Berotralstat Dosage

Medically reviewed by Drugs.com. Last updated on Feb 1, 2023.

Applies to the following strengths: 150 mg; 110 mg

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.