VUMERITY 231 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

DIROXIMEL FUMARATE

Dostopno od:

MEDISON PHARMA LTD

Farmacevtska oblika:

CAPSULES DELAYED RELEASE

Sestava:

DIROXIMEL FUMARATE 231 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

BIOGEN INC., USA

Terapevtske indikacije:

Vumerity is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis.

Datum dovoljenje:

2021-12-23

Navodilo za uporabo

1
Vumerity-Cap-231mg-PIL-ENG-D6-F
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Vumerity 231 mg
Delayed release capsules
Name and quantity of active ingredient:
Each delayed-release capsule contains:
diroximel fumarate 231 mg.
For a list of inactive ingredients and allergens in this medicine, see
section 6 ‘Additional
information’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1.
What is this medicine intended for?
Vumerity is intended to treat adult patients with relapsing-remitting
multiple sclerosis.
Therapeutic group: medicine that affects the nervous system.
2.
Before using this medicine
Do not use this medicine if:

you are sensitive (allergic) to diroximel fumarate or any of the other
ingredients in
this medicine

you have moderately or severely impaired kidney function or if you
have mildly,
moderately or severely impaired liver function

you have a human immunodeficiency virus (HIV) infection

you have severe active infections or active chronic infections such as
tuberculosis,
hepatitis B and C

you have severe stomach or digestive system disorders (conditions such
as an
ulcer in the intestines)

the number of white blood cells is below threshold (leukocytes < 3.0 X
10
9
/L and
lymphocytes < 0.5 X 10
9
/L)

you have PML (progressive multifocal leukoencephalopathy) or if you
are
suspected of having the disease. Progressive multifocal
leukoencephalopathy is an
infection of the brain.

Do not start Vumerity therapy if you are pregnant.

Do not use Vumerity in children and adolescents under 18 years of age.
Special warnings about using this medicine
Before

Lastnosti izdelka

PHYSICIAN PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Vumerity 231 mg
diroximel fumarate 231 mg
Delayed-release capsule
PHARMACEUTICAL FORM
Gastro-resistant hard capsules
White capsules with gastro-resistant microtablets containing 231 mg of
the active substance
diroximel fumarate and printed with “DRF 231 mg”.
THERAPEUTIC INDICATIONS
VUMERITY is indicated for the treatment of adult patients with
relapsing remittind forms of
multiple sclerosis.
DOSAGE/ADMINISTRATION
_General information _
Treatment with Vumerity must be started and monitored by a neurologist
experienced in treating
MS patients
.
Treatment with Vumerity can be started on the day after treatment with
dimethyl fumarate has
been stopped.
_Method of administration _
Vumerity is for oral use.
Vumerity should be swallowed whole and intact. Vumerity should not be
crushed, divided,
sprinkled, sucked, or chewed.
VUMERITY may be taken with or without food. Administration of VUMERITY
with food may
reduce the incidence of flushing. If taken with food, avoid a
high-calorie meal/snack; the
meal/snack should contain no more than 700 calories and no more than
30 g fat.
_Dosage _
_Adults _
The starting dose for Vumerity is 231 mg twice a day orally. After 7
days, the dose should be
increased to the maintenance dose of 462 mg (administered as two 231
mg capsules) twice a
day orally.
Temporary dose reductions to 231 mg twice a day may be considered for
patients who do not
tolerate the maintenance dose due to adverse effects. Within 4 weeks,
the recommended dose
(462 mg twice a day) should be resumed. Discontinuation of Vumerity
should be considered for
patients unable to tolerate resumption of the maintenance dose.
Administration of non-gastro-resistant acetylsalicylic acid 30 minutes
prior to Vumerity dosing
may reduce the occurrence and severity of flushing (See “Undesirable
effects”).
Avoid co-administration of Vumerity with alcohol (see
“Pharmacokinetics”).
_Special patient groups _
_Elderly _
The efficacy and safety of Vumerity have not be