A Safety Study of The Thai Red Cross Society Intravenous
Immunoglobulin in Various Diseases
Kumutpongpanich T, MD¹, Boonyapisit K, MD¹, Thongngarm T, MD², Sanpakit K, MD³, Narkbunnam N, MD³,
Jitprapaikulsan J, MD¹, Likasitwattanakul S, MD⁴, Charuvanij S, MD⁵, Koolvisoot A, MD⁶, Pacharn P, MD⁷,
Piboonpocanun O, MD⁷, Sirisamut T, BPharm⁸, Anansakunwatt W, BPharm⁸, Ruchutrakool T, MD⁹,
Prayoonwiwat N, MD¹, Poungvarin N, MD¹
Affiliation : ¹ Division of Neurology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand ² Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand ³ Division of Hematology and Oncology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand ⁴ Division of Neurology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand ⁵ Division of Rheumatology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand ⁶ Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand ⁷ Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand ⁸ Pharmacy Department, Siriraj Hospital, Bangkok, Thailand ⁹ Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
Objective: Intravenous immunoglobulin (IVIG) is an effective treatment in several diseases with few adverse effects. The authors studied
the safety of locally manufactured IVIG by the Thai Red Cross Society (TRCS).
Materials and Methods: The present report was a prospective descriptive study to collect the safety data of TRCS-IVIG in various diseases. Patients indicated for IVIG treatment at Siriraj Hospital were enrolled between September 2016 and August 2017. The authors collected demographic data of the patients and side effects at each cycle of IVIG administration and compared with other commercial IVIG.
Results: Forty-three patients including 18 children and 25 adults, with 100 cumulative IVIG infusions, were included in this study. Indications for treatment were immune thrombocytopenic purpura (ITP) (13 patients), chronic inflammatory demyelinating polyneuropathy (11 patients), autoimmune encephalitis (7 patients), myasthenia gravis (5 patients), inflammatory myopathy (4 patients), and primary immunodeficiency (3 patients). There was no transfusion-related infection or life-threatening side effect. One pediatric chronic ITP patient died from a condition unrelated to the treatment. Minor side effects such as electrolyte imbalance, anemia, renal impairment, and transaminitis were found in less than 10% of the patients. Allergic rash was reported in 3% of the patients.
Conclusion: The authors found no serious adverse event and only some minor side effects from the TRCS-IVIG. When compared to safety profiles data of conventional IVIG from previous study at Siriraj Hospital, the TRCS-IVIG appeared to have comparable safety profiles. TRCS-IVIG, as a locally manufactured product, can be safely used in various conditions.
Keywords : Intravenous immunoglobulin, IVIG, Thai Red Cross Society, Safety
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