Intravenous Immunoglobulin Deemed Safe in Pediatric Patients
IVIG found to have a good safety profile in pediatric patients, with low risk of severe adverse drug reactions.
Researchers at Hamad General Hospital in Qatar have found that intravenous immunoglobulin (IVIG) generally has a good safety profile in pediatric patients with a low risk of adverse drug reactions (ADR). The results were published in Therapeutic Advances in Drug Safety.
IVIGs are sterile, purified immunoglobulin (IgG) products manufactured from pooled human plasma and typically contain more than 95% unmodified IgG. There are currently various IVIG products available on the market, which results in differences in the efficacy and safety profiles. Researchers therefore wanted to assess the safety profile of IVIG use in pediatric patients and its association with other predicted factors.
Researchers used a retrospective chart review study of all pediatric patients who had received IVIG as an inpatient at Hamad General Hospital in Qatar during 2014. They also investigated the occurrence of ADR for any association with other predicated factors, such as a patient’s age, IVIG dose, brand, and adherence to infusion protocol.
A total of 345 IVIG prescriptions were prescribed and received by 120 pediatric patients during the study period. IVIG was used equally between male and female patients (51.9% and 48.1%, respectively). Patient age ranged from 20 days to 14 years (median 7 years). IVIG infusion protocol was followed in 84.1%. Approximately 52.8% of the IVIG prescriptions were not preceded by administration of premedication. However, when premedication was prescribed, diphenhydramine was the most common medication used.
The most common adverse events were fever (5.8%), chills (2.6%), and headache (2%). Renal insufficiency was observed in only 6 cases, with 5 of those in ‘Risk’ category according to RIFLE criteria. A hypersensitivity reaction was documented in 7 patients, despite being premedicated with paracetamol and/or diphenhydramine and following the infusion protocol. None of the predicted factors were found to be significantly associated with ADR incidence except IVIG brand.
The researchers concluded that IVIG generally has a good safety profile in pediatric patients, with a low risk of severe ADR. They also noted that more studies are needed to evaluate the correlation between ADR and IVIG formulation, taking into account other factors that may affect results.
- Elajez R, Ezzeldin A, Gaber H, et al. Safety evaluation of intravenous immunoglobulin in pediatric patients: a retrospective, 1-year observational study. Therapeutic Advances in Drug Safety. 2019; 10: 2042098619876736. Published October 3, 2019. doi: 10.1177/2042098619876736. Accessed November 4, 2019.