Lonquex Special Precautions

Traceability: In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file.
General: The safety and efficacy of Lonquex have not been investigated in patients receiving high dose chemotherapy. Lonquex should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Allergic reactions and immunogenicity: Patients who are hypersensitive to G-CSF or derivatives are also at risk of hypersensitivity reactions to lipegfilgrastim due to possible cross-reactivity. No lipegfilgrastim therapy should be commenced in these patients because of the risk of cross-reaction.
Most biological medicinal products elicit some level of anti-drug antibody response. This antibody response can, in some cases, lead to undesirable effects or loss of efficacy. If a patient fails to respond to treatment, the patient should undergo further evaluation.
If a serious allergic reaction occurs, appropriate therapy with close patient follow-up over several days should be administered.
Haematopoietic system: Treatment with lipegfilgrastim does not preclude thrombocytopenia and anaemia caused by myelosuppressive chemotherapy. Lipegfilgrastim may also cause reversible thrombocytopenia (see Adverse Reactions). 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.
Leukocytosis may occur (see Adverse Reactions). 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 x 10⁹/l after the expected nadir, lipegfilgrastim should be discontinued immediately.
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings. This should be considered when interpreting bone-imaging results.
Patients with myeloid leukaemia or myelodysplastic syndromes: Granulocyte-colony stimulating factor can promote growth of myeloid cells and some non-myeloid cells in vitro.
The safety and efficacy of Lonquex 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.
Splenic adverse reactions: Generally asymptomatic cases of splenomegaly have been reported after administration of lipegfilgrastim (see Adverse Reactions) and infrequent cases of splenic rupture, including fatal cases, have been reported after administration of G-CSF or derivatives (see Adverse Reactions). 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.
Pulmonary adverse reactions: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after administration of lipegfilgrastim (see Adverse Reactions). 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) (see Adverse Reactions). In such circumstances Lonquex should be discontinued at the discretion of the physician and appropriate treatment given.
Vascular adverse reactions: 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 (see Adverse Reactions).
Patients with sickle cell anaemia: Sickle cell crisis has been associated with the use of G-CSF or derivatives in patients with sickle cell anaemia (see Adverse Reactions). Physicians should therefore exercise caution when administering Lonquex 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.
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. See also Adverse Reactions.
Hypokalaemia: Hypokalaemia may occur (see Adverse Reactions). 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.
Glomerulonephritis: 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 (see Adverse Reactions).
Excipients with known effect: This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially 'sodium-free'.
Effects on ability to drive and use machines: Lonquex has no or negligible influence on the ability to drive and use machines.