Drug Detail:Berotralstat (Berotralstat [ ber-oh-tral-stat ])
Drug Class: Hereditary angioedema agents
Usual Adult Dose for Angioedema
Recommended dose: 150 mg orally once daily with food
Maximum dose: 150 mg once daily
Comments:
- This drug should not be used for treatment of acute hereditary angioedema (HAE) attacks.
- Additional doses or doses higher than 150 mg once daily are not recommended due to the potential for QT prolongation.
Use: To prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older
Usual Pediatric Dose for Angioedema
12 years of age and older:
Recommended dose: 150 mg orally once daily with food
Maximum dose: 150 mg once daily
Comments:
- The safety and effectiveness of this drug in patients younger than 12 years old have not been established.
- This drug should not be used for treatment of acute hereditary angioedema (HAE) attacks.
- Additional doses or doses higher than 150 mg once daily are not recommended due to the potential for QT prolongation
Use: To prevent attacks of hereditary angioedema (HAE) in pediatric patients 12 years of age and older
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
Mild liver dysfunction: No adjustment recommended
Moderate and Severe liver dysfunction (Child-Pugh B or C): 110 mg once daily with food
Dose Adjustments
Recommended dosage for concomitant chronic use with P-gp (P glycoprotein) or BCRP (Breast Cancer Resistance Protein) inhibitors: 110 mg orally once daily with food
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 12 years.
Consult WARNINGS section for additional precautions.
Dialysis
Not recommended in patients with end-stage renal disease (ClCr less than 15 mL/min) or patients requiring hemodialysis.
Other Comments
Administration advice:
- Take with food only one capsule per day
Storage requirements:
- Store at 20C to 25C (68F to 77F)
Patient advice:
- Do not take more than one capsule a day.
- This drug may interact with other drugs. Report to your healthcare provider the use of any other prescription or nonprescription medication or herbal products.
- This drug is not to treat an acute attack of HAE. Take your usual rescue medication.
