くすりのしおり

Internal
Revised: 5/2019

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 :
GILENYA Capsules 0.5mg
 Active ingredient:
Fingolimod hydrochloride
 Dosage form:
bright yellow/white capsule, major axis: 15.9 mm, minor axis: 5.8 mm
 Print on wrapping:
ジレニア0.5mg

Effects of this medicine

This medicine acts on lymphocytes to block release of lymphocytes including autoreactive T-cells which attack autologous nerve from secondary lymphoid tissues such as lymph nodes. It consequently reduces nerve inflammation.
It is usually used for prevention of relapse and delay of progression of physical disability in multiple sclerosis.

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: infections, second-degree or greater atrioventricular block, sick sinus syndrome, ischemic heart disease, congestive heart failure, low heart rate, macular edema, history of uveitis, hepatic dysfunction or its history, diabetes mellitus, no history of varicella or herpes zoster who have not been vaccinated.
  • 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, take 1 capsule (0.5 mg of fingolimod) at a time, once daily. Strictly follow the instructions.
  • Electrocardiogram is measured prior to taking the medicine and 6 hours after the initial dose. The measurement of heart rate/blood pressure and continuous monitoring of electrocardiogram may be performed for 24 hours after the initial dose. If symptoms related to bradyarrhythmia such as dizziness, fatigue or palpitation are occurred, consult with your doctor immediately.
  • If you miss a dose, take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
  • 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 restart this medicine after stop taking it, consult with your doctor.

Precautions while taking this medicine

  • The medicine may cause severe infections. If you noticed any infectious symptoms (fever, malaise, etc.), contact with your doctor immediately. Pay attention to occurrence of infection after discontinuation of the medicine because it shows long-term efficacy (maximum two months).
  • The medicine may cause dizziness and light-headedness in the beginning of the treatment. Be careful when you drive a car or operate dangerous machinery.
  • 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.
  • Avoid getting pregnant during the treatment and two months after discontinuation of the treatment.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nasopharyngitis, bradycardia and headache. 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 [infection]
  • dizziness, fatigue, palpitation [bradyarrhythmia (bradycardia, atrioventricular block, etc.)]
  • blurred vision, decreased visual acuity [macular edema]
  • generalized lymph node enlargement, fever, decreased weight [malignant lymphoma]
  • disturbed consciousness, convulsion, visual disturbance [posterior reversible encephalopathy 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 at 25℃ or lower and away from direct sunlight, heat, moisture and freezing.
  • Discard the remainder. Do not store them. Ask the pharmacy or medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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