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Orladeyo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Orladeyo Indications
Indications
Limitations of Use
Orladeyo Dosage and Administration
Adult
Take with food. 150mg once daily. Moderate or severe hepatic impairment (Child-Pugh B or C) or patients with persistent GI reactions: 110mg once daily.
Children
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. Pregnancy. Nursing mothers.
Orladeyo Pharmacokinetics
Absorption
Median time to maximum plasma concentration: 5 hours (range: 1–8 hours).
Distribution
Plasma protein bound: ~99%.
Elimination
Fecal (79%), renal (9%). Half-life: ~93 hours.
Orladeyo Interactions
Interactions
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
Orladeyo Clinical Trials
See Literature
Orladeyo Note
Not Applicable
Orladeyo Patient Counseling
See Literature
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