くすりのしおり

Internal
Revised: 7/2018

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 :
IMBRUVICA Capsules 140 mg
 Active ingredient:
Ibrutinib
 Dosage form:
white opaque capsule, length 21.7 mm, diameter 7.6 mm
 Print on wrapping:
(face) イムブルビカカプセル140mg, イムブルビカ, 140mg
(back) imbruvicacapsules 140mg, JP501118AN, イムブルビカ140mg, イムブルビカ

Effects of this medicine

This medicine suppresses cell growth of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) by inhibiting activity of Bruton's tyrosine kinase.
It is usually used to treat CLL including small lymphocytic lymphoma (SLL) and relapsed or refractory MCL.

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: liver or kidney dysfunction, infection, a history of hepatitis/ tuberculosis/ herpes zoster, decreased bone-marrow function (with anemia, fever, or bleeding tendency), arrhythmia or its history.
    If you recently had surgery including dental surgery like tooth extraction.
  • 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))
  • CLL including SLL:In general, for adults, take 3 capsules (420 mg of the active ingredient) at a time, once a day. The dosage may be adjusted according to the age or symptoms.
    Relapsed or refractory MCL:Ingeneral, for adults, take 4 capsules (560 mg of the active ingredient) at a time, once a day. The dosage may be adjusted according to the age or symptoms.
    In either case, strictly follow the instructions.
  • You should never take two doses at a time. If you miss a dose, take the missed dose as soon as possible if it is within the same day. Follow your regular dosing schedule from the next day.
  • 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

  • Tell your doctor or pharmacist if you are scheduled to have any surgery; that includes dental surgery such as tooth extraction as it can increase the risk of bleeding.
  • Infection or opportunistic infection can be developed. Contact your doctor or pharmacist if symptoms of those are appeared.
  • You may be instructed to have regular blood screening as it may cause conditions such as anemia.
  • You may be instructed to have regular heart function tests such as electrocardiogram as it may cause arrhythmia.
  • You may be instructed to have regular liver function tests as it may cause serious liver dysfunction.
  • Avoid taking food containing grapefruit juice with this medicine as it may increase the blood level of the medicine and intensify adverse reactions of the medicine.
  • Avoid taking any food containing St. John's wort as it may decrease the blood level of the medicine and diminish medicinal effects.
  • If you have possibility to be pregnant, use appropriate fertility control while taking this medicine and for a certain period after you discontinue this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include anemia, rash, diarrhea, mouth ulcer, nausea, joint pain, loss of appetite, fatigue, muscle spasm and pneumonia. 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.
  • headaches, consciousness disorder, hemiplegia [bleeding]
  • fever, malaise, flu like symptoms [infection]
  • fever, breezing difficulty/shortness of breath, hives [hypersensitivity]
  • abdominal distension, yellow discoloration of the skin or conjunctiva/dark urine, coma [liver failure, liver dysfunction]
  • fever, dry coughs, respiratory distress [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. Consult your pharmacist or medical institution about how to dispose them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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