Patient leaflet - VUMERITY 231 MG GASTRO-RESISTANT HARD CAPSULES
1. What Vumerity is and w it is used for
hat
2. What you need to know before you take Vumerit
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3. How to take Vumerity
4. Possible side effects
5. How to store Vumerity
6. Contents of the pack an other information
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What Vumerity is what it is used for
What Vumerity is
Vumerity contains the a substance diroximel fum
and
ctive
arate.
2^^^^
What you ne before you ta
Do not take Vu
- if you are aller fumarate, relat (called fumara
d to know ke Vumerity
erity
gic to diroximel ed substances es or fumaric
What Vumerity is use
Vumerity is used to trea relapsing-remitting mul sclerosis (MS) in adult p MS is a long-term condi in which the immune sy (the body’s natural defe malfunctions and attack of the central nervous s (the brain, spinal cord a optic nerve of the eye) inflammation that dama
d for
t tiple atients. tion stem nces) s parts
ystem nd the
ausing ges the
acid esters) or ingredients of t (listed in sectio
- If you are susp from a rare bra called progres leukoencephal or if PML has b
Warnings and p
Vumerity may aff white blood cell
any of the other his medicine n 6).
ected to suffer in infection sive multifocal opathy (PML) een confirmed.
recautions
ect your
counts , your
nerves and the insulatio them. Relapsing-remitti characterised by repeat attacks (relapses) on th system. Symptoms vary patient to patient, but t include walking difficult feeling off balance and difficulties (e.g. blurred vision). These symptom disappear completely w the relapse is over, but s
n around ng MS is ed
e nervous from
ypically ies, visual
or double
s may hen
ome
kidneys and liver. start Vumerity, yo do a blood test to white blood cells that your kidneys working properly. will test these per treatment. If your cells decrease du your doctor may additional tests o treatment.
Before you ur doctor will count your and will check and liver are Your doctor iodically during white blood ring treatment, consider r stop your
problems may remain.
How Vumerity works
The medicine is though work by increasing the of a protein called ‘Nrf2 regulates certain genes produce ‘antioxidants’ i in protecting cells from This helps control the a the immune system and
to
action
’ which that nvolved damage. ctivity of reduce
If you believe you worse (e.g. weakn changes) or if you symptoms, talk to straight away bec may be the symp brain infection ca multifocal leukoe (PML). PML is a s that may lead to s disability or death
r MS is getting ess or visual notice any new your doctor ause these toms of a rare lled progressive ncephalopathy rious condition evere
. Read the
cord.
information abou lymphocyte coun of this leaflet.
Talk to your doct
- Vumerity if you h a serious infect pneumonia)
- severe kidney d severe liver dis a disease of the
bowel
t ‘PML and lower ts’ in section 4
or before taking ave: ion (such as isease ease
stomach or
Flushing (reddeni and body) is a co effect. Serious flu additional sympto sign of a severe a and has been see number of patien allergic reactions’ this leaflet. Talk to flushing is causin as your doctor m give you medicin
ng of the face mmon side shing with
ms can be a llergic reaction n in a small :s – see ‘Severe in section 4 of your doctor if you problems, ay be able to
to treat this.
Vumerity can cau allergic reaction k hypersensitivity r need to know abo important signs a look out for while Vumerity. Read th about ‘Severe alle in section 4 of thi
Shingles (herpes z with Vumerity tre
se a serious nown as a eaction. You ut all of the
nd symptoms to you are taking e information rgic reactions’
s leaflet.
oster ) may occur atment. In some
occurred. You sho your doctor imme suspect you have of shingles. These section 4 of this le
A rare but serious disorder (Fanconi been reported for containing related
uld inform diately if you any symptoms are listed in aflet.
kidney syndrome) has a medicine active
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 mi
medicines.
In particular:
ght take any other
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 ” types of
(diuretics ), certain
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 ) get an inf
may cause you to ection and should,
therefore, be avoided. Your doctor will advise whether
other typ (non-live given.
es of vaccines vaccines) should be
Pregnancy and breast-feeding
If you are p
regnant or
breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist taking this
Pregnancy
Do not use
for advice before medicine.
