くすりのしおり

Internal
Revised: 1/2018

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 :
Sprycel Tablets 20 mg
 Active ingredient:
Dasatinib hydrate
 Dosage form:
white to pale yellowish white round tablet, major axis: 5.6 mm, thickness 3.3 mm
 Print on wrapping:
スプリセル錠 20 mg, SPRYCEL 20 mg, BMS 527

Effects of this medicine

This medicine is an anti-malignant tumor medicine having an inhibitory effect of tyrosine kinases. It prevents leukemia cell proliferation by selectively inhibiting the action of the abnormal protein necessary for leukemia cell proliferation.
It is usually used to treat chronic myeloid leukemia, recurrent / refractory philadelphia chromosome-positive acute lymphoblastic leukemia.

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 previously experienced any adverse reactions with imatinib.
  • If you have had interstitial pneumonia.
  • If you have impaired hepatic function, abnormal electrocardiogram, heart disease.
  • If you use a thorombotic inhibitor.
  • 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))
  • Chronic myeloid leukemia: (chronic phase) In general, for adults, take 100 mg as dasatinib hydrate at a time once a day. The dosage may be adjusted according to the symptoms. The dose may be increased to 140 mg at a time once a day. (accelerated phase / blast phase) In general, for adults, take 70 mg as dasatinib hydrate at a time twice a day. The dosage may be adjusted according to the symptoms. The dose may be increased to 90 mg at a time twice a day.
    Recurrent/refractory philadelphia chromosome-positive acute lymphoblastic leukemia: In general, for adults, take 70 mg as dasatinib hydrate at a time twice a day. The dosage may be adjusted according to the symptoms. The dose may be increased to 90 mg at a time twice a day.
    Each tablet contains 20 mg of dasatinib hydrate. Same medicine containing 50 mg of dasatinib hydrate may be used in combination. Strictly follow the instructions.
  • If you missed a 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

  • Visit your doctor regularly to check the effects or adverse reactions of this medicine.
  • Avoid taking grapefruit juice since it may increase the drug levels in the blood and may intensify the effect of this medicine.
  • Avoid eating any food containing St. John's Wort since it may decrease the drug levels in the blood and diminish the effect of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include anemia, fever, rash, headache, diarrhea, malaise, edema, pleural effusion, cough, inflammation of nose and throat, constipation, nausea, body weight increased, muscle pain. 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.
  • fever, chill, cough, nasal discharge, dizziness, bleeding tendency, continuous bleeding, bruise, dullness, easy fatigability, shortness of breath, sore throat [marrow depression]
  • headache, consciousness disorder, abdominal pain [brain/subdural/gastrointestinal bleeding]
  • breathing difficulty, dry cough, body weight increased [body fluid retension including pleural effusion/pulmonary edema/pericardial effusion/ascites/generalized edema]
  • fever, malaise, chill [infection]
  • fever, cough, breathing difficulty [interstitial pneumonia]
  • decreased urination [oncolytic syndrome]
  • palpitation, faint [QT prolongation]
  • palpitation, shortness of breath, chest pain, breathing difficulty [heart failure, myocardial infarction]
  • inability to pass urine, urine with blood [acute renal failure]
  • breathing difficulty on exertion, easy fatigability, dullness, faint, swollen legs [pulmonary hypertension]
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 pharmacist how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.