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Outline
What is the generic name?
BEROTRALSTAT HYDROCHLORIDE
What is the Trade Name for BEROTRALSTAT HYDROCHLORIDE?
Orladeyo
What are the Indications for BEROTRALSTAT HYDROCHLORIDE?
- 1 INDICATIONS AND USAGE ORLADEYO‚Ñ¢ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older. ORLADEYO is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. ( 1 ) Limitations of Use : ORLADEYO should not be used for treatment of acute HAE attacks. ( 1 ) Limitations of Use : The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for treatment of acute HAE attacks. Additional doses or doses of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation [see Warnings and Precautions (5.1) ].
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References: https://open.fda.gov/
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