Sign Out
Traceability: In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Limited clinical data suggest that the effect on time to recovery of severe neutropenia between pegfilgrastim and filgrastim is comparable in patients with de novo acute myeloid leukaemia (AML). However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it should be used with caution in this patient population.
Granulocyte-colony stimulating factor (G-CSF) can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
No dose change is recommended in patients with renal impairment, including those with end-stage renal disease.
The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Pulmonary adverse events: The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Adults Respiratory Distress Syndrome (ARDS). In such circumstances pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment given.
Glomerulonephritis: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim. Urinalysis monitoring is recommended.
Capillary leak syndrome: Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterized by hypotension, hypoalbuminaemia, oedema and hemoconcentration. Patients who develops symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
Splenomegaly and splenic rupture: Uncommon but generally asymptomatic cases of splenomegaly and uncommon cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim. Spleen size should be carefully monitored. Patients receiving pegfilgrastim who report left upper abdominal and/or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture.
Thrombocytopenia and anaemia: Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of platelet count and haematocrit is recommended.
Medication error as a result of device failure: There is a risk of medication error, particularly a partial or missed dose of pegfilgrastim, in the event of a device failure. In the event of a partial or missed dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered. Comprehensive instructions for use for healthcare professionals and patients are given in the package leaflet. The patient should also be given the Patient Alert Card.
Sickle cell anemia: Sickle cell crisis has been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease. Physicians should use caution when prescribing the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease.
Leukocytosis: White blood cell (WBC) counts of 100 × 109/L or greater have been observed in less than 1% of patients receiving pegfilgrastim. No adverse events directly attributable to this degree of leukocytosis have been reported. Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicine. Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy. If leukocyte counts exceed 50 × 109/L after the expected nadir, this medicine should be discontinued immediately.
Hypersensitivity: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with pegfilgrastim. Permanently discontinue pegfilgrastim in patients with clinically significant hypersensitivity. Do not administer pegfilgrastim to patients with a history of hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Stevens-Johnson syndrome: Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
Immunogenicity: As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of antibodies against pegfilgrastim is generally low. Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralizing activity at present.
Aortitis: 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.
Other warning: The safety and efficacy of pegfilgrastim for the mobilization of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
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 result.
Pegfilgrastim contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machine: No studies on the effects on the ability to drive and use machines have been performed.
