VUMERITY 231 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Vumerity 231 mg hard gastro-resistant capsules
   1. What is Vumerity and what it is used for
   2. What you need to know before you take Vumerity
   3. How to take Vumerity
   4. Possible side effects
   5. How to store Vumerity
   6. Contents of the pack and other information

Vumerity 231 mg hard gastro-resistant capsules

diroximel fumarate

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Vumerity and what it is used for

What is Vumerity
Vumerity contains the active ingredient diroximel fumarate.

What is Vumerity used for
Vumerity is used to treat relapsing-remitting multiple sclerosis (RRMS) in adult patients.
Multiple sclerosis is a chronic disease in which the immune system (the body's natural defenses
) does not function properly and attacks parts of the central nervous system (the brain, the
spinal cord and the optic nerve of the eye) causing inflammation that damages the nerves and the
sheath surrounding them. Relapsing-remitting multiple sclerosis is characterized by repeated attacks
on the nervous system (relapses). Symptoms vary from patient to patient, but generally include difficulty
walking, a feeling of imbalance and visual disturbances (e.g. blurred or double vision). These symptoms may disappear completely when the relapse resolves,
but some problems may remain.

How Vumerity works
The medicine is believed to work by increasing the action of a protein called “Nrf2” which regulates
some genes that produce “antioxidants”, involved in the defense of cells. This helps to
control the activity of the immune system and reduce damage to the brain and spinal cord.

2. What you need to know before you take Vumerity

Do not take Vumerity

• if you are allergic to diroximel fumarate, to related substances (called fumarates or fumaric acid esters)or to any of the other ingredients of this medicine (listed in section 6)
• if you suspect you have a rare brain infection called progressive multifocal leukoencephalopathy (PML)or if the diagnosis of PML has been confirmed.

Warnings and precautions
Vumerity may affect the number of white blood cells in the blood, the kidneysand the liver. Before
starting to take Vumerity, your doctor will perform a blood test to check the number
of white blood cells in your body and will check that your kidneys and liver are functioning properly. Your
doctor will perform the tests periodically during treatment. If the number of white
blood cells decreases during treatment, your doctor may consider further tests or
discontinuation of therapy.
If you think that the MS is getting worse (for example, if you experience weakness or changes in vision) or if
you notice new symptoms, consult your doctor immediately because these could be symptoms of
a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is
a serious condition that can lead to severe disability or death. Read the information contained
in “PML and low lymphocyte counts” in section 4 of this leaflet.

Talk to your doctorbefore taking Vumerity if you have:

• a severe infection(such as pneumonia)
• a serious illness of the kidneys
• a serious illness of the liver
• an illness of the stomachor intestine

Flushing (redness of the face and body) is a common side effect. Severe flushing
together with other symptoms may be a sign of a serious allergic reaction and has been observed in
a small number of patients (see “Serious allergic reactions” in section 4 of this leaflet). If the
flushing causes you problems, consult your doctor, who can provide you with appropriate treatment.
Vumerity can cause a serious allergic reaction known as a hypersensitivity reaction. You must
be aware of all the important signs and symptoms to watch out for while taking Vumerity.
Read the information contained in “Serious allergic reactions” in section 4 of this leaflet.
Cases of herpes zoster infection (shingles) can occur with Vumerity treatment. In some cases, serious
complications have occurred. Tell your doctorimmediately if
you suspect you have any symptoms of herpes zoster infection, listed in section 4 of this
leaflet.
A rare but serious kidney disorder (Fanconi syndrome) has been observed with a medicine containing related active ingredients (dimethyl fumarate in association with other fumaric acid esters). If you notice
urinating more frequently, if you are more thirsty and drink more than usual, or if your muscles are more
weak, or in case of fracture or just pain, contact your doctor as soon as possible so that
further investigations can be initiated.

Children and adolescents
Do not give this medicine to children and adolescents because there is limited experience with the safety and
efficacy of Vumerity in this population.

