Briumvi

Relapsing Forms of Multiple Sclerosis

Briumvi is approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults. This classification includes several specific types of the disease:

• Clinically isolated syndrome (CIS): This refers to a first episode of neurologic symptoms that lasts at least 24 hours and is caused by inflammation or damage to the myelin in the central nervous system.
• Relapsing-remitting disease (RRMS): This is the most common form of MS, where patients experience clearly defined attacks of new or increasing neurologic symptoms (relapses) followed by periods of partial or complete recovery (remissions).
• Active secondary progressive disease (SPMS): This occurs in patients who previously had relapsing-remitting MS and now experience a steady worsening of disability, but still have active relapses or new lesions visible on imaging.

The primary goals of treatment with Briumvi are to decrease the number of relapses and to delay the worsening of physical disability. It is administered by a healthcare professional as an intravenous infusion in a clinical setting.

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.

Common Side Effects

The most common side effects associated with Briumvi include:

• Infusion reactions, which may cause symptoms like fever, chills, headache, nausea, and throat irritation.
• Upper respiratory tract infections, such as the common cold.
• Lower respiratory tract infections.
• Herpes virus infections, including shingles and cold sores.
• Pain in the arms or legs.
• Difficulty sleeping.
• Fatigue.

Serious Side Effects

Briumvi can cause serious health issues that require prompt medical evaluation:

• Severe Infusion Reactions: These reactions can be life-threatening and typically occur during or shortly after the treatment.
• Serious Infections: Because Briumvi affects the immune system, it can increase the risk of severe bacterial, viral, or fungal infections.
• Progressive Multifocal Leukoencephalopathy (PML): This is a rare but life-threatening brain infection. Symptoms may include confusion, vision changes, or weakness on one side of the body.
• Hepatitis B Reactivation: In people who have had hepatitis B, the virus can become active again during or after treatment.
• Low Immunoglobulin Levels: A decrease in certain antibodies in the blood, which can make it harder for the body to fight infections.

Infusion-Related Reactions

Infusion reactions are a significant risk, especially during the first administration. Symptoms can include fever, chills, headache, nausea, rapid heartbeat, and skin rash. Healthcare providers typically administer medications such as corticosteroids and antihistamines before the infusion to reduce these risks and monitor patients for at least one hour after the infusion ends.

Infections

Because Briumvi affects the immune system, it can increase the likelihood of developing serious infections. These may include:

• Progressive Multifocal Leukoencephalopathy (PML): This is a rare, serious brain infection caused by the JC virus that can lead to severe disability or death.
• Hepatitis B Reactivation: The medication must not be used in patients with an active hepatitis B infection. Screening for hepatitis B is required before starting treatment, as the drug can cause the virus to become active again.
• General Infections: Increased rates of upper respiratory tract infections and other viral or bacterial infections have been reported.

Low Immunoglobulin Levels

Briumvi may lower the levels of certain proteins in the blood (immunoglobulins) that help fight infection. Healthcare providers may perform blood tests to monitor these levels during and after treatment, as very low levels can increase the risk of infection.

Vaccinations

All required vaccinations should be completed at least four weeks before starting Briumvi for live or live-attenuated vaccines, and at least two weeks before starting for non-live vaccines. Live vaccines should be avoided during treatment and until immune function returns to normal after stopping the medication.

Pregnancy and Fetal Risk

This medication may cause harm to a developing fetus. Individuals who can become pregnant are advised to use effective birth control during treatment and for at least six months after the final dose.

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.

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.

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.

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.