くすりのしおり

Internal
Revised: 2/2020

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 :
ALECENSA Capsule 150mg
 Active ingredient:
Alectinib hydrochloride
 Dosage form:
white to yellowish white, major axis: approximately 19 mm
 Print on wrapping:
アレセンサ150mg

Effects of this medicine

This medicine suppress cancer cell growth by selective inhibition of ALK fusion protein essential for cancer cell growth.
It is usually used to treat ALK fusion gene-positive unresectable, advanced or recurrent non-small cell lung cancer, recurrent or refractory ALK fusion gene-positive anaplastic large cell 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 interstitial lung disease or have a history of it.
    If you have liver dysfunction.
  • 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))
  • ALK fusion gene-positive unresectable, advanced or recurrent non-small cell lung cancer: In general, for adults, take 2 capsules (300 mg of Alectinib) twice a day.
    Recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma: In general, for adults, take 2 capsules (300 mg of Alectinib) twice a day. But if you weigh less than 35kg, take 1 capsule (150 mg) twice a day. Strictly follow the instructions in any case.
  • 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. The disease may become worse by discontinuing the medicine, or adjusting the dose on your own judgment because you feel better.

Precautions while taking this medicine

  • This medicine may cause serious adverse reactions. You should be informed of precautions, etc. until you fully understand them.
  • Since this medicine may cause liver dysfunction or blood disorder (neutropenia, leukopenia etc), periodic blood test will be performed while taking this medicine.
  • Since this medicine may cause interstitial lung disease, chest CT examination will be performed. Pulmonary function test may be performed, if needed.
  • If you have a possibility of getting pregnant, avoid pregnancy while you are using 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 taste disorder, constipation and rash. 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.
  • cough, shortness of breath, breathing difficulty, fever [interstitial lung disease]
  • easy fatigability, general dullness, loss of strength, nausea, loss of appetite [liver dysfunction]
  • sudden high fever, chills, sore throat [neutropenia, leukopenia]
  • nausea, vomiting, chills, fever, severe stomachache, lightheadedness, shortness of breath, decreased consciousness [perforation of the digestive tract]
  • nausea, vomiting, lassitude, paralysis, severe headache, chest pain, constrictive chest pain, sudden shortness of breath, severe abdominal pain, abdominal bloating, severe leg pain [thromboembolism]
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 at room temperature (1 to 30°C), away from direct sunlight and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist and the 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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