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Drug Information Sheet("Kusuri-no-Shiori")

Injection

Revised: 06/2022

|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:TECENTRIQ Intravenous Infusion 840mg |[pic] |

|Active ingredient:Atezolizumab (genetical recombination) | |

|Dosage form:injection | |

|Imprint or print on wrapping: | |

|Effects of this medicine |

|This medicine inhibits binding of PD-1, a receptor on T cells (immune cells), to PD-L1, substances expressed on cancer cells. It is considered to |

|enhance T cell activation and suppress tumor growth. |

|It is usually used to treat inoperable or recurrent breast cancer with PD-L1 positive, hormone receptor negative and HER2 negative. |

|The following patients may need to be careful when 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 or foods. |

|If you have or have a history of autoimmune disease or interstitial lung disease. |

|・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, for adults, administer by intravenous infusion once a day, every 2 weeks. |

|・Ask the doctor about the treatment span. |

|Precautions while taking this medicine |

|・Since this medicine activates T-cells, diseases or clinical conditions due to excessive immunoreaction may occur. In addition, serious adverse |

|reactions may occur after medication. If you feel abnormality during or after using this medicine, consult with your doctor immediately. |

|・This medicine may cause interstitial lung disease. If the first symptoms (respiratory distress, cough, fever, etc.) appear, consult with your |

|doctor immediately. Examinations such as chest X-ray, chest CT or serum marker test may be performed, if needed. |

|・Since this medicine may cause type 1 diabetes, periodic blood sugar test will be performed while using this medicine. |

|・Since this medicine may cause liver dysfunction, hepatitis or sclerosing cholangitis, periodic liver function test will be performed while using |

|this medicine. |

|・Since this medicine may cause thyroid/adrenal/pituitary dysfunction, periodic endocrine function test will be performed while using this medicine.|

|Imaging test may be performed, if needed. |

|・Since this medicine may cause renal dysfunction, periodic renal function test will be performed while using this medicine. |

|・Since this medicine may cause myositis or rhabdomyolysis, creatinine kinase level test, myoglobin blood test, urine myoglobin test may be |

|performed while using this medicine. |

|・Since this medicine may cause myocarditis, creatinine kinase level test, electrocardiography test may be performed while using this medicine. |

|・If you have a possibility of pregnancy, consult with your doctor. If you have a possibility of getting pregnant, avoid pregnancy while you are |

|using this medicine and for a certain period after you discontinue this medicine. |

|Possible adverse reactions to this medicine |

|The most commonly reported adverse reactions include fatigue, diarrhea, nausea. 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. |

|・fever, cough, breathing difficulty, shortness of breath [interstitial lung disease] |

|・easy fatigability, general malaise, weakness, nausea, loss of appetite, vomiting, fever, upper abdominal pain, yellowing of the white of eyes, |

|yellowing of the skin, itch, dark urine [liver dysfunction, hepatitis, sclerosing cholangitis] |

|・fever, enlarged feeling of abdomen, abdominal pain, watery stool, lead to blood in the stool (scarlet to dark red stool) [colitis] |

|・repeated watery stool, lower abdominal pain, general malaise, fever [severe diarrhea] |

|・severe pain in the abdomen, back pain, enlarged feeling of abdomen, nausea, vomiting, weight loss, thirst, increased urinary volume, yellowing of |

|the skin, oily diarrhea [pancreatitis] |

|・general malaise, weight loss, thirst, excessive fluid intake, increased urinary volume, nausea, bittersweet breath, deep breathing [type 1 |

|diabetes] |

|・easy fatigability, swollen eyelid, intolerance to cold, weight gain, constant sleepiness, constipation, hoarseness, loss of hair, palpitation, |

|fast pulse, shaky hands and fingers, weight loss, tendency to sweat, irritation, mild fever, nausea, swollen neck, sleeplessness, bulging eyes, |

|pounding heart [thyroid dysfunction] |

|・general malaise, decreased consciousness, loss of consciousness, decreased blood pressure, nausea, vomiting, abdominal pain, loss of appetite, |

|fever, cold sweat, pale face, cold limbs, shaky limbs [adrenal dysfunction] |

|・headache, focus disorder, general malaise, easy fatigability, loss of appetite, decreased consciousness, falling in blood pressure, decrease in |

