Briumvi 150 mg concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Briumvi is and what it is used for
2. What you need to know before you are given Briumvi
3. How Briumvi is given
4. Possible side effects
5. How to store Briumvi
6. Contents of the pack and other information

Briumvi contains the active substance ublituximab. It is a type of protein called a monoclonal antibody. Antibodies work by attaching to specific targets in your body.

Briumvi is used to treat adults with relapsing forms of multiple sclerosis (RMS), where the patient has flare-ups (relapses) followed by periods with milder or no symptoms.

Multiple Sclerosis (MS) affects the central nervous system, especially the nerves in the brain and spinal cord. In MS, white blood cells called B cells that are part of the immune system (the body’s defence system) work incorrectly and attack a protective layer (called myelin sheath) around nerve cells, causing inflammation and damage. Breakdown of the myelin sheath stops the nerves from working properly and causes symptoms of MS. Symptoms of MS depend on which part of the central nervous system is affected and can include problems with walking and balance, muscle weakness, numbness, double vision and blurring, poor coordination and bladder problems.

In relapsing forms of MS, the patient has repeated attacks of symptoms (relapses) that can appear suddenly within a few hours, or slowly over several days. The symptoms disappear or improve between relapses but damage may build up and lead to permanent disability.

Briumvi works by attaching to a target called CD20 on the surface of B cells. B cells are a type of white blood cell which are part of the immune system. In multiple sclerosis, the immune system attacks the protective layer around nerve cells. B cells are involved in this process. Briumvi targets and removes the B cells and thereby reduces the chance of a relapse, relieves symptoms and slows down the progression of the disease.

• if you are allergic to ublituximab or any of the other ingredients of this medicine (listed in section 6),
• if you are suffering from a severe infection,
• if you have been told that you have severe problems with your immune system, or
• if you have cancer.

If you are not sure, talk to your doctor before you are given Briumvi.

Talk to your doctor before you are given Briumvi if any of the following apply to you. Your doctor may decide to delay your treatment with Briumvi, or may decide you cannot receive Briumvi if:

• you have an infection. Your doctor will wait until the infection is resolved before giving you Briumvi.
• you have ever had hepatitis B or are a carrier of the hepatitis B virus. This is because medicines like Briumvi can cause the hepatitis B virus to become active again. Before your Briumvi treatment, your doctor will check if you are at risk of hepatitis B infection. Patients who have had hepatitis B or are carriers of the hepatitis B virus will have a blood test and will be monitored by a doctor for signs of hepatitis B infection.
• you have recently been given any vaccine or might be given a vaccine in the near future.
• you have cancer or if you have had cancer in the past. Your doctor may decide to delay your treatment.

Infusion-related reactions

• The most common side effect of Briumvi treatment are infusion-related reactions, types of allergic reactions that develop during or shortly after a medicine is given. These can be serious.
• Symptoms of an infusion-related reaction may include:
  • itchy skin
  • hives
  • redness of the face or skin
  • throat irritation
  • trouble breathing
  • swelling of tongue or throat
  • wheezing
  • chills
  • fever
  • headache
  • dizziness
  • feeling faint
  • nausea
  • abdominal (belly) pain
  • rapid heartbeat.
• Tell your doctor or nurse straight away if you have or think you may have any infusion-related reaction. Infusion-related reactions can happen during the infusion or up to 24 hours after the infusion.
• To reduce the risk of infusion-related reaction, your doctor will give you other medicines before each infusion of Briumvi (see section 3) and you will be closely monitored during the infusion.
• If you get an infusion reaction, your doctor may need to stop or slow down the rate of infusion.

Infections

• Talk to your doctor before you are given Briumvi if you have or think you have an infection. Your doctor will wait until the infection is resolved before giving you Briumvi.
• You might get infections more easily with Briumvi. This is because the immune cells that Briumvi targets also help to fight infection.
• Tell your doctor or nurse straight away if you have an infection or any of the following signs of infection during or after Briumvi treatment:
  • fever or chills
  • cough that does not go away
  • herpes (such as cold sore, shingles or genital sores)
• Tell your doctor or nurse straight away if you think your MS is getting worse or if you notice any new symptoms. This is because of a very rare and life-threatening brain infection, called ‘progressive multifocal leukoencephalopathy’ (PML), which can cause symptoms similar to those of MS. PML can occur in patients taking medicines like Briumvi, and other medicines used for treating MS.
• Tell your partner or carer about your Briumvi treatment. They might notice symptoms of PML that you do not, such as memory lapses, trouble thinking, difficulty walking, sight loss, changes in the way you talk, which your doctor may need to investigate.

Vaccinations

• Tell your doctor if you have recently been given any vaccine or might be given a vaccine in the near future.
• Your doctor will check if you need any vaccinations before you start your treatment with Briumvi. You should receive a type of vaccine called a live or live attenuated vaccines at least 4 weeks before you start treatment with Briumvi. While you are being treated with Briumvi, you should not be given live or live attenuated vaccines until your doctor tells you that your immune system is no longer weakened.
• When possible, you should receive other types of vaccine called inactivated vaccines at least 2 weeks before you start treatment with Briumvi. If you would like to receive any inactivated vaccines while you are being treated with Briumvi, talk to your doctor.

