tially father a child should be counselled regarding the potential for serious risk to the foetus and the need for effective contraception (see section 4.6).
Women of childbearing potential must prevent pregnancy by use of effective contraception during cladribine treatment and for at least 6 months after the last dose (see section 4.5).
Male patients must take precautions to prevent pregnancy of their female partner during cladribine treatment and for at least 6 months after the last dose.
Blood transfusions
In patients who require blood transfusion, irradiation of cellular blood components is recommended prior to administration to prevent transfusion-related graft-versus-host disease. Consultation with a haematologist is advised.
Switching to and from cladribine treatment
In patients who have previously been treated with immunomodulatory or immunosuppressive medicinal products the mode of action and duration of effect of the other medicinal product should be considered prior to initiation of MAVENCLAD (see section 4.2). A potential additive effect on the immune system should also be considered when such medicinal products are used after treatment with MAVENCLAD (see section 4.5).
When switching from another MS medicinal product, a baseline MRI should be performed (see subsection 'Infections' above).
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) (see section 4.2).
Frutose intolerance
MAVENCLAD contains sorbitol. Patients with hereditary problems of fructose intolerance should not take this medicinal product.
4.5 Interaction with other medicinal products and other forms of interaction
MAVENCLAD contains hydroxypropylbetadex, which may be available for complex formation with other medicinal products, potentially leading to an increase in bioavailability of such a product (especially medicinal products with low solubility, see section 5.2). Therefore, 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.
Immunosuppressive medicinal products
Initiation of cladribine treatment is contraindicated in immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy with, e.g., methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids because of a risk of additive effects on the immune system (see section 4.3).
Acute short-term therapy with systemic corticosteroids can be administered during cladribine treatment.
Other disease-modifying medicinal products
The use of MAVENCLAD with interferon beta results in an increased risk of lymphopenia. Safety and efficacy of MAVENCLAD in combination with other disease-modifying treatments for MS have not been established. Concomitant treatment is not recommended.
Haemtotoxic medicinal products
Because of the cladribine-induced reduction in lymphocyte count, additive haematological adverse reactions may be expected if cladribine is administered prior to or concomitantly with other substances that affect the haematological profile (e.g. carbamazepine). Careful monitoring of hae |
