Tolerability and security of the intravenous immunoglobulin octagam® 10% in sufferers with immune thrombocytopenia: a post-authorisation security evaluation of two non-interventional part IV trials.
Hematology. 2018 Might;23(four):242-247
Authors: Wietek S, Svorc D, Debes A, Svae TE
OBJECTIVES: To supply detailed information on the tolerability and security of octagam® 10%, a ready-to-use intravenous immunoglobulin, in a subgroup of sufferers with immune thrombocytopenia (ITP) concerned in an built-in evaluation of post-authorisation security surveillance (PASS) research.
METHODS: A subgroup evaluation was carried out utilizing information collected from two non-interventional research that included sufferers with ITP handled with octagam® 10%. Sufferers have been noticed and monitored for attainable antagonistic drug reactions (ADRs) throughout or after administration of octagam® 10%, with a specific deal with thromboembolic occasions (TEEs). ADRs have been analysed on the case and occasion degree.
RESULTS: On this evaluation of 112 sufferers receiving octagam® 10% (imply dose zero.four?g/kg/infusion), there have been 5 instances with no less than one antagonistic drug response (ADR) related to 626 infusions of octagam® 10% (case incidence of zero.eight% per infusion). ADRs have been of delicate or average severity. There have been a complete of 10 occasions, mostly again ache (n?=?three) and headache (n?=?2). Nausea, dizziness and a sensation of heaviness have been additionally reported. The remaining two occasions concerned drug publicity throughout being pregnant. There have been no TEEs or different critical ADRs.
DISCUSSION: On this subgroup evaluation of sufferers who obtained octagam® 10% (manufactured utilizing an amended course of) in two PASS research, the general ADR fee was low, with ADRs occurring in solely zero.eight% of all infusions. No TEEs or different critical ADRs have been reported.
CONCLUSIONS: Routine medical use of octagam® 10% was secure and properly tolerated, with no surprising issues of safety, in sufferers with ITP. The 2 research from which information have been taken are registered with the Worldwide Normal Randomised Managed Trial Quantity Registry, numbers ISRCTN58800347 and ISRCTN02245668.
PMID: 29020871 [PubMed – indexed for MEDLINE]