Lonquex Adverse Reactions

Summary of the safety profile: The most frequent undesirable effects are musculoskeletal pains and nausea.
Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported mostly in cancer patients undergoing chemotherapy after administration of G-CSF or derivatives (see Precautions and following text).
Tabulated list of adverse reactions: The safety of lipegfilgrastim has been evaluated based on results from clinical studies including 506 patients and 76 healthy volunteers treated at least once with lipegfilgrastim.
The adverse reactions listed as follows in Table 3 are classified according to System organ class. Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 3.)

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Description of selected adverse reactions: Thrombocytopenia and leukocytosis have been reported (see Precautions).
Splenomegaly, generally asymptomatic, has been reported (see Precautions).
Hypersensitivity reactions such as allergic skin reactions, urticaria, angioedema and serious allergic reactions may occur.
Hypokalaemia has been reported (see Precautions).
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported (see Precautions). These pulmonary adverse reactions may also include pulmonary oedema, pulmonary infiltrates, pulmonary fibrosis, respiratory failure or ARDS (see Precautions).
Nausea was very commonly observed in patients receiving chemotherapy.
Skin reactions such as erythema and rash may occur.
Injection site reactions such as injection site induration and injection site pain may occur.
The most frequent adverse reactions are musculoskeletal pains such as bone pain and myalgia. Musculoskeletal pains are generally of mild to moderate severity, transient and can be controlled in most patients with standard analgesics. However cases of severe musculoskeletal pain (mainly bone pain and back pain) have been reported, including cases that led to hospitalization.
Reversible, mild to moderate elevations in alkaline phosphatase and lactate dehydrogenase may occur, with no associated clinical effects. Elevations in alkaline phosphatase and lactate dehydrogenase most likely originate from the increase in neutrophils.
Certain adverse reactions have not yet been observed with lipegfilgrastim, but are generally accepted as being attributable to G-CSF and derivatives: Blood and lymphatic system disorders: Splenic rupture including some fatal cases (see Precautions).
Sickle cell crisis in patients with sickle cell anaemia (see Precautions).
Vascular disorders: Capillary leak syndrome: Cases of capillary leak syndrome have been reported in postmarketing experience after administration of G-CSF or derivatives. These have generally occurred in patients suffering from advanced malignant diseases, having sepsis, taking multiple chemotherapy medications or undergoing apheresis (see Precautions).
Aortitis (see Precautions).
Skin and subcutaneous tissue disorders: Acute febrile neutrophilic dermatosis (Sweet's syndrome).
Cutaneous vasculitis.
Renal and urinary disorders: Glomerulonephritis (see Precautions).
Paediatric population: The experience in children is limited to a single-dose phase 1 study in 21 paediatric patients aged 2 to <18 years (see Pharmacology: Pharmacodynamics under Actions), which did not indicate a difference in the safety profile of lipegfilgrastim in children compared to that in adults. Treatment-related adverse events were back pain, bone pain and increased neutrophil count (1 event each).
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.