Vumerity 231 mg capsulas duras gastrorresistentes

Prescribing Information for the Patient

Vumerity 231 mg Hard, Gastric-Resistant Capsules

Diroximel Fumarate

Read this entire prescribing information carefully before starting to take this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prescribing information. See section 4.

What is Vumerity

Vumerity contains the active ingredient 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) functions abnormally and attacks parts of the central nervous system (the brain, spinal cord, and optic nerve of the eye), causing inflammation that damages nerves and the insulation surrounding them. Relapsing-remitting MS is characterized by repeated episodes (flares) of neurological impairment. Symptoms vary from patient to patient, but often include: difficulty walking, balance problems, and visual problems (e.g., blurry or double vision). These symptoms may completely disappear when the flare ends, but some problems may persist.

How Vumerity works

It is believed that the medication acts by increasing the action of a protein called «Nrf2» that regulates certain genes that produce «antioxidants» involved in protecting cells from damage. This contributes to controlling immune system activity and reducing damage to the brain and spinal cord.

Do not take Vumerity

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

Warnings and precautions

Vumerity may affect thenumber of white blood cells, thekidneysand theliver. Before starting treatment with Vumerity, your doctor will perform a blood test to get a white blood cell count and check that your kidneys and liver are functioning correctly. Your doctor will perform periodic blood tests during treatment. If you experience a decrease in the number of white blood cells during treatment, your doctor may consider additional tests or stop your treatment.

If you think your MS is getting worse (e.g., weakness or visual changes) or notice the appearance of any new symptoms, speak directly with your doctor, as they may 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.

Consult your doctorbefore starting to take Vumerity if you have:

• aserious infection(e.g., pneumonia)
• severerenal disease
• severehepatic disease
• a disease of thestomachor theintestine

Flush (redness of the face and body) is a frequent side effect. Severe flush 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 the flush is causing you problems, as your doctor may be able to administer medication to treat it.

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

You must be aware of all the important signs and symptoms to which you should be alert 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, severe complications have occurred. You must 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 medication that contains related active ingredients (dimethylfumarate in combination with other esters of fumic acid). If you notice that you are urinating more, are more thirsty and drink more than normal, or if your muscles seem weaker, break a bone or simply have pain and discomfort, inform your doctor as soon as possible so that this can be investigated further.

Children and adolescents

Do not administer this medication to children or adolescents, as there is limited experience regarding the knowledge of how safe and effective Vumerity is in these populations.

Other medications and Vumerity

Inform your doctor or pharmacistif you are taking, have taken recently or may need to take any other medication, in particular:

• medications that containesters of fumic acid(fumarates)
• medications that affect the body's immune system,includingchemotherapeutic agents, immunosuppressants, or other medications used to treat MS
• medications that affect the kidneys, includingsomeantibiotics(such asaminoglycosidesused to treat infections),diuretics(tablets that increase urine elimination),certain types of analgesics(such as ibuprofen or other similar anti-inflammatory medications, and over-the-counter medications) and medications that containlithium
• The use of Vumerity and the administration of certain types of vaccines (attenuated vaccines) may cause an infection and, therefore, should be avoided. Your doctor will indicate if you should receive other types of vaccines (inactivated vaccines).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

The excretion of diroximel fumarate or its metabolites in breast milk is unknown. Your doctor will help you decide whether to stop breastfeeding or whether to stop taking Vumerity. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and operating machinery

Vumerity is not expected to affect your ability to drive and operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Starting Dose

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

Take this starting 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.

Capsules should be swallowed whole with some water. Do not crush, chew, or sprinkle the contents of the capsules on food as this may increase some adverse effects.

Vumerity can be taken with a meal or on an empty stomach. If you experience adverse 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,inform your doctor immediately. You may experience adverse effects similar to those described 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 medication and the amount ingested.

If You Forget to Take Vumerity

Do not take a double doseto make up for the missed dose.

If there are at least 4 hours left 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 about the use of this medication, ask your doctor or pharmacist.

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

Severe side effects

Low lymphocyte count and low white blood cell count

The frequency of LMP cannot be estimated from the available data (unknown frequency).

Vumerity may decrease your lymphocyte count (a type of white blood cell). A low white blood cell count can increase the risk of infection, including a 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 dimethylfumarate medication, so your doctor must continue to monitor your white blood cells throughout treatment and you must remain alert to any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medication that suppresses your immune system.

The symptoms of PML may be similar to those of multiple sclerosis (MS). Symptoms may include new weakness or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or changes in personality, or difficulty speaking and communicating that may persist for several days. Therefore, it is very important that you speak with your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while taking Vumerity. Additionally, speak with your partner or caregivers about your treatment. You may develop symptoms of which you may not be aware on your own.

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

Severe allergic reactions

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

Redness is a very frequent adverse effect..However, if the redness is accompanied by a skin rash of red color or hives and you experience any of the following symptoms:

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

it may then constitute a severe allergic reaction(anaphylaxis).

→ Stop taking Vumerity and call your doctor immediately

Other side effects

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

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

Side effects that may appear in blood or urine tests

• ketones in urine
• low white blood cell count (lymphopenia, leukopenia) 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), inform your doctor immediately.

Consult your doctorabout how to treat these side effects. Your doctor may reduce your dose. You must 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 disorders
• burning sensation
• sweating, feeling of intense heat
• skin itching(pruritus)
• exanthema
• rosy or reddish patches accompanied by itching on the skin(erythema)
• hair loss (alopecia)

Side effects that may appear in blood or urine tests

• protein in urine(proteinuria)
• increase in liver enzymes (ALT, AST) in blood

Frequent(may affect up to 1 in 100 people)

• Allergic reactions(hypersensitivity)
• reduction in platelet count

Rare(may affect up to 1 in 1000 people)

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

Unknown frequency(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 the infection, followed by numbness, itching, or red patches with intense pain.
• runny nose(rhinorrhea)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

Store below 25 °C.

Store in the original bottle to protect it from moisture.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Vumerity

The active ingredientis diroximel fumarate.

Each capsule contains 231 mg of diroximel fumarate.

The other componentsare: capsule content: copolymer of methacrylic acid and ethyl acrylate (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 imprint: iron oxide black (E172), shellac, potassium hydroxide.

Appearance of Vumerity and packaging contents

Vumerity 231 mg hard-gastrorresistant capsules are white and have "DRF 231 mg" printed in black ink.

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

Only some packaging sizes may be commercially available.

Marketing authorization holderandmanufacturer

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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:02/2025.

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.