Briumvi (ublituximab-xiiy)

Briumvi (ublituximab-xiiy) is a brand-name biologic drug. Briumvi is not currently available in a biosimilar version. (The reason “-xiiy” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future.)

Biologic drugs are made from living cells. Traditional (nonbiologic) drugs are usually made from chemicals. A generic is an exact copy of the active ingredient in a traditional brand-name medication. Since it’s not possible to make an exact copy of a biologic drug’s active ingredient, they have biosimilars. A biosimilar is a biological medication that’s similar to the original biologic drug (the parent drug) that’s already been approved by the Food and Drug Administration (FDA).

Biosimilars are considered to be just as safe and effective as their parent drug. And like generics, biosimilars usually cost less than brand-name biologic drugs.

Here are answers to some frequently asked questions about Briumvi.

How does Briumvi compare with Ocrevus?

No clinical trials have directly compared Briumvi and Ocrevus. So, it’s not known whether one drug is more effective than the other for treating multiple sclerosis (MS). These medications are similar in key ways and different in others.

For example, both are anti-CD20 monoclonal antibodies given as intravenous (IV) infusions. (To learn about CD20, see “How does Briumvi work?” below.) After the first two doses of either Briumvi or Ocrevus, you’ll receive one infusion every 6 months.

One difference is that Briumvi infusions generally take less time than Ocrevus infusions. Your first Briumvi infusion may take about 4 hours, and subsequent infusions may take about 1 hour or longer (for details, see “Briumvi dosage” below). The first two Ocrevus infusions usually take about 2.5 hours or longer, and subsequent infusions may take 2 hours or longer.

Also, unlike Briumvi, Ocrevus is approved to treat primary progressive MS. Both medications are approved to treat relapsing-remitting MS, active secondary progressive MS, and clinically isolated syndrome. (For details, see the “Briumvi uses” section below.)

To learn more about Briumvi versus Ocrevus, talk with your doctor or pharmacist. You can also read this article about injectable treatments for MS.

Is Briumvi similar to Kesimpta?

Yes, in some ways. Both Briumvi and Kesimpta are anti-CD20 monoclonal antibodies prescribed for the same forms of MS in adults. For details, see the “Briumvi uses” section below.)

But these drugs differ in several ways, including how each drug is given and their dosing schedule. After the first few doses, Kesimpta is given as a subcutaneous injection once a month. In contrast, Briumvi is given as an IV infusion. After the first two doses, Briumvi infusions are given once every 6 months. (See “Briumvi dosage” below for details.)

Talk with your doctor if you’d like to learn more about Briumvi versus Kesimpta. They can tell you if one of these treatment options may be right for you.

How does Briumvi work?

Briumvi is a monoclonal antibody drug that targets certain B cells.

B cells are part of your immune system that fight infections by attacking germs. However, in people with MS, the immune system attacks specific tissues that are important for nerve function.

The monoclonal antibody drug attaches to a specific protein called CD20 on the surface of B cells. This action makes the B cells die. The drug has been shown to reduce the number of B cells in the body.

By reducing the number of B cells in your body, Briumvi is thought to slow or stop the immune system from attacking the nervous system. This may help slow or stop MS from getting worse and may reduce MS symptoms.

If you’d like to learn more about how Briumvi works, talk with your doctor.

Briumvi can cause mild or serious side effects. The following lists contain some of the key side effects that may occur with Briumvi. These lists do not include all possible side effects.

For more information about the possible side effects of Briumvi, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Briumvi, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Briumvi. To learn about other mild side effects, talk with your doctor or pharmacist, or view the drug’s prescribing information.

Mild side effects of Briumvi can include:

• mild infusion reactions, such as nausea or headache
• mild respiratory tract infections, such as the common cold
• increased risk of herpes viral infections
• pain in your hands and feet
• insomnia
• fatigue

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Briumvi aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• severe infusion reactions, which may include symptoms such as:
  • difficulty breathing
  • rapid heart rate
  • fever and chills
• anaphylaxis (a severe type of allergic reaction that can be life threatening), which may include symptoms such as:
  • hives
  • swelling of the face or mouth
  • wheezing
• serious respiratory tract infections, such as pneumonia, which may include symptoms such as:
  • cough
  • fever
  • chest congestion
• other serious infections, such as progressive multifocal leukoencephalopathy, which may include symptoms such as:
  • weakness on one side of the body that worsens over time
  • vision changes
  • confusion

ALLERGIC REACTION

For some people, Briumvi infusions can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should continue receiving Briumvi infusions.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Briumvi, your doctor may recommend a different medication instead.

As with all medications, the cost of Briumvi can vary. The actual price you’ll pay depends on your treatment plan and insurance coverage (if you have insurance).

Financial and insurance assistance: If you need financial support to pay for Briumvi, or if you need help understanding your insurance coverage, help is available.

The Briumvi Copay Assistance Program and Briumvi Patient Assistance Program are available for Briumvi. For more information and to find out if you’re eligible for support, call 833-274-8684 or visit the Briumvi website.

Biosimilar version: Briumvi is a biologic drug that’s not available in a biosimilar form. Biosimilars tend to cost less than brand-name medications. To learn more, check out the “Briumvi generic or biosimilar” section above.

To learn more about saving money on prescriptions, check out this article.

The following information describes the Briumvi dosage that’s commonly prescribed or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug form and strengths

Briumvi comes as a solution in a vial. A healthcare professional will prepare the medication and administer it as an intravenous (IV) infusion. You’ll go to a hospital or infusion clinic to receive your infusions.

Briumvi is available in single-dose vials that contain 150 milligrams (mg) in 6 milliliters (mL) of solution (25 mg/mL).

Dosage for multiple sclerosis (MS)

Briumvi treatment for MS starts with a low dose. This helps your body get used to the medication.

The typical starting dose is 150 mg. The second dose is 450 mg, given 2 weeks after your first infusion. Each subsequent dose is 450 mg, beginning 24 weeks after your first infusion. You’ll continue to receive 450 mg by infusion every 24 weeks (6 months). This is the recommended Briumvi infusion schedule for MS.

If you have questions about your Briumvi dosage, talk with your doctor for more information.

Briumvi infusion times

Your first Briumvi infusion usually takes at least 4 hours. Your second and subsequent infusions usually take about 1 hour or longer. However, the time can vary depending on how your body responds to the infusion. Your doctor may pause, slow, or stop the infusion if you have an infusion reaction. (Infusion reactions are a possible side effect of Briumvi. To learn more, see “Briumvi side effects” above.)

Infusion reactions are usually mild to moderate, but in rare cases they can be severe or even life threatening. A healthcare professional will monitor you for infusion reactions during each infusion. They may also monitor you for at least 1 hour after each dose. This way, if infusion reactions occur, you’ll receive supportive care right away.

To help reduce the risk of infusion reactions, you’ll typically receive medications before each infusion. For details, see the section just below.

About Briumvi infusions

Briumvi infusions involve some preparation. Before each dose, your doctor will:

• Check for infection: If you have signs or symptoms of an infection, such as fever, your doctor will hold off on giving your infusion. They’ll reschedule it after the infection is treated or goes away.
• Check for pregnancy: If you can become pregnant, your doctor may order a pregnancy test to confirm you’re not pregnant. To learn more about Briumvi and pregnancy, see the “Things to consider with Briumvi treatment” section below.
• Give you medication: You’ll receive certain medications (premedications) 30 to 60 minutes before each Briumvi infusion. They can help prevent or minimize infusion reactions. They may include:
  • a corticosteroid, such as methylprednisolone (Medrol)
  • an antihistamine, such as diphenhydramine (Benadryl)
  • a fever reducer, such as acetaminophen (Tylenol)

Below you’ll find information about other key dosage issues:

• If you miss a dose: If you miss your appointment for a Briumvi infusion, call your doctor as soon as possible to reschedule. They’ll adjust your dosing schedule as needed. Briumvi infusions should be given at least 5 months apart.
• Length of treatment: Briumvi is meant to be a long-term treatment. If you and your doctor determine that Briumvi is safe and effective for you, you’ll likely receive it long term.
• Length of time to work: Briumvi starts working within 24 hours after your infusion. But it may take several weeks or months of treatment before you and your doctor can determine whether the drug is working for you.

To learn more about what to expect with Briumvi infusions, talk with your doctor. You can also visit the manufacturer’s website.

The Food and Drug Administration (FDA) approves prescription drugs such as Briumvi to treat certain conditions. Briumvi may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Briumvi for multiple sclerosis (MS)

With MS, your immune system mistakenly attacks certain tissues that are important for nerve function. This causes inflammation (swelling) and damage, which leads to symptoms. Symptoms of MS commonly include fatigue, muscle weakness, and difficulty walking.

The FDA has approved Briumvi to treat the following conditions in adults:

• Clinically isolated syndrome (CIS): With CIS, symptoms occur that resemble MS. It’s a short-term episode that lasts at least 24 hours. People who have an episode of CIS are likely to develop MS in the future.
• Relapsing-remitting MS: With this form of MS, there are periods of bothersome or worsening symptoms (relapses), followed by periods without symptoms (remissions).
• Active secondary progressive MS: This is a more severe form of MS in which symptoms worsen over time, without periods of remission.

Visit our MS hub to learn more about MS and find helpful resources.

Briumvi and children

Briumvi is only FDA approved for use in adults. It’s not known whether this medication is safe or effective for people under 18 years old.

The manufacturer of Briumvi didn’t look at interactions in clinical trials of the drug. But based on how Briumvi works, it’s possible that this drug can interact with certain other medications.

Before starting Briumvi treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

Interactions with medications

Below is a list of medications that may interact with Briumvi. This list does not contain all drugs that may interact with Briumvi. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

Alcohol is not known to interact with Briumvi. It’s likely safe to consume alcohol during Briumvi treatment.

If you have questions about how much alcohol is safe to drink while receiving Briumvi infusions, talk with your doctor or pharmacist.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Briumvi, talk with your doctor. They can tell you about other MS medications that may work well for you.

The following drugs are similar to Briumvi:

• ocrelizumab (Ocrevus)
• ofatumumab (Kesimpta)
• natalizumab (Tysabri)
• natalizumab-sztn (Tyruko)
• alemtuzumab (Lemtrada)

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Briumvi and pregnancy

Briumvi should not be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before starting this medication. Your doctor may suggest birth control options to use during treatment with Briumvi. In addition, they may ask you to take a pregnancy test before each infusion to confirm that you’re not pregnant. (See “Briumvi dosage” for what to expect with Briumvi infusions.)

If you become pregnant during Briumvi treatment or within 6 months after treatment ends, tell your doctor. The medication may cause your baby to be born with an immune system that’s weaker than is typical. This should be temporary, but certain vaccines may need to be postponed until your baby’s immune system gets stronger. Your doctor can tell you more about this.

Briumvi and birth control

It’s not known whether Briumvi is safe to use during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs during Briumvi treatment.

Note: Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

For females receiving Briumvi

Females who can become pregnant should use birth control to help prevent pregnancy during Briumvi treatment. You should continue using birth control throughout your treatment and for at least 6 months after your last dose.

If you have questions about your birth control options, talk with your doctor.

For males receiving Briumvi

The manufacturer of Briumvi doesn’t give specific recommendations about birth control use in males during treatment. If you’re male, talk with your doctor about your birth control needs.

Briumvi and breastfeeding

It’s not known whether Briumvi should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before receiving this medication.

This drug comes with several precautions.

Before starting Briumvi, discuss your health history with your doctor. Briumvi may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

• active or past hepatitis B infection
• other active infection
• previous allergic reaction to this or a similar drug
• pregnancy
• breastfeeding

Note: For more information about the potential negative effects of Briumvi, see the “Briumvi side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.