奥拉迪约说明书

[Drug name] Berotralstat capsules, berotralstat, Orladeyo

[Dosage form] Oral capsule (110 mg; 150 mg)

[Mechanism of Action] Oradejo is a plasma kallikrein inhibitor that binds to plasma kallikrein and inhibits its proteolytic activity. In the absence 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. Oladidate reduces plasma kallikrein activity to control excessive bradykinin production in hospitalized patients with HAE.

[Indications] Oradejo is used to prevent hereditary angioedema (HAE) in adults and children over 12 years of age. Oradejo is not suitable for the treatment of HAE that has already occurred and should only be used for prevention.

[Usage and Dosage] The recommended dose is Oradejo, 150 mg capsule, taken orally with food once a day.

[Adverse Reactions] Signs of an allergic reaction: Signs of an allergic reaction, such as rash; hives; itching; redness, swelling, or flaking of the skin with or without fever; wheezing; tightness in the chest or throat; difficulty breathing, swallowing, or speaking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

【Notes】

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

(2) Drug interactions: Inform patients that Oladijo 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.

(3) Not suitable for acute treatment of acute ischemic encephalopathy: It is recommended that patients take commonly used rescue drugs to treat acute ischemic encephalopathy. Inform patients that the safety and effectiveness of using Oladijo as an acute treatment for HAE attacks have not been established. Advise patients not to take daily doses of more than 150 mg or additional doses of Oradejo once daily to treat acute exacerbations of HAE due to the risk of QT prolongation.

[Storage] Store Oradejo at room temperature between 68ºF and 77ºF (20℃ and 25℃).

The above instructions are instructions. Please use the medicine 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.