2016年11月21日，两款新药elbasvir和grazoprevir在日本获批上市
默沙东在日本刚刚上市了两款口服丙型肝炎新药，分别为50mg的Erelsa（elbasvir）片剂和50mg的Grazyna（grazoprevir hydrate）片剂。NS5A抑制剂Erelsa 和NS3/4A蛋白酶抑制剂和Grazyna均由Merck & Co开发，用于基因 1型慢性丙肝或代偿性丙型肝硬化患者的病毒血症治疗，每日一剂，持续12周。在日本进行的II/III期针对于基因1型慢性丙肝病人的临床试验中，Erelsa和Grazyna对不同背景的患者（不同治疗历史、性别、IL28B基因型、有无耐药性等）均显示了有效性和安全性，其中包括中度至重度的肾功能损伤患者。
ERELSA Tablets 50 mg（エレルサ錠50mg）
Brand name : ERELSA Tablets 50 mg
Active ingredient: Elbasvir
Dosage form: pink oval tablet, major axis: 14.54 mm, minor axis: 8.18 mm, thickness: 5.14 mm
Print on wrapping: （Face）ERELSA 50mg, 220, エレルサ 50mg
（Back）エレルサ 50mg
Effects of this medicine
This medicine inhibits proteins involved in hepatitis C virus replication, thereby suppressing hepatitis C virus multiplication (antiviral action). It is used with grazoprevir.
It is usually used to treat chronic hepatitis C or compensated cirrhosis type C.
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 ever diagnosed as hepatitis B.
•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, take 1 tablet (50 mg of the active ingredient) at a time, once a day, for 12 weeks. Strictly follow the instructions.
•This medicine is used concomitantly with grazoprevir. Follow the instruction about grazoprevir.
•Remove the medicine from a press-through package (PTP) immediately before use.
•If you miss a dose, consult with your doctor or pharmacist. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•Avoid taking any food containing St. John's wort, since it may decrease the blood level of the medicine and diminish medicinal effects.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include headache, general malaise, diarrhea, constipation and rash. 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.
•general malaise, loss of appetite, nausea/vomiting [liver dysfunction]
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
•Keep out of reach of children. Store away from direct sunlight, heat and moisture.
•Do not take the tablets out of the PTP sheet to avoid moisture.
•Discard the remainder. Do not store them.
MSD K.K.Internal
Published: 11/2016
The information on this sheet is based on approvals granted by the Japanese re |
