くすりのしおり

Internal
Published: 10/2019

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 :
VANFLYTA TABLETS 26.5mg
 Active ingredient:
Quizartinib Hydrochloride
 Dosage form:
yellow tablet, diameter : 10.2 mm, thickness : approx. 4. 6 mm
 Print on wrapping:
ヴァンフリタ26.5mg、DSC512、VANFLYTA26.5mg、取出し後は速やかに服用

Effects of this medicine

This medicine suppresses proliferation of tumor cells by inhibiting the action of FMS-like tyrosine kinase 3 (FLT3).
It is usually used for the treatment of patients with relapsed or refractory acute myeloid leukemia with FLT3-ITD (Internal Tandem Duplication) mutation positive.

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 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 tablet (26.5 mg of quizartinib) at a time, once a day for 2 weeks, and thereafter the dose will be increased by 2 tablets (53 mg of quizartinib) at a time, once a day.
    The dosage may be decreased according to your conditions. 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 on the same 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

  • Avoid taking any food containing St. John's wort, since it may diminish medicinal effects.
  • If you or your partner have a possibility of pregnancy, avoid pregnancy while you are taking this medicine and for a certain period of time after you discontinue this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, vomiting, diarrhea, anemia and asthenia. 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.
  • chest pain, palpitation, chest discomfort, dizziness, syncope, breathing difficulty [QT-interval prolongation, ventricular arrhythmia]
  • chill, fever, fast pulse, cough, phlegm, shortness of breath [infection]
  • sudden headache, nausea, vomiting, consciousness disorder, motor paralysis [bleeding]
  • anemia, fever, bleeding tendency (nasal bleeding, gum bleeding, subcutaneous bleeding)  [myelosuppression]
  • acute feeling of pressure in the chest, anginal pain, cold sweat [myocardial infarction]
  • general malaise, decreased urine output, edema [acute renal disorder]
  • bloody phlegm, dry cough, shortness of breath, breathing difficulty, fever [interstitial lung 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 the pharmacist or 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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