FDA approves Briumvi (Ublituximab-Xiiy) for the treatment of relapsing forms of multiple sclerosis (MS) in adults

Briumvi, also known as ublituximab-xiiy, is a medication approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. 

FDA Approval and Manufacture Details

On  Dec 28, 2022, Briumvi (ublituximab) received FDA approval for the treatment of relapsing forms of multiple sclerosis (MS). Briumvi is manufactured by TG Therapeutics and is the only B-cell therapy for people with relapsing MS that is administered in a 1-hour infusion twice per year.

Indication

BRIUMVI is a cytolytic antibody directed at CD20, approved for treating relapsing forms of multiple sclerosis (MS) in adults, encompassing clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Mechanism Of BRIUMVI

The exact mechanism through which ublituximab-xiiy achieves its therapeutic effects in multiple sclerosis is not fully understood. It is presumed to involve binding to CD20, a surface antigen found on pre-B and mature B lymphocytes. This binding leads to cell lysis, utilizing mechanisms such as antibody-dependent cellular cytolysis and complement-dependent cytolysis.

Dosage Information

Prior to the initial dose, mandatory screenings for Hepatitis B virus and quantitative serum immunoglobulin are required. Pre-medication with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) is recommended before each infusion. 

• BRIUMVI injection is administered via intravenous infusion, with the first infusion at 150 mg, the second at 450 mg two weeks later, and subsequent infusions at 450 mg every 24 weeks following the initial dose. 
• Before administration, it is imperative to dilute in 0.9% Sodium Chloride Injection, USP. 
• Vigilant monitoring is crucial throughout and for a minimum of one hour following the initial two infusions. 
• For subsequent infusions, post-infusion monitoring is at the discretion of the physician unless there are observed infusion reactions or hypersensitivity.

Drug Interaction

Some immune-modulating or immunosuppressant medicines may increase the risk of infection if taken together with Briumvi. It is important to discuss all medicines you’re taking with your doctor before starting your treatment. Briumvi is administered as an intravenous infusion over a period of 1 hour.

Contraindication 

BRIUMVI is contraindicated in individuals with an active hepatitis B virus infection or a history of life-threatening infusion reactions to BRIUMVI.  If one has had hepatitis B, it may come back or worsen. Inform the doctor if there is a lack of well-being accompanied by right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of the skin or eyes. So before starting the medicine inform your doctor if you have any mentioned condition. 

Warning And Precaution

Brain infection: Briumvi may cause a brain infection leading to disability or death. Report to the doctor any difficulties with speech, thought, vision, or muscle movement, as these symptoms can deteriorate rapidly.

Reactions during infusion: Management of infusion reactions depends on their type and severity. If a life-threatening or disabling infusion reaction occurs, permanently discontinue BRIUMVI 

Infections: Serious, potentially fatal infections have been reported. Postpone BRIUMVI administration in patients with an active infection until resolved. Avoid live vaccines during BRIUMVI treatment and post-discontinuation until B-cell repletion.

Immunoglobulin reduction: Monitor immunoglobulin levels at the start, during, and after BRIUMVI discontinuation until B-cell repletion, especially when recurrent serious infections are suspected. Consider discontinuing BRIUMVI in cases of serious opportunistic or recurrent infections, and if prolonged hypogammaglobulinemia requires intravenous immunoglobulin treatment. 

Usage in Specific Population

• Pregnancy: It is not known whether Briumvi can harm an unborn baby. Females of reproductive potential should be informed of the risk to a fetus and advised to use effective contraception during BRIUMVI treatment and for at least 6 months post-discontinuation. Hence patients should discuss with their doctor if they are pregnant or planning to become pregnant. 

• Lactation: It is not known whether Briumvi passes into breast milk or if it could harm a nursing baby. Patients should discuss with their doctor if they are breastfeeding.

• Pediatric: The safety and effectiveness of Briumvi in pediatric patients have not been established.

• Geriatric: Clinical trials for Briumvi did not enroll an adequate number of patients aged 65 and older to assess potential differences in their response compared to younger patients.

Side Effects

Common side effects of Briumvi include dizzy, nauseated, light-headed, itchy, sweaty,  headache, chest tightness, back pain, trouble breathing, or swelling in your face. Infusion reactions are one of the most common side effects of Briumvi, which can be serious and may require hospitalization. Patients should contact their healthcare provider if they experience any concerning symptoms.

Conclusion

In conclusion, Briumvi (ublituximab) is a CD20-directed monoclonal antibody approved for the treatment of relapsing forms of multiple sclerosis in adults. It works by depleting immune B-cells and is administered as a 1-hour infusion twice per year. It is important for patients to be aware of the potential side effects and discuss any concerns with their healthcare provider.

FAQs: 

1. Are there specific precautions for Briumvi?

Yes, precautions include monitoring for infusion reactions, delaying administration in patients with active infections, and avoiding live-attenuated or live vaccines during treatment and after discontinuation until B-cell repletion.

2. How should BRIUMVI vials be stored?

BRIUMVI vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light. It is important not to freeze or shake the vials.

3. Is Briumvi considered safe and effective for pediatric patients?

The safety and effectiveness of Briumvi in pediatric patients have not been established. Hence, before starting the medicine, if is advised to mention your children’s age to th physician. 

4. How To Buy Briumvi Online? 

To buy Briumvi online, consider contacting SANSFRO or other pharmaceutical procurement firms specializing in importing medicines from the US and Europe. For specific information tailored to India, reach out to the dedicated Patient Support Team at (+91) 9315705373.

5. What is the Briumvi price?

As for the Briumvi price, it is determined by various factors and product specifications. For accurate and current information on the Briumvi price in India, contact our Patient Support Team at (+91) 9315705373 or help@sansfro.com. The team will provide the latest and precise details regarding the cost of Briumvi.

Reference:

1.  https://briumvi.com/what-is-briumvi/ 
2.  https://www.drugs.com/briumvi.html 
3.  https://www.nationalmssociety.org/Treating-MS/Medications/Briumvi