くすりのしおり

Internal
Published: 4/2021

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 :
CALQUENCE Capsules 100mg
 Active ingredient:
Acalabrutinib
 Dosage form:
a blue and a yellow capsule, long diameter: approx. 19.4 mm, short diameter: approx. 6.9 mm
 Print on wrapping:
(face) カルケンスカプセル100mg, カルケンス, ACA100mg,(back)CALQUENCE CAPSULE100mg, カルケンスカプセル100mg

Effects of this medicine

This medicine binds to Bruton's tyrosine kinase (BTK), inhibiting BTK kinase activity, which leads to inhibition of proliferation of B cell malignancies.
It is usually used to treat relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma).

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 plan surgery or just have undergone surgery.
  • If you are easy to bleed or catch a cold, having infections.
  • If you have a medical history of hepatitis B.
  • If you have: interstitial lung disease, heart disease, arrhythmia.
  • If you are 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 (100 mg as the active ingredient) at a time, twice a day. However, the dosage may be decreased according to your symptoms. Strictly follow the instructions.
  • If you miss a dose, take the missed dose if you have 6 hours or more before taking the next dose. However, if it is less than 6 hours for the next dose, skip the missed dose and follow your regular dosing schedule. You should not 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

  • This medicine may cause serious adverse reactions. You should receive an explanation until you fully understand the precautions and other important points.
  • If you may possibly be pregnant, you should use appropriate contraceptive measures during treatment and for a certain period of time following the end of this medicine treatment.
  • Avoid taking orange juice same time, since it may diminish medicinal effects.
  • Avoid taking any food containing St. John's wort, since it may diminish medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include headache, diarrhoea, bruising, and fatigue. 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.
  • bleeding, vomiting, consciousness disorder, hemiplegia, sudden headache, partly hard to see in the view [bleeding]
  • fever, general malaise, cough, phlegm, shortness of breath [infections]
  • shortness of breath, breathing difficulty, cough, fever [interstitial lung disease]
  • fever, sore throat, bleeding tendency, dizziness, tire easily, shortness of breath  [bone marrow depression]
  • dizziness, palpitation, pulse jumps, chest pain, clammy sweat [arrhythmia, ischemic heart disease]
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. Ask your pharmacy or medical institution on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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