Patient leaflet - Vumerity 231 mg gastro-resistant hard capsules
What Vumerity is and what it is used for
What Vumerity is
Vumerity contains the active substance diroximel fumarate.
What Vumerity is used for
Vumerity is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients. MS is a long-term condition in which the immune system (the body’s natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and the optic nerve of the eye) causing inflammation that damages the nerves and the insulation around them. Relapsing-remitting MS is characterised by repeated attacks (relapses) on the nervous system. Symptoms vary from patient to patient, but typically include walking difficulties, feeling off balance and visual difficulties (e.g. blurred or double vision). These symptoms may disappear completely when the relapse is over, but some problems may remain.
How Vumerity works
The medicine is thought to work by increasing the action of a protein called ‘Nrf2’ which 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 fumaric acid esters) or any of the other ingredients of this medicine (listed in section 6).
- If you are suspected to suffer from a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.
Warnings and precautions
Vumerity may affect your white blood cell counts, your kidneys and liver. Before you start Vumerity, your doctor will do a blood test to count your white blood cells and will check that your kidneys and liver are working properly. Your doctor will test these periodically during treatment. If your white blood cells decrease during treatment, your doctor may consider additional tests or stop your treatment.
If you believe your MS is getting worse (e.g. weakness or visual changes) or if you notice any new symptoms, talk to your doctor straight away because these may be the symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe
disability or death. Read the information about ‘PML and lower lymphocyte counts’ in section 4 of this leaflet.
Talk to your doctor before taking Vumerity if you have:
a serious infection (such as
pneumonia)
- severe kidney disease
- severe liver disease
a disease of the stomach or
bowel
Flushing (reddening of the face and body) is a common side effect. Serious flushing with additional symptoms can be a sign of a severe allergic reaction and has been seen in a small number of patients – see ‘Severe allergic reactions’ in section 4 of this leaflet. Talk to your doctor if flushing is causing you problems, as your doctor may be able to give you medicine to treat this.
Vumerity can cause a serious allergic reaction known as a hypersensitivity reaction. You need to know about all of the important signs and symptoms to look out for while you are taking Vumerity. Read the information about ‘Severe allergic reactions’ in section 4 of this leaflet.
Shingles (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 shingles. 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 fumaric acid esters). If you notice you are passing more urine, are more thirsty and drinking more than normal, or if your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Children and adolescents
Do not give this medicine to children and adolescents because there is limited experience to know how safe and effective Vumerity is in this population.
Other medicines and Vumerity Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular:
medicines that contain fumaric
acid esters (fumarates)
medicines that affect the body’s immune system
including chemotherapy, immunosuppressants or other medicines used to treat MS
medicines that affect the kidneys including
some antibiotics (such as aminoglycosides used to treat infections), “water tablets” (diuretics), certain types of painkillers (such as ibuprofen and other similar anti-inflammatories and medicines purchased without a doctor’s prescription) and medicines that contain lithium
Taking Vumerity with certain
types of vaccines (live
vaccines) may cause you to get an infection and should, therefore, be avoided. Your doctor will advise whether other types of vaccines (non-live vaccines) should be given.
Pregnancy and breast-feeding
If you are pregnant or
breast-feeding, 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 use Vumerity if you are pregnant unless you have discussed this with your doctor. This is because Vumerity could harm your unborn baby. If you are able to get pregnant, you should use reliable contraception.
Breast-feeding
It is not known whether diroximel fumarate or its metabolites pass into breast milk. Your doctor will help you decide whether you should stop breast-feeding or stop using Vumerity. This involves balancing the benefit of
breast-feeding for your child, and the benefit of therapy for you.
Driving and using machines
Vumerity is not expected to affect your ability to drive and use machines.
3.
How to take Vumerity
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
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 for oral use.
Swallow each capsule whole, with some water. Do not crush or chew or sprinkle the capsule contents on food as this may increase some side effects.
You can take Vumerity with a meal or on an empty stomach. If you have 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, talk to your doctor straight away. You may
experience side effects similar to those described below in section 4.
If you forget to take Vumerity Do not take a double dose to make up for a forgotten dose.
If there are still at least 4 hours until your next planned dose, you can take the missed dose. Otherwise skip the missed dose and take your next planned dose at the normal 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 everybody gets them.
