Orladeyo Generic Name & Formulations
Berotralstat 110mg, 150mg; caps.
Plasma kallikrein inhibitor.
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 Boxed Warnings
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.
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
Abdominal pain, vomiting, diarrhea, back pain, gastroesophageal reflux disease.
Orladeyo Clinical Trials
Orladeyo Patient Counseling