VUMERITY 231 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Patient Information Leaflet

Vumerity 231 mg hard gastro-resistant capsules

diroximel fumarate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Vumerity and what is it used for

What is Vumerity

Vumerity contains the active substance diroximel fumarate.

What is Vumerity used for

Vumerity is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients. MS is a long-term disease in which the immune system (the body's natural defenses) malfunctions and attacks parts of the central nervous system (the brain, spinal cord, and optic nerve of the eye), causing inflammation that damages the nerves and the insulation that surrounds them. Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms. Symptoms vary from patient to patient but often include difficulty walking, balance problems, and vision problems (e.g., blurred or double vision). These symptoms can disappear completely when the relapse is over, but some problems may persist.

How Vumerity works

It is believed that the medicine works by increasing the action of a protein called "Nrf2" that regulates certain genes that produce "antioxidants" involved in protecting cells from damage. This helps 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, related substances (called fumarates or esters of fumaric acid)or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Vumerity may affect your white blood cell count, kidneys, and liver. Before starting treatment with Vumerity, your doctor will perform a blood test to obtain a white blood cell count and check that your kidneys and liver are working properly. Your doctor will perform periodic tests during treatment. If you experience a decrease in white blood cell count during treatment, your doctor may consider additional tests or stop your treatment.

If you think your MS is getting worse (e.g., weakness or vision changes) or you notice the appearance of any new symptoms, talk to your doctor immediately, as they could be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause death or severe disability. Read the information on "PML and low white blood cell count" in section 4 of this leaflet.

Talk to your doctorbefore taking Vumerity if you have:

• a severe infection(e.g., pneumonia)
• severe kidney disease
• severe liver disease
• a stomach or intestinal disease

Flushing (redness of the face and body) is a common side effect. Severe flushing with additional symptoms may be a sign of a severe allergic reaction and has been observed in a small number of patients; see "Severe allergic reactions" in section 4 of this leaflet. Inform your doctor if flushing is causing you problems, as your doctor may be able to give you medication to treat it.

Vumerity may cause a severe allergic reaction known as a hypersensitivity reaction.

You should be aware of all the important signs and symptoms to watch out for while taking Vumerity. Read the information on "Severe allergic reactions" in section 4 of this leaflet.

Herpes (herpes zoster) may occur with Vumerity treatment. In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect you have any symptoms of herpes zoster. These are listed in section 4 of this leaflet.

A rare but serious kidney disorder (Fanconi syndrome) has been reported for a medicine containing related active substances (dimethyl fumarate in combination with other esters of fumaric acid). If you notice that you are urinating more, are thirstier, and drink more than usual, or if your muscles seem weaker, you break a bone, or simply have aches and pains, inform your doctor as soon as possible so that this can be investigated further.

Children and adolescents

Do not give this medicine to children or adolescents, as there is limited experience regarding the safety and efficacy of Vumerity in these populations.

Other medicines and Vumerity

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines, in particular:

• medicines containing esters of fumaric acid(fumarates)
• medicines that affect the immune system of the body,including chemotherapy, immunosuppressants, or other medicines used to treat MS
• medicines that affect the kidneys, includingsome antibiotics(such as aminoglycosides used to treat infections), diuretics(pills that increase urine production), certain types of painkillers(such as ibuprofen or similar anti-inflammatory medicines, and over-the-counter medicines), and medicines containing lithium
• The use of Vumerity and the administration of certain types of vaccines (live vaccines) could cause you to become infected, and therefore should be avoided. Your doctor will tell you if you should receive other types of vaccines (inactivated vaccines).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Vumerity during pregnancy unless you have discussed it with your doctor. This is because Vumerity may harm your unborn baby. If you can become pregnant, you must use a reliable method of contraception.

Breastfeeding

It is not known whether diroximel fumarate or its metabolites are excreted in breast milk. Your doctor will help you decide whether to stop breastfeeding or stop taking Vumerity. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and using machines

Vumerity is not expected to affect your ability to drive or use machines.

3. How to take Vumerity

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor again.

Initial dose

The recommended initial dose is 231 mg (one capsule) twice a day.

Take this initial dose for the first 7 days, then take the maintenance dose.

Maintenance dose

The recommended maintenance dose is 462 mg (two capsules) twice a day. Vumerity is taken orally.

The capsules should be swallowed whole, with some water. Do not crush, chew, or sprinkle the contents of the capsules on food because some side effects may increase.

You can take Vumerity with a meal or on an empty stomach. If you experience side effects such as flushing 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, tell your doctor immediately. You may experience side effects similar to those described below in section 4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Vumerity

Do not take a double doseto make up for a forgotten dose.

If there are at least 4 hours until the next scheduled dose, you can take the missed dose. Otherwise, skip the missed dose and take the next dose at the usual time.

If you have any other 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 everybody gets them.

Serious side effects

PML and low white blood cell count

The frequency of PML cannot be estimated from the available data (frequency not known).

Vumerity may decrease your lymphocyte count (a type of white blood cell in the blood). A low white blood cell count can increase the risk of infection, including the rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause death or severe disability. PML has occurred after 1 to 5 years of treatment with the related medicine dimethyl fumarate, so your doctor must continue to monitor your white blood cell count during treatment, and you must remain alert to any possible symptoms of PML, as described below. The risk of PML may be greater if you have previously taken a medicine that suppresses your immune system.

The symptoms of PML can be similar to those of an MS relapse. Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes, or difficulty speaking and communicating that may persist for several days. Therefore, it is very important that you talk to your doctor as soon as possible if you think your MS is getting worse or if you notice any new symptoms while being treated with Vumerity. Also, talk to your partner or caregivers about your treatment. You may develop symptoms that you are not aware of yourself.

→ Call your doctor immediately if you have any of these symptoms

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (frequency not known).

Flushing is a very common side effect. However, if the redness is accompanied by a rash and you have any of these symptoms:

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

this could be a severe allergic reaction (anaphylaxis).

→ Stop taking Vumerity and call your doctor immediately

Other side effects

Very common(may affect more than 1 in 10 people)

• redness of the face or body, feeling of heat, heat, burning sensation, or itching (flushing)
• soft stools (diarrhea)
• nausea or vomiting
• stomach pain or cramps

Side effects that may appear in blood or urine tests

• it is very common for urine tests to show ketones, substances produced naturally in the body, while being treated with Vumerity.
• low white blood cell count (lymphopenia, leucopenia) in blood. A decrease in white blood cells can make the body less able to fight infections. If you have a severe infection (such as pneumonia), tell your doctor immediately.

Talk to your doctorabout how to treat these side effects. Your doctor may be able to reduce your dose. Do not reduce the dose unless your doctor tells you to.

Frequent(may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal problems (gastrointestinal disorders)
• burning sensation
• hot flashes, feeling of heat
• itching (pruritus)
• rash
• red or pink patches with itching on the skin (erythema)
• hair loss (alopecia)

Side effects that may appear in blood or urine tests

• proteins (albumin)in urine (proteinuria)
• increased liver enzymes (ALT, AST) in blood

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decrease in blood platelet count

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

• liver damage due to the medicine and increased liver enzyme levels measured in blood tests (ALT or AST simultaneously with bilirubin)

Frequency not known(cannot be estimated from the available data)

• herpes zoster (shingles) with symptoms such as blisters, burning, itching, or pain on the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness in the early stages of infection, followed by numbness, itching, or red spots with severe pain.
• runny nose (rhinorrhea)

Reporting of side effects

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

5. Storage of 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 carton and blister after EXP. The expiry date refers to the last day of the month stated.

Store below 25°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Vumerity Composition

The active ingredientis diroximel fumarate.

Each capsule contains 231 mg of diroximel fumarate.

The other ingredientsare: capsule content: methacrylic acid - ethyl acrylate copolymer (1:1) type A; crospovidone type A; microcrystalline cellulose; anhydrous colloidal silica; triethyl citrate; talc; magnesium stearate; capsule shell: hypromellose; titanium dioxide (E171); potassium chloride; carrageenan; capsule imprint: iron oxide black (E172), shellac, potassium hydroxide.

Appearance of Vumerity and Package Contents

Vumerity 231 mg hard gastro-resistant capsules are white and have «DRF 231 mg» printed in black ink.

Vumerity is available in packs containing 120 or 360 capsules (3 x 120).

Only some pack sizes may be marketed.

Marketing Authorization 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 about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:02/2025.

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.