Briumvi is used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is given as an intravenous infusion every 6 months by a healthcare provider.

Clinical trials report that Briumvi is superior to teriflunomide at reducing relapses and significantly reducing brain lesions on magnetic resonance imaging (MRI).

• 49 % to 59 % fewer relapses were reported with Briumvi vs teriflunomide in 2 clinical trials.
• Both studies also reported near complete (97%) suppression of brain lesions (T1 Gd+ lesions) per MRI over 2 years.
• Zero relapses were reported in 86% to 87% of people taking Briumvi.

Briumvi (ublituximab-xiiy) gained FDA approval on December 28, 2022. There is no generic or biosimilar.

How does Briumvi work?

Briumvi’s mechanism of action involves targeting and destroying B cells (a type of immune cell) in the body. It does this by binding to a protein called CD20 on the B cells’ surface. By reducing B cells, Briumvi helps mitigate the immune system’s effect on the nervous system, which drives MS symptoms. 

Briumvi belongs to the drug class called CD20 monoclonal antibodies.

Briumvi side effects

The most common Briumvi side effects are:

• infusion reactions, which may include symptoms such as dizziness, nausea, light-headed, itchy, sweaty, headache, chest tightness, back pain, trouble breathing, or swelling in your face;
• cold sores around your mouth (herpes infections), skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• pain in your hands and feet;
• sleep problems (insomnia); or
• tiredness.

Serious side effects and warnings

Briumvi can cause the following serious side effects.

Infusion reactions. Infusion reactions are one of the most common side effects of Briumvi. Infusion reactions can be serious and may require you to be hospitalized. You will be monitored during your infusion and may be monitored after each infusion of Briumvi for signs and symptoms of an infusion reaction. Tell your healthcare provider if you get any of these symptoms:

• fever
• itchy skin
• wheezing
• chills
• dizziness
• nausea
• headache
• feeling faint
• abdominal pain
• flu-like symptoms
• swelling of the tongue or throat
• throat irritation
• fast heartbeat
• trouble breathing
• red face or skin
• hives.

These infusion reactions can happen over 24 hours after your infusion. You must call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion.

Infections. Infections are a common side effect, and upper respiratory tract infections are one of the most common side effects of Briumvi. Briumvi increases your risk of getting infections caused by bacteria or viruses that may be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection, including fever, chills, a cough that does not go away, or painful urination. Your healthcare provider should delay your treatment with Briumvi until your infection is gone.

Hepatitis B virus (HBV) reactivation: Before starting treatment with Briumvi, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had a hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Briumvi. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Briumvi.

Weakened immune system: Briumvi taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Progressive Multifocal Leukoencephalopathy (PML): PML may happen with Briumvi. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These symptoms may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, and changes in thinking and memory, which may lead to confusion, and personality changes.

Low immunoglobulins: Briumvi may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Briumvi may also cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Briumvi, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

It is not known if Briumvi is safe or effective in children.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before receiving this medicine

Do not receive Briumvi if you:

• have had a life-threatening allergic reaction to ublituximab, Briumvi, or any of the inactive ingredients in the infusion
• have an active hepatitis B virus (HBV) infection.

Before receiving, tell your healthcare provider about all your medical conditions, including if you:

• have or think you have an infection
• take or plan to take medicines that affect your immune system. These medicines may increase your risk of getting an infection
• have ever had hepatitis B or you are a carrier of the hepatitis B virus
• have had a recent vaccination or are scheduled to receive any vaccinations.
  • Make sure all your vaccinations are up to date before starting Briumvi. You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Briumvi. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Briumvi and until your healthcare provider tells you that your immune system is no longer weakened.
  • When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Briumvi. If you would like to receive any non-live vaccines while you are being treated with Briumvi, talk to your healthcare provider.
  • If you have a baby and you received Briumvi during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Briumvi so they can decide when your baby should be vaccinated.
• are pregnant, think that you might be pregnant, or plan to become pregnant
• are breastfeeding, or plan to breastfeed.

Pregnancy

Briumvi may harm your unborn baby. You should use birth control (contraception) during treatment with Briumvi and for at least 6 months after your last infusion of Briumvi. Talk with your healthcare provider about what birth control method is right for you during this time. You may need to have a negative pregnancy test before each infusion of Briumvi.

Pregnancy Registry. There is a pregnancy registry for women who take Briumvi during pregnancy. If you become pregnant while receiving Briumvi or within 6 months following the last dose of Briumvi, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Briumvi Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can enroll you in this registry by calling 1-877-411-4546 or visiting www.briumvipregnancyregistry.com.

