くすりのしおり

Internal
Revised: 5/2020

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 :
ERLEADA Tablets 60mg
 Active ingredient:
Apalutamide
 Dosage form:
pale yellowish green to grayish green tablet, major axis: 16.8 mm, minor axis: 8.7 mm, thickness: 6.0 mm
 Print on wrapping:
(Face)アーリーダ, AR60, アーリーダ錠60mg
(Back)アーリーダ, AR60, アーリーダ錠60mg

Effects of this medicine

This medicine inhibits binding of androgen (male hormone) against androgen receptors in prostate cells and consequently shows anti-tumor effects.
It is usually used to treat castration-resistant prostate cancer without distant metastasis and prostate cancer with distant metastases.

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 convulsive diseases such as epilepsy, or hepatic dysfunction.
    If you have or have a history of brain damage, stroke, or interstitial lung disease.
  • 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 4 tablets (240 mg of the active ingredient) 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 you remember. However, if it is almost time for the next dose, skip the missed dose and follow 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

  • This medicine may cause convulsive seizure. Pay attention when operating dangerous machinery such as driving a car.
  • This medicine may cause cardiac disorders.
    Cardiac function tests such as electrocardiography and echocardiography may be conducted before and during use of this medicine.
  • This medicine may cause interstitial lung disease, initial symptoms occur, such as shortness of breath, breathing difficulty, dry cough, or fever, etc. are checked and chest X-ray and others are performed. If you experience these initial symptoms occur, consult with your doctor or pharmacist immediately.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include fatigue, rash, hypothyroidism (edema of the whole face or malaise may occur as the initial symptom), itching and decreased body weight. 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.
  • dizziness, tremor, muscle spasm  [convulsive seizure]
  • chest pain, cold sweat, palpitation, shortness of breath, edema [cardiac disorder]
  • bloodshot eyes, lips sores, sore throat, red eruption, fever, joint pain [severe skin disorder]
  • shortness of breath, breathing difficulty, dry cough, 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. Consult with your pharmacy or medical institution how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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