くすりのしおり

Injection
Revised: 4/2019

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 :
TOPOTECIN INTRAVENOUS DRIP INFUSION 40mg
 Active ingredient:
Irinotecan hydrochloride hydrate
 Dosage form:
Injection
 Print on wrapping:

Effects of this medicine

This medicine inhibits DNA synthesis by inhibiting topoisomerase I, thereby suppressing the proliferation of cancer cells.
It is usually used to treat inoperable or recurrent gastric cancer, inoperable or recurrent colorectal cancer, small cell lung cancer, non-small cell lung cancer, inoperable or recurrent breast cancer, cervical cancer, ovarian cancer, squamous cell carcinoma, malignant lymphoma (non-Hodgkin's lymphoma), pediatric malignant solid tumor, and unresectable pancreatic 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 myelosuppression, infectious diseases, diarrhea, intestinal tract paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, ascites, pleural effusion, jaundice, hepatic disorder, renal disorder, diabetes mellitus, remarkable general weakness or hereditary fructose intolerance.
  • 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, inject this medicine intravenously gradually, once a day. Ask the doctor about the treatment span.

Precautions while taking this medicine

  • The effect of the medicine may be affected by some kind of foods. Do not take grapefruit juice when you are injected this medicine, since it may intensify the medicinal effects. Do not take foods containing herbs such as St. John's wort (hypericum perforatum) when you are injected this medicine, since they may diminish the effect of the medicine.
  • If you have decreased bone marrow function, infection or bleeding may occur. These symptoms are difficult to detect. In order to find out these symptoms as early as possible, regularly blood test is recommended (once or twice a week or even more frequently in some case).

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include anemia, diarrhea, nausea/vomiting, loss of appetite, abdominal pain and depilation. 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.
  • feel malaise and fever, subcutaneous hemorrhage [myelosuppression]
  • chills, sudden high fever with tremor, pulse rate increase, myalgia, joint pain, blood pressure decreased, cough and sputum, shortness of breath [severe infection (sepsis, pneumonia, etc.)]
  • palpitation at climbing stairs or hills, shortness of breath, malaise, bleeding tendency such as nasal bleeding, gum bleeding, subcutaneous bleeding [disseminated intravascular coagulation (DIC)]
  • muddy or watery stools persist, sudden diarrhea, nausea, and severe pain, diarrhea or abnormal bowel movement in the long term, mucus in the stool [diarrhea/enterocolitis]
  • severe abdominal pain appears and persists, strawberry jelly stools, black stools, tarry stools, dark red and bright blood attaches to the surface of the stool (fecal occult blood), gastric distension with pain and nausea, stagnation of stools of flatus stopping [Intestinal perforation, gastrointestinal tract obstruction, haemorrhage intestinal obstruction]
  • dry cough, breathless, shortness of breath [interstitial pneumonia]
  • pale face after diarrhea and vomiting, cold sweat, dizziness on standing up, dizziness, shortness of breath, loss of consciousness, feeling unpleasant in the mouth, labial numbness, breathing difficulty, hives or itching, swelling around the eyes and lips, consciousness disorder, palpitation, shortness of breath, malaise, reddish cheeks [shock, anaphylaxis]
  • malaise with nausea, dark urine, the white of eyes and skin become yellowish [hepatic dysfunction, jaundice]
  • decreased urine output, loss of appetite. malaise, swelling [acute kidney injury]
  • breathing difficulty, chest pain, decreased consciousness, impaired mind, poor judgment, cough, sweating, fever, swelling at blood stasis in the lower body or bluish-purple in lips and cheeks, increases pain by walking [thromboembolism]
  • sudden paralysis of one hand, foot, or face, numbness, headache, difficulty speaking, invisible or full invisible of the shape of the object following by impaired visual acuity, decreased consciousness, impaired mind, poor judgment [stroke]
  • sudden, severe, prolonged chest tightening or burning pain, suddenly squeezed feeling, compressed, or stuck in pain in chest, pain near the pit of the stomach, the left arm and the shoulder [myocardial infarction, angina attack]
  • instantaneously palpitation, sluggish pulse, feeling dyspnea [ventricular extrasystoles]
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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