Briumvi injection for relapsing forms of multiple sclerosis in adults

Briumvi is an injectable medication approved for treating relapsing forms of multiple sclerosis (MS) in adults. It targets a specific protein on immune cells (CD20), helping to modify the disease process.

Indicated use: Briumvi is used to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS.

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Briumvi is a monoclonal antibody that targets the CD20 protein on B-cells, a type of immune cell involved in MS. By attaching to CD20, it leads to the destruction of these B-cells, which are believed to play a role in the inflammatory processes that damage nerves in MS.

Dosage schedule:

• First infusion: 150 mg by intravenous infusion
• Second infusion: 450 mg IV two weeks after the first
• Subsequent infusions: 450 mg IV every 24 weeks starting 24 weeks after the first infusion

Administration details:

• Dilute Briumvi in 0.9% Sodium Chloride Injection before infusion
• Infusion rate for first dose: start at 10 mL/hour, gradually increasing to 100 mL/hour over 4 hours
• Infusion rate for second and subsequent doses: start at 100 mL/hour increasing to 400 mL/hour over 1 hour
• Premedicate with 100 mg intravenous methylprednisolone (or equivalent corticosteroid) approximately 30 minutes prior, and an antihistamine 30-60 minutes prior to reduce infusion reactions
• Monitor closely for infusion reactions during and for at least 1 hour after the first two infusions; subsequent monitoring at physician discretion

Missed dose instructions:

If an infusion is missed, administer as soon as possible and reset the schedule to give the next infusion 24 weeks after the missed dose. Maintain at least 5 months between infusions.

• Active hepatitis B virus infection confirmed by positive hepatitis B surface antigen and anti-HBV tests
• History of life-threatening infusion reaction to Briumvi

Key warnings and precautions:

• Infusion reactions: Can range from mild to life-threatening. Monitor patients during and after infusions. Permanently discontinue for life-threatening or disabling reactions.
• Infections: Serious and fatal infections have occurred. Delay treatment if active infection is present. Vaccination with live or live-attenuated vaccines is not recommended during treatment and until B-cell recovery.
• Hepatitis B virus (HBV): Screen all patients before treatment. Briumvi is contraindicated in active HBV infection. Consult liver disease experts for HBV carriers before and during treatment.
• Reduction of immunoglobulins: Monitor immunoglobulin levels periodically. Consider discontinuation if recurrent serious infections occur due to low immunoglobulin levels.
• Fetal risk: May cause fetal harm. Women of reproductive potential should use effective contraception during treatment and for 6 months after stopping Briumvi.
• Liver injury: Obtain liver function tests before and during treatment. Discontinue Briumvi if liver injury occurs without other cause.
• Progressive multifocal leukoencephalopathy (PML): Serious brain infection has been reported with similar therapies. Withhold treatment and evaluate if symptoms suggestive of PML occur.

Common side effects:

• Infusion reactions including fever, chills, headache, influenza-like illness, nausea, tachycardia, throat irritation, and rash
• Upper respiratory tract infections (about 45%)
• Urinary tract infections (about 10%)

Serious adverse reactions:

• Serious infusion reactions requiring hospitalization occurred in approximately 0.6% of patients
• Serious infections including fatal cases such as pneumonia, post-measles encephalitis, and post-operative infections have been reported

Combining Briumvi with other immunosuppressive agents may increase the risk of immunosuppression. Adequate caution is advised when switching between Briumvi and other immunosuppressants. Briumvi has not been studied in combination with other MS therapies.

Pregnancy:

Briumvi may cause fetal harm based on animal studies. Women of reproductive potential should use effective contraception during treatment and for at least 6 months after stopping the medication.

Lactation:

Information on use during breastfeeding is not provided in the label.

Store Briumvi vials refrigerated between 2°C and 8°C (36°F to 46°F). After dilution with 0.9% Sodium Chloride Injection, use the infusion solution immediately or store refrigerated at 2°C to 8°C for up to 24 hours. Do not freeze. Before administration, allow the infusion solution to reach room temperature (about 2 hours). The diluted solution may be kept at room temperature up to 8 additional hours, including infusion time.