贝罗司他胶囊(berotralstat)的中文说明书，贝罗司他胶囊的功效和作用

[Drug name] capsule, Orladeyo, berotralstat, Orladeyo

[Indications] ORLADEYO is a plasma kallikrein inhibitor that can prevent hereditary angioedema (HAE) in adults and pediatric patients over 12 years of age.

[Mechanism of Action] Berosostat is a plasma kallikrein inhibitor that binds to plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein is a protease that cleaves high molecular weight kininogen (HMWK) to produce cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability, leading to the swelling and pain associated with HAE. In patients with HAE due to C1 deficiency or dysfunction of the inhibitor (C1-INH), plasma kallikrein activity is not regulated normally, which leads to an uncontrolled increase in plasma kallikrein activity and leads to angioedema attack. Berosostat decreases plasma kallikrein activity to control excessive bradykinin production in hospitalized patients with HAE.

[Usage and Dosage] Recommended dosage: Take one capsule (150mg) orally once a day with food.

[Side Effects] Heart rhythm problems. Taking more than one Orladeyo capsule a day may cause heart rhythm problems with QT prolongation, a condition that causes an abnormal heartbeat. The most common adverse reactions (≥10%) were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. Less common side effects include: Abnormal liver function tests. Less common side effects: transient, itchy rash

【Notes】

Risk of QT prolongation at higher than recommended doses: Orladeyo should not be used to treat acute exacerbations of HAE. Additional once daily doses or doses higher than 150 mg of Orladeyo are not recommended. A concentration-dependent increase in QT was observed at doses above the recommended daily dose of 150 mg.

Drug Interactions: Inform patients that Orladeyo may interact with other drugs. Advise patients to report the use of any other prescription or over-the-counter medications or herbal products to their physician.

Not indicated for the acute treatment of acute ischemic encephalopathy attacks: Advise patients to take commonly used rescue medications for the treatment of acute ischemic encephalopathy attacks. Inform patients that the safety and effectiveness of using Orladeyo as an acute treatment for HAE attacks has not been established. Advise patients not to take daily doses of more than 150 mg or additional doses of Orladeyo once daily to treat acute attacks of HAE due to the risk of QT prolongation.

The above is the instructions for Berostat. Please use it correctly under the guidance of a doctor.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.