Question 1

What is Briumvi?

Accepted Answer

Briumvi is a type of prescription medicine known as a CD20-directed cytolytic antibody. It is a laboratory-made monoclonal antibody designed to target and bind to specific proteins on the surface of B cells, which are a type of white blood cell in the immune system.

By targeting these cells, the medication helps to reduce the immune system's activity against the body's own nerve tissues. This action helps to manage the underlying biological processes associated with specific neurological disorders.

Question 2

What is Briumvi used for?

Accepted Answer

Briumvi is used to treat multiple sclerosis .

Question 3

How does Briumvi work?

Accepted Answer

Targeting B-Cells

Briumvi belongs to a class of medications known as monoclonal antibodies. It is designed to seek out and attach to a specific protein called CD20, which is found on the surface of certain white blood cells known as B-lymphocytes (B-cells).

Reducing Inflammation

In patients with relapsing forms of multiple sclerosis (MS), these B-cells are thought to play a key role in attacking the protective coating of nerves in the brain and spinal cord. This attack leads to inflammation and nerve damage.

When Briumvi binds to the CD20 protein, it triggers the immune system to deplete these specific B-cells. By lowering the number of circulating B-cells, the medication helps to:

Decrease the inflammatory response in the central nervous system.

Reduce the frequency of MS relapses.

Slow the progression of physical disability associated with the condition.

Question 4

What are the active ingredients in Briumvi?

Accepted Answer

The active ingredient in Briumvi is ublituximab .

Question 5

What are the side effects of Briumvi?

Accepted Answer

Common side effects of Briumvi may include:

infusion reactions

headache

fatigue

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Briumvi?

Accepted Answer

Briumvi belongs to the anti-CD20 monoclonal antibody drug class.

Question 7

What is the dosage of Briumvi and how do I take it?

Accepted Answer

Administration

Briumvi is given as an infusion into a vein by a healthcare professional in a clinical setting, such as a doctor's office or infusion center. The infusion process usually takes about one hour, though the first infusion may take longer. Patients are monitored by medical staff during and after the infusion for any signs of a reaction.

Dosing Schedule

The treatment usually begins with an initial infusion, followed by a second infusion two weeks later. After these first two doses, maintenance infusions are typically scheduled every six months.

Before the Infusion

To help prevent or reduce the severity of infusion-related reactions, a healthcare provider may give other medications shortly before each Briumvi treatment. These premedications often include a corticosteroid, an antihistamine, and a fever reducer.

Missed Doses

If an appointment for a Briumvi infusion is missed, it should be rescheduled as soon as possible. It is important to receive doses on the schedule recommended by a healthcare provider. The timing of future doses may be adjusted based on when the missed dose is eventually administered.

Question 8

Is Briumvi safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

Briumvi can cause harm to a developing fetus. Healthcare providers typically perform a pregnancy test before starting treatment to ensure the patient is not pregnant. Individuals who can become pregnant are advised to use effective birth control during treatment and for at least 6 months after the final dose of Briumvi.

If you become pregnant while receiving this medication or within 6 months after your last dose, you should notify your healthcare provider immediately. Because Briumvi targets specific immune cells, it may cause a temporary decrease in those same cells in a newborn if the mother is treated during pregnancy.

Breastfeeding

It is not known if Briumvi passes into human breast milk or how it might affect a nursing infant. Because many medications are excreted in human milk and there is a potential for serious side effects in a baby, it is important to discuss the risks and benefits of breastfeeding with a healthcare provider before starting treatment.

Question 9

What forms and strengths does Briumvi come in?

Accepted Answer

Dosage Forms

Briumvi is supplied as a concentrated solution in a vial. It is a sterile, preservative-free liquid that is clear to opalescent and colorless to pale yellow.

Administration

This medication is administered by a healthcare professional as an intravenous infusion. The concentrated solution is diluted into an infusion bag before administration.

Question 10

What is the FDA approval status of Briumvi?

Accepted Answer

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Briumvi (ublituximab-xiiy) in December 2022. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. The specific conditions covered by this approval include:

Clinically isolated syndrome

Relapsing-remitting disease

Active secondary progressive disease

Safety Requirements and Contraindications

The FDA has established specific safety protocols that must be followed before starting treatment. Healthcare providers are required to screen patients for hepatitis B virus (HBV) infection and assess quantitative serum immunoglobulins prior to the first infusion. Briumvi is contraindicated in patients with:

Active hepatitis B virus infection.

A history of life-threatening infusion-related reactions to the medication.

Regulatory Monitoring and Safety Signals

Briumvi is subject to ongoing regulatory oversight. The FDA monitors the Adverse Event Reporting System (FAERS) for potential signals of serious risks or new safety information. While the medication is part of routine safety surveillance, there is currently no Risk Evaluation and Mitigation Strategy (REMS) required for its distribution. No major safety-related recalls or boxed warnings have been issued since its initial approval.

Question 11

What should I know about Briumvi and cost?

Accepted Answer

Insurance and Coverage

The total cost of Briumvi is primarily influenced by an individual's insurance plan. Most private insurance companies, Medicare, and Medicaid provide coverage for the medication when it is used for approved indications. However, patients may still be responsible for out-of-pocket expenses such as deductibles, copayments, or coinsurance.

Administration and Facility Fees

Because Briumvi is administered as an intravenous infusion by a healthcare professional, the total cost of therapy includes more than the price of the medication itself. Patients may encounter additional charges for:

The medical staff's time to monitor and perform the infusion.

Facility fees for the use of an infusion center, hospital, or clinic.

Pre-medications often required before the infusion to prevent reactions.

Financial Assistance Programs

The manufacturer of Briumvi offers support services to help eligible patients manage treatment costs. These programs may include:

Copay Assistance: Financial support for patients with commercial insurance to help lower out-of-pocket drug costs.

Insurance Navigation: Support coordinators who can help patients understand their benefits and assist with the prior authorization process.

Patients are encouraged to contact their insurance provider and the manufacturer's support program to receive a detailed estimate of their expected costs.

Briumvi

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

📚References

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