Briumvi is not intended to be used in children and adolescents under 18 years old. This is because it has not yet been studied in this age group.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular tell your doctor:

• if you are taking, have recently taken or might take medicines that affect your immune system, such as chemotherapy, immunosuppressants (except corticosteroids) or other medicines used to treat MS. This is because these may have an added effect on the immune system.
• if you plan to have any vaccinations (see “Warnings and Precautions” above).

If any of the above apply to you (or you are not sure), talk to your doctor before you are given Briumvi.

• Tell your doctor before being given Briumvi if you are pregnant, think that you might be pregnant or are planning to have a baby. This is because Briumvi may cross the placenta and affect your baby.
• Do not use Briumvi if you are pregnant unless you have discussed this with your doctor. Your doctor will consider the benefit of you taking Briumvi against the risk to your baby.
• If you have a baby and you received Briumvi during your pregnancy, it is important to tell your baby’s doctor about receiving Briumvi so they can recommend when your baby should get vaccinated.
• It is not known whether Briumvi passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Briumvi.

If you are able to become pregnant (conceive), you must use contraception:

• during treatment with Briumvi and
• for at least 4 months after your last infusion of Briumvi.

Briumvi is unlikely to affect your ability to drive and use machines.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free.’

Before you are given Briumvi, you will receive other medicines to prevent or reduce possible side effects such as infusion-related reactions (see sections 2 and 4 for information about infusion-related reactions).

You will receive a corticosteroid and an antihistamine before each infusion and you may also receive other medicines to reduce fever.

• The first dose of Briumvi will be 150 mg. This infusion will last 4 hours.
• The second dose of Briumvi will be 450 mg given 2 weeks after the first dose. This infusion will last 1 hour.
• Subsequent dosing of Briumvi will be 450 mg given 24 weeks after the first dose and every 24 weeks thereafter. These infusions will last 1 hour.

• Briumvi will be given to you by a doctor or a nurse. Briumvi must be diluted before it is given to you. Dilution will be done by a healthcare professional. It will be given as an infusion into a vein (intravenous infusion).
• You will be closely monitored while you are being given Briumvi and for at least 1 hour after the first two infusions have been given. This is in case you have any side effects such as infusion-related reactions. The infusion may be slowed, temporarily stopped, or permanently stopped if you have an infusion-related reaction, depending on how serious it is (see sections 2 and 4 for information about infusion-related reactions).

• If you miss an infusion of Briumvi, talk to your doctor to arrange to have it as soon as possible. Do not wait until your next planned infusion.
• To get the full benefit of Briumvi, it is important that you receive each infusion when it is due.

• It is important to continue your treatment for as long as you and your doctor decide that it is helping you.
• Some side effects can be related to having low levels of B cells. After you stop Briumvi treatment, you may still experience such side effects until your B cells return to normal levels.
• Before your start any other medicines, tell your doctor when you had your last Briumvi infusion.

Infusion-related reactions

• Infusion-related reactions are the most common side effect of Briumvi treatment (very common: may affect more than 1 in 10 people). In most cases these are mild reactions, but some serious reactions can happen.
• Tell your doctor or nurse straight away if you experience any signs or symptoms of an infusion-related reaction during the infusion or up to 24 hours after the infusion.
  Symptoms can include, but are not limited to:
  • itchy skin
  • hives
  • redness of the face or skin
  • throat irritation
  • trouble breathing
  • swelling of tongue or throat
  • wheezing
  • chills
  • fever
  • headache
  • dizziness
  • feeling faint
  • nausea
  • abdominal (belly) pain
  • rapid heartbeat.
• If you have an infusion-related reaction, you will be given medicines to treat it and the infusion may need to be slowed down or stopped. When the reaction has stopped, the infusion may be continued. If the infusion-related reaction is life-threatening, your doctor will permanently stop your treatment with Briumvi.

Infections

• You might get infections more easily with Briumvi. Some of them might be serious. The following infections have been seen in patients treated with Briumvi in MS:
  • Very common (may affect more than 1 in 10 people)
    • upper respiratory tract infections (nose and throat infections)
    • respiratory tract infections (infection of the airways)
  • Common (may affect up to 1 in 10 people)
    • lower respiratory tract infections (infection of the lungs such as bronchitis or pneumonia)
    • herpes infections (cold sore or shingles)
• Tell your doctor or nurse straight away if you notice any of these signs of infection:
  • fever or chills
  • cough which does not go away
  • herpes (such as cold sore, shingles or genital sores)

Your doctor will wait until the infection is resolved before giving you Briumvi.

Common (may affect up to 1 in 10 people)

• neutropenia (low levels of neutrophils, a type of white blood cell)
• pain in extremity (arms or legs)

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is ublituximab. Each vial contains 150 mg of ublituximab in 6 mL at a concentration of 25 mg/mL.
• The other ingredients are sodium chloride, trisodium citrate dihydrate, polysorbate 80, hydrochloric acid and water for injections.

• Briumvi is a clear to opalescent, and colourless to slightly yellow solution.
• It is supplied as a concentrate for solution for infusion.
• This medicine is available in packs containing 1 vial (glass vial of 6 mL concentrate).