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Mayzent

Mayzent® (siponimod)

Drug identification number (DIN): 02496429 (0.25mg), 02496437 (2mg)

Novartis Pharmaceutical Canada Inc.

Mayzent is an oral disease modifying treatment for secondary-progressive MS from the sphingosine 1-phosphate receptor (S1PR) modulators class of medications.

Indications and use

Mayzent is indicated for the treatment of patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, to delay the progression of physical disability.

It is not known if Mayzent is safe and effective in children under age 18 or adults over 65.

Before initiation of treatment with Mayzent the CYP2C9 genotype should be determined to establish CYP2C9 metaboliser status (the ability of the body to break down a drug). Mayzent should not be used in patients with a CYP2C9*3*3 genotype. For more information about the CYP2C9 genotype, please consult your prescribing neurologist.

Mayzent is contraindicated in people: with certain heart-related conditions; are allergic (hypersensitive) to fingolimod or to any of the other ingredients in the formulation or component of the container; have a weakened immune system due to disease or medications or treatments that suppress the immune system; have a severe active infection or an active chronic infection such as hepatitis or tuberculosis; have an active cancer (except for a type of skin cancer called basal cell carcinoma); have severe liver disease; pregnant or nursing.

​Administration and dose

Mayzent comes in the following dosage forms: film-coated tablets, 0.25 mg and 2 mg taken once a day, with or without food.

​Mechanism of action (MOA)

Siponimod works by entering the central nervous system (CNS) and binding to specific subtypes of the sphingosine 1-phosphate (S1P) receptor. The S1P receptor is found on the surface of specific immune cells called T cells and B cells that play a role in causing damage to the CNS in MS. By binding to the S1P receptor, siponimod prevents these harmful immune cells – specifically B cells and both CD4+ and CD8+ T cells – from being activated and released from the lymph nodes and thymus gland into the blood circulation and, hence, the brain and spinal cord.

​Side effects

Most common side effects - headache, high blood pressure with signs such as headache and dizziness (hypertension), abnormal liver function test results that give information about the health of the liver (liver function test increased).

Common - moles that appear recently, dizziness, tremor, diarrhea, nausea, extremity pain, swollen hands, ankles, legs or feet, weakness and decreased results lung function tests.

Serious side effects: Herpes zoster, lymphopenia, seizures, macular edema, irregular heartbeat, slow heartbeat, fungal infection.

This is not a comprehensive list of all possible side effects of Mayzent. Please see the Mayzent product monograph for a list of other potentially serious side effects. It is important that individuals discuss side effects of any medication they are considering with their physician. (*Health Canada, product monograph for Mayzent.)

Avoid becoming pregnant while taking MAYZENT and for at least 10 days after you stop taking it. Mayzent may be harmful to a developing fetus. Female patients who might become pregnant should use effective birth control methods during treatment and for at least 10 days after stopping Mayzent.

Breastfeeding: Mayzent can pass into breast milk and there is a risk of serious side effects for a breast-fed baby. Talk with your doctor before breast-feeding while you take Mayzent.

​Clinical trials

EXPAND in secondary progressive MS

EXPAND study was a phase III, multicenter, randomized, double-blind, parallel group, placebo-controlled clinical trial. The study enrolled 1645 people from 31 countries between the ages of 18 to 60 with SPMS and an Expanded Disability Status Scale (EDSS) score of 3.0–6.5. Participants were randomly assigned to once daily 2 mg of oral siponimod, or placebo for up to three years, or until specific evidence of disability progression was observed. Data from EXPAND showed that siponimod met its primary endpoint of reduced risk of three-month confirmed disability progression (CDP) by 21% versus placebo. Siponimod also resulted in reduced six-month CDP by 26%. On imaging measures, siponimod slowed the rate of brain volume loss by 23% and decreased T2 lesion volume by approximately 80% over 12 and 24 months. Siponimod was also shown to reduce the annualized relapse rate by 55%. No difference in the Timed 25-Foot Walk test and MS Walking Scale was observed.

​Drug support program

Go Program: 1-855-PILL-4MS (1-855-745-5467). Please discuss any other questions about treatment options with your doctor.

​References

  1. Kappos L, Bar-Or A, Cree BAC, Fox RJ, Giovannoni G, Gold R, Vermersch P, Arnold DL, Arnould S, Scherz T, Wolf C, Wallström E, Dahlke F; EXPAND Clinical Investigators. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018 Mar 31;391(10127):1263-1273. doi: 10.1016/S0140-6736(18)30475-6.

Mayzent® is a registered trademark of Novartis Pharmaceuticals Canada Inc.

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