くすりのしおり

Internal
Revised: 5/2014

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 :
Giotrif Tablets 20mg
 Active ingredient:
Afatinib maleate
 Dosage form:
white to slightly yellowish white tablet, diameter: ca. 8.1 mm, thickness: ca. 3.6 mm
 Print on wrapping:
(Face) GIOTRIF 20mg, 抗悪性腫瘍剤, チロシンキナーゼ阻害剤, T20, 湿気と光を避けて保存し,服用直前に取りだして下さい (Back) ジオトリフ 20mg, 抗悪性腫瘍剤, チロシンキナーゼ阻害剤, Boehringer Ingelheim, 湿気と光を避けて保存し,服用直前に取りだして下さい

Effects of this medicine

This medicine inhibits not only epidermal growth factor receptor (EGFR [ErbB1]) but HER2 (ErbB2) and HER4 (ErbB4), the members of ErbB receptor family, to suppress the growth of tumor cells.
It is usually used to treat inoperable or recurrent non-small cell lung cancer in patients with EGFR gene mutations.

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 or have a history of interstitial lung disease.
    If you have liver or renal disorder.
    If you have or have a history of cardiac failure symptoms.
    If you have decreased pumping action of the heart (left ventricular ejection fraction).
  • 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 40 mg of afatinib at a time, once a day, at a regular time everyday, but take the medicine at least 1 hour before or 3 hours after a meal. The dosage may be increased up to 50 mg at a time, once a day, although the dosage may be adjusted according to your general status.
    This preparation contains 20 mg of afatinib in a tablet. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. If there is less than 8 hours to the next dose, skip the missed dose and take the next dose at your regular time. 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 serious adverse reactions. Receive an adequate explanation enough to understand the precautions, etc.
  • Caution should be exercised because St. John's wort may diminish medical effects.
  • Prevent pregnancy if you have chance of becoming pregnant.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, rash, paronychia and stomatitis. 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, breathing difficulty [interstitial lung disease]
  • sweating, nausea, abdominal pain, severe diarrhea, watery stool, muddy stool [severe diarrhea]
  • rash, acne [severe skin disorder]
  • general malaise, nausea, loss of appetite, yellowing of the skin and/or the white of eyes, dark urine [liver failure, liver dysfunction]
  • palpitation/shortness of breath, chest pain, general swelling [cardiac disorder]
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 reach of children after opening. Store away from light, heat and moisture.
  • This medicine is unstable to moisture and light. Get out of a sheet just before taking.
  • Discard the remainder. Do not store them. If you dispose of unused medicines, seek advice of your pharmacist or medical facility about proper disposal of them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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