Other medicines and Vumerity
Tell your doctor or pharmacistif you are taking, have recently taken or might take
any other medicine.
In particular:

• medicines that contain fumaric acid esters(fumarates)
• medicines that affect the immune system,including chemotherapy drugs, immunosuppressive therapiesor other medicines used to treat multiple sclerosis
• medicines that affect the kidneys, includingsome antibiotics(such as aminoglycosides, used to treat infections), diuretics, certain types of pain relievers(such as ibuprofen and other similar anti-inflammatory drugs and over-the-counter medicines) and medicines that contain lithium
• taking Vumerity with certain types of vaccines ( live vaccines) could cause an infection and should therefore be avoided. Your doctor will tell you whether other types of vaccines ( non-live vaccines) should be administered.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Vumerity if you are pregnant unless you have discussed this with your doctor. This
is because Vumerity may harm the fetus. If you are a woman of childbearing potential, you should use reliable
contraceptive measures.
Breastfeeding
It is not known whether diroximel fumarate or its metabolites pass into breast milk. Your doctor will help you
decide whether to stop breastfeeding or treatment with Vumerity. This involves
assessing the benefit of breastfeeding for your baby versus the benefit of therapy for
you.

Driving and using machines
It is not expected that Vumerity will affect your ability to drive and use machines.

3. How to take Vumerity

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult
your doctor.

Initial dose
The recommended initial dose is 231 mg (one capsule) twice daily.
Take this initial dose for the first 7 days, and then take the maintenance dose.

Maintenance dose
The recommended maintenance dose is 462 mg (two capsules) twice daily.
Vumerity is for oral use.
Swallow each capsule whole, with a little water. You must not crush, chew or disperse the
contents of the capsule in food, as this could increase some undesirable effects.
You can take Vumerity with meals or on an empty stomach. If you experience undesirable effects such as redness or
stomach problems, taking it with food may reduce these symptoms.

If you take more Vumerity than you should
If you have taken too many capsules, seek immediate medical advice. You may experience undesirable
effects similar to those described below in paragraph 4.

If you forget to take Vumerity
Do not take a double doseto make up for a missed dose.
If at least 4 hours remain until the next scheduled dose, you can take the forgotten dose.
Otherwise, do not take the forgotten dose and take the next scheduled dose at the
scheduled time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
PML and low lymphocyte counts
The frequency of PML cannot be defined based on available data (not known).
Vumerity may reduce the levels of lymphocytes (a type of white blood cell). Persistently low levels of
white blood cells may increase the risk of infections, including the risk of a rare brain infection
called progressive multifocal leukoencephalopathy (PML). PML can cause
severe disability or death. PML has occurred after a period of 1 to 5 years of treatment with the
related medicine dimethyl fumarate, so the doctor must continue to monitor white blood cell
counts throughout the duration of treatment. Be careful to closely observe any potential symptom
of PML, as described below. The risk of PML may be higher if you have previously
taken medicines that suppress the function of the immune system.
The symptoms of PML can be similar to those of a relapse of multiple sclerosis. Symptoms
may include the onset or worsening of weakness on one side of the body; poor
coordination; changes in vision, thinking, or memory; confusion or changes in
personality or difficulty with speech and communication lasting more than a few days.
Therefore, if you believe that your MS is worsening or if you notice any new symptoms during therapy
with Vumerity, it is very important that you contact your doctor as soon as possible. Also, talk to your
partner or caregiver and inform them about the characteristics of the treatment. Symptoms may develop
that you may not be aware of.

If you experience any of these symptoms, call your doctor immediately
Serious allergic reactions
The frequency of serious allergic reactions cannot be defined based on available data (not
known).
Flushing is a very common side effect .However, if it should be accompanied by
red or hive-like rash andyou have any of these symptoms:

• swelling of the face, lips, mouth or tongue (angioedema)
• shortness of breath, difficulty breathing or breathlessness (dyspnea, hypoxia)
• dizziness or loss of consciousness (hypotension)

you may be experiencing a serious allergic reaction (anaphylaxis)

Stop taking Vumerity and call a doctor immediately
Other side effects
Very common(may affect more than 1 in 10 people)

• flushing of the face or body, feeling of warmth, intense heat, burning or itching ( flushing)
• loose stools (diarrhea)
• feeling of impending vomiting (nausea)
• stomach pain or stomach cramps

Side effects that may emerge from blood or urine tests

• the presence of substances called ketones, which are produced naturally by the body, is very commonly revealed in urine tests during the use of Vumerity
• low levels of white blood cells ( lymphopenia, leukopenia) in the blood. A decrease in the number of white blood cells in the blood may indicate that you are unable to fight off an infection adequately. If you have a serious infection (such as pneumonia), contact your doctor immediately

Contact your doctorto find out how to manage these side effects. Your doctor may reduce the
dose of the medicine. Do not reduce the dose unless your doctor tells you to do so.