Breastfeeding

It is not known if Briumvi passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Briumvi.  

How will I receive Briumvi?

Briumvi is given through a needle placed in your vein (intravenous infusion) in your arm.

• Your healthcare provider may do a pregnancy test before each infusion of Briumvi.
• Before treatment with Briumvi, you will receive a corticosteroid and an antihistamine medicine to help reduce the risk of infusion reactions by making them less frequent and less severe.
• You may also receive other medicines to help reduce the risk of an infusion reaction.

Your first dose of Briumvi will last about 4 hours.

• Your second dose of Briumvi will be given 2 weeks after your first dose. This infusion will last about 1 hour.
• Your next doses of Briumvi will be given as 1 infusion every 24 weeks. These infusions will last about 1 hour.  

Dosing information

Dose of Briumvi for Multiple Sclerosis (Adults):

• First Infusion: 150 mg IV over at least 4 hours.
• Second Infusion (2 weeks after the first infusion): 450 mg IV over at least 1 hour.
• Subsequent Infusions (24 weeks after the first infusion and every 24 weeks thereafter): 450 mg IV every 24 weeks over at least 1 hour.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Briumvi injection.

What should I avoid while receiving Briumvi?

Avoid receiving a “live” vaccine while you are being treated with Briumvi, and for at least 4 weeks before your treatment. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Avoid receiving a “non-live” vaccine for at least 2 weeks before your treatment with Briumvi.

What other drugs will affect Briumvi?

Tell your doctor about all your other medicines, especially:

• Drugs that weaken the immune system, such as cancer medications, steroids, and medicines to prevent organ transplant rejection.

Beyfortus is used to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants under 1 year born during or entering their first RSV season. It may also be given to children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season. Beyfortus helps to protect healthy and at-risk infants from RSV complications and hospitalizations by providing rapid, long-lasting passive immunity against the respiratory syncytial virus (RSV). 

Beyfortus contains a long-acting monoclonal antibody, called nirsevimab-alip, that targets the RSV F protein, stopping the virus from entering cells and multiplying, and causing infections. 

Beyfortus is used in newborns and infants in their first RSV season from autumn to spring. It is administered as a single intramuscular injection (into the muscle) of the upper thigh for protection through a typical RSV season of 5 months.

Beyfortus gained FDA approval on July 17, 2023, following positive results of three clinical trials (MELODY phase IIb trial [Trial 03], NCT02878330; MELODY phase III trial [Trial 04], NCT03979313; and MEDLEY phase II/III [Trial 05], NCT03959488).

• In healthy late preterm and term infants, Beyfortus reduced medically attended RSV lower respiratory tract infections by 74.5%, hospitalizations by 76.8%, and very severe infections by 78.6%.
• Beyfortus demonstrated a favorable safety and tolerability profile in high-risk infants. 

Side effects

The most common side effects of Beyfortus are:

• a rash
• pain, swelling, or a hard area at the site of your child’s injection. 

Serious side effects and warnings

Beyfortus may cause the following serious side effects:

• Serious allergic reactions. Beyfortus may cause serious allergic (hypersensitivity) reactions, including anaphylaxis. Your child should not receive Beyfortus if they have had serious allergic reactions in the past to nirsevimab-alip, Beyfortus, or any inactive ingredients in the Beyfortus injection. Get medical help right away if your child has any of the following signs or symptoms of a serious allergic reaction:
  • swelling of the face, mouth, or tongue
  • difficulty swallowing or breathing
  • unresponsiveness or loss of muscle tone (goes floppy)
  • bluish color of skin, lips, or under the fingernails
  • muscle weakness
  • severe rash, hives (urticaria), or itching.

It is not known if Beyfortus is safe and effective in children older than 24 months of age.

These are not all of the possible side effects of Beyfortus. Call your doctor for medical advice about side effects.

Before taking

Your child should not receive the Beyfortus vaccine if they have had serious allergic reactions in the past to nirsevimab-alip, Beyfortus, or any inactive ingredients in the Beyfortus injection.

Before your child receives Beyfortus, tell your healthcare provider about all of your child’s medical conditions, including if your child:

• has ever reacted Beyfortus or nirsevimab-alip
• has bleeding or bruising problems. If your child has a problem with bleeding or bruises easily, an injection could cause a problem.

How is Beyfortus administered?

Beyfortus is given by a healthcare provider as an injection into the upper thigh.

