くすりのしおり

Internal
Published: 11/2020

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 :
JYSELECA Tablets 100mg
 Active ingredient:
Filgotinib maleate
 Dosage form:
pale brown tablet, major axis: approx. 12 mm, minor axis: approx. 7 mm, thickness: approx. 5.2 mm
 Print on wrapping:
(Face) ジセレカ錠 100mg, ジセレカ GSI 100
(Back)Jyseleca 100mg, ジセレカ 100mg

Effects of this medicine

This medicine affects the action of several substances associated with expression of inflammation or pain by inhibiting the activity of an enzyme called Janus Kinase (JAK), thereby showing improvement on symptoms of rheumatoid arthritis.
It is usually used to treat rheumatoid arthritis (including prevention of structural joint damage) for which the effect of existing therapies were insufficient.

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 (pneumonitis, sepsis, viral infection, etc.), active tuberculosis, renal dysfunction, liver dysfunction, decreased neutrophils, decreased lymphocyte, decreased hemoglobin, hepatitis B or a history of herpes zoster.
  • 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 2 tablets (200 mg of filgotinib) at a time, once a day. The dosage may be decreased to 1 tablet (100 mg) at a time, once a day, according to your condition. Strictly follow the instructions.
  • If you miss a dose, take the missed 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.

Precautions while taking this medicine

  • If you have a childbearing potential, use birth control to avoid pregnancy while using this medicine and for a certain period after the completion of the therapy with this medicine.
  • This medicine may cause impaired spermatogenesis and reduced fertility in men.
  • You should routinely undergo laboratory tests such as chest X-ray while using this medicine in order to monitor for tuberculosis infection.
  • This medicine may cause decreased neutrophils, decreased lymphocyte, decreased hemoglobin level or abnormal lipid level. You should routinely undergo blood test, including before treatment initiation.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, upper respiratory infection, bronchitis, epipharyngitis, urinary tract infection, headache, constipation, upper abdominal pain and diarrhea. 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, see your doctor immediately.
  • rash with painful small blisters appearing in a belt-like shape, fever, chills, malaise [infection]
  • severe abdominal pain, nausea, vomiting [perforation of digestive tract]
  • sudden high fever, sore throat, malaise, dizziness, headache [decreased neutrophils, decreased lymphocyte, decreased hemoglobin]
  • malaise, loss of appetite, nausea [liver dysfunction]
  • fever, cough, breathing difficulty [intestinal lung disease]
  • fever, skin turning blueish purple or dark purple, pain in lower limbs [venous thromboembolism]
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

  • Do not receive live vaccines (such as BCG, measles, rubella, measles-rubella (MR), chicken pox, and mumps vaccines) while using this medicine. If you wish to receive vaccination, consult with your doctor.
  • Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist and the 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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