rding to the treatment schedule.
A missed dose must not be taken together with the next scheduled dose on the following day. In the case of a missed dose, the patient must take the missed dose on the following day, and extend the number of days in that treatment week. If two consecutive doses are missed, the same rule applies, and the number of days in the treatment week is extended by two days.
Concomitant use of other oral medicinal products
It is recommended that administration of any other oral medicinal product be separated from that of MAVENCLAD by at least 3 hours during the limited number of days of cladribine administration (see section 4.5).
Special populations
Renal impairment
No dedicated studies have been conducted in patients with renal impairment.
In patients with mild renal impairment (creatinine clearance 60 to 89 mL/min), no dosage adjustment is considered necessary (see section 5.2).
Safety and efficacy in patients with moderate or severe renal impairment have not been established. Therefore, MAVENCLAD is contraindicated in these patients (see section 4.3).
Hepatic impairment
No studies have been conducted in patients with hepatic impairment.
Although the importance of hepatic function for the elimination of cladribine is considered negligible (see section 5.2), in the absence of data, use of MAVENCLAD is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh score >6).
Elderly
Clinical studies with oral cladribine in MS did not include patients over 65 years of age; therefore, it is not known whether they respond differently from younger patients.
Caution is recommended when MAVENCLAD is used in elderly patients, taking into account the potential greater frequency of decreased hepatic or renal function, concomitant diseases and other medicinal therapies.
Paediatric population
The safety and efficacy of MAVENCLAD in patients below the age of 18 years have not been established. No data are available.
Method of administration
MAVENCLAD is for oral use. The tablets must be taken with water, and swallowed without chewing. The tablets can be taken independent of food intake.
As the tablets are uncoated, they must be swallowed immediately once removed from the blister and not be left exposed on surfaces or handled for any period of time greater than that required for dosing. If a tablet is left on a surface, or if a broken or fragmented tablet is released from the blister, the area must be thoroughly washed.
The patient's hands must be dry when handling the tablets and washed thoroughly afterwards.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Infection with human immunodeficiency virus (HIV).
Active chronic infection (tuberculosis or hepatitis).
Initiation of cladribine treatment in immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy (see section 4.5).
Active malignancy.
Moderate or severe renal impairment (creatinine clearance <60 mL/min) (see section 5.2).
Pregnancy and breast-feeding (see section 4.6).
4.4 Special warnings and precautions for use
Haematological monitoring
Cladribine's mode of action is closely linked to a reduction in lymphocyte count. The effect on lymphocyte count is dose-dependent. Decreases in neutrophil count, red blood cell count, haematocrit, haemoglobin or platelet count compared to baseli |
