英文药名：PREVYMIS Tablets(Letermovir)PREVYMIS INJECTION

中文药名：莱特莫韦片.冻干粉注射剂

生产厂家：默沙东
药品介绍
Prevymis(Letermovir)-获准成15年来首个预防CMV感染的新药
——抗病毒新药Prevymis获欧美批准上市，用于预防和治疗巨细胞病毒（CMV）感染
2018年03月26日，美国制药巨头默沙东（Merck & Co）抗病毒新药Prevymis（letermovir，MK-8228）片剂和静脉制剂已获欧盟委员会（EC）批准，用于巨细胞病毒（CMV）血清反应阳性的异基因造血干细胞移植（allo-HSCT）成人受者（R+），用于预防CMV的重新激活及感染疾病。在美国，Prevymis已于2017年11月获批，成为美国市场在过去15年来用于预防和治疗CMV感染的首个新药。
CMV是allo-HSCT受者中一种常见且潜在严重的病毒感染。接受HSCT的CMV血清学阳性患者存在高风险的CMV重新激活。任何水平的CMV感染均与HSCT患者升高的死亡率相关。Prevymis的上市，将为这一高危群体提供一种重要的治疗选择
letermovir是一种首创（first-in-class）抗病毒药物，该药属于一类新的非核苷类CMV抑制剂（3,4-二氢喹唑啉），通过靶向病毒终止酶（terminase）复合物抑制病毒的复制。此前，在美国、欧盟、日本，letermovir均被授予了用于高危群体预防CMV感染的孤儿药地位。
包装规格[注：以下产品是美国和德国产品，均可拿到货，欢迎咨询采购]
美国上市
PREVYMIS VL 240MG/12ML 30ML DS  LETERMOVIR  MERCK SHARP & DOHME  00006-5003-01
PREVYMIS VL 480MG/24ML 30ML DS  LETERMOVIR  MERCK SHARP & DOHME  00006-5004-01
PREVYMIS TAB 240MG 7X2 DS  LETERMOVIR  MERCK SHARP & DOHME  00006-3075-04
PREVYMIS TAB 480MG 7X2 DS  LETERMOVIR  MERCK SHARP & DOHME  00006-3076-04
PREVYMIS TAB 240MG 7X4 DS  LETERMOVIR  MERCK SHARP & DOHME  00006-3075-02
PREVYMIS TAB 480MG 7X4 DS  LETERMOVIR  MERCK SHARP & DOHME  00006-3076-02
德国上市包装
240mgx28片
480mg针药粉 x1瓶
240mg针药粉x1瓶
生产厂家：默沙东

Prevymis Tablets(Letermovir)
PREVYMIS Rx
Generic Name and Formulations:
Letermovir 240mg, 480mg; tabs.
Company:
Merck & Co., Inc.
Select therapeutic use: Viral infections
Indications for PREVYMIS:
Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).
Adult:
Swallow whole. Start between Days 0 and 28 post-transplantation (before or after engraftment) and continue through Day 100 post-transplant. 480mg once daily. Concomitant cyclosporine: 240mg once daily.
Children:
<18yrs: not established.
Contraindications:
Concomitant pimozide, ergot alkaloids. Concomitant pitavastatin, simvastatin when co-administered with cyclosporine.
Warnings/Precautions:
Monitor for CMV reactivation after therapy completion. Renal impairment (CrCl <50mL/min): closely monitor serum creatinine (in IV use). Severe hepatic impairment (Child-Pugh C): not recommended. Pregnancy. Nursing mothers.
Interactions:
See Contraindications. Specific interactions with cyclosporine: see full labeling. May be potentiated by OATP1B1/3 inhibitors. Potentiates CYP3A substrates (eg, midazolam, alfentanil, fentanyl, quinidine), OATP1B1/3 substrates: see full labeling for dose adjustment. Concomitant amiodarone, phenytoin, voriconazole, sirolimus, tacrolimus, omeprazole, pantoprazole: monitor frequently and adjust dose if necessary. Monitor INR with warfarin. Concomitant glyburide, repaglinide, rosiglitazone: monitor glucose levels; avoid repaglinide if co-administered with cyclosporine. Concomitant rifampin, pitavastatin, simvastatin: not recommended. Concomitant atorvastatin (max 20mg daily): monitor closely; avoid if co-administered with cyclosporine. Concomitant fluvastatin, lovastatin, pravastatin, rosuvastatin: monitor and reduce statin dose if necessary; avoid lovastatin if co-administered with cyclosporine.
See Also:
PREVYMIS INJECTION
Pharmacological Class:
CMV DNA terminase complex inhibitor.
Adverse Reactions:
Nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, abdominal pain, lab abnormalities.
Generic Availability:
NO
How Supplied:
Tabs—14, 28; Single-dose vial (30mL)—1
PREVYMIS INJECTION(Letermovir)
Generic Name and Formulations:
Letermovir 240mg/12mL, 480mg/24mL; soln for IV infusion after dilution; contains hydroxypropyl betadex; preservative-free.
Company:
Merck & Co., Inc.
Select therapeutic use: Viral infections
Indications for PREVYMIS INJECTION:
Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).
Adult:
Give as IV infusion over 1hr; do not give as IV bolus. Start between Days 0 and 28 post-transplantation (before or after engraftment) and continue through Day 100 post-transplant. 480mg once daily. Concomitant cyclosporine: 240mg once daily. Switch to oral therapy as soon as able to take oral meds.
Children:
<18yrs: not established.
Contraindications:
Concomitant pimozide, ergot alkaloids. Concomitant pitavastatin, simvastatin when co-administered with cyclosporine.
Warnings/Precautions:
Monitor for CMV reactivation after therapy completion. Renal impairment (CrCl <50mL/min): closely monitor serum creatinine (in IV use). Severe hepatic impairment (Child-Pugh C): not recommended. Pregnancy. Nursing mothers.
Interactions:
See Contraindications. Specific interactions with cyclosporine: see full labeling. May be potentiated by OATP1B1/3 inhibitors. Potentiates CYP3A substrates (eg, midazolam, alfentanil, fentanyl, quinidine), OATP1B1/3 substrates: see full labeling for dose adjustment. Concomitant amiodarone, phenytoin, voriconazole, sirolimus, tacrolimus, omeprazole, pantoprazole: monitor frequently and adjust dose if necessary. Monitor INR with warfarin. Concomitant glyburide, repaglinide, rosiglitazone: monitor glucose levels; avoid repaglinide if co-administered with cyclosporine. Concomitant rifampin, pitavastatin, simvastatin: not recommended. Concomitant atorvastatin (max 20mg daily): monitor closely; avoid if co-administered with cyclosporine. Concomitant fluvastatin, lovastatin, pravastatin, rosuvastatin: monitor and reduce statin dose if necessary; avoid lovastatin if co-administered with cyclosporine.
See Also:
PREVYMIS
Pharmacological Class:
CMV DNA terminase complex inhibitor.
Adverse Reactions:
Nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, abdominal pain, lab abnormalities.
Generic Availability:
NO
How Supplied:
Tabs—14, 28; Single-dose vial (30mL)—1