Vumerity

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Diroximel fumarate (BIIB098)

Saatavilla:

Biogen Netherlands B.V.

ATC-koodi:

L04AX07

INN (Kansainvälinen yleisnimi):

diroximel fumarate

Terapeuttinen ryhmä:

Immunosuppressants

Terapeuttinen alue:

Multiple Sclerosis, Relapsing-Remitting

Käyttöaiheet:

Vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see Section 5.1 for important information on the populations for which efficacy has been established).

Tuoteyhteenveto:

Revision: 4

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2021-11-15

Pakkausseloste

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VUMERITY 231 MG GASTRO-RESISTANT HARD 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.
WHAT IS IN 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 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

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vumerity 231 mg gastro-resistant hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant hard capsule contains 231 mg diroximel fumarate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant hard capsule
White capsule, size 0 (approximately 18 mm in length), printed with
‘DRF 231 mg’ in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vumerity is indicated for the treatment of adult patients with
relapsing remitting multiple sclerosis
(see section 5.1 for important information on the populations for
which efficacy has been established).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under supervision of a physician
experienced in the treatment of
multiple sclerosis.
Posology
The starting dose is 231 mg twice a day. After 7 days, the dose should
be increased to the
recommended maintenance dose of 462 mg twice a day (see section 4.4).
Temporary dose reductions to 231 mg twice a day may reduce the
occurrence of flushing and
gastrointestinal adverse reactions. Within 1 month, the recommended
dose of 462 mg twice a day
should be resumed.
If a patient misses a dose, a double dose should not be taken. The
patient may take the missed dose
only if they leave 4 hours between doses. Otherwise, the patient
should wait until the next scheduled
dose.
_Special populations _
_Elderly _
_ _
Based on uncontrolled study data, the safety profile of diroximel
fumarate in patients ≥55 years of age
seems to be comparable to patients <55 years of age. Clinical studies
with diroximel fumarate had
limited exposure to patients aged 65 years and above and did not
include sufficient numbers of
patients aged 65 years and above to determine whether they respond
differently than younger patients
(see section 5.2). Based on the mechanism of action of the active
substance there are no theoretical
reasons for any requirement for dose adjustments in the elderly.
_ _