英文药名：PEGASYS S.C. Injection（Peginterferon Alfa-2a[Genetical Recombination]）

中文药名：重组聚乙二醇干扰素α-2a皮下注射

生产厂家：中外制药

ペガシス皮下注45μg／ペガシス皮下注90μg／ペガシス皮下注180μg

治疗类别名称
聚乙二醇干扰素-α-2a的配方
商標名
PEGASYS
一般名
ペグインターフェロン アルファ-2a（遺伝子組換え）
［Peginterferon Alfa-2a（Genetical Recombination）］
本　質
インターフェロン アルファ-2a（遺伝子組換え）のリジン残基の1箇所に、1分子の分枝ポリエチレングリコールが、アミド結合を介して共有結合している修飾蛋白質
分子式
インターフェロン アルファ-2a（遺伝子組換え）：
C860H1349N227O255S9
分枝ポリエチレングリコール：
リジン分子のα及びεアミノ基にカルボニル基を介して分子量約20,000ダルトンのモノメトキシポリエチレングリコール鎖が1本ずつ結合したものからなる。
分子量
約60,000
インターフェロン アルファ-2a（遺伝子組換え）：
分子量19,236.87
分枝ポリエチレングリコール：分子量約40,000
药效药理
1.抗病毒作用
在HCV-RNA亚基因组复制子测定法中，抑制了HCV-RNA复制子的复制。此外，相对于水泡性口炎病毒和脑心肌炎病毒，它表现出抗病毒活性。
在体外，相比于α-干扰素-2a（遗传重组）PEG-IFN的抗病毒效果也下降。
当这种药物皮下给药于HBV感染的人肝细胞的嵌合小鼠，观察到HBV-DNA含量下降。
2. 肿瘤细胞生长的抑制作用
伯基特淋巴瘤衍生细胞（的Daudi），人肾癌来源的细胞（A-498等），慢性骨髓性白血病衍生细胞（K562），黑色素瘤来源的细胞（Hs294T等）和成胶质细胞瘤来源的细胞（T98G）它显示出对细胞的生长抑制作用。此外，抑制人肾癌细胞来源的细胞的生长被移植到裸鼠（A-498，ACHN和株Caki-1）。
在体外，PEG-IFN的肿瘤细胞生长的抑制效果不得不比α干扰素-2a（遗传重组），在体内观察到降低高的抗肿瘤作用。
3. 作用机序
与体外干扰素α受体结合，并且诱导的DNA的转录因子复合物（STAT二聚体，ISGF3配合物）的形成和干扰素α诱导性基因表达的结合。
适应病症
1、慢性乙型肝炎：本品适用于治疗成人慢性乙型肝炎。患者不能处于肝病失代偿期，慢性乙型肝炎必须经过血清标志物（转氨酶升高、HBsAg，HBV DNA）确诊。通常也需获取组织学证据。
2、慢性丙型肝炎：本品适用于治疗之前未接受过治疗的慢性丙型肝炎成年患者。患者必须无肝脏失代偿表现，慢性丙型肝炎须经血清标记物确证（抗HCV抗体和HCV RNA）。通常诊断要经组织学确证。
用法用量
1、慢性乙型肝炎用于慢性乙型肝炎患者时本品的推荐剂量为每次180μg，每周1次，共48周，腹部或大腿皮下注射。
2、慢性丙型肝炎本品单药或与利巴韦林联合应用时的推荐剂量为每次180μg，每周1次，腹部或大腿皮下注射。
包装规格
皮下注射
45μg：1瓶

90μg：1瓶

180μg：1瓶

制造厂商
中外制药有限公司
注：以上资料仅供参考，使以原处方为准：http://www.info.pmda.go.jp/go/pack/6399419A1022_1_21/6399419A1022_1_21?view=body

