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 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.
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 been studied.
Criteria for initiating and continuing therapy
Lymphocyte counts must be
• normal before initiating MAVENCLAD in year 1,
• at least 800 cells/mm3 before initiating MAVENCLAD 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.
Distribution of dose
The distribution of the total dose over the 2 years of treatment is provided in Table 1. For some weight ranges the number of tablets may vary from one treatment week to the next. Use of oral cladribine in patients weighing less than 40 kg has not been investigated.
Table 1 Dose of MAVENCLAD per treatment week by patient weight in each treatment year
Weight range
Dose in mg (number of 10 mg tablets) per treatment week
kg
Treatment week 1
Treatment week 2
40 to <50
40 mg (4 tablets)
40 mg (4 tablets)
50 to <60
50 mg (5 tablets)
50 mg (5 tablets)
60 to <70
60 mg (6 tablets)
60 mg (6 tablets)
70 to <80
70 mg (7 tablets)
70 mg (7 tablets)
80 to <90
80 mg (8 tablets)
70 mg (7 tablets)
90 to <100
90 mg (9 tablets)
80 mg (8 tablets)
100 to <110
100 mg (10 tablets)
90 mg (9 tablets)
110 and above
100 mg (10 tablets)
100 mg (10 tablets)
Table 2 shows how the total number of tablets per treatment week is distributed over the individual days. It is recommended that the daily cladribine doses in each treatment week be taken at intervals of 24 hours at approximately the same time each day. If a daily dose consists of two tablets, both tablets are taken together as a single dose.
Table 2 MAVENCLAD 10 mg tablets per week day
Total number of tablets per week
Day 1
Day 2
Day 3
Day 4
Day 5
4
1
1
1
1
0
5
1
1
1
1
1
6
2
1
1
1
1
7
2
2
1
1
1
8
2
2
2
1
1
9
2
2
2
2
1
10
2
2
2
2
2
A missed dose must be taken as soon as remembered on the same day acco |
