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Berotralstat is a prescription plasma kallikrein inhibitor sold as Orladeyo. It is approved to prevent hereditary angioedema attacks in adults and children age 2 and older. Patients age 12 and older use oral capsules, while younger children use weight-based oral pellets. Berotralstat is taken once daily with food and is not used to treat an acute attack.
read more about berotralstat ...Berotralstat binds to plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein contributes to formation of bradykinin, a potent vasodilator that increases vascular permeability and causes swelling and pain in hereditary angioedema. Reducing kallikrein activity lowers excess bradykinin generation and reduces attack frequency.
Berotralstat is approved for prevention of hereditary angioedema attacks in adults and pediatric patients age 2 and older. It is not indicated for acute attacks. Patients still need access to medicine used for acute hereditary angioedema treatment according to their care plan.
Adults and patients age 12 and older take 150 mg once daily with food. Children age 2 to under 12 use weight-based oral pellets ranging from 72 mg to 132 mg once daily. Moderate or severe liver impairment changes dosing for patients age 12 and older, while use is avoided in younger children with those liver conditions.
Doses above the recommended amount can prolong the QTc interval and cause abnormal heart rhythm. Common adverse reactions include abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. Berotralstat also interacts with several medicines through P-glycoprotein and cytochrome P450 pathways, so the medication list needs review before treatment.
Berotralstat is used to prevent hereditary angioedema attacks in adults and children age 2 and older.
No. Berotralstat is preventive treatment and should not be used for an acute hereditary angioedema attack.
Berotralstat is taken once daily with food. The formulation and dose depend on age, body weight, and liver function.
Yes. Higher-than-recommended dosing has been linked to QTc interval prolongation.
Berotralstat. MedlinePlus. https://www.medlineplus.gov/druginfo/meds/a626011.html. Date Accessed September 16, 2026.
DailyMed - ORLADEYO (berotralstat) capsules and oral pellets. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3527ece1-e7e0-40b1-b0c5-6baeb0deabeb. Date Accessed September 16, 2026.
FDA Label - ORLADEYO (berotralstat) Capsules and Oral Pellets. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214094s005lbl.pdf. Date Accessed September 16, 2026.
ORLADEYO (berotralstat) Prescribing Information. https://www.biocryst.com/wp-content/uploads/sites/13/2025/12/ORLADEYO_USPI.pdf. Date Accessed September 16, 2026.
Orladeyo (berotralstat) Oral Pellets Approval Letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219776Orig1s000ltr.pdf. Date Accessed September 16, 2026.