Berotralstat
What Is Berotralstat?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- 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 ?[edit | edit source]
- Berotralstat (ORLADEYO) should not be used for treatment of acute HAE attacks.
Is this medicine FDA approved?[edit | edit source]
- It was approved for use in the United States in 2020.
How should this medicine be used?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
Common possible side effects of this medicine include:
- abdominal pain
- vomiting
- diarrhea
- back pain
- gastroesophageal reflux disease
What special precautions should I follow?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- 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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