Nescler®

For the patient

Medicinal product for monotherapy in adult patients with highly active relapsing-remitting multiple sclerosis

Indications for use:

Neskler® is indicated as monotherapy in adult patients with highly active relapsing-remitting multiple sclerosis (RRMS) in the following groups:

• Patients with high disease activity despite treatment with at least one disease-modifying therapy (DMT). These patients are considered "non-responders" to a full and adequately administered course of DMT (typically at least one year of treatment). They must have had at least one relapse in the previous year while on therapy, and either at least 9 T2 hyperintense lesions on brain MRI or at least one gadolinium-enhancing lesion. “Non-responders” may also be defined as patients with an unchanged or increasing relapse rate, or continuing severe relapses compared to the previous year
• Patients with rapidly evolving severe RRMS, defined as having two or more disabling relapses within one year, or having one or more gadolinium-enhancing lesions on brain MRI, or a significant increase in T2 lesion load compared to a previous MRI scan
• Fingolimod is prescribed to reduce the frequency of clinical exacerbations and to slow the progression of disability

Contraindications:

• Immunodeficiency syndrome
• Increased risk of opportunistic infections, including in immunocompromised patients currently or previously treated with immunosuppressive therapy
• Active phases of severe or chronic infections (e.g., hepatitis, tuberculosis)
• Known active malignancies, except for basal cell carcinoma of the skin
• Severe liver impairment (Child-Pugh Class C)
• Hypersensitivity to fingolimod or any component of the product
• The safety and efficacy of Neskler® in children and adolescents under 18 years of age have not been established