Living with multiple sclerosis (MS) often involves managing complex treatments designed to slow disease progression and alleviate symptoms. Briumvi (ublituximab) is one such medication, an intravenous infusion approved for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. While Briumvi offers a valuable therapeutic option, like all medications, it comes with potential side effects. Understanding these effects, both common and serious, is crucial for patients and caregivers to ensure safe and effective treatment.

This comprehensive guide aims to provide detailed information about Briumvi's side effects, how to recognize them, what to do if they occur, and when to seek medical attention. Our goal is to empower you with the knowledge needed to have informed discussions with your healthcare provider and manage your MS treatment effectively.

What is Briumvi (Ublituximab)?

Briumvi is a monoclonal antibody that targets CD20, a protein found on the surface of B cells. By depleting these B cells, Briumvi helps to reduce inflammation and damage to the myelin sheath in the central nervous system, which are hallmarks of MS. It is administered via intravenous infusion, typically with a shorter infusion time compared to some other CD20-targeting therapies.

Common Side Effects of Briumvi

Many people receiving Briumvi experience side effects, most of which are mild to moderate and manageable. The most frequently reported side effects are infusion-related reactions and infections.

Infusion-Related Reactions (IRRs)

Infusion-related reactions are the most common side effects associated with Briumvi, often occurring during or within 24 hours of an infusion. These reactions are usually mild to moderate but can sometimes be severe.

Symptoms: The symptoms of IRRs can vary widely but commonly include:
- Headache
- Fever or chills
- Nausea
- Rash
- Hives (urticaria)
- Itching (pruritus)
- Flushing
- Fatigue
- Shortness of breath or wheezing
- Dizziness
- Throat irritation or pain
- Increased heart rate (tachycardia)
Causes: IRRs are believed to be caused by the release of inflammatory chemicals in the body in response to the drug.
Prevention & Management: To minimize the risk and severity of IRRs, healthcare providers typically administer pre-medications before each Briumvi infusion. These may include:
- Antihistamines (e.g., diphenhydramine)
- Corticosteroids (e.g., methylprednisolone)
- Pain relievers/fever reducers (e.g., acetaminophen)
During the infusion, medical staff will monitor you closely for any signs of a reaction. If an IRR occurs, the infusion may be slowed down or temporarily stopped, and additional medications may be given to manage the symptoms. It’s crucial to report any symptoms you experience during or after the infusion immediately to your healthcare team.

Infections

Briumvi works by depleting B cells, which are an important part of the immune system. This can increase your risk of developing infections.

Types of Infections: The most common infections reported in clinical trials include:
- Upper respiratory tract infections (e.g., common cold, sinusitis)
- Urinary tract infections (UTIs)
- Herpes viral infections (e.g., oral herpes, shingles)
Symptoms: Be vigilant for signs of infection such as:
- Fever
- Chills
- Sore throat
- Cough
- Burning during urination
- Unusual skin sores or rashes
- Fatigue that is worse than usual
Prevention & Management: Your doctor will monitor you for signs of infection throughout your treatment. It's important to report any symptoms of infection promptly. Good hygiene practices, such as frequent handwashing, can help reduce your risk. Your doctor may also recommend certain vaccinations before starting Briumvi, though live-attenuated vaccines are generally not recommended during treatment and for a period afterward.

Other Common Side Effects

Beyond IRRs and infections, other frequently reported side effects include:

Headache
Fatigue
Nausea
Diarrhea
Back pain
Muscle aches

These side effects are generally mild and often resolve on their own. If they persist or become bothersome, discuss them with your doctor.

Serious Side Effects of Briumvi

While less common, Briumvi can cause serious side effects that require immediate medical attention. It is vital to be aware of these potential risks.

Progressive Multifocal Leukoencephalopathy (PML)

PML is a rare but very serious brain infection caused by the John Cunningham (JC) virus. It can lead to severe disability or death. Briumvi, like other CD20-targeting therapies, carries a risk of PML.

