Download Drug Information Sheet("Kusuri-no-Shiori") Injection Revised: 06

Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 06/2014
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:IRINOTECAN HYDROCHLORIDE HYDRATE INTRAVENOUS
INFUSION 100mg "TOWA"
Active ingredient:Irinotecan hydrochloride hydrate
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine suppresses proliferation of cancer cells by inhibiting DNA synthesis of cancer cells.
It is usually used to treat inoperable/recurrent gastric/colon/rectum/breast cancer, small-cell lung cancer,
non-small cell lung cancer, cervical cancer, ovary cancer, squamous cell cancer, malignant lymphoma
(non-Hodgkin's lymphoma), childhood malignant solid tumor and pancreatic cancer not amenable to curative
resection..
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 are a patient with myelosuppresion, infectious disease, diarrhea (watery stool), intestinal tract paralysis,
intestinal obstruction, interstitial pneumonia/pulmonary fibrosis, large quantities of ascites/pleural effusion,
jaundice, hepatic disorder, renal disorder, diabetic mellitus or generalized weakness.
・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, administered by intravenous infusion.
・For inoperable/recurrent gastric/colon/rectum cancer, cervical cancer, ovary cancer: In general, administer once a
day for every other week and repeat this 3 to 4 times. Then set a drug cessation period of at least 2 weeks. This is
counted as one cycle and repeat this cycle, or, administer once a day for every 2 weeks and repeat this 2 to 3
times. Then set a drug cessation period of at least 3 weeks. This is counted as one cycle and repeat this cycle.
For small-cell lung cancer, non-small cell lung cancer, inoperable/recurrent breast cancer, squamous cell cancer:
In general, administer once a day for every other week and repeat this 3 to 4 times. Then set a drug cessation
period of at least 2 weeks. This is counted as one cycle and repeat this cycle.
For malignant lymphoma (non-Hodgkin's lymphoma): In general, administer once a day for 3 consecutive days.
Repeat this every other week for 2 to 3 times and set a drug cessation period of at least 2 weeks. This is counted as
one cycle and repeat this cycle.
For childhood malignant solid tumor: In general, administer by intravenous infusion once a day for 5 consecutive
days. Repeat this every other week twice and set a drug cessation period of at least one week. This is counted as
one cycle and repeat this cycle.
For pancreatic cancer not amenable to curative resection: In general, administer by intravenous infusion once a
day. Then set a drug cessation period of at least 2 weeks. This is counted as one cycle and repeat this cycle.
・The treatment schedule depends on the concomitant medicine and your conditions. The treatment span depends on
the effect of this medicine after taking it for a certain period. Ask your doctor about your treatment span.
Precautions while taking this medicine
・The effects of the medicine may be affected by some kind of foods and drinks. Avoid taking grapefruit juice during
treatment, since it may intensify the effects of the medicine. Avoid taking hypericum perforatum (Saint John's
wort)-contained food with this medicine during treatment, since it may weaken the effects 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 symptoms as early as possible, periodic blood test is needed (1 to 2 times a week, or
more frequently in some cases).
Possible adverse reactions to this medicine
1/2
The most commonly reported adverse reactions include nausea/vomiting, loss of appetite, or stomachache. 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.
・anemic symptoms, fever, bleeding tendency [myelosuppresion]
・muddy/watery stool, stomachache, nausea [diarrhea, intestinal inflammation]
・sever stomachache, nausea, vomiting [intestinal perforation, gastrointestinal bleeding, intestinal obstruction]
・fever, dry cough, respiratory distress [interstitial pneumonia]
・pale face, cold sweat, dizziness on standing up [shock, anaphylaxis]
・yellowing of skin/conjunctiva, general dullness, loss of appetite [impaired liver function, jaundice]
・decreased urine output, swelling, headache [acute renal failure]
・respiratory distress, chest pain, cough [pulmonary embolism, venous thrombosis]
・paralysis of face/limbs on one side, headache, speech disability [cerebral infarction]
・acute precordial pressure, anginal pain, cold sweat [myocardial infarction, angina attack]
・abnormal cardiac contraction other than normal heartbeat, uncomfortable feeling in chest, palpitation [premature
ventricular contraction]
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.
2/2