くすりのしおり

Internal
Revised: 6/2018

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 :
XELJANZ Tablets 5mg
 Active ingredient:
Tofacitinib citrate
 Dosage form:
white tablet, diameter: 8.0 mm, thickness: 4.2 mm
 Print on wrapping:
ゼルヤンツ 5mg, XELJANZ 5mg, Pfizer, JKI 5

Effects of this medicine

By strongly blocking an enzyme called Janus Kinase (JAK), this medicine suppresses the action of the immune-related cytokines relating to lymphocyte response, and inhibits inflammation associated with rheumatoid arthritis or ulcerative colitis.
It is usually used to treat patients with rheumatoid arthritis who have not had shown enough efficacy with existing therapies. It is also used for inducing clinical remission and maintaining therapy in patients with moderate to severe ulcerative colitis (only who have not had shown enough efficacy with existing therapies).

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: serious infections (pneumonia, sepsis, viral infection), active tuberculosis, liver dysfunction, neutropenia, lymphopenia, low hemoglobin level, malignant tumor or its history, hepatitis B, or 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))
  • For rheumatoid arthritis: In general, for adults, take 1 tablet (5 mg of Tofacitinib) at a time, twice a day. Depending on the severity of liver or renal disorder, the dosage may be reduced to 5 mg once a day.
    For ulcerative colitis: In general, for adults, take 2 tablets (10 mg) at a time, twice a day for induction for 8 weeks. If the effect is insufficient, the treatment may be continued for extra 8 weeks. For maintenance therapy, for adults, take 1 tablet (5 mg) at a time, twice a day. The dosage may be increased up to 2 tablets (10 mg) at a time, twice a day if the effect is diminished during the maintenance therapy. If previous medicinal therapy turns out to be intractable, the dosage may be increased up to 2 tablets (10 mg) at a time, twice a day. Depending on the severity of liver or renal disorder, the dosage may be decreased.
    In any case, strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. Then, take a dose at the regular time. 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

  • Do not receive live vaccinations [for measles, rubella, mumps, chickenpox, BCG and polio] while taking this medicine. Please consult with your doctor when you need to receive a vaccination.
  • Avoid taking any food containing St. John's wort with this medicine, since it may diminish medicinal effects.
  • Avoid taking grapefruit with this medicine, since it may intensify the therapeutic effects of this medicine.
  • If you are planning to become pregnant, avoid the pregnancy while taking this medicine and at least 1 menstrual cycle after the completion of the therapy with this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include headache, upper respiratory tract infection, nasopharyngitis, herpes zoster (small painful blister appearing in a belt-like figure), diarrhea, fever, nausea, and bronchitis. 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.
  • cold-like symptoms, general malaise, fever [infection]
  • nausea, vomiting, severe abdominal pain [gastrointestinal perforation]
  • fever, sore throat, anemia [neutropenia, lymphopenia, low hemoglobin level]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver dysfunction, jaundice]
  • fever, dry cough, breathing difficulty [interstitial pneumonia]
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 away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. If you dispose of unused medicines, seek advice of your pharmacist or healthcare provider about proper disposal of them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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