Background Approved therapeutic indications for human normal immunoglobulin (HNIg) in the paediatric population are: primary immunodeficiency syndromes, hypogammaglobulinaemia post-stem cell transplantation, AIDS with recurrent infections and primary immune thrombocytopenia (ITP), among others. Apart from those, HNIg are also used off-label in many clinical indications.
Purpose To describe the use of the HNIg in haematological and oncologic patients of a paediatric teaching hospital.
Material and methods We collected and analysed data from all patients treated with HNIg during 8 months in 2017, based on medical history records.
The variables analysed were: clinical area, patients’ diagnosis indication (replacement or immunomodulation), and the agreement between prescribed dose and the hospital guidelines.
Our HNIg dosing guidelines are 300 to 400 mg/kg every 3 to 4 weeks as a replacement therapy and 1000 to 2000 mg/kg of HNIg per course as immunomodulatory indication.
Results After analysing data from patients’ records, 74 patients received HNIg prescribed by an oncologist or haematologist, of which 54 were haematologic patients and 20 were oncologic.
The main haematological patients’ indication was low HNIg serum levels during a high-intensive chemotherapy regimen (28/56) (acute lymphoblastic leukaemia (23/28) and acute myeloid leukaemia (5/28)), followed by replacement therapy in patients after HSCT (7/54). HNIg were also used for treating active viral infections in patients with LLA (9/54). Finally, (12/54) patients received it for immunomodulation indication (ITP).
Regarding oncology prescriptions, the main indication of HNIg was replacement therapy in patients at high risk of infections (16/20). They could receive it as a treatment per protocol, such as Langerhans cell histiocytosis (5/16) or due to poor HNIg plasma levels after either a high-intensity chemotherapy or high cumulative chemotherapy dose; and neuroblastoma (5/16), central nervous system tumours (3/16) and other systemic oncologic health problems (3/16). 4/20 patients received HNIg to treat active viral infections and any patient received HNIg for immunomodulation purposes.
All except one HNIg prescription adhered to our centre’s dosing policy, the exception was for treating an unresponsive unclassified active infection.
Conclusion Despite HNIg in haematological and oncologic paediatric patients being used off-label, there are many indications in daily practice. Further studies are necessary in paediatric patients to increase the evidence and optimise the resources.
References and/or Acknowledgements Acknowledgements to all our colleagues
No conflict of interest
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