PEGASYS S.C. Injection 45 mcg（ペガシス皮下注45μg） 
Brand name : PEGASYS S.C. Injection 45 mcg
　Active ingredient: Peginterferon alfa-2a (genetical recombination)
　Dosage form: injection
　Print on wrapping:
PEGASYS S.C. Injection 90 mcg（ペガシス皮下注90μg） 
Brand name : PEGASYS S.C. Injection 90 mcg
　Active ingredient: Peginterferon alfa-2a (genetical recombination)
　Dosage form: injection
　Print on wrapping:
PEGASYS S.C. Injection 180 mcg（ペガシス皮下注180μg） 
Brand name : PEGASYS S.C. Injection 180 mcg
　Active ingredient: Peginterferon alfa-2a (genetical recombination)
　Dosage form: injection
　Print on wrapping:
Effects of this medicine
This medicine inhibits growth of hepatitis B virus and hepatitis C virus, helps the body to eliminate virus and improves liver dysfunction.
It is usually used to treat compensated cirrhosis related to hepatitis C and chronic active hepatitis B.
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 neurosychiatric disease such as depression, pneumonia, heart disease or diabetes.
If you ever had any of those diseases mentioned above.
If you are a patient with autoimmune disease (autoimmune hepatitis, psoriasis, systemic lupus erythematosus (SLE), rheumatoid arthritis, etc.) or its predisposing condition.
If you are a patient with renal/hepatic disorder, hypertension, convulsive seizure, myelosuppresion (anemia, leukopenia, thrombocytopenia), impaired glucose intolerance.
If any of your relatives ever had diabetes.
•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 subcutaneously once a week.
•Treatment period will be determined according to the symptoms.
•Before you use this medicine, you take blood sampling for blood examination.
Precautions while taking this medicine
•While you are taking this medicine, you need to take periodic blood examination. You also may need to take periodic blood examination even after the use is completed. Following the instructions by the doctor, take the examination.
•Since dizziness, confusion (confusion of consciousness), somnolence (hazy with drowsiness), and fatigue may occur, avoid operating dangerous machinery such as driving a car.
•Teratogenic action (possibility to cause fetal malformation) has been reported in animal experiments for COPEGUS Tablet. If you/your partner have/has a possibility of pregnancy, avoid pregnancy while you are taking COPEGUS Tablet and for 6 months after you discontinue it. Also, you/your partner need to have a pregnancy test once a month in order to confirm that you/your partner do/does not become pregnant.
Active ingredient of COPEGUS Tablet may be moved into sperm. If your partner is pregnant or she has a possibility to have gotten pregnant, you need to be informed of it until you fully understand it. Use condom to prevent COPEGUS Tablet from moving into the womb while you are taking it and for 6 months after you discontinue it.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include headache, fever, lassitude, injection site reaction and pruritus. 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.
•shortness of breath, breathlessness, fever, cough, phlegm, weight loss, loss of appetite [interstitial pneumonia, pulmonary infiltration, breathing difficulty]
•discouraged feeling, sleeplessness, depressed feeling, indisposition, anxiety, irritation, considering suicide on impulse, suicide attempt [depression, suicidal thought, suicide attempt]
•coming up many ideas, difficulty in falling asleep, talkativeness, highly strung nerves, intense emotion, feeling irritated, excitement, anxiety [manic high, aggressive behavior]
•palpitation, shortness of breath, headache, ear ringing, dizziness, lassitude, nose bleeding, blue spot, gum bleeding, subcutaneous bleeding, continuous bleeding, bleeding tendency, fever, sore throat [anemia, aplastic anemia, pure red-cell aplasia, pancytopenia, agranulocytosis, leukopenia, thrombocytopenia]
•gum/nose bleeding, fever, subcutaneous bleeding, purplish bruise, blue spot, anemia, shortness of breath, breathlessness, yellowness in the skin and/or the white of the eye, yellow urine, decreased consciousness, impaired mind/judgment, numbness, decreased urinary volume, convulsion, swelling [thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS)]
