Berotralstat

What Is Berotralstat?

• Berotralstat (ORLADEYO) is a plasma kallikrein inhibitor, a prescription medicine used to prevent attacks of Hereditary Angioedema (HAE) in adults and children 12 years of age and older.

What are the uses of this medicine?

• This medicine is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older.

How does this medicine work?

• Berotralstat is a plasma kallikrein inhibitor that binds to plasma kallikrein and inhibits its proteolytic activity.
• In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks.
• Berotralstat decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE.

Who Should Not Use this medicine ?

• Berotralstat (ORLADEYO) should not be used for treatment of acute HAE attacks.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• The recommended dosage of Berotralstat is one 150 mg capsule taken orally once daily with food.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• This medicine is available as 150 mg, 110 mg Capsules.

This medicine is available in fallowing brand namesː

• ORLADEYO

What side effects can this medication cause?

Common possible side effects of this medicine include:

• abdominal pain
• vomiting
• diarrhea
• back pain
• gastroesophageal reflux disease

What special precautions should I follow?

• ORLADEYO should not be used for treatment of acute attacks of HAE.
• Additional doses or doses of ORLADEYO higher than 150 mg once daily are not recommended.
• An increase in QT was observed at dosages higher than the recommended 150 mg once daily dosage and was concentration dependent.

What to do in case of emergency/overdose?

Taking more than one capsule of ORLADEYO a day may cause serious side effects, including:

• heart rhythm problems.
• A heart rhythm problem called QT prolongation can happen in people who take more than one capsule of ORLADEYO a day.
• This condition can cause an abnormal heart beat.
• Do not take more than one capsule of ORLADEYO a day.

Can this medicine be used in pregnancy?

• There are insufficient data in pregnant women available to inform drug-related risks with ORLADEYO use in pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of ORLADEYO for prophylaxis to prevent attacks of hereditary angioedema have been established in pediatric patients aged 12 and older.
• The safety and effectiveness of ORLADEYO in pediatric patients < 12 years of age have not been established.

What should I know about storage and disposal of this medication?

• Store ORLADEYO at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• Each carton contains a tamper evident seal.
• Do not use ORLADEYO if the tamper evident seal is broken or missing.

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• Dailymed label info on Berotralstat
• FDA Berotralstat