MAVENCLAD cladribine 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cladribine, Quantity: 10 mg

Available from:

Merck Healthcare Pty Ltd

INN (International Name):

Cladribine

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: hydroxypropylbetadex; sorbitol; magnesium stearate

Administration route:

Oral

Units in package:

6 tablets, 10 tablets, 9 tablets, 1 tablet, 5 tablets, 4 tablets, 7 tablets, 8 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MAVENCLAD is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability.,Following completion of the 2 treatment courses, no further cladribine treatment is required in years 3 and 4. Re-initiation of therapy after year 4 has not been studied.

Product summary:

Visual Identification: White, round, biconvex tablets engraved "C" on one side, "10" on other; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2010-09-09

Patient Information leaflet

MAVENCLAD
®
_Cladribine tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MAVENCLAD.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
MAVENCLAD against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT MAVENCLAD IS
USED FOR
MAVENCLAD is used to treat a type
of multiple sclerosis (MS) known as
relapsing remitting MS. In this type
of MS, MAVENCLAD has been
shown to result in fewer relapses,
less disease activity in the brain and
less progression of disability.
The active substance in
MAVENCLAD is cladribine.
Cladribine acts on cells in your
immune system, known as
lymphocytes, to reduce inflammation
in the nervous system caused by MS.
MAVENCLAD has been studied for
safety and effectiveness when given
as 2 treatment courses over 2 years,
each treatment course consists of 2
treatment weeks.
Following completion of the 2
treatment courses, no further
cladribine treatment is required in
years 3 and 4.
Your doctor is the best person to
discuss the long term effects of
MAVENCLAD treatment beyond
above.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS OR CONCERNS ABOUT TAKING
MAVENCLAD.
This medicine is available only with
a doctor's prescription.
MAVENCLAD is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT START OR CONTINUE TAKING
MAVENCLAD IF:
•
You are allergic to cladribine or
any of the other ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath,
•
wheezing or difficulty
breathing,
•
swelling of the face, lips,
tongue or other parts of the
body,
•
rash, itching or hives on the
skin.
•
You are HIV positive and/or have
a weakened immune system, e.g.
du

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION
MAVENCLAD

(CLADRIBINE) TABLETS
1.
NAME OF THE MEDICINE
Cladribine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
of
MAVENCLAD
contains
10
mg
cladribine.
The
tablets
also
contain
hydroxypropylbetadex, sorbitol and magnesium stearate.
3.
PHARMACEUTICAL FORM
MAVENCLAD tablets are uncoated, white, round and biconvex, and
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-remitting
multiple sclerosis (RRMS)
to reduce the frequency of clinical relapses and to delay the
progression of physical disability.
Following completion of the 2 treatment courses, no further cladribine
treatment is required in
years 3 and 4. Re-initiation of therapy after year 4 has not been
studied.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
General Treatment Schedule
The recommended cumulative dose of MAVENCLAD 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 year. 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.
Patients should receive no more than 2 treatment courses over two
consecutive years. The
recommended dose should not be exceeded. Following completion of the 2
treatment courses,
no further cladribine treatment is required in year 3 and year 4.
Re-initiation of therapy after
year 4 has not been studied. (refer to section 5.1 PHARMACODYNAMIC
PROPERTIES,
Clinical trials)
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Criteria for Starting and Continuing Therapy
_Screening for infections _
HIV infection, active tuberculosis and active hepatitis must be
excluded before initiation of
MAVENCLAD (refer to section 4.3