MAVENCLAD TABLET 10MG

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

Cladribine

Disponible depuis:

MERCK PTE. LTD.

Code ATC:

L04AA40

forme pharmaceutique:

TABLET

Composition:

Cladribine 10mg

Mode d'administration:

ORAL

Type d'ordonnance:

Prescription Only

Fabriqué par:

NerPharMa S.R.L.

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2019-05-24

Résumé des caractéristiques du produit

Page 1 of 20
1
PRODUCT NAME
MAVENCLAD® 10 mg tablets
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.
4.2
Dose and method of administration
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 (refer
to 5.1 Pharmacodynamic
properties, Clinical efficacy and safety). Re-initiation of therapy
after year 4 has not been studied.
CRITERIA FOR STARTING AND CONTINUING THERAPY
Lymphocyte monitoring
Lymphocyte counts must be
•
normal before initiating MAVENCLAD therapy,
•
at least 800 cells/mm³ before the second treatment course 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
MAVENCLAD anymore.
Page 2 of 20
DOSE
DISTRIBUTION OF DOSE
The distribution of the total dose over the 2 years of treatment is