8.
Traceability:
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 4). Possible interactions with other haematopoietic growth factors and cytokines have yet to be investigated in clinical trials.
6 Fertility, pregnancy and lactation Pregnancy There are no adequate data from the use of lenograstim in pregnant women. 3). The potential risk for humans is unknown. GRANOCYTE should not be used during pregnancy unless clearly necessary.
Breast-feeding 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 GRANOCYTE. 7. Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed.
8 Undesirable effects The safety profile in children, adolescents, and adults is comparable. 4). In Peripheral Stem Cells or Bone Marrow Transplantation and Chemotherapy-Induced Neutropenia In clinical trials, the most frequently reported adverse events (15%) were the same in patients treated with either GRANOCYTE 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.
In PBPC mobilisation in healthy donors 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.
4). 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).
Medra System Organ Class Very common Common Uncommon Rare Very rare Not known Investigations Elevated LDH C-reactive protein increased Blood and lymphatic system disorders Leucocytosis Thrombocytopenia Enlarged spleen size Splenic rupture (5) Nervous system disorders Headache Asthenia Vascular Disorders Capillary leak syndrome6 Aortitis Venous thromboembolism Arterial thromboembolism Respiratory, thoracic and mediastinal disorders Haemoptysi s (8) Pulmonary edema Interstitial pneumonia (3) Pulmonary infiltrates Pulmonary fibrosis Pulmonary haemorrhage (8) Gastrointestina l disorders Abdominal pain Skin and subcutaneous tissue disorders Cutaneous vasculitis Sweet’s syndrome (4) Erythema nodosum Pyoderma gangrenosum Lyell’s syndrome Musculoskelet al and connective tissue disorders Musculoskeletal pain (7) Pain (1) Renal and urinary disorders Glomerulonephritis General disorders and administration site condition Injection site reaction Immune system disorders Allergic reaction Anaphylactic shock Hepatobiliary disorders Elevated ASAT/ALAT (2) Elevated Alkaline- phosphatase 1 / The risk of occurrence of pain is increased in subjects with high peak WBC values, especially when WBC ≥ 50 x 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.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. […]