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Berotralstat Dosage

Medically reviewed by Drugs.com. Last updated on Feb 11, 2021.

Applies to the following strengths: 150 mg; 110 mg

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

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.

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