Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 12/2014
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:AVASTIN I.V. Infusion 100mg/4mL
Active ingredient:Bevacizumab(genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine suppresses tumor growth by inhibiting the function of VEGF, a glycoprotein necessary for cancer
growth.
It is usually used to treat colon cancer, rectal cancer, non-small cell lung cancer other than squamous cell cancer,
ovarian cancer, breast cancer, and malignant glioma.
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 previously experienced hemoptysis.
If you have gastrointestinal inflammation.
If the wound is not healed since you had a large operation.
If you are diagnosed with tumor metastasis to brain.
If you have predisposition of prolonged bleeding.
If you ever experienced thromboembolism (myocardial infarction, cerebral infarction, deep-vein thrombosis,
pulmonary embolism).
If you have: hypertension, heart problem.
・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, administer by intravenous infusion at an interval of more than two weeks or three weeks. It will take 90
minutes for the first time to be administered with intravenous infusion. For the second time and thereafter, there
may be the case when the time for the intravenous infusion is shorten, depending on the situation.
・The treatment interval and period with this medicine depend on your response to the treatment.
Precautions while taking this medicine
・Delay in wound healing may occur. If you will have an operation or a dental extraction, inform your doctor that you
are using this medicine.
・Since hypertension or proteinuria may occur, blood pressure and urine protein should be measured regularly.
・If you have a possibility of pregnancy, avoid pregnancy while you are taking this medicine. Also avoid pregnancy for
at least six months after you discontinue this medicine. If you wish to be pregnant, consult with your doctor.
・Avoid breastfeeding while you are taking this medicine. Also avoid breastfeeding for at least six months after you
discontinue this medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hemorrhage, hypertension, neurotoxicity, fatigue/malaise,
appetite decreased, nausea, stomatitis, and alopecia. 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.
・cold sweat, dizziness, lightheadedness, glow, general dullness, faint consciousness, impaired judgment/mind, pale
face, palpitation, shortness of breath, breathing difficulty, hoarseness, swelling around the eye and lips, hives
[shock, anaphylaxis]
・severe abdominal pain, nausea, vomiting, fever, breathing difficulty, shortness of breath, cough, vomiting of blood,
1/4
bubble in urine, cloudy urine, leakage of intestinal juice and stool from the holes around the anus and the skin,
leakage of stool and urine from the vagina, vaginal bleeding, yellowing of skin and/or white of eyes, brown urine
[gastrointestinal perforation, fistula (gastrointestinal fistula, bronchopleural fistula, genitourinary fistula, biliary
fistula)]
・delay in healing the wound [delayed wound healing]
・vomiting of blood, nausea, vomiting, abdominal pain, bloody stool, black stool [gastrointestinal hemorrhage]
・bloody sputum, vomiting of blood [pulmonary hemorrhage]
・nausea, vomiting, hemiplegia, decreased consciousness, impaired judgment/mind, headache, difficulty talking,
paralysis and numbness in limbs, partial paralysis, loss of consciousness into deep sleep [cerebral hemorrhage]
・vomiting of blood, mucosal bleeding such as bleeding from the nose, gum, vagina [mucosal hemorrhage (nasal
hemorrhage, gingival bleeding, vaginal bleeding)]
・dull headache, headache, dizziness on standing up, cold sweat, hemiplegia, dizziness, decreased consciousness,
difficulty talking, decreased visual acuity, numbness, chest tightness, chest pain, breathing difficulty, cough,
sweating, skin, lips and nails turning bluish purple [arterial thromboembolism, including cerebrovascular accident,
transient ischemic attack, myocardial infarction, angina pectoris, cerebral ischemia, cerebral infarction]
・severe pain in the legs, swelling of lower limbs, sweating, fever, decreased consciousness, cough, chest pain,
breathing difficulty [venous thromboembolism, including deep-vein thrombosis and pulmonary embolism]
・dizziness, headache, sudden severe headache, nausea, numbness in the limbs [hypertensive encephalopathy,
hypertensive crisis]
・convulsion, consciousness disorder, vision impairment [reversible posterior leukoencephalopathy syndrome]
・marked general edema, decreased urinary volume [nephrose syndrome]
・general dullness, fever, prolonged bleeding, bleeding tendency, gum bleeding, nose bleeding, blue spot, shortness of
breath [myelosuppression (pancytopenia, neutropenia, leukopenia, anemia, thrombocytopenia)]
・chills, fever, cough, sputum, shortness of breath, joint/muscle pain, purple-red swelling of the skin, painful blisters,
darkness of the skin or sores/collapse of the skin/muscles with the progression of symptom [infection (pneumonia,
sepsis, necrotizing fasciitis)]
・general dullness, general edema, nausea, breathing difficulty, shortness of breath on exertion [congestive heart
failure]
・fever, dry cough, breathing difficulty, shortness of breath [interstitial pneumonia]
・bleeding tendency, gum bleeding, nose bleeding, internal bleeding, bloody urin [thrombotic microangiopathy
(thrombotic thrombocytopenic purpura, hemolytic uremic syndrome)]
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: 12/2014
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:AVASTIN I.V. Infusion 400mg/16mL
Active ingredient:Bevacizumab(genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine suppresses tumor growth by inhibiting the function of VEGF, a glycoprotein necessary for cancer
growth.
