Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 04/2024
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails 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:TEMODAL Infusion 100mg
Active ingredient:Temozolomide
Dosage form:injection
Imprint or print on wrapping:Effects of this medicine
This medicine suppresses tumor cell growth and shows anticancer effect.
It is usually used to treat malignant glioma and recurrent or refractory Ewing's sarcoma.
The following patients may need to be careful when using this medicine.Be sure to tell your doctor andpharmacist.
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods.
If you have: bleeding tendency, renal disorder, liver disorder, infectious diseases or varicella.
・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 over 90 minutes at a time.
For treatment of newly-diagnosed malignant glioma: Concomitantly with radiotherapy, in general, for adults,
administer once a day, for 42 days, and withdraw the medication for 4 weeks. After the above-described course, inadministration of Temodal alone, administer once a day, for 5 days, and withdraw the medication for 23 days. This
28-day is defined as one course.
For treatment of recurrent malignant glioma: In general, for adults, administer once a day, for 5 days, and withdraw
the medication for 23 days. This 28-day is defined as one course.
For treatment of recurrent or refractory Ewing's sarcoma: Concomitantly with irinotecan, in general, administer
once a day, for consecutive 5 days, and withdraw the medication for 16 days or longer. This is defined as one course
and this treatment course is repeated.
・Ask the doctor about the treatment span.
Precautions while taking this medicine
・Follow the instructions of your doctor and receive a blood test regularly.
・If female patients have a possibility of becoming pregnant, avoid pregnancy in an appropriate way while using thismedicine and for 6 months after completion of the treatment.
・Male patients should use a barrier method (condom) for contraception while using this medicine and for 3 months
after completion of the treatment.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include malaise, headache, anemia, nausea, vomiting, loss ofappetite, constipation, diarrhea and fatigue. 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 indicatedin brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
・anemic symptom, fever, bleeding tendency [myelosuppression]・fever, cough, phlegm [Pneumocystis pneumonia, infectious diseases]
・fever, dry cough, breathing difficulty [interstitial pneumonia]
・headache, vomiting, hemiplegia [cerebral bleeding]・breathing difficulty, hives, swelling around the eyes or lips [anaphylaxis]
・general malaise, loss of appetite, yellow discoloration of skin and/or conjunctiva [liver dysfunction, jaundice]・fever, erythema (red rash) with dropsical swelling in the center, bloodshot eyes [toxic epidermal necrolysis,
Stevens-Johnson syndrome]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
For healthcare professional use only//1 / 2

For further information, talk to your doctor or pharmacist.
SIE①

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