Qulipta Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.
Qulipta Indications
Indications
Preventive treatment of migraine.
Qulipta Dosage and Administration
Adult
Episodic: 10mg, 30mg, or 60mg once daily. Chronic: 60mg once daily. Concomitant strong CYP3A4 inhibitors (episodic): 10mg once daily; (chronic): avoid use. Concomitant strong, moderate, or weak CYP3A4 inducers (episodic): 30mg or 60mg once daily; (chronic): avoid use. Concomitant OATP inhibitors (episodic): 10mg or 30mg once daily; (chronic): 30mg once daily. Severe renal impairment, ESRD (episodic): 10mg once daily; (chronic): avoid use.
Children
Renal Impairment
Patients with severe renal impairment (CrCl 15–29 mL/min), and in patients with end-stage renal disease (ESRD) (CrCl <15 mL/min), the recommended dosage is 10mg once daily.
Patients with ESRD undergoing intermittent dialysis: Take Qulipta after dialysis.
No dosage adjustment is recommended for patients with mild/moderate renal impairment.
Hepatic Impairment
Mild or moderate hepatic impairment: No dose adjustment recommended.
Severe hepatic impairment: Avoid use.
Qulipta Contraindications
Not Applicable
Qulipta Boxed Warnings
Not Applicable
Qulipta Warnings/Precautions
Warnings/Precautions
Discontinue if hypersensitivity reaction occurs; treat appropriately. Severe hepatic impairment: avoid. Severe renal impairment (CrCl 15–29mL/min), ESRD (CrCl <15mL/min): adjust dose; see Adult. ESRD on intermittent dialysis: give after session. Elderly. Pregnancy. Nursing mothers.
Qulipta Pharmacokinetics
Absorption
Peak plasma concentrations ~1 to 2 hours.
Distribution
Unbound fraction of atogepant was ~4.7% in human plasma.
Elimination
Half-life: ~11 hours. Fecal (42%), renal (5%)
Qulipta Interactions
Interactions
Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin) or OATP inhibitors (eg, cyclosporine, rifampin); adjust dose with concomitant use; see Adult. Antagonized by strong, moderate, or weak CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John's wort, efavirenz, etravirine); adjust dose with concomitant use; see Adult.
Qulipta Adverse Reactions
Adverse Reactions
Nausea, constipation, fatigue/somnolence.
Qulipta Clinical Trials
Qulipta Note
Not Applicable
Qulipta Patient Counseling
Cost Savings Program
Images
