Ublituximab-xiiy (Briumvi)
Immune Modulator | Immunological Agent
Briumvi (ublituximab-xiiy) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
- Mechanism of Action: Briumvi works by targeting CD20-positive B cells, which are believed to play a crucial role in the pathogenesis of multiple sclerosis by contributing to the immune and inflammatory responses.
- Administration Protocol: Briumvi is administered as an intravenous infusion. The initial dose is split into two infusions, two weeks apart. Subsequent doses are given every six months. Monitor patients during and after infusions for reactions.
- Infusion Reactions: Patients may experience infusion-related reactions. Pre-medicate with corticosteroids, antihistamines, and antipyretics to minimize these risks. Observe patients closely during the first infusion and for at least one hour after.
- Screening Before Initiation: Prior to starting treatment with Briumvi, screen patients for hepatitis B virus (HBV) infection as reactivation may occur in carriers of this virus during or after treatment. Also, assess baseline immunoglobulin levels.
- Risk of Infections: Given its immunomodulatory effects, Briumvi increases the risk of infections. Teach patients to report symptoms of infection promptly. Avoid live or live-attenuated vaccines during treatment and until B-cell repletion.
- PML Warning: Progressive multifocal leukoencephalopathy (PML) has been reported with other CD20-targeting antibodies though not specifically with Briumvi. Monitor patients for neurological symptoms suggestive of PML.
- Laboratory Monitoring: Periodic monitoring of blood counts and immunoglobulin levels is recommended, as treatments targeting B cells can cause prolonged hypogammaglobulinemia and an increased risk of infection.
- Use in Specific Populations: Exercise caution and monitor pregnant women and nursing mothers closely if treatment with Briumvi is considered necessary.
- Patient Education: Inform patients about the potential side effects, signs of infusion reactions, and symptoms of infections. Emphasize the importance of keeping follow-up appointments for regular monitoring.
https://www.tgtherapeutics.com/label-prescribing-info/uspi-briumvi.pdf -
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