• Usually, only 1 dose is needed.
• A second dose may be given if your child remains at increased risk for RSV the following year.

Your child should be given Beyfortus before or during the RSV season. 

• RSV season is usually late fall (November) through spring (April), with a peak in January and February.
• Your child may still get RSV disease after receiving Beyfortus. Talk to your child’s healthcare provider about what symptoms to look for.

If your child has heart surgery, your child’s healthcare provider may need to give your child an additional Beyfortus injection soon after surgery.

Beyfortus can be administered at the same time as childhood vaccines, at a different injection site. Do not mix Beyfortus with any vaccines or medications in the same syringe or vial.

Dosing information

Dose of Beyfortus for infants aged under 1 year born during or entering their first RSV season:

• Weight less than 5 kg (11 lb): 50 mg as a single injection.
• Weight more than or equal to 5 kg (11 lb): 100 mg as a single injection.

Dose of Beyfortus for children who remain vulnerable through their second RSV season:

• Any weight: 200 mg administered as two IM injections (2 x 100 mg injections).

Is Beyfortus a vaccine?

Technically, Beyfortus is not a vaccine, because it provides infants with the antibodies needed to protect them against RSV, unlike vaccines that teach your immune system to make its own antibodies.

• This is called passive immunity.
• Beyfortus protects your baby immediately from getting sick with RSV.
• The protection lasts around 5 months.

Beyfortus cost

Beyfortus is included in the approved immunization schedule and may be available at no cost for parents through private health insurance companies and the Vaccines for Children (VFC) program.

What other drugs will affect Beyfortus?

Other drugs may interact with Beyfortus, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all the current medicines your baby takes. Especially tell your healthcare provider if your baby:

• has received palivizumab (another monoclonal antibody for RSV) recently
• receives anticoagulants (such as heparin or warfarin).

Ingredients

Active ingredients: nirsevimab-alip.
Inactive ingredients: L-histidine, L-histidine hydrochloride, L-arginine hydrochloride, sucrose, polysorbate 80, water for injections.

Available as:

• Beyfortus 50 mg/0.5 mL in a single-dose pre-filled syringe
• Beyfortus 100 mg/1 mL in a single-dose pre-filled syringe.

Company

Beyfortus is manufactured by Astra Zeneca AB, Södertälje, Sweden, and distributed by Sanofi Pasteur, Inc., Swiftwater, PA 18370 USA.

Beyfortus Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Beyfortus.Beyfortus (nirsevimab-alip) – AstraZeneca AB

Bevacizumab injection is a targeted cancer drug used to treat types of colon and rectal cancer, non-small cell lung cancer (NSCLC), glioblastoma, renal cell cancer (RCC), cervical cancer, ovarian cancer, fallopian tube cancer, or peritoneal cancer. Avastin is also used to treat types of hepatocellular carcinoma (HCC).

Bevacizumab belongs to a class of medications called antiangiogenic agents. Bevacizumab works by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors.

Avastin was the first brand of bevacizumab to be approved by the FDA on February 26, 2004, and is called the reference product.  Biosimilars of Avastin are Alymsys, Jobevne, Mvasi, Vegzelma, and Zirabev.
Bevacizumab is used together with other chemotherapy medications.

Bevacizumab side effects

Common bevacizumab side effects may include increased blood pressure, headache, back pain, dry or watery eyes, dry or flaky skin, stuffy nose, runny nose, sneezing, or altered sense of taste.

Serious bevacizumab side effects 

Get emergency medical help if you have signs of an allergic reaction to bevacizumab, including hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver right away if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Bevacizumab can cause a serious but rare neurologic disorder that affects the brain. Symptoms may occur within hours of your first dose or may not appear for up to a year after your treatment started. Call your doctor at once if you have extreme weakness or tiredness, headache, confusion, vision problems, fainting, or seizures (blackout or convulsions).

Bevacizumab can cause you to bleed more easily. Call your doctor or seek emergency medical attention if you have:

• easy bruising, unusual bleeding, or any bleeding that will not stop;
• signs of bleeding in your digestive tract – severe stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• signs of bleeding in the brain – sudden numbness or weakness, slurred speech, severe headache, problems with vision or balance.

Some people taking bevacizumab have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) in the stomach, intestines, throat, lungs, gallbladder, kidney, bladder, or vagina. Call your doctor if you have severe stomach pain or if you feel like you are choking when you eat or drink.

