くすりのしおり

Internal
Revised: 8/2019

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 :
AFINITOR Tablets 2.5mg [unresectable and/or metastatic renal cell carcinoma]
 Active ingredient:
Everolimus
 Dosage form:
white to faintly yellowish white tablet, major axis: 10.1 mm, minor axis: 4.1 mm, thickness: 2.9 mm
 Print on wrapping:
アフィニトール 2.5mg, AFINITOR 2.5mg, NVR LCL

Effects of this medicine

This medicine suppresses proliferation of cancer cells by selectively inhibiting the actions of proteins required for growth, proliferation and vascularization of cancer cells.
It is usually used to treat unresectable and/or metastatic renal cell carcinoma.

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 respiratory disease.
    If you have or have a history of hepatitis or tuberculosis.
  • If you are pregnant, breastfeeding or possibly pregnant.
  • 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 (10 mg of the active ingredient) at a time, once a day, on an empty stomach. The dosage may be decreased according to your condition. Strictly follow the instructions.
  • The indication of taking this medicine on an empty stomach will be more than 1 hour before a meal or 2 hours after a meal.
  • If you miss a dose and remember within 6 hours after the usual time, take the missed dose as soon as possible. However, if more than 6 hours have passed since the usual time, skip the missed dose and follow your next 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 make you susceptible to infection. Try to maintain hygiene by frequently washing hands and gargling.
  • Avoid taking grapefruit juice, since it may intensify medicinal effects.
  • Avoid taking any health food containing St. John's wort, since it may diminish medicinal effects.
  • If you are capable of becoming pregnant, use effective contraception while taking this medicine and for at least 8 weeks after completion of treatment, since toxicity has been reported in animal studies.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include stomatitis, rash, anemia, fatigue, diarrhea, asthenia, mucosal inflammation, loss of appetite, nausea, infection, vomiting, peripheral edema, cough, pruritus, dry skin, interstitial lung disease, nose bleeding, taste abnormality and respiratory distress. 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, cough, shortness of breath [interstitial lung disease]
  • cold-like symptoms, malaise, vomiting [infection]
  • edema, loss of appetite, thirst [renal failure]
  • excessive fluid intake, excessive urination, weight loss [hyperglycemia, diabetes mellitus]
  • anemic symptoms, fever, bleeding tendency [blood disorder such as decreased platelets]
  • respiratory distress, hives, redness with generalized itching [anaphylaxis]
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.
  • To avoid light and moisture, do not take out the tablet from the PTP sheet until immediately before taking them.
  • Discard the remainder. Do not store them. Ask your pharmacy or medical institution on how to discard the remainder.
  • Consult with your doctor or pharmacist when you receive a vaccination.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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