Mavenclad 10mg Tablets

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Cladribine

Available from:

MERCK SDN. BHD.

INN (International Name):

Cladribine

Units in package:

1 Tablets

Manufactured by:

NerPharma S.R.L.

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP)_
1
MAVENCLAD
® 10MG TABLETS
Cladribine 10 mg
WHAT IS IN THIS LEAFLET
1.
What Mavenclad
®
is used for
2.
How Mavenclad
®
works
3.
Before you use Mavenclad
®
4.
How to take Mavenclad
®
5.
While you are using Mavenclad
®
6.
Side effects
7.
Storage and disposable of
Mavenclad
®
8.
Product description
9.
Manufacturer and Product
registration holder
10.
Date of revision
WHAT MAVENCLAD
® IS USED FOR
MAVENCLAD is a prescription
medicine used to treat relapsing forms
of multiple sclerosis (MS), to include
relapsing-remitting disease and active
secondary progressive disease, in
adults. Because of its safety profile,
MAVENCLAD is generally used in
people who have tried another MS
medicine that they could not tolerate
or that has not worked well enough.
MAVENCLAD is not recommended
for use in people with clinically
isolated syndrome (CIS).
It is not known if MAVENCLAD is
safe and effective in children under 18
years of age.
HOW MAVENCLAD
® WORKS
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.
Treatment with MAVENCLAD
®
has
been shown to reduce flare-ups of
symptoms and to slow down
progression of disability.
BEFORE YOU USE MAVENCLAD®
_When you must not take it _
Do not take MAVENCLAD
®
:
•
if you are allergic to cladribine or
any of the other ingredients of this
medicine (listed in excipients)
•
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 example after organ
transplantation);
•
methotrexate (used to

Summary of Product characteristics

1
MAVENCLAD
®
10mg tablets
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 relapsing forms of multiple
sclerosis (MS), to include
relapsing-remitting disease and active secondary progressive disease,
in adults. Because of its safety
profile, use of MAVENCLAD
®
is generally recommended for patients who have had an inadequate
response to, or are unable to tolerate, an alternate drug indicated
for the treatment of MS.
Limitations of Use
MAVENCLAD
®
is not recommended for use in patients with clinically isolated
syndrome (CIS)
because of its safety profile
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 (eg, 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
2
MAVENCLAD
®
10mg tablets
L