Also call your doctor if you have:

• slow wound healing;
• skin infection or open sores;
• missed menstrual periods;
• kidney problems – swelling, urinating less, feeling tired or short of breath;
• signs of a blood clot – chest pain, sudden cough or shortness of breath, dizziness, coughing up blood, pain, swelling, or warmth in one leg;
• heart problems – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating, swelling, rapid weight gain, feeling short of breath; or
• low white blood cell counts – fever, mouth sores, skin sores, sore throat, cough.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Bevacizumab can make it easier for you to bleed. Seek emergency medical attention if you have any bleeding that will not stop. You may also have bleeding on the inside of your body.

Call your doctor if you have: signs of bleeding in your digestive tract–feeling very weak or dizzy, severe stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or signs of bleeding in the brain–sudden numbness or weakness, slurred speech, severe headache, problems with vision or balance.

Bevacizumab can also cause problems with wound healing, which could result in bleeding or infection. Do not use bevacizumab within 28 days before or after a planned surgery.

Bevacizumab can cause a rare but serious neurologic disorder affecting the brain. Symptoms include headache, confusion, vision problems, feeling very weak or tired, fainting, and seizure (blackout or convulsions). These rare symptoms may occur within hours of your first dose of bevacizumab, or they may not appear for up to a year after your treatment started. Call your doctor at once if you have any of these side effects.

Some people receiving a bevacizumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your medical caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chills, wheezing, or chest pain during the injection.

Before taking this medicine

You may not be able to use bevacizumab if you are being treating with other cancer medicines such as doxorubicin, daunorubicin, or if you have or ever had:

• ovarian cancer with symptoms such as severe stomach pain or pelvic pain;
• slow healing of a skin wound or surgical incision;
• surgery within the past 4 weeks (28 days);
• you plan to have surgery within the next 4 weeks (28 days); or
• coughing up blood or vomit that looks like coffee grounds.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• diabetes;
• heart problems such as a heart attack, stroke, blood clot or blood clotting disorder;
• high blood pressure;
• bleeding problems or a perforation (a hole or tear) in your esophagus, stomach, or intestines; or
• kidney disease.

Pregnancy

Bevacizumab may harm an unborn baby. Do not use if you are pregnant. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using bevacizumab and for at least 6 months after your last dose. Tell your doctor at once if you become pregnant.

This medicine may cause a woman’s ovaries to stop working correctly. Symptoms of ovarian failure include 3 or more missed menstrual periods in a row. It may be harder for you to get pregnant while you are using this medicine and after this treatment. Talk to your doctor about your individual risk.

Breastfeeding

Do not breastfeed while using bevacizumab and for at least 6 months after your last dose.

How is bevacizumab given?

Bevacizumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Tell your caregivers right away if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, shortness of breath, or chest pain during the injection.

Bevacizumab is usually given once every 2 or 3 weeks.

Doses are based on weight. Your dose may change if you gain or lose weight.

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

For detailed bevacizumab dosing information, click the link below.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your bevacizumab injection.

What happens if I overdose?

In a medical setting, an overdose would be treated quickly.

What should I avoid while receiving bevacizumab?

Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

What other drugs will affect bevacizumab?

Tell your doctor about all other cancer treatments you are receiving.

Other drugs may interact with bevacizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Ingredients and manufacturer

Active ingredient: bevacizumab

Avastin (bevacizumab)
Inactive ingredients: a,a-trehalose dihydrate, polysorbate 20, sodium phosphate dibasic (anhydrous), sodium phosphate monobasic (monohydrate), and Water for Injection, USP.
Manufacturer: Genentech, Inc, 1 DNA Way South San Francisco, CA 94080, USA.

Alymsys (bevacizumab-maly)
inactive ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 20, trehalose, and Water for Injection, USP.
Manufacturer: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Product of Spain 

Mvasi (bevacizumab-awwb)
Inactive ingredients: α,α-trehalose dihydrate, polysorbate 20, sodium phosphate dibasic, anhydrous, sodium phosphate monobasic, monohydrate, and Water for Injection, USP.
Manufacturer: Amgen, Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 

Vegzelma (bevacizumab-adcd)
Inactive ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 20, trehalose, and Water for Injection, USP.
Manufacturer: CELLTRION, Inc. 20, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea. 

Zirabev (bevacizumab-bvzr)
Inactive ingredients: edetate disodium dihydrate, polysorbate 80, succinic acid, sucrose, and Water for Injection, USP. Sodium hydroxide is added to adjust the pH.
Manufacturer: Pfizer Inc. NY, NY 10017.

Bevacizumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for bevacizumab.Avastin (bevacizumab) – Genentech, Inc.