くすりのしおり

Internal
Revised: 1/2021

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
Mayzent Tablet 2mg
 Active ingredient:
Siponimod fumaric acid
 Dosage form:
pale yellow tablet, diameter: 6.2 mm, thickness: 2.8 mm
 Print on wrapping:
メーゼント2mg

Effects of this medicine

This medicine acts on lymphocytes to suppress inflammation of nerves and protect nerves, thereby preventing relapse of multiple sclerosis and suppressing progression of physical disability.
It is usually used to prevent recurrence of secondary progressive multiple sclerosis and to suppress progression of physical disability.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have: infection, myocardial infarction or unstable angina or heart failure within 6 months, atrioventricular block second degree or higher, sick sinus syndrome or QT prolongation, or CYP2C9*3/*3 genotype.
    If you received vaccination.
  • If you are pregnant, possibly pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, for adults, start with 0.25 mg of siponimod, and take 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and 2 mg on Day 6, once daily in the morning. On Day 7 and thereafter, for the maintenance phase, take 2 mg at a time, once a day. The dosage may be decreased according to your condition. This preparation contains 2 mg of siponimod in a tablet. Strictly follow the instructions.
  • This medicine is to be used when you take 2 mg.
  • If you have CYP2C9*1/*3 or *2/*3, you may be instructed to take 1 mg once daily during the maintenance period from Day 5 onwards.
  • Your heart rate, blood pressure and electrocardiogram will be measured before the first dose and for 6 hours after the first dose. If any symptoms of bradyarrhythmia (fainting, dizziness, shortness of breath, etc.) occur, consult with your doctor immediately.
  • Before you start taking this medicine, blood tests to check their blood cell counts and liver function, genetic tests to check the genotype of the liver catabolic (metabolism) enzyme CYP2C9, and ophthalmologic tests are done if you have or have had diabetes, uveitis, or a retinal disorder.
  • Because initial infection with varicella or herpes zoster during the use of this medicine may be severe, whether you have had varicella or herpes zoster and whether you have received vaccination before the use of this medicine will be confirmed. Vaccination may be given as needed. If the vaccine is given, this medicine start only after the vaccine is fully effective.
  • Consult with your doctor if you miss a dose at least one day during the dose escalation phase. If you miss a dose after the maintenance phase, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time. If you miss a dose for more than 4 days in a row, consult with your doctor.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so. If you start taking this medicine again, consult with your doctor.

Precautions while taking this medicine

  • Infection may occur. If you develop any symptoms of infection (fever, malaise, etc.), contact your doctor immediately.
  • Blood count, ophthalmologic tests, liver function test, and blood pressure measurement will be done regularly while you are taking this medicine.
  • This medicine may cause dizziness or lightheadedness in the beginning of the treatment. Be careful when you drive a car or operate dangerous machinery.
  • Avoid getting pregnant during the treatment and 10 days after discontinuation of the treatment.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include headache, hypertension and bradycardia. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • malaise, fever, chills [infections]
  • blurred vision, decreased vision [macular edema]
  • syncope, dizziness, shortness of breath [bradyarrhythmia (bradycardia, atrioventricular block)]
  • dizziness, palpitations, syncope [QT interval prolonged]
  • headache, consciousness disorder, convulsion [reversible posterior leukoencephalopathy syndrome]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of the reach of children. Store in a refrigerator (2 to 8 degrees Celsius), away from direct sunlight and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacy or medical institution how to discard them.
  • Never receive live vaccines during the treatment because vaccination may cause to develop infection of the received vaccine. Consult with your doctor or pharmacist when you receive a vaccination.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.