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Orladeyo Generic Name & Formulations
Legal Class
Rx
General Description
Berotralstat 110mg, 150mg; caps.
Pharmacological Class
Plasma kallikrein inhibitor.
How Supplied
Caps—28
Manufacturer
Generic Availability
NO
Orladeyo Indications
Indications
Prophylaxis to prevent hereditary angioedema (HAE) attacks.
Limitations of Use
Not for the treatment of acute HAE attacks.
Orladeyo Dosage and Administration
Adult
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.
Children
<12yrs: not established.
Orladeyo Contraindications
Not Applicable
Orladeyo Boxed Warnings
Not Applicable
Orladeyo Warnings/Precautions
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
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
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