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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a report, two women aged 29 years and 35 years were described, who developed hypersensitivity reaction manifesting as infusion-related reactions during treatment with rituximab for muscle-specific kinase antibody-positive myasthenia gravis [not all times to reactions onsets and outcomes stated].
Patient 1: A-29-year-old woman had muscle-specific kinase antibody-positive myasthenia gravis, had received mycophenolate mofetil, pyridostigmine, prednisone and immunoglobulin with limited benefits or side effects. Therefore, she started receiving rituximab 1000mg IV infusion. The first 2 doses of rituximab were administered at increasing rate up to 400 mg/h separated by 14 days, following premedication with methylprednisolone, diphenhydramine and acetaminophen. She was then...
- Suh J, et al. Rituximab desensitization in two patients with muscle-specific kinase myasthenia gravis. Muscle and Nerve 60: E35-E37, No. 5, Nov 2019. Available from: URL: http://doi.org/10.1002/mus.26691 - USA