Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - briumvi

Document Subject

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identifier: http://ema.europa.eu/identifier/EU/1/23/1730/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Briumvi 150 mg concentrate for solution for infusion

type: Full name

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-33fea74e578b9f917fc6255f1897937f

identifier: http://ema.europa.eu/identifier/EU/1/23/1730/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - briumvi

Attesters

What is in this leaflet

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

What Briumvi is

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.

What Briumvi is used for

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.

What is Multiple Sclerosis

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. How does Briumvi work?

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.

You must not be given Briumvi:

• 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.

Warnings and precautions

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.

Children and adolescents

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.

Other medicines and Briumvi

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.

Pregnancy and breast-feeding

• 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.

Contraception for women

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.

Driving and using machines

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

Briumvi contains sodium

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

Briumvi will be given to you by a doctor or nurse who is experienced in the use of this treatment. They will watch you closely while you are being given this medicine. This is in case you get any side effects. You will always be given Briumvi as a drip (intravenous infusion).

Medicines you will have before you are given Briumvi

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.

How much and how often you will be given Briumvi

• 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.

How Briumvi is given

• 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

• 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.

If you stop Briumvi treatment

• 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.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with Briumvi:

Serious side effects

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.

Other side effects

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 of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Store in a refrigerator (2 C 8 C).

Briumvi will be stored by the healthcare professionals at the hospital or clinic under the following conditions:

• This medicine is not to be used after the expiry date which is stated on the outer carton and the vial label after EXP . The expiry date refers to the last day of that month.
• This medicine is to be stored in a refrigerator (2 C - 8 C). It is not to be frozen. The vial is to be kept in the outer carton in order to protect from light.

It is recommended that the product is used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the healthcare professional and would normally not be longer than 24 hours at 2 C - 8 C and subsequently 8 hours at room temperature.

Do not throw away any medicines via wastewater. These measures will help to protect the environment.

What Briumvi contains

• 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, sodium citrate, polysorbate 80, hydrochloric acid and water for injections.

What Briumvi looks like and contents of the pack

• 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 or 3 vials (glass vials of 6 ml concentrate). Not all pack sizes may be marketed

Marketing Authorisation Holder

Neuraxpharm Pharmaceuticals, S.L. Avda. Barcelona 08970 Sant Joan Desp Barcelona Spain

Manufacturer

Millmount Healthcare Block 7, City North Business Campus Stamullen Co. Meath
Ireland K32 YDNeuraxpharm Pharmaceuticals, S.L. Avda. Barcelona 08970 Sant Joan Desp
Barcelona - Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Neuraxpharm Belgium T l/Tel: +32 (0)2 732 56 Lietuva Neuraxpharm Pharmaceuticals, S.L. Tel:+34 93 475 96
Neuraxpharm Pharmaceuticals, S.L. Te .: +34 93 475 96 Luxembourg/Luxemburg Neuraxpharm France T l/Tel: +32 474 62 24 esk republika Neuraxpharm Bohemia s.r.o. Tel: +420 739 232 Magyarorsz g Neuraxpharm Hungary Kft. Tel.: +3630 464 6Danmark Neuraxpharm Sweden AB Tlf: +46 (0)8 30 91 (Sverige)

Malta Neuraxpharm Pharmaceuticals, S.L. Tel.:+34 93 475 96 Deutschland neuraxpharm Arzneimittel GmbH Tel: +49 2173 1060 0

Nederland Neuraxpharm Netherlands B.V. Tel.: +31 70 208 5Eesti Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 Norge Neuraxpharm Sweden AB Tlf:+46 (0)8 30 91 (Sverige)

Brain Therapeutics PC : +302109931 sterreich Neuraxpharm Austria GmbH Tel.:+ 43 (0) 2236 320Espa a Neuraxpharm Spain, S.L.U. Tel: +34 93 475 96 Polska Neuraxpharm Polska Sp. z.o.o. Tel.: +48 783 423 France Neuraxpharm France T l: +33 1.53.62.42.Portugal Neuraxpharm Portugal, Unipessoal Lda Tel: +351 910 259 Hrvatska Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 Ireland Neuraxpharm Ireland Ltd Tel: +353 (0)1 428 7Rom nia Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 Slovenija Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 sland Neuraxpharm Sweden AB S mi: +46 (0)8 30 91 (Sv j )

Slovensk republika Neuraxpharm Slovakia a.s. Tel: +421 255 425 Italia Neuraxpharm Italy S.p.A. Tel: +39 0736 980Suomi/Finland Neuraxpharm Sweden AB Puh/Tel: +46 (0)8 30 91 (Ruotsi/Sverige)

Brain Therapeutics PC : +302109931Sverige Neuraxpharm Sweden AB Tel: +46 (0)8 30 91 Latvija Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 United Kingdom (Northern Ireland) Neuraxpharm Ireland Ltd Tel: +353 (0)1 428 7This leaflet was last revised

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: