Active Ingredient: Inebilizumab
Inebilizumab is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 300 milligrams inebilizumab, one dose, over the duration of 2 weeks. Afterwards, intravenous, 300 milligrams inebilizumab, once every 6 months.
Treatment should be initiated under the supervision of a physician experienced in the treatment of NMOSD and with access to appropriate medical support to manage potential severe reactions such as serious infusion-related reactions.
The patient should be monitored for infusion reactions during and for at least one hour after the completion of the infusion.
Prior to initiating treatment, testing should be performed for:
All immunisations should be administered according to immunisation guidelines at least 4 weeks prior to initiation of inebilizumab for live or live-attenuated vaccines.
If loss of efficacy is thought to be caused by immunogenicity, the physician should follow B-cell counts as a direct measure of clinical impact.
The recommended loading dose is 300 mg intravenous infusion followed 2 weeks later by a second 300 mg intravenous infusion.
The recommended maintenance dose is 300 mg intravenous infusion every 6 months. Inebilizumab is for chronic treatment.
If an infusion of inebilizumab is missed, it should be administered as soon as possible and not delayed until the next planned dose.
Prior to every infusion of inebilizumab, it should be determined whether there is a clinically significant infection. In case of infection, infusion of inebilizumab should be delayed until the infection resolves.
Premedication with a corticosteroid (e.g. methylprednisolone 80-125 mg intravenous or equivalent) should be administered approximately 30 minutes prior to each inebilizumab infusion; and an antihistamine (e.g. diphenhydramine 25-50 mg orally or equivalent) and an anti-pyretic (e.g. paracetamol 500-650 mg orally or equivalent) approximately 30-60 minutes prior to each inebilizumab infusion.
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