Ublituximab

Conditions Treated

Ublituximab is specifically indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. This category of MS includes several specific stages of the disease:

• Clinically isolated syndrome (CIS): This refers to a single, first episode of neurologic symptoms that lasts at least 24 hours.
• Relapsing-remitting disease (RRMS): This is a form of MS where patients experience clearly defined attacks of new or worsening neurologic symptoms, followed by periods of partial or complete recovery.
• Active secondary progressive disease (SPMS): This is a stage of MS that follows a relapsing-remitting course, where the disease begins to progress more steadily, though the patient still experiences occasional relapses.

Treatment Goals

The primary purpose of using ublituximab is to manage the course of MS by reducing the frequency of clinical relapses. It is also used with the goal of slowing the progression of physical disability caused by the disease. Healthcare providers typically prescribe this medication after confirming a diagnosis of one of the relapsing forms of MS mentioned above.

Mechanism of Action

Ublituximab belongs to a class of medications known as monoclonal antibodies. These are laboratory-made proteins designed to recognize and attach to specific targets in the body.

Targeting B-Cells

This medication specifically targets a protein called CD20, which is found on the surface of certain white blood cells known as B-lymphocytes (B-cells). In people with relapsing forms of multiple sclerosis (MS), these B-cells are believed to play a key role in attacking the protective covering of nerves in the brain and spinal cord.

Reducing Nerve Damage

When ublituximab binds to the CD20 protein, it triggers the immune system to remove these specific B-cells from the bloodstream. By depleting these cells, the medication helps to:

• Decrease the inflammatory response that leads to MS relapses.
• Reduce the formation of new lesions (damaged areas) in the central nervous system.
• Slow the progression of physical disability associated with the disease.

While the exact way ublituximab exerts its therapeutic effects in MS is not fully understood, it is primarily attributed to this reduction in B-cell activity.

Common Side Effects

The most frequently reported side effects of ublituximab include:

• Infusion reactions, such as fever, chills, headache, nausea, and throat irritation
• Upper respiratory tract infections (such as the common cold)
• Pain in the arms or legs
• Insomnia (trouble sleeping)
• Fatigue

Serious Side Effects

Ublituximab can cause serious side effects that may require immediate medical attention. These include:

• Severe Infusion Reactions: These typically occur during or within 24 hours of the infusion and may involve breathing difficulties, chest pain, dizziness, or swelling of the face and tongue.
• Infections: An increased risk of serious bacterial, viral, or fungal infections. This includes the reactivation of the hepatitis B virus and shingles (herpes zoster).
• Progressive Multifocal Leukoencephalopathy (PML): A rare but life-threatening brain infection. Symptoms may include confusion, vision changes, or weakness on one side of the body.
• Low White Blood Cell Counts: A decrease in neutrophils (neutropenia), which can make it harder for the body to fight off infections.
• Low Immunoglobulin Levels: A decrease in certain antibodies (hypogammaglobulinemia) in the blood.

Infusion Reactions

Infusion reactions are common and can be severe. These typically occur during or within 24 hours of the infusion. Symptoms may include fever, chills, headache, flu-like symptoms, fast heartbeat, nausea, or throat irritation. Healthcare providers usually administer medications, such as corticosteroids and antihistamines, before the infusion to reduce this risk.

Infections

This medication affects the immune system, which may increase the risk of infections. Common infections include respiratory tract infections and urinary tract infections. Treatment is typically delayed if an active infection is present.

Hepatitis B Reactivation

Testing for hepatitis B virus (HBV) is required before starting treatment. In people who have had HBV, the virus can become active again during or after treatment, which can cause serious liver problems or death.

Progressive Multifocal Leukoencephalopathy (PML)

PML is a rare but serious brain infection that has been associated with similar medications. Symptoms include worsening weakness, changes in vision, or confusion. Immediate medical evaluation is necessary if these symptoms occur.

Low Immunoglobulin Levels

Treatment may lead to a decrease in certain antibodies (immunoglobulins) in the blood. Healthcare providers may monitor these levels, as low levels can increase the risk of infection.

Vaccinations

Live or live-attenuated vaccines should not be administered during treatment or until B-cell levels have recovered. It is recommended to complete all necessary vaccinations at least four weeks before starting ublituximab.

Pregnancy and Contraception

Ublituximab may cause harm to a developing fetus by depleting its B-cells. Individuals of childbearing potential are advised to use effective contraception during treatment and for at least six months after the final dose.

Pregnancy

Ublituximab may cause harm to an unborn baby. There is limited information regarding its use in pregnant individuals, but animal studies suggest it may lead to a decrease in certain immune cells in the fetus. Healthcare providers typically perform a pregnancy test before starting this medication to ensure the patient is not pregnant.

Individuals who can become pregnant should use effective birth control during treatment and for at least 6 months after the last dose. If you become pregnant during this time, contact your healthcare provider right away.

Breastfeeding

It is currently unknown if ublituximab is present in human breast milk or if it affects milk production. Because many medications can pass into breast milk and potentially cause side effects in a nursing infant, it is important to discuss the risks and benefits with a healthcare provider. They will help determine if you should continue breastfeeding or use this medication based on your specific health needs.

Dosage Forms

Ublituximab is supplied as a sterile, preservative-free solution. It is available in the following form:

• Injection: A concentrated liquid solution provided in a vial for intravenous infusion.

This medication must be diluted with a compatible solution before administration. The liquid is clear to slightly opalescent and colorless to pale yellow.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved ublituximab-xiiy in December 2022. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, which includes:

• Clinically isolated syndrome
• Relapsing-remitting multiple sclerosis
• Active secondary progressive disease

Safety Monitoring and Regulatory Actions

Ublituximab is classified as a CD20-directed cytolytic antibody. As part of ongoing safety monitoring, the FDA tracks adverse events through the FDA Adverse Event Reporting System (FAERS). Recent regulatory evaluations have identified potential signals of serious risks, specifically serious infections, which are monitored to determine if further labeling changes or regulatory actions are necessary.

Currently, there is no Boxed Warning or Risk Evaluation and Mitigation Strategy (REMS) program required for ublituximab. However, the medication must be administered by a healthcare professional in a clinical setting equipped to manage potential infusion-related reactions. Patients are typically screened for Hepatitis B virus and quantitative serum immunoglobulins prior to starting treatment.

Insurance and Coverage

Ublituximab is a specialty medication, and its cost is largely determined by your insurance plan's formulary. Most insurance providers require prior authorization before they will cover the treatment. This process involves your healthcare provider submitting documentation to prove the medical necessity of the drug for your condition.

Administration Costs

Because ublituximab is given as an intravenous infusion in a clinical setting, the total price includes more than just the medication. Patients may be billed for several components, including:

• The cost of the drug itself.
• Nursing services and clinical supervision during the infusion.
• Equipment and supplies used for the intravenous administration.

Financial Assistance Programs

The manufacturer of ublituximab often provides support services to help patients navigate insurance requirements. These services may include co-pay assistance for those with commercial insurance or patient assistance programs for individuals who are uninsured or underinsured. It is recommended to speak with a specialty pharmacy or the manufacturer's patient support line to explore these options and determine specific out-of-pocket costs.