くすりのしおり

Injection
Revised: 6/2020

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 :
BEVACIZUMAB BS FOR INTRAVENOUS DRIP INFUSIONS 100mg "DAIICHI SANKYO"
 Active ingredient:
Bevacizumab (Genetical recombination) [Bevacizumab biosimilar 2]
 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 and rectal cancer.

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: diabetes, 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. 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 shortened, depending on the situation.
  • The treatment interval and period with this medicine depends 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, proteinuria or myelosuppression may occur, blood pressure, urine protein and blood test should be measured regularly.
  • If you have a possibility of pregnancy, avoid pregnancy while you are using 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.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include 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, cough, vomiting of blood, bubble in urine, cloudy urine, 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 phlegm, vomiting of blood [pulmonary hemorrhage]
  • nausea, vomiting, hemiplegia, decreased consciousness, impaired judgment/mind, headache, difficulty talking, paralysis and numbness in limbs, loss of consciousness into deep sleep [cerebral hemorrhage]
  • vomiting of blood, mucosal bleeding such as bleeding from the nose, gum, vagina [mucosal hemorrhage]
  • 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, bluish purple skin/lips/fingertips of limbs [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, nausea, numbness in the limbs [hypertensive encephalopathy, hypertensive crisis]
  • convulsion, consciousness disorder, vision impairment [reversible posterior leukoencephalopathy syndrome]
  • marked general edema, decreased urinary volume [nephrotic syndrome]
  • general dullness, fever, prolonged bleeding, bleeding tendency, nose bleeding, blue spot, shortness of breath [myelosuppression (pancytopenia, neutropenia, leukopenia, anemia, thrombocytopenia)]
  • chills, fever, cough, phlegm, shortness of breath, joint/muscle pain, purple-red swelling of the skin, painful blisters [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, nose bleeding, gum bleeding, internal bleeding, bloody urine [thrombotic microangiopathy (thrombotic thrombocytopenic purpura, hemolytic uremic syndrome)]
  • acute abdominal pain, acute chest pain, acute back pain [arterial dissection]
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 : Day Month Year

For further information, talk to your doctor or pharmacist.

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