•nausea, vomiting, loss of appetite, yellowness in the skin and/or the white of the eye, dark urine, itch, lassitude [worsening of hepatitis, hepatic function disorder]
•nausea, vomiting, lassitude, loss of appetite, yellowness in the skin and/or the white of the eye, brown urine, dizziness, lightheadedness, dizziness on standing up, easy fatigability, top-heavy feeling, palpitation/shortness of breath when moving, gum bleeding, subcutaneous bleeding, nose bleeding, fever, abdominal pain, mucous/bloody stool, diarrhea, joint pain, rigid hand in the morning, butterfly-shaped red punctum on the face, angialgia, purplish bruise, swelling, bloodshot eye, seeing flash-like light, scotoma in the visual field, failing vision, ear ringing, difficulty hearing, headache, loss of hair, gray hair, white spots on the skin [autoimmune phenomenon]
•breathlessness, shortness of breath, palpitation, palpitation when moving, pounding heart, fast pulse, easy breathing in upright position, chest pain, anginal pain, chest oppressive/constrictive feeling, strongly pressured feeling in the chest, swollen body, lassitude, cold sweat, dizziness, faint, fever [myocardiosis, cardiac failure, angina, arrhymia (ventricular tachycardia), myocardial infarction, endocarditis, pericarditis]
•sudden fever with shiver, joint/muscle pain, chills [sepsis]
•nausea, vomiting, paralysis in one side of the body, paralysis/numbness of the limbs, partial paralysis, difficulty speaking, headache, decreased consciousness, impaired mind/judgment, falling asleep in a faint [cerebral hemorrhage, cerebral infarction]
•chest pain, sweat, decreased consciousness, cough, fever, breathlessness [pulmonary embolism]
•decreased/confused/disturbed consciousness, loss of consciousness, impaired mind/judgment, muscle stiffness/tremor, retrograde amnesia, inability to recognize place, time, self and name, seeing or hearing something that is not really there, bad memory loss, inability to memorize/calculate [consciousness disorder, convulsion, epilepsy seizure, disorientation, coma, delirium, confusion, hallucination, dementia-like symptom]
•excess intake of water, increased urinary volume, lassitude, weight loss, thirst [diabetes]
•swollen thyroid, sleeplessness, weight loss, tendency to sweat, bulging eyes, pounding heart, shakey hands, lassitude, slowness in conversation or in motion, swelling, intorelance to cold [thyroid dysfunction]
•high fever, fever, inflamed eyelid/eye, conjunctival sore, severe stomatitis, lip/intraoral sore, red rash with dropsical swelling in the center, red rash, red spots and breakable blisters (bullas) all over the body, rash and blister, joint pain, pain in the genitalia, lassitude, loss of appetite [mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrosis (TEN), erythema multiforme]
•itch, scab, dry skin [psoriasis]
•decreased consciousness, swollen eyes, easy fatigability, decreased urinary volume, headache, lassitude, breathlessness, swollen body [acute renal failure, nephrotic syndrome]
•bloody stool, black stool, nausea, vomiting, vomiting of blood, abdominal pain, heavy stomach feeling, heartburn, feeling sick at the stomach, back pain, fever, diarrhea [gastrointestinal bleeding (melena, bloody stool, etc.), peptic ulcer, ischemic colitis]
•cold sweat, dizziness, faint consciousness, impaired judgment/mind, pale face, shortness of breath [shock]
•failing vision, scotoma in the visual field [retinopathy]
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
•To the family members:
This medicine may make patients feel depressed or feel like dying. It may also make patients feel high, be aggressive or sometimes cause harm to others.
Patients and their families should be made fully aware of the possibility of developing such symptoms as those above symptoms, manic state, sleeplessness, anxiety, frustrating, restlessness, excitement, aggression or irritability and they should be instructed to immediately contact the doctor if such symptoms occur.
Chugai Pharmaceutical Co., Ltd.Injection
Published: 1/2014
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.