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 use reliable
pregnant, you should contraception.
Breast -f eeding -----------------
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.
substances (dimethyl fumarate, in combination with other fumaric
How to take Vumerity
Possible side effects
- loose stools (diarrhoea)
- feeling sick (nausea)
- stomach pain or stomach
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 c
an 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.
Serious effects
PML and lower lymphocyte counts
The frequency of PML cannot estimated from the available d (not known).
Vumerity may lower lymphocy 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).
be
ata
te
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 physicia should continue to monitor yo white blood cells throughout your treatment, and you shoul
n ur
remain observant of any potential
symptoms of PML as describe
below. The risk of PML may be
higher if you have previously taken a medicine that suppres your body’s immune system.
The symptoms of PML may be similar to an MS relapse. Symptoms may include new o
ses
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 possib
e.
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 a of these symptoms
Severe allergic reactions
ny
The frequency of severe allergic reactions cannot be estimated from
the available data (not known).
Flushing is a very common sid
effect. However, should flushing
be accompanied by a red rash hives and you get any of these symptoms:
or
- 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)
cramps
| Side effects which may | show up |
| in your blood or urine te | sts |
| ones, oduced in only show taking |
| Vumerity.
Talk to your doctor abo manage these side effec | od cells enia ) white n your ht an a serious umonia), mediately ut how to ts. Your |
| doctor may reduce your Do not reduce your dos your doctor tells you to. Common (may affect up 10 people)
| dose. e unless to 1 in ning of enteritis ) ) ning of ) lems |
| (gastrointestinal disor
Side effects which may | der) n the skin show up |
| in your blood or urine te | sts |
| urine |
| enzymes (ALT, AST ) i blood Uncommon (may affect 100 people)
(hypersensitivity )
Not known (frequency c be estimated from the a data) | er n the up to 1 in telets annot vailable |
| ication of ed in ST in ubin ) r ) with sters, in of the side of face, like fever arly |
| stages of infection, fo by numbness, itching patches with severe p
Reporting of side effec If you get any side effec to your doctor. This incl possible side effects not this leaflet. You can also side effects directly via Yellow Card Scheme. Website: www mhra gov | llowed or red ain ea ) ts ts, talk udes any listed in report the .uk/ |
| yellowcard or search for Yellow Card in the Goog Apple App Store. By reporting side effect help provide more infor the safety of this medici | MHRA le Play or s you can mation on ne. |
| 5^^^^ |
How to store
Keep this medicin sight and reach of
Do not use this m expiry date which bottle and the car
Vumerity
e out of the children.
edicine after the is stated on the ton after “EXP”. fers to the last
EM
Contents other inf
What Vume The active fumarate.
Each capsu
of the pack and ormation
rity contains
substance is diroximel
le contains 231 mg of
day of that month
Store below 25°C Store in the origin order to protect f
Do not throw awa via wastewater or waste. Ask your p to throw away me longer use. These help protect the e
al bottle in rom moisture.
y any medicines household harmacist how dicines you no measures will nvironment.
diroximel fu
The other i capsule con acid-ethyl a (1:1) type A; cellulose, m colloidal an citrate; talc; capsule she titanium dio chloride; ca
marate.
ngredients are tents: methacrylic crylate copolymer crospovidone type A;
icrocrystalline; silica, hydrous; triethyl magnesium stearate; ll: hypromellose;
xide (E171); potassium rrageenan; capsule
print: black shellac, pot
What Vume contents of
Vumerity 2 hard capsul printed with black ink.
Vumerity is containing 1 capsules.
iron oxide (E172), assium hydroxide.
rity looks like and the pack
1 mg gastro-resistant es are white and
‘DRF 231 mg’ in
available in packs
20 or 360 (3×120)
Not all pack marketed.
Marketing
Biogen Net Prins Maurit 1171 LP Bad The Netherl
Manufactur
Alkermes P Monksland
sizes may be
uthorisation Holder
herlands B.V. slaan 13 hoevedorp ands
er
harma Ireland Limited
Athlone Co. Westme
Ireland
N37 EA09
This leaflet
September
ath
was last revised in
2021