MAYZENT Film-coated tablet (2023)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Mayzent 0.25 mg film-coated tablets. Mayzent 1 mg film-coated tablets. Mayzent 2 mg film-coated tablets.

2. Qualitative and quantitative composition

Mayzent 0.25 mg film-coated tablets Each film-coated tablet contains siponimod fumaric acid equivalent to 0.25 mg siponimod. Excipient with known effect: Each tablet contains 59.1 mg lactose (as ...

3. Pharmaceutical form

Film-coated tablet. Mayzent 0.25 mg film-coated tablets: Pale red, round, biconvex, bevelled-edged film-coated tablet of approximately 6.1 mm diameter with company logo on one side and T on the ...

4.1. Therapeutic indications

Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity (see ...

4.2. Posology and method of administration

Treatment with siponimod should be initiated and supervised by a physician experienced in the management of multiple sclerosis. Before initiation of treatment, patients must be genotyped for CYP2C9 to ...

4.3. Contraindications

Hypersensitivity to the active substance, or to peanut, soya or any of the excipients listed in section 6.1. Immunodeficiency syndrome. History of progressive multifocal leukoencephalopathy or cryptococcal ...

4.4. Special warnings and precautions for use

Infections Risk of infections A core pharmacodynamic effect of siponimod is a dose-dependent reduction of the peripheral lymphocyte count to 20-30% of baseline values. This is due to the reversible sequestration ...

4.5. Interaction with other medicinal products and other forms of interaction

Antineoplastic, immune-modulating or immunosuppressive therapies Siponimod has not been studied in combination with antineoplastic, immune-modulating or immunosuppressive therapies. Caution should be exercised ...

4.6. Pregnancy and lactation

Women of childbearing potential/Contraception in females Siponimod is contraindicated in women of childbearing potential not using effective contraception (see section 4.3). Therefore, before initiation ...

4.7. Effects on ability to drive and use machines

Siponimod has no or negligible influence on the ability to drive and use machines. However, dizziness may occasionally occur when initiating therapy with siponimod. Therefore, patients should not drive ...

4.8. Undesirable effects

Summary of the safety profile The most common adverse drug reactions are headache (15%) and hypertension (12.6%). Tabulated list of adverse reactions Within each system organ class, the adverse drug reactions ...

4.9. Overdose

In healthy subjects, the single maximum tolerated dose was determined to be 25 mg based upon the occurrence of symptomatic bradycardia after single doses of 75 mg. A few subjects received unintended doses ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants ATC code: L04AA42 Mechanism of action Siponimod is a sphingosine-1-phosphate (S1P) receptor modulator. Siponimod binds selectively ...

5.2. Pharmacokinetic properties

Absorption The time (Tmax) to reach maximum plasma concentrations (Cmax) after multiple oral administration of siponimod is about 4 hours (range: 2 to 12 hours). Siponimod absorption ...

5.3. Preclinical safety data

In repeat-dose toxicity studies in mice, rats and monkeys, siponimod markedly affected the lymphoid system (lymphopenia, lymphoid atrophy and reduced antibody response), which is consistent with its primary ...

6.1. List of excipients

Mayzent 0.25 mg film-coated tablets Tablet core: Lactose monohydrate Microcrystalline cellulose Crospovidone Glycerol dibehenate Colloidal anhydrous silica Tablet coating: Polyvinyl alcohol ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Mayzent 0.25 mg film-coated tablets: Titration packs of 12 film-coated tablets in PA/alu/PVC/alu blister in wallet. Packs of 84 or 120 film-coated tablets in PA/alu/PVC/alu blisters. Mayzent ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

8. Marketing authorization number(s)

Mayzent 0.25 mg film-coated tablets: EU/1/19/1414/001 EU/1/19/1414/002 EU/1/19/1414/004 Mayzent 1 mg film-coated tablets: EU/1/19/1414/007 EU/1/19/1414/008 Mayzent 2 mg film-coated tablets: ...

9. Date of first authorization / renewal of the authorization

13 January 2020

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