with lenograstim should be considered and appropriate medical care given.
Capillary leak syndrome has been reported after G-CSF administration, and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration. Lenograstim should be discontinued if patients develop symptoms of capillary leak syndrome, and appropriate symptomatic treatment, which may include a need for intensive care, should be given.
Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)
An increased risk for secondary myeloid leukaemia or myelodysplastic syndrome associated with CSFs has been reported in children with ALL. A comparable risk has been established by a systematic review of 25 randomized controlled trials in 12.804 adult patients with solid tumors or lymphomas, a risk, however, without negative impact on long term outcome in the adults investigated. Therefore, lenograstim 13 million IU/mL and lenograstim 34 million IU/ml should be used in children, in particular with favorable long term prognosis, only after careful weighting of short term benefits versus long term risks.
There are no adequate data from the use of lenograstim in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Lenograstim should not be used during pregnancy unless clearly necessary.
It is unknown whether lenograstim is excreted in human milk. The excretion of lenograstim in milk has not been studied in animals. Breast-feeding should be discontinued during therapy with lenograstim.
No studies on the effects on the ability to drive and use machines have been performed.
The safety profile in children, adolescents, and adults is comparable.
In double-blind placebo-controlled trials the mean platelet count was lower in patients treated with lenograstim as compared with placebo without an increase in incidence of adverse events related to blood loss and the median number of days following BMT to last platelet infusion was similar in both groups.
In clinical trials, the most frequently reported adverse events (15%) were the same in patients treated with either lenograstim or placebo. These adverse events were those usually encountered with conditioning regimens and those observed in cancer patients treated with chemotherapy. The most commonly reported adverse events were infection/inflammatory disorder of the buccal cavity, sepsis and infection, fever, diarrhoea, abdominal pain, vomiting, nausea, rash, alopecia, and headache.
The most frequently reported undesirable effects were transient and mild to moderate: pain, bone pain, back pain, asthenia, fever, headache and nausea, increased ALAT, ASAT, blood alkaline phosphatise and LDH.
Apheresis-related thrombocytopenia and leukocytosis were observed in 42% and 24% respectively in study subjects.
Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported.
Allergic reactions including anaphylaxis have been reported very rarely after the first subcutaneous administration of lenograstim.
Capillary leak syndrome which can be life-threatening if treatment is delayed has been reported uncommonly (≥1/1000 to <1/100) in the post-marketing setting following administration of granulocyte-colony-stimulating factors, mostly in cancer patients undergoing chemotherapy.
Frequency of adverse reactions issued from clinical trials and post-marketing surveillance data. Very common (≥10%); common (≥1/100 to <1/10); uncommon (≥1/1000 to ≤1/100); rare (≥1/10000 to ≤1/1000); very rare (≤1/10000); not known (cannot be estimated from the available data).
Very common: Elevated LDH
Very common: Leucocytosis, Thrombocytopenia
Common: Enlarged spleen size
Very rare: Splenic rupture5
Very common: Headache, Asthenia
Uncommon: Capillary leak syndrome6
Rare: Aortitis
Uncommon: Haemoptysis8
Rare: Pulmonary edema, Interstitial pneumonia3, Pulmonary infiltrates, Pulmonary fibrosis, Pulmonary haemorrhage8
Common: Abdominal pain
Very rare: Cutaneous vasculitis, Sweet’s syndrome4, Erythema nodosum, Pyoderma gangrenosum, Lyell’s syndrome
Very common: Musculoskeletal pain7
Common: Pain1
Not known: Glomerulonephritis
Common: Injection site reaction
Very rare: Allergic reaction, Anaphylactic shock
Very common: Elevated ASAT/ALAT2, Elevated Alkaline-phosphatase
1 The risk of occurrence of pain is increased in subjects with high peak WBC values, especially when WBC ≥50 × 109/L.
2 Transient increase of ASAT and/or ALAT was observed. In most cases, liver function abnormalities improved after lenograstim discontinuation.
3 Some of the respiratory reported cases have resulted in respiratory failure or acute respiratory distress syndrome (ARDS) which may be fatal.
4 Sweet’s syndrome, erythema nodosum and pyoderma gangrenosum were mainly described in patients with hematological malignancies, a condition known to be associated with neutrophilic dermatosis, but also in non-malignant related neutropenia.
5 Splenic ruptures have been reported in either healthy donors or patients receiving G-CSFs.
6 There have been post-marketing reports of life-threatening capillary leak syndrome.
7 Includes bone pain, back pain, arthralgia, myalgia and pain in extremity
8 Pulmonary adverse reactions have been reported like dyspnoea, hypoxia or haemoptysis, including very rarely Acute Respiratory Distress Syndrome (ARDS).
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