Briumvi

About Briumvi 

• Briumvi received approval from the US FDA administration on December 28, 2022.
• Briumvi is a neurologics which belongs to the class of anti-CD20 monoclonal antibodies. It works by decreasing the action of immune cells that may cause nerve damage.
• Briumvi is a cytolytic antibody targeting CD20 that is used to treat various relapsing forms of multiple sclerosis (MS) in adults. These forms include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
• Multiple sclerosis (MS) symptoms encompass fatigue, mobility challenges, sensory disturbances, vision problems, coordination difficulties, bladder and bowel issues, pain, cognitive and emotional changes, speech difficulties, and heat sensitivity, with symptom severity varying among individuals. 
• Seeking prompt medical assessment is crucial for accurate diagnosis and effective symptom management.

Strength

Injection: 150 mg/6 mL (25 mg/mL) in a single-dose vial

Recommended Dosage

Administering intravenous (IV) injections is a medical procedure requiring trained healthcare professionals. It is essential to maintain aseptic technique, involving hand washing, glove use, and site cleaning. Continuous patient monitoring for adverse reactions during and after the injection is crucial. Additionally, proper disposal of all used materials should adhere to medical waste disposal guidelines.

• Prior to commencing treatment, hepatitis B virus screening and quantitative serum immunoglobulin screening are prerequisites. 
• Pre-medication with methylprednisolone (or an equivalent corticosteroid) and an antihistamine, like diphenhydramine, is advised prior to each infusion. 
• Briumvi is administered intravenously, with the first infusion at 150 mg, the second infusion of 450 mg two weeks later, and subsequent infusions of 450 mg every 24 weeks after the initial infusion. 
• Dilution in 0.9% Sodium Chloride Injection, USP is essential before administration. 
• Close patient monitoring is mandatory during and for at least one hour after the first two infusions, and post-infusion monitoring for subsequent infusions is at the physician’s discretion unless prior infusion reactions or hypersensitivity have been observed.

Important

In the event of a missed planned infusion of Briumvi, it should be administered without delay, and there’s no need to wait until the next scheduled infusion. The infusion schedule should be adjusted to deliver the following sequential infusion 24 weeks after the missed one is given. It’s important to ensure that there is a minimum of 5 months between consecutive infusions of Briumvi.

Warnings & Precautions

• Do not take Briumvi if you have a current hepatitis B virus infection or if you’ve had a severe allergic reaction to it before. Make sure to let your doctor know if you’ve had an allergic reaction to Briumvi in the past.
• Before starting Briumvi, inform your healthcare provider about your medical conditions, such as current or suspected infections and any medications that affect your immune system, which may increase your infection risk. 
• Mention if you’ve had hepatitis B or are a carrier of the virus, and disclose recent or upcoming vaccinations. ‘Live’ or ‘live-attenuated’ vaccines should be received at least 4 weeks before Briumvi treatment, and you shouldn’t get them while on Briumvi until your healthcare provider confirms your immune system is no longer weakened. 
• Ideally, ‘non-live’ vaccines should be given at least 2 weeks before starting Briumvi, but discuss this with your healthcare provider if you need them while on treatment. 
• If you received Briumvi during pregnancy and have a baby, notify your baby’s healthcare provider to determine the appropriate vaccination schedule.

Common Briumvi Side Effects:

• Infusion reactions
• Upper and lower respiratory tract infections
• Herpes infections
• Extremity pain
• Insomnia
• Fatigue

Use in Specific Population

• There is no available data regarding the developmental risks associated with the use of Briumvi in pregnant women, and information on the presence of Ublituximab-xiiy in human milk, its impact on breastfed infants, and its effects on milk production is lacking. 
• Females of reproductive potential are advised to use effective contraception during Briumvi treatment and for 6 months following the last dose. 
• Briumvi’s safety and effectiveness have not been established for pediatric patients. 
• Clinical studies involving Briumvi did not include a sufficient number of patients aged 65 and older to determine potential differences in response compared to younger adult patients.

Storage and Handling

• Store Briumvi at room temperature of 2°C to 8°C.
• Protect Briumvi from light and moisture.
• Do not store Briumvi in the bathroom or in other areas where it may be exposed to heat or humidity.
• Keep Briumvi out of the reach of children and pets.