Lipegfilgrastim interacts in the following cases:
In animal models, concomitant administration of G-CSF and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Leukocytosis may occur. No adverse events directly attributable to leukocytosis have been reported. Elevation in white blood cells (WBC) is consistent with the pharmacodynamic effects of lipegfilgrastim. A WBC count should be performed at regular intervals during therapy owing to the clinical effects of lipegfilgrastim and the potential for leukocytosis. If WBC counts exceed 50 × 109/l after the expected nadir, lipegfilgrastim should be discontinued immediately.
Sickle cell crisis has been associated with the use of G-CSF or derivatives in patients with sickle cell anaemia. Physicians should therefore exercise caution when administering lipegfilgrastim in patients with sickle cell anaemia, monitor appropriate clinical parameters and laboratory results and be attentive to the possible association of lipegfilgrastim with splenic enlargement and vaso-occlusive crisis.
Generally asymptomatic cases of splenomegaly have been reported after administration of lipegfilgrastim and infrequent cases of splenic rupture, including fatal cases, have been reported after administration of G-CSF or derivatives. Spleen size should therefore be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Treatment with lipegfilgrastim does not preclude thrombocytopenia and anaemia caused by myelosuppressive chemotherapy. Lipegfilgrastim may also cause reversible thrombocytopenia. Regular monitoring of the platelet count and haematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic medicinal products that are known to cause severe thrombocytopenia.
Hypokalaemia may occur. For patients with increased risk on hypokalaemia due to underling disease or co-medications, it is recommended to monitor the serum potassium level carefully and to substitute potassium if necessary.
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after administration of lipegfilgrastim. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
The onset of pulmonary symptoms such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function together with an increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS). In such circumstances lipegfilgrastim should be discontinued at the discretion of the physician and appropriate treatment given.
Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count). In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF.
Glomerulonephritis has been reported in patients receiving filgrastim, lenograstim or pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim, lenograstim or pegfilgrastim. Urinalysis monitoring is recommended.
Capillary leak syndrome has been reported after administration of G-CSF or derivatives and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
Granulocyte-colony stimulating factor can promote growth of myeloid cells and some non-myeloid cells in vitro.
The safety and efficacy of lipegfilgrastim have not been investigated in patients with chronic myeloid leukaemia, myelodysplastic syndromes or secondary acute myeloid leukaemia; it should therefore not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
There are very limited data (less than 300 pregnancy outcomes) on the use of lipegfilgrastim in pregnant women. Animal studies have shown reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of lipegfilgrastim during pregnancy.
It is unknown whether lipegfilgrastim/metabolites are excreted in human milk. A risk to the breast-fed child cannot be excluded. Breast-feeding should be discontinued during treatment with lipegfilgrastim.
No data are available. Animal studies with G-CSF and derivatives do not indicate harmful effects with respect to fertility.
Lipegfilgrastim has no or negligible influence on the ability to drive and use machines.
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