• Hereditary angioedema

Orladeyo Generic Name & Formulations

General Description

Berotralstat 110mg, 150mg; caps.

Pharmacological Class

Plasma kallikrein inhibitor.

How Supplied


Generic Availability


Orladeyo Indications


Prophylaxis to prevent hereditary angioedema (HAE) attacks.

Limitations of Use

Not for the treatment of acute HAE attacks.

Orladeyo Dosage and Administration


Take with food. 150mg once daily. Moderate or severe hepatic impairment (Child-Pugh B or C), concomitant P-gp or BCRP inhibitors, or patients with persistent GI reactions: 110mg once daily.


<12yrs: not established.

Orladeyo Contraindications

Not Applicable

Orladeyo Boxed Warnings

Not Applicable

Orladeyo Warnings/Precautions


Additional doses or doses >150mg/day: not recommended. Increased risk of QT prolongation at doses >150mg/day. ESRD (CrCl <15mL/min or eGFR <15mL/min/1.73m2 or patients requiring hemodialysis): not recommended. Moderate or severe hepatic impairment (see Adults and Children). Pregnancy. Nursing mothers.

Orladeyo Pharmacokinetics

See Literature

Orladeyo Interactions


Concomitant with P-gp or BCRP inhibitors (eg, cyclosporine); reduce dose (see Adults and Children). May be antagonized by P-gp inducers (eg, rifampin, St. John’s wort); not recommended. Concomitant drugs with a narrow therapeutic index that are predominantly metabolized by CYP2D6 (eg, thioridazine, pimozide) or CYP3A4 (eg, cyclosporine, fentanyl); monitor and titrate dose. Concomitant with P-gp substrates (eg, digoxin); monitor and titrate dose of substrate.

Orladeyo Adverse Reactions

Adverse Reactions

Abdominal pain, vomiting, diarrhea, back pain, gastroesophageal reflux disease.

Orladeyo Clinical Trials

See Literature

Orladeyo Note

Not Applicable

Orladeyo Patient Counseling

See Literature