|sexual desire, amenorrhea, thirst, weight loss, dry skin, excessive fluid intake, increased urinary volume [pituitary dysfunction] |

|・fever, paralysis, decreased consciousness, headache, nausea, vomiting [encephalitis, meningitis] |

|・numbness in the limbs, pain in limbs, loss of strength, muscle atrophy, shaky limbs, loss of strength in the limbs, stumble in walking, unable to |

|go up the stairs, difficult to grasp object, slow sensory of the limbs, paralysis of the facial muscle, hard to swallow, breathing difficulty |

|[neuropathy] |

|・heavy feeling of eyelids, drooping of upper eyelid, double vision, muscle fatigue [myasthenia gravis] |

|・widespread redness in the skin and multiple breakable blister, fever, mucous sore, inflamed eye, lip/intraoral sore, boil with the circular bulge |

|by edema in the marginal region of circular spot, joint pain, sore throat [severe skin disorder] |

|・decreased urine output, edema, fever, rash, joint pain, nausea, vomiting, diarrhea, abdominal pain [renal dysfunction] |

|・muscle weakness, muscle pain, swollen muscle, feverish [myositis] |

|・stiff limbs, numbness of limbs, lassitude, muscle pain, reddish brown urine [rhabdomyolysis] |

|・general malaise, breathing difficulty, shortness of breath, palpitation, chest pain, edema [myocarditis] |

|・fever, rash, decreased consciousness, convulsion, abnormal behavior, swollen lymph nodes such as neck/under the arms/the groin, general malaise, |

|bleeding tendency [hemophagocytic syndrome] |

|・general itching, rash, itchy throat, lightheadedness, palpitation, breathing difficulty, respiratory distress, decreased consciousness, loss of |

|consciousness, swelling of eyelids/lips/tongue, fever, chills, vomiting, cough, dizziness, palpitation [infusion reaction] |

|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.

Drug Information Sheet("Kusuri-no-Shiori")

Injection

Revised: 06/2022

|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:TECENTRIQ Intravenous Infusion 1200mg |[pic] |

|Active ingredient:Atezolizumab (genetical recombination) | |

|Dosage form:injection | |

|Imprint or print on wrapping: | |

|Effects of this medicine |

|This medicine inhibits binding of PD-1, a receptor on T cells (immune cells), to PD-L1, substances expressed on cancer cells. It is considered to |

|enhance T cell activation and suppress tumor growth. |

|It is usually used to treat unresectable advanced/recurrent non-small-cell lung cancer and extensive-stage small cell lung cancer/unresectable |

|heptatocellular carcinoma. It is also used for postoperative adjuvant chemotherapy for non-small-cell lung cancer. |

|The following patients may need to be careful when 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 or foods. |

|If you have or have a history of autoimmune disease or interstitial lung disease. |

|・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, for adults, administer by intravenous infusion once a day, every 3 weeks. |

|・Ask the doctor about the treatment span. |

|Precautions while taking this medicine |

|・Since this medicine activates T-cells, diseases or clinical conditions due to excessive immunoreaction may occur. In addition, serious adverse |

|reactions may occur after medication. If you feel abnormality during or after using this medicine, consult with your doctor immediately. |

|・This medicine may cause interstitial lung disease. If the first symptoms (respiratory distress, cough, fever, etc.) appear, consult with your |

|doctor immediately. Examinations such as chest X-ray, chest CT or serum marker test may be performed, if needed. |

|・Since this medicine may cause type 1 diabetes, periodic blood sugar test will be performed while using this medicine. |

|・Since this medicine may cause liver dysfunction, hepatitis or sclerosing cholangitis, periodic liver function test will be performed while using |

|this medicine. |

|・Since this medicine may cause thyroid/adrenal/pituitary dysfunction, periodic endocrine function test will be performed while using this medicine.|

|Imaging test may be performed, if needed. |

|・Since this medicine may cause renal dysfunction, periodic renal function test will be performed while using this medicine. |

|・Since this medicine may cause myositis or rhabdomyolysis, creatinine kinase level test, myoglobin blood test, urine myoglobin test may be |