Common(may affect up to 1 in 10 people)

• inflammation of the lining of the intestine (gastroenteritis)
• feeling unwell (vomiting)
• indigestion (dyspepsia)
• inflammation of the stomach (gastritis)
• digestive problems (gastrointestinal disorder)
• burning sensation
• hot flash, feeling of heat
• itching
• rash
• pink or red spots on the skin ( erythema)
• hair loss ( alopecia)

Side effects that may emerge from blood or urine tests

• proteins ( albumin) in the urine ( proteinuria)
• increased levels of liver enzymes ( alanine-aminotransferase, ALTand aspartate-aminotransferase, AST) in the blood

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduced platelets in the blood

Rare(may affect up to 1 in 1,000 people)

• liver damage caused by the drug and increased levels of liver enzymes measured with blood tests ( ALT or AST in combination with bilirubin)

Not known(frequency cannot be estimated based on available data)

• herpes zoster infection (shingles) with symptoms such as blisters, burning, itching, or skin pain, usually on one side of the trunk or face, and other symptoms such as fever and

weakness in the early stages of the infection, followed by numbness, red or itchy
spots with severe pain

• runny nose ( rhinorrhea)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vumerity

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after
“Exp.”.
The expiry date refers to the last day of that month.
Store at a temperature below 25 °C.
Store in the original bottle to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vumerity contains
The active ingredientis diroximel fumarate.
Each capsule contains 231 mg of diroximel fumarate.

Other ingredientsare: capsule content: acrylic acid-ethyl methacrylate copolymer
(1:1) type A; crospovidone type A; microcrystalline cellulose; anhydrous colloidal silica; triethyl citrate;
talc; magnesium stearate; capsule coating: hypromellose; titanium dioxide (E171); potassium
chloride; carrageenan; capsule printing: black iron oxide (E172), shellac and potassium
hydroxide.

Description of Vumerity and contents of the pack
Vumerity 231 mg hard gastro-resistant capsules are white in colour and bear the inscription “DRF
231 mg” printed with black ink.
Vumerity is available in packs containing 120 or 360 (3 × 120) capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands

Manufacturer
Alkermes Pharma Ireland Limited
Connaught House
1 Burlington Road
Dublin 4
Ireland
D04 C5Y6
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Biogen Belgium NV/SA
Tél/Tel: +32 2 2191218

Lietuva
Biogen Lithuania UAB
Tel: +370 5 259 6176

България
ЕВОФАРМА ЕООД
Teл: +359 2 962 12 00

Luxembourg/Luxemburg
Biogen Belgium NV/SA
Tél/Tel: +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
Tel: +420 255 706 200

Magyarország
Biogen Hungary Kft.
Tel: + 36 1 899 9883

Danmark
Biogen (Denmark) A/S
Tlf.: +45 77 41 57 57

Malta
Pharma. MT Ltd.
Tel: +356 21337008

Deutschland
Biogen GmbH
Tel: +49 (0) 89 99 6170

Nederland
Biogen Netherlands B.V.
Tel: +31 20 542 2000

Eesti
Biogen Estonia OÜ
Tel: +372 618 9551

Norge
Biogen Norway AS
Tlf: +47 23 40 01 00

Ελλάδα
Genesis Pharma SA
Τηλ: +30 210 8771500

Österreich
Biogen Austria GmbH
Tel: +43 1 484 46 13

España
Biogen Spain, S.L.
Tel: +34 91 310 7110

Polska
Biogen Poland Sp. z o.o.
Tel: +48 22 351 51 00

France
Biogen France SAS
Tél: +33 (0)1 41 37 95 95

Portugal
Biogen Portugal Sociedade Farmacêutica
Unipessoal, Lda.
Tel: +351 21 318 8450

Hrvatska
Biogen Pharma d.o.o.
Tel: +385 (0) 1 775 73 22

România
Johnson & Johnson Romania S.R.L.
Tel: +40 21 207 18 00

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
Tel: +386 1 511 02 90

Slovenská republika
Biogen Slovakia s.r.o.
Tel: +421 2 323 340 08

Ísland
Icepharma hf
Sími: +354 540 8000

Suomi/Finland
Biogen Finland Oy
Puh/Tel: +358 207 401 200

Italia
Biogen Italia s.r.l.
Tel: +39 02 5849901

Sverige
Biogen Sweden AB
Tel: +46 8 594 113 60

Κύπρος
Genesis Pharma Cyprus Ltd
Τηλ: +357 22765715

Latvija
Biogen Latvia SIA
Tel: +371 68 688 158

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu .