MAVENCLAD 10 MG TABLETS

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

CLADRIBINE

Disponible desde:

MERCK SERONO LTD

Código ATC:

L01BB04

formulario farmacéutico:

TABLETS

Composición:

CLADRIBINE 10 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricado por:

MERCK EUROPE B.V., THE NETHERLANDS

Área terapéutica:

CLADRIBINE

indicaciones terapéuticas:

Mavenclad 10mg tablets is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features

Fecha de autorización:

2018-01-10

Información para el usuario

Prescribers Guide
2
CONTENT
Introduction to MAVENCLAD
®
3
Treatment regimens
4
Monitoring during treatment
7
•
Lymphocyte counts
•
Severe infections
•
Progressive Multifocal Leukoencephalopathy (PML)
•
Malignancies
Prevention of pregnancy
10
•
Information for Female Patients
•
Information for Male Patients
3
Introduction to MAVENCLAD
®
This guide provides information on the most important risks
associated with MAVENCLAD
®
and the activities required to
minimise these risks
The patient guide is part of the risk minimisation measures,
and use of the material in your discussion with the patient,
may support the early identification of signs and symptoms of
potential adverse reactions and their timely treatment
This guide should be read in conjunction with the information
provided in the approved Prescribing Information (PI) of
MAVENCLAD
®
Careful consideration should be given to the information in the
PI regarding blood count monitoring and screening for latent
infections before initiating treatment
YEAR 1
YEAR 3
YEAR 2
YEAR 4
No additional active
treatment with
MAVENCLAD
®
Month 2
Month 2
2 treatment
weeks
2 treatment
weeks
Month 1
Month 1
4
Treatment regimens
MAVENCLAD
®
therapy consists of two treatment courses administered at
the beginning of two consecutive years
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 The dose administered is dependent on the
individual patient’s body weight (see Figure)
5
Following completion of the 2 treatment courses in two consecutive
years,
no further cladribine treatment is required in years 3 and 4
MAVENCLAD
®
tablets are packed in a reclosable, child resistant carton
The package leaflet will include a step-by-step guide on how to handle
the
package and take MAVENCLAD
®
tablets
The number of MAVENCLAD
®
tablets is calculated according to the
body weight of the patient The table below provides the number of
MAVENCLAD
®
tablets to be taken each w

Ficha técnica

1
PRESCRIBING INFORMATION
MAVENCLAD 10 MG 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.
PATIENT GUIDE
The marketing of Mavenclad is subject to a risk management plan (RMP)
including a Patient guide. The
Patient guide, emphasizes important safety information that the
patient should be aware of before and
during treatment.
Please explain to the patient the need to review the card before
starting treatment.
PRESCRIBER GUIDE
This product is marketed with prescriber providing important safety
information. Please ensure you are
familiar with this material as it contains important safety
information.
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 with MAVENCLAD must be initiated and supervised by a
physician experienced in the
treatment of MS.
2
Posology
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 treatment 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. 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
bee