Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients
should understand their medication and cooperate with the treatment.
Brand name:KADCYLA Intravenous Infusion 100mg
Active ingredient:Trastuzumab emtansine (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine suppresses growth of cancer cells both by selectively suppressing the actions of protein named HER2
necessary for growth of cancer cells and by selectively penetrating into cancer cells with HER2 and thus stopping
cancer cells divisions.
It is usually used to treat inoperable or recurrent breast cancer with HER2 positive.
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 difficulty breathing even at ease.
If you have previously been treated with anthracycline drugs.
If you are or were treated with radiation therapy.
If you have or have previously experienced heart disease.
If you have or have been diagnosed as hypertension.
If you have liver disorder.
If you have thrombocytopenia.
If you are treated with anticoagulant agent.
・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>>
・In general, administer by intravenous infusion once a day at an interval of once every three weeks.
・Treatment period depends on the results from checking on the patient's conditions.
Precautions while taking this medicine
・If you have a possibility of pregnancy, avoid pregnancy while you are taking this medicine.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include malaise, nasal bleeding, nausea, fever and decreased
appetite. 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・fatigue, loss of appetite, weight loss, dry cough, cough, phlegm, fever, shortness of breath, breathing difficulty, pale
lips, rapid breathing with difficulty, pale nails on limbs, respiratory distress [interstitial pneumonia]
・general dullness, nausea, general edema, easier breathing at sitting than at lying, shortness of breath, shortness of
breath on exertion, breathing difficulty, palpitation on exertion [cardiac disorder]
・general dullness, glow, chill, lightheadedness, sweating, fever, swellings around eyes and mouth/lips, shortness of
breath, breathing difficulty, itch, rash, hives, hoarse voice, impaired mind/judgment, faint consciousness,
decreased consciousness [hypersensitivity]
・chill, vomiting, cough, fever, dizziness, swellings of eyelids, lips and tongue, palpitation, breathing difficulty,
disturbance of consciousness, breathing difficulty, decreased blood pressure, breathing wheezingly, increased
pulse rate, glow, chill [infusion reaction]
・general dullness, itch, loss of appetite, nausea, vomiting, yellowing of white of the eyes and the skins, dark urine,
tremor of hands like flapping [liver dysfunction, liver failure]
・mucosal bleeding such as nose bleeding, gum bleeding, blue spot, subcutaneous bleeding, prolonged bleeding,
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hemiplegia, decreased consciousness, impaired mind, headache, difficulty talking, nausea, vomiting, paralysis and
numbness in limbs, partial paralysis, loss of consciousness into deep sleep, impaired judgment
[thrombocytopenia]
・numbness and pain in limbs, motor and sensory paralysis [peripheral neuropathy]
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
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
2/4
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients
should understand their medication and cooperate with the treatment.
Brand name:KADCYLA Intravenous Infusion 160mg
Active ingredient:Trastuzumab emtansine (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine suppresses growth of cancer cells both by selectively suppressing the actions of protein named HER2
necessary for growth of cancer cells and by selectively penetrating into cancer cells with HER2 and thus stopping
cancer cells divisions.
It is usually used to treat inoperable or recurrent breast cancer with HER2 positive.
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 difficulty breathing even at ease.
If you have previously been treated with anthracycline drugs.
If you are or were treated with radiation therapy.
If you have or have previously experienced heart disease.
If you have or have been diagnosed as hypertension.
If you have liver disorder.
If you have thrombocytopenia.
If you are treated with anticoagulant agent.
・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>>
・In general, administer by intravenous infusion once a day at an interval of once every three weeks.
・Treatment period depends on the results from checking on the patient's conditions.
Precautions while taking this medicine
・If you have a possibility of pregnancy, avoid pregnancy while you are taking this medicine.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include malaise, nasal bleeding, nausea, fever and decreased
appetite. 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・fatigue, loss of appetite, weight loss, dry cough, cough, phlegm, fever, shortness of breath, breathing difficulty, pale
lips, rapid breathing with difficulty, pale nails on limbs, respiratory distress [interstitial pneumonia]
・general dullness, nausea, general edema, easier breathing at sitting than at lying, shortness of breath, shortness of
breath on exertion, breathing difficulty, palpitation on exertion [cardiac disorder]
・general dullness, glow, chill, lightheadedness, sweating, fever, swellings around eyes and mouth/lips, shortness of
breath, breathing difficulty, itch, rash, hives, hoarse voice, impaired mind/judgment, faint consciousness,
decreased consciousness [hypersensitivity]
・chill, vomiting, cough, fever, dizziness, swellings of eyelids, lips and tongue, palpitation, breathing difficulty,
disturbance of consciousness, breathing difficulty, decreased blood pressure, breathing wheezingly, increased
pulse rate, glow, chill [infusion reaction]
・general dullness, itch, loss of appetite, nausea, vomiting, yellowing of white of the eyes and the skins, dark urine,
tremor of hands like flapping [liver dysfunction, liver failure]
・mucosal bleeding such as nose bleeding, gum bleeding, blue spot, subcutaneous bleeding, prolonged bleeding,
3/4
hemiplegia, decreased consciousness, impaired mind, headache, difficulty talking, nausea, vomiting, paralysis and
numbness in limbs, partial paralysis, loss of consciousness into deep sleep, impaired judgment
[thrombocytopenia]
・numbness and pain in limbs, motor and sensory paralysis [peripheral neuropathy]
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
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
4/4