It is usually used to treat colon cancer, rectal cancer, non-small cell lung cancer other than squamous cell cancer,
ovarian cancer, breast cancer, and malignant glioma.
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 previously experienced hemoptysis.
If you have gastrointestinal inflammation.
If the wound is not healed since you had a large operation.
If you are diagnosed with tumor metastasis to brain.
If you have predisposition of prolonged bleeding.
If you ever experienced thromboembolism (myocardial infarction, cerebral infarction, deep-vein thrombosis,
pulmonary embolism).
If you have: hypertension, heart problem.
・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, administer by intravenous infusion at an interval of more than two weeks or three weeks. It will take 90
minutes for the first time to be administered with intravenous infusion. For the second time and thereafter, there
may be the case when the time for the intravenous infusion is shorten, depending on the situation.
・The treatment interval and period with this medicine depend on your response to the treatment.
Precautions while taking this medicine
・Delay in wound healing may occur. If you will have an operation or a dental extraction, inform your doctor that you
are using this medicine.
・Since hypertension or proteinuria may occur, blood pressure and urine protein should be measured regularly.
・If you have a possibility of pregnancy, avoid pregnancy while you are taking this medicine. Also avoid pregnancy for
at least six months after you discontinue this medicine. If you wish to be pregnant, consult with your doctor.
・Avoid breastfeeding while you are taking this medicine. Also avoid breastfeeding for at least six months after you
discontinue this medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hemorrhage, hypertension, neurotoxicity, fatigue/malaise,
appetite decreased, nausea, stomatitis, and alopecia. 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.
・cold sweat, dizziness, lightheadedness, glow, general dullness, faint consciousness, impaired judgment/mind, pale
face, palpitation, shortness of breath, breathing difficulty, hoarseness, swelling around the eye and lips, hives
[shock, anaphylaxis]
・severe abdominal pain, nausea, vomiting, fever, breathing difficulty, shortness of breath, cough, vomiting of blood,
3/4
bubble in urine, cloudy urine, leakage of intestinal juice and stool from the holes around the anus and the skin,
leakage of stool and urine from the vagina, vaginal bleeding, yellowing of skin and/or white of eyes, brown urine
[gastrointestinal perforation, fistula (gastrointestinal fistula, bronchopleural fistula, genitourinary fistula, biliary
fistula)]
・delay in healing the wound [delayed wound healing]
・vomiting of blood, nausea, vomiting, abdominal pain, bloody stool, black stool [gastrointestinal hemorrhage]
・bloody sputum, vomiting of blood [pulmonary hemorrhage]
・nausea, vomiting, hemiplegia, decreased consciousness, impaired judgment/mind, headache, difficulty talking,
paralysis and numbness in limbs, partial paralysis, loss of consciousness into deep sleep [cerebral hemorrhage]
・vomiting of blood, mucosal bleeding such as bleeding from the nose, gum, vagina [mucosal hemorrhage (nasal
hemorrhage, gingival bleeding, vaginal bleeding)]
・dull headache, headache, dizziness on standing up, cold sweat, hemiplegia, dizziness, decreased consciousness,
difficulty talking, decreased visual acuity, numbness, chest tightness, chest pain, breathing difficulty, cough,
sweating, skin, lips and nails turning bluish purple [arterial thromboembolism, including cerebrovascular accident,
transient ischemic attack, myocardial infarction, angina pectoris, cerebral ischemia, cerebral infarction]
・severe pain in the legs, swelling of lower limbs, sweating, fever, decreased consciousness, cough, chest pain,
breathing difficulty [venous thromboembolism, including deep-vein thrombosis and pulmonary embolism]
・dizziness, headache, sudden severe headache, nausea, numbness in the limbs [hypertensive encephalopathy,
hypertensive crisis]
・convulsion, consciousness disorder, vision impairment [reversible posterior leukoencephalopathy syndrome]
・marked general edema, decreased urinary volume [nephrose syndrome]
・general dullness, fever, prolonged bleeding, bleeding tendency, gum bleeding, nose bleeding, blue spot, shortness of
breath [myelosuppression (pancytopenia, neutropenia, leukopenia, anemia, thrombocytopenia)]
・chills, fever, cough, sputum, shortness of breath, joint/muscle pain, purple-red swelling of the skin, painful blisters,
darkness of the skin or sores/collapse of the skin/muscles with the progression of symptom [infection (pneumonia,
sepsis, necrotizing fasciitis)]
・general dullness, general edema, nausea, breathing difficulty, shortness of breath on exertion [congestive heart
failure]
・fever, dry cough, breathing difficulty, shortness of breath [interstitial pneumonia]
・bleeding tendency, gum bleeding, nose bleeding, internal bleeding, bloody urin [thrombotic microangiopathy
(thrombotic thrombocytopenic purpura, hemolytic uremic syndrome)]
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