Serious effects
PML and lower lymphocyte counts
The frequency of PML cannot be estimated from the available data (not known).
Vumerity may lower lymphocyte counts (a type of white blood cell). Having a low white blood cell count can increase your risk of infection, including the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML may lead to severe disability or death. PML has occurred after 1 to 5 years of treatment with the related medicine dimethyl fumarate and so your physician should continue to monitor your white blood cells throughout your treatment, and you should remain observant of any potential symptoms of PML as described below. The risk of PML may be higher if you have previously taken a medicine that suppresses your body’s immune system.
The symptoms of PML may be similar to 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 speech and communication difficulties lasting for more than several days.
Therefore, if you believe your MS is getting worse or if you notice any new symptoms while you are on Vumerity treatment, it is very important that you speak to your doctor as soon as possible. Also speak with your partner or caregivers and tell them about your treatment. Symptoms might develop that you do not notice yourself.
Call your doctor straight away if you experience any of these symptoms
Severe allergic reactions
The frequency of severe allergic reactions cannot be estimated from the available data (not known).
Flushing is a very common side effect. However, should flushing be accompanied by a red rash or hives and you get any of these symptoms:
swelling of the face, lips, mouth
or tongue (angioedema)
wheezing, difficulty breathing
or shortness of breath
(dyspnoea, hypoxia)
dizziness or loss of
consciousness (hypotension)
then this may represent a severe allergic reaction (anaphylaxis)
Stop taking Vumerity and call a doctor straight away
Other side effects
Very common (may affect more than 1 in 10 people)
reddening of the face or body
feeling warm, hot, burning or itchy (flushing)
- loose stools (diarrhoea)
- feeling sick (nausea)
stomach pain or stomach
cramps
Side effects which may show up in your blood or urine tests
substances called ketones,
which are naturally produced in the body, very commonly show up in urine tests while taking Vumerity.
low levels of white blood cells
(lymphopenia, leukopenia) in the blood. Reduced white blood cells could mean your body is less able to fight an infection. If you have a serious infection (such as pneumonia), talk to your doctor immediately
Talk to your doctor about how to manage these side effects. Your doctor may reduce your dose. Do not reduce your dose unless your doctor tells you to.
Common (may affect up to 1 in 10 people)
inflammation of the lining of
the intestines (gastroenteritis)
- being sick (vomiting)
- indigestion (dyspepsia)
inflammation of the lining of
the stomach (gastritis)
digestive system problems
(gastrointestinal disorder)
- burning sensation
- hot flush, feeling hot
- itchy skin (pruritus)
- rash
pink or red blotches on the skin
(erythema)
Side effects which may show up in your blood or urine tests
proteins (albumin) in urine
(proteinuria)
increase in levels of liver
enzymes (ALT, AST) in the blood
Uncommon (may affect up to 1 in 100 people)
Allergic reactions
(hypersensitivity)
- reduction in blood platelets
Not known (frequency cannot be estimated from the available data)
liver injury due to medication
and increase in levels of liver enzymes measured in blood tests (ALT or AST in combination with bilirubin)
shingles (herpes zoster) with
symptoms such as blisters, burning, itching or pain of the skin, typically on one side of the upper body or the face, and other symptoms, like fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
- runny nose (rhinorrhoea)
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme.
Website: 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.
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 below 25°C.
Store in the original bottle in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Vumerity contains
The active substance is diroximel fumarate.
Each capsule contains 231 mg of diroximel fumarate.
The other ingredients are capsule contents: methacrylic acid-ethyl acrylate copolymer (1:1) type A; crospovidone type A; cellulose, microcrystalline; silica, colloidal anhydrous; triethyl citrate; talc; magnesium stearate; capsule shell: hypromellose; titanium dioxide (E171); potassium chloride; carrageenan; capsule print: black iron oxide (E172), shellac, potassium hydroxide.
What Vumerity looks like and contents of the pack
Vumerity 231 mg gastro-resistant hard capsules are white and printed with ‘DRF 231 mg’ in black ink.
Vumerity is available in packs containing 120 or 360 (3x120) capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Manufacturer
Alkermes Pharma Ireland Limited Monksland
Athlone
Co. Westmeath
Ireland
N37 EA09
This leaflet was last revised in September 2021
English
ART05428