Symptoms: Symptoms of PML can develop over weeks or months and may include:
- Progressive weakness on one side of the body
- Clumsiness or problems with coordination
- Changes in vision (e.g., double vision, vision loss)
- Changes in thinking, memory, or orientation
- Personality changes
- Difficulty speaking or understanding speech
Diagnosis: Your doctor will monitor you for any new or worsening neurological symptoms. If PML is suspected, diagnostic tests such as MRI of the brain, lumbar puncture to test cerebrospinal fluid for JC virus DNA, and sometimes a brain biopsy may be performed.
When to See a Doctor: Seek emergency medical attention if you experience any new or worsening neurological symptoms.

Hepatitis B Virus (HBV) Reactivation

For individuals who have previously been infected with Hepatitis B virus, Briumvi can cause the virus to reactivate, leading to serious liver problems, including liver failure and death. This risk is particularly high in patients who are carriers of HBV.

Prevention & Diagnosis: Your doctor will screen you for HBV infection before you start Briumvi treatment. If you test positive for HBV, your doctor may consult with a liver specialist and might recommend antiviral treatment to prevent reactivation before and during Briumvi therapy.
Symptoms of HBV Reactivation:
- Yellowing of your skin or the whites of your eyes (jaundice)
- Dark urine
- Light-colored stools
- Tiredness
- Loss of appetite
- Nausea or vomiting
- Pain in the upper right side of your stomach
When to See a Doctor: Report any of these symptoms to your doctor immediately.

Other Serious Infections

Beyond common infections, Briumvi can increase the risk of more severe infections, including those caused by bacteria, fungi, or other viruses, such as herpes zoster (shingles).

Symptoms: Severe infections may present with:
- High fever
- Persistent cough with phlegm
- Severe body aches
- Widespread or blistering rash
- Signs of sepsis (confusion, rapid heart rate, low blood pressure)
When to See a Doctor: Any signs of a severe or worsening infection warrant immediate medical evaluation.

Hypogammaglobulinemia

Briumvi can lead to a reduction in immunoglobulin levels (antibodies) in the blood, a condition called hypogammaglobulinemia. This can further compromise the immune system and increase the risk of recurrent or severe infections.

Monitoring: Your doctor will monitor your immunoglobulin levels periodically during treatment.
Management: If your immunoglobulin levels drop significantly and you experience frequent or severe infections, your doctor may consider intravenous immunoglobulin (IVIg) therapy or discontinuing Briumvi.

Malignancies (Cancers)

There is a theoretical risk of an increased incidence of malignancies (cancers), including skin cancer and breast cancer, with immunosuppressive therapies like Briumvi. This risk is being continually evaluated in ongoing studies.

Monitoring: Regular cancer screenings, as recommended for your age and risk factors, remain important.
When to See a Doctor: Report any new or unusual lumps, skin changes, or persistent symptoms to your doctor.

When to See a Doctor

While many side effects are mild, it's crucial to know when to seek medical advice. Contact your doctor immediately or seek emergency care if you experience any of the following:

Signs of a severe infusion-related reaction:
- Difficulty breathing, wheezing, or chest tightness
- Swelling of your face, lips, tongue, or throat
- Severe dizziness or fainting
- Rapid heartbeat
- Sudden, severe rash or hives
Signs of a serious infection:
- Fever above 100.4°F (38°C) that doesn't go down
- Chills, body aches, or flu-like symptoms
- Persistent cough or sore throat
- Pain or burning when urinating, or frequent urination
- Unusual discharge or skin sores
New or worsening neurological symptoms (potential PML):
- Weakness on one side of your body
- Problems with coordination or balance
- Changes in vision, speech, thinking, or memory
- Confusion or personality changes
Signs of liver problems (potential HBV reactivation):
- Yellowing of your skin or eyes (jaundice)
- Dark urine or light-colored stools
- Severe nausea, vomiting, or stomach pain
- Unusual tiredness
Any other severe or persistent symptoms that concern you.

Managing Side Effects and Staying Safe

Proactive management and open communication with your healthcare team are key to safely navigating Briumvi treatment.

Pre-medication: Always take any prescribed pre-medications (antihistamines, corticosteroids, fever reducers) before your Briumvi infusion to reduce the risk of IRRs.
Report Symptoms Promptly: Do not hesitate to report any new or worsening symptoms, however minor, to your doctor or nurse. Early detection can prevent complications.
Infection Prevention: Practice good hand hygiene, avoid close contact with sick individuals, and discuss recommended vaccinations with your doctor.
Stay Hydrated: Drinking plenty of fluids can help with some common side effects like headache and fatigue.
Maintain Regular Appointments: Attend all scheduled follow-up appointments and laboratory tests (e.g., blood counts, immunoglobulin levels, HBV monitoring) as recommended by your doctor.
Inform Your Doctors: Make sure all your healthcare providers (including dentists, specialists, and emergency personnel) know you are taking Briumvi, especially before any procedures or new medications.
Vaccinations: Discuss your vaccination history and future vaccination needs with your doctor. Live vaccines are generally contraindicated during Briumvi treatment and for a period after.

Who Should Not Take Briumvi?

Briumvi may not be suitable for everyone. You should not take Briumvi if you have:

An active Hepatitis B virus (HBV) infection.
A history of life-threatening infusion-related reactions to Briumvi.
An active, serious infection.

Additionally, discuss your full medical history with your doctor, including any history of:

Hepatitis B or other liver problems
Any type of infection, especially chronic or recurring infections
Weakened immune system
Other medical conditions
Allergies to medications
Current medications, including over-the-counter drugs, supplements, and herbal remedies
Pregnancy, planning to become pregnant, or breastfeeding

Briumvi and Pregnancy/Breastfeeding

It is not known whether Briumvi can harm an unborn baby. Women who are pregnant or planning to become pregnant should discuss the risks and benefits with their doctor. It is recommended to use effective contraception during Briumvi treatment and for at least 6 months after the last dose.

It is also unknown if Briumvi passes into breast milk. Nursing mothers should discuss the best feeding option with their doctor while on Briumvi.

Drug Interactions

Briumvi's effect on the immune system means it can potentially interact with other medications, particularly those that also suppress the immune system. Always provide your doctor with a complete list of all medications, supplements, and herbal products you are currently taking to avoid potential interactions.

Frequently Asked Questions (FAQs)

How long do Briumvi side effects last?

Infusion-related reactions typically occur during or within 24 hours of the infusion and usually resolve within a few hours to a day. Other common side effects like headache or fatigue may last for a few days. The increased risk of infection can persist for several months after your last Briumvi dose as your B cell levels recover.

What are the long-term side effects of Briumvi?

Long-term risks include a sustained reduction in immunoglobulin levels, which can lead to an increased susceptibility to infections. There is also an ongoing assessment of the long-term risk of malignancies, though more data is needed. Your doctor will monitor you for these potential long-term effects.

Can Briumvi cause hair loss?

Hair loss is not listed as a common or serious side effect in the official prescribing information for Briumvi. If you experience hair loss while on Briumvi, discuss it with your doctor to rule out other potential causes.

Is Briumvi an immunosuppressant?

Yes, Briumvi is considered an immunosuppressant because it works by depleting B cells, which are a type of white blood cell crucial for the immune system's function. This action helps treat MS but also increases the risk of infections.

What should I do if I miss a Briumvi dose?

If you miss a Briumvi dose, contact your healthcare provider immediately. They will advise you on the next steps and reschedule your infusion to maintain the effectiveness of your treatment.

Conclusion

Briumvi offers an important treatment option for individuals with relapsing forms of multiple sclerosis. While effective, it's essential for patients to be well-informed about its potential side effects. By understanding what to expect, recognizing symptoms, and maintaining open communication with your healthcare team, you can manage your treatment safely and effectively. Always remember that your doctor is your best resource for personalized medical advice and guidance regarding Briumvi and your MS treatment plan.

Sources / Medical References

Healthline: https://www.healthline.com/health/drugs/briumvi-side-effects
Briumvi (ublituximab) Prescribing Information. TG Therapeutics, Inc.
U.S. Food and Drug Administration (FDA) website.