新类型Viberzi(eluxadoline)获美国FDA批准治疗腹泻肠易激综合征(IBS-D)
Viberzi其中含一种新活性成分,是与食物口服给药每天2次。Viberzi激活在神经系统中受体可减少肠道收缩。Viberzi旨在治疗成人IBS-D。
VIBERZI(eluxadoline)片为口服,C-X
美国初次批准:2015
Generic Name and Formulations:
Eluxadoline 75mg, 100mg; tabs.
Company:
Allergan
Select therapeutic use: Colorectal disorders
Indications for VIBERZI:
Treatment of irritable bowel syndrome with diarrhea (IBS-D).
Adult:
Take with food. 100mg twice daily. Patients without a gallbladder, have mild or moderate hepatic impairment, receiving concomitant OATP1B1 inhibitors (see Interactions), or unable to tolerate 100mg dose: 75mg twice daily.
Children:
Not established.
Contraindications:
Biliary duct obstruction. Sphincter of Oddi disease or dysfunction. Alcoholism, alcohol abuse/addiction, or >3 alcoholic drinks/day. History of pancreatitis or structural disease of the pancreas (including pancreatic duct obstruction). Severe hepatic impairment. History of chronic or severe constipation or sequelae from constipation. Mechanical GI obstruction.
Warnings/Precautions:
Discontinue if severe constipation develops >4 days. Increased risk of sphincter of Oddi spasm and pancreatitis; monitor (esp. those without a gallbladder) for new or worsening abdominal pain, with or without nausea/vomiting, or biliary pain with liver or pancreatic enzyme elevations; discontinue and treat if symptoms occur; do not restart if biliary duct obstruction or sphincter of Oddi spasm develops. Pregnancy. Nursing mothers.
Interactions:
Avoid excessive alcohol. Potentiated by OATP1B1 inhibitors (eg, cyclosporine, gemfibrozil, atazanavir, lopinavir, ritonavir, saquinavir, tipranavir, rifampin, eltrombopag). May be potentiated by strong CYP inhibitors (eg, ciprofloxacin, gemfibrozil, fluconazole, clarithromycin, paroxetine, bupropion); monitor. Increased risk for constipation with alosetron, anticholinergics, opioids; avoid. May potentiate OATP1B1 and BCRP substrates (eg, rosuvastatin: use lowest effective dose of rosuvastatin) or CYP3A substrates with narrow therapeutic index (eg, alfentanil, cyclosporine, ergots, fentanyl, pimozide, quinidine, sirolimus, tacrolimus); monitor.
Pharmacological Class:
Mu-opioid receptor agonist.
Adverse Reactions:
Constipation, nausea, abdominal pain; sphincter of Oddi spasm, pancreatitis.
Generic Availability:
NO
How Supplied:
Tabs—60