くすりのしおり

Internal
Revised: 11/2019

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 :
ZYKADIA Capsules 150mg
 Active ingredient:
Ceritinib
 Dosage form:
blue/white capsule, major axis: 23.3 mm, minor axis: 8.6 mm
 Print on wrapping:
ジカディア150 mg, ZYKADIA 150 mg, NVR LDK150MG

Effects of this medicine

This medicine suppresses cancer cell growth by selective inhibition of ALK fusion proteins (tyrosine kinase), which is essential to cancer cell growth.
It is usually used to treat patients with unresectable/recurrent ALK fusion gene-positive non-small cell lung cancer.

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 3 capsules (450 mg as ceritinib) at a time, once a day after a meal. The dosage may be decreased according to the symptoms. Strictly follow the instructions.
  • If you miss 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

  • Avoid taking any food containing St. John's wort (a kind of herb) with the medicine, since St John's wort may diminish medicinal effects.
  • Women of reproductive potential should use effective contraception while taking this medicine, since fetal toxicity has been reported in animal studies.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, vomiting, diarrhea, loss of appetite, abdominal pain 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.
  • fever, dry cough, respiratory distress  [interstitial lung disease]
  • general malaise, loss of appetite, jaundice  [liver dysfunction]
  • palpitation, dizziness, consciousness disorder [QT interval prolongation, bradycardia]
  • muddy or watery stool  [severe diarrhea]
  • dry mouth, excessive fluid intake, excessive urination [hyperglycemia/diabetes mellitus]
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.