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

Received 6 Aug 2018 | Revised 3 Dec 2018 | Accepted 7 Dec 2018