Mavenclad

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

Cladribine

Tillgänglig från:

Merck Europe B.V.

ATC-kod:

L04AA40

INN (International namn):

cladribine

Terapeutisk grupp:

Immunosuppressants

Terapiområde:

Multiple Sclerosis

Terapeutiska indikationer:

Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.

Produktsammanfattning:

Revision: 9

Bemyndigande status:

Authorised

Tillstånd datum:

2017-08-22

Bipacksedel

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
MAVENCLAD 10 MG TABLETS
cladribine
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 MAVENCLAD is and what it is used for
2.
What you need to know before you take MAVENCLAD
3.
How to take MAVENCLAD
4.
Possible side effects
5.
How to store MAVENCLAD
6.
Contents of the pack and other information
1.
WHAT MAVENCLAD IS AND WHAT IT IS USED FOR
MAVENCLAD contains the active substance cladribine, a cytotoxic (cell
killing) substance that works
mostly on lymphocytes, cells of the immune system that are involved in
inflammation.
MAVENCLAD is a medicine used to treat
MULTIPLE SCLEROSIS
(MS) in
ADULTS
. MS is a disease in
which inflammation destroys the protective sheath around the nerves.
Treatment with MAVENCLAD has been shown to reduce flare-ups of
symptoms and to slow down
progression of disability.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAVENCLAD
DO NOT
TAKE MAVENCLAD
-
if you are
ALLERGIC
to
CLADRIBINE
or any of the
OTHER
INGREDIENTS
of this medicine (listed in
section 6).
-
if you are
HIV POSITIVE
, meaning you are infected with the human immunodeficiency virus
(HIV).
-
if you have active tuberculosis or liver inflammation (hepatitis).
-
if you have a
WEAKENED IMMUNE SYSTEM
due to medical conditions or because you are
TAKING
OTHER MEDICINES THAT WEAKEN YOUR IMMUNE SYSTEM OR
reduce the production of blood cells in
your
BONE MARROW
. These include:
-
ciclosporin, cyclophosphamide and azathioprine (used to suppress the
immune system,
for

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
MAVENCLAD 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of cladribine.
Excipients with known effect
Each tablet contains 64 mg sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, biconvex tablets of 8.5 mm diameter, engraved with 'C'
on one side and '10' on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MAVENCLAD is indicated for the treatment of adult patients with highly
active relapsing multiple
sclerosis (MS) as defined by clinical or imaging features (see section
5.1).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and supervised by a physician experienced
in the treatment of MS.
Posology
The recommended cumulative dose is 3.5 mg/kg body weight over 2 years,
administered as
1 treatment course of 1.75 mg/kg per year. Each treatment course
consists of 2 treatment weeks, one at
the beginning of the first month and one at the beginning of the
second month of the respective
treatment year. If medically necessary (e.g. for recovery of
lymphocytes), the treatment course in
year 2 can be delayed for up to 6 months. Each treatment week consists
of 4 or 5 days on which a
patient receives 10 mg or 20 mg (one or two tablets) as a single daily
dose, depending on body weight.
For details, see Tables 1 and 2 below.
_ _
Following completion of the 2 treatment courses, no further cladribine
treatment is required in years 3
and 4 (see section 5.1). Re-initiation of therapy after year 4 has not
been studied.
_ _
_Criteria for initiating and continuing therapy _
Lymphocyte counts must be
•
normal before initiating treatment in year 1,
•
at least 800 cells/mm³ before initiating treatment in year 2.
_ _
If necessary, the treatment course in year 2 can be delayed for up to
6 months to allow for recovery of
lymphocytes. If this recovery takes more than 6 months, the patient
should not receive cladribine
tablets