|performed while using this medicine. |

|・Since this medicine may cause myocarditis, creatinine kinase level test, electrocardiography test may be performed while using this medicine. |

|・Since this medicine may cause febrile neutropenia, periodic blood test may be performed while using this medicine. |

|・If you have a possibility of pregnancy, consult with your doctor. If you have a possibility of getting pregnant, avoid pregnancy while you are |

|using this medicine and for a certain period after you discontinue this medicine. |

|Possible adverse reactions to this medicine |

|The most commonly reported adverse reactions include fatigue, diarrhea, nausea. 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. |

|・fever, cough, breathing difficulty, shortness of breath [interstitial lung disease] |

|・easy fatigability, general malaise, weakness, nausea, loss of appetite, vomiting, fever, upper abdominal pain, yellowing of the white of eyes, |

|yellowing of the skin, itch, dark urine [liver dysfunction, hepatitis, sclerosing cholangitis] |

|・fever, enlarged feeling of abdomen, abdominal pain, watery stool, lead to blood in the stool (scarlet to dark red stool [colitis] |

|・repeated watery stool, lower abdominal pain, general malaise, fever [severe diarrhea] |

|・severe pain in the abdomen, back pain, enlarged feeling of abdomen, nausea, vomiting, weight loss, thirst, increased urinary volume, yellowing of |

|the skin, oily diarrhea [pancreatitis] |

|・general malaise, weight loss, thirst, excessive fluid intake, increased urinary volume, nausea, bittersweet breath, deep breathing [type 1 |

|diabetes] |

|・easy fatigability, swollen eyelid, intolerance to cold, weight gain, constant sleepiness, constipation, hoarseness, loss of hair, palpitation, |

|fast pulse, shaky hands and fingers, weight loss, tendency to sweat, irritation, mild fever, nausea, swollen neck, sleeplessness, bulging eyes, |

|pounding heart [thyroid dysfunction] |

|・general malaise, decreased consciousness, loss of consciousness, decreased blood pressure, nausea, vomiting, abdominal pain, loss of appetite, |

|fever, cold sweat, pale face, cold limbs, shaky limbs [adrenal dysfunction] |

|・headache, focus disorder, general malaise, easy fatigability, loss of appetite, decreased consciousness, falling in blood pressure, decrease in |

|sexual desire, amenorrhea, thirst, weight loss, dry skin, excessive fluid intake, increased urinary volume [pituitary dysfunction] |

|・fever, paralysis, decreased consciousness, headache, nausea, vomiting [encephalitis, meningitis] |

|・numbness in the limbs, pain in limbs, loss of strength, muscle atrophy, shaky limbs, loss of strength in the limbs, stumble in walking, unable to |

|go up the stairs, difficult to grasp object, slow sensory of the limbs, paralysis of the facial muscle, hard to swallow, breathing difficulty |

|[neuropathy] |

|・heavy feeling of eyelids, drooping of upper eyelid, double vision, muscle fatigue [myasthenia gravis] |

|・widespread redness in the skin and multiple breakable blister, fever, mucous sore, inflamed eye, lip/intraoral sore, boil with the circular bulge |

|by edema in the marginal region of circular spot, joint pain, sore throat [severe skin disorder] |

|・decreased urine output, edema, fever, rash, joint pain, nausea, vomiting, diarrhea, abdominal pain [renal dysfunction] |

|・muscle weakness, muscle pain, swollen muscle, feverish [myositis] |

|・stiff limbs, numbness of limbs, lassitude, muscle pain, reddish brown urine [rhabdomyolysis] |

|・general malaise, breathing difficulty, shortness of breath, palpitation, chest pain, edema [myocarditis] |

|・fever, rash, decreased consciousness, convulsion, abnormal behavior, swollen lymph nodes such as neck/under the arms/the groin, general malaise, |

|bleeding tendency [hemophagocytic syndrome] |

|・general itching, rash, itchy throat, lightheadedness, palpitation, breathing difficulty, respiratory distress, decreased consciousness, loss of |

|consciousness, swelling of eyelids/lips/tongue, fever, chills, vomiting, cough, dizziness, palpitation [infusion reaction] |

|・sudden high fever, chills, sore throat [febrile neutropenia] |

|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.

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