Indications for ORLADEYO:
Prophylaxis to prevent hereditary angioedema (HAE) attacks.
Limitations of Use:
Not for the treatment of acute HAE attacks.
Adults and Children:
<12yrs: not established. Take with food. ≥12yrs: 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.
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.
Plasma kallikrein inhibitor.
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.
Abdominal pain, vomiting, diarrhea, back pain, gastroesophageal reflux disease.
Generic Drug Availability: