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  • CLASSES

    Calcitonin Gene-Related Peptide (CGRP) Antagonists

    DEA CLASS

    Rx

    DESCRIPTION

    Oral, calcitonin gene-related peptide (CGRP) receptor antagonist
    Used for the acute treatment of migraine with or without aura
    Coadministration of certain other drugs may need to be avoided or dosage adjustments may be necessary

    COMMON BRAND NAMES

    Ubrelvy

    HOW SUPPLIED

    Ubrelvy Oral Tab: 50mg, 100mg

    DOSAGE & INDICATIONS

    For the acute treatment of migraine with or without aura.
    Oral dosage
    Adults

    50 or 100 mg PO as a single dose. A second dose may be taken at least 2 hours after the initial dose if needed. Max: 200 mg/day. The safety of treating more than 8 migraines within 30 days has not been established. Coadministration of certain other drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

    MAXIMUM DOSAGE

    Adults

    200 mg/day PO.

    Geriatric

    200 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment is needed in mild or moderate hepatic impairment (Child-Pugh Class A or B). Limit the initial and second dose of ubrogepant to 50 mg in patients with severe hepatic disease (Child-Pugh Class C).

    Renal Impairment

    No dosage adjustment is needed with mild or moderate renal impairment (CrCl 30 mL/minute or more). Limit the initial and second dose of ubrogepant to 50 mg in patients with severe renal impairment (CrCl 15 to 29 mL/minute). Avoid ubrogepant use in end-stage renal disease (CrCl less than 15 mL/minute).

    ADMINISTRATION

    Oral Administration
    Oral Solid Formulations

    Administer with or without food.

    STORAGE

    Ubrelvy:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    - Store in a cool, well ventilated, dry place

    CONTRAINDICATIONS / PRECAUTIONS

    Hepatic disease

    In patients with preexisting mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe hepatic impairment (Child-Pugh Class C), ubrogepant exposure was increased by 7%, 50%, and 115%, respectively. Ubrogepant dose adjustment is recommended for patients with severe hepatic disease.

    Renal disease, renal failure, renal impairment

    The renal route of elimination plays a minor role in the clearance of ubrogepant. Dose adjustment is recommended for patients with severe renal impairment (CrCl 15 to 29 mL/minute). Avoid ubrogepant use in patients with renal failure or end-stage renal disease (CrCl less than 15 mL/minute).

    Pregnancy

    There are no adequate data on the developmental risk associated with ubrogepant use during human pregnancy. Women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. In pregnant rabbits, ubrogepant (0, 15, 45, 75, or 250 mg/kg/day) administered orally throughout organogenesis resulted in abortion and increased embryofetal mortality in surviving offspring at the highest dose tested (250 mg/kg/day). Plasma exposure (AUC) at the highest no-effect dose (75 mg/kg/day) for adverse effects on embryofetal development in rabbits is approximately 8 times that in humans at the maximum recommended human dose (MRHD). Oral administration of ubrogepant (0, 25, 60, or 160 mg/kg/day) throughout gestation and lactation resulted in decreased body weight in the offspring of pregnant rats at birth and during the lactation period at the mid and high doses. Plasma exposure (AUC) at the no-effect dose for adverse effects on pre- and postnatal development in rats (25 mg/kg/day) is approximately 15 times that in humans at the MRHD.

    Breast-feeding

    There are no data on the presence of ubrogepant in human milk, the effects on the breast-fed infant, or the effects on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for ubrogepant and any potential adverse effects on the breast-fed infant from ubrogepant or the underlying maternal condition. In lactating rats, oral dosing with ubrogepant resulted in concentrations of ubrogepant in milk comparable to peak plasma concentrations.

    ADVERSE REACTIONS

    Mild

    nausea / Early / 2.0-4.0
    fatigue / Early / 2.0-3.0
    xerostomia / Early / 0-2.0

    DRUG INTERACTIONS

    Abrocitinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with abrocitinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; abrocitinib is a P-gp inhibitor.
    Acalabrutinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with acalabrutinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; acalabrutinib is a BCRP inhibitor.
    Amiodarone: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with amiodarone. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; amiodarone is a moderate CYP3A4 inhibitor and a P-gp inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Amobarbital: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with amobarbital as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; amobarbital is a moderate CYP3A4 inducer.
    Amoxicillin; Clarithromycin; Omeprazole: (Contraindicated) Coadministration of ubrogepant and clarithromycin is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; clarithromycin is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Apalutamide: (Major) Avoid the coadministration of ubrogepant and apalutamide as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; apalutamide is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Aprepitant, Fosaprepitant: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with aprepitant. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate. Aprepitant, when administered as a 3-day oral regimen (125 mg/80 mg/80 mg), is a moderate CYP3A4 inhibitor. When administered as a single oral or single intravenous dose, the inhibitory effect of aprepitant on CYP3A4 is weak and did not result in a clinically significant increase in the AUC of a sensitive substrate. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Armodafinil: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with armodafinil as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; armodafinil is a weak CYP3A4 inducer.
    Asciminib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with asciminib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A substrate; asciminib is a weak CYP3A inhibitor.
    Aspirin, ASA; Butalbital; Caffeine: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with butalbital as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; butalbital is a moderate CYP3A4 inducer.
    Aspirin, ASA; Butalbital; Caffeine; Codeine: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with butalbital as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; butalbital is a moderate CYP3A4 inducer.
    Atazanavir: (Contraindicated) Coadministration of ubrogepant and atazanavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; atazanavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Atazanavir; Cobicistat: (Contraindicated) Coadministration of ubrogepant and atazanavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; atazanavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant. (Contraindicated) Coadministration of ubrogepant and cobicistat is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; cobicistat is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Avacopan: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with avacopan. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A substrate; avacopan is a weak CYP3A inhibitor.
    Belumosudil: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with belumosudil. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A substrate; belumosudil is a weak CYP3A inhibitor.
    Belzutifan: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with belzutifan as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A substrate; belzutifan is a weak CYP3A inducer.
    Berotralstat: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with berotralstat. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; berotralstat is a P-gp and moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Bexarotene: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with bexarotene as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; bexarotene is a moderate CYP3A4 inducer.
    Bicalutamide: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with bicalutamide. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; bicalutamide is a weak CYP3A4 inhibitor.
    Bosentan: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with bosentan as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; bosentan is a moderate CYP3A4 inducer.
    Brigatinib: (Major) Ubrogepant dose adjustment is necessary if coadministered with brigatinib as concurrent use may decrease ubrogepant exposure and efficacy or increase ubrogepant exposure and side effects. Ubrogepant is a P-glycoprotein (P-gp), BCRP, and CYP3A substrate; brigatinib is a P-gp and BRCP inhibitor and a weak CYP3A inducer.
    Butabarbital: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with butabarbital as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; butabarbital is a moderate CYP3A4 inducer.
    Butalbital; Acetaminophen: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with butalbital as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; butalbital is a moderate CYP3A4 inducer.
    Butalbital; Acetaminophen; Caffeine: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with butalbital as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; butalbital is a moderate CYP3A4 inducer.
    Butalbital; Acetaminophen; Caffeine; Codeine: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with butalbital as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; butalbital is a moderate CYP3A4 inducer.
    Cabozantinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with cabozantinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; cabozantinib is a P-gp inhibitor.
    Cannabidiol: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with cannabidiol. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; cannabidiol is a P-gp inhibitor.
    Capmatinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with capmatinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-glycoprotein (P-gp) drug transporters; capmatinib is a BCRP and P-gp inhibitor.
    Carbamazepine: (Major) Avoid the coadministration of ubrogepant and carbamazepine as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; carbamazepine is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Carvedilol: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with carvedilol. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; carvedilol is a P-gp inhibitor.
    Cenobamate: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with cenobamate as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; cenobamate is a moderate CYP3A4 inducer.
    Ceritinib: (Contraindicated) Coadministration of ubrogepant and ceritinib is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ceritinib is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Chloramphenicol: (Contraindicated) Coadministration of ubrogepant and chloramphenicol is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; chloramphenicol is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Cimetidine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with cimetidine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; cimetidine is a weak CYP3A4 inhibitor.
    Ciprofloxacin: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with ciprofloxacin. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ciprofloxacin is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Clarithromycin: (Contraindicated) Coadministration of ubrogepant and clarithromycin is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; clarithromycin is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Clobazam: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with clobazam as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; clobazam is a weak CYP3A4 inducer.
    Cobicistat: (Contraindicated) Coadministration of ubrogepant and cobicistat is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; cobicistat is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Cocaine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with cocaine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; cocaine is a weak CYP3A4 inhibitor.
    Conivaptan: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with conivaptan. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A and P-gp substrate; conivaptan is a moderate CYP3A and P-gp inhibitor. Coadministration with another moderate CYP3A inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Crizotinib: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with crizotinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; crizotinib is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Cyclosporine: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with cyclosporine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4, BCRP, and P-gp substrate; cyclosporine is a moderate CYP3A4 inhibitor and a BCRP and P-gp inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Dabrafenib: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with dabrafenib as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; dabrafenib is a moderate CYP3A4 inducer.
    Daclatasvir: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with daclatasvir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; daclatasvir is a BCRP and P-gp inhibitor.
    Dalfopristin; Quinupristin: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with quinupristin. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; quinupristin is a weak CYP3A4 inhibitor.
    Danazol: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with danazol. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; danazol is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Darolutamide: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with darolutamide. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; darolutamide is a BCRP inhibitor.
    Darunavir: (Contraindicated) Coadministration of ubrogepant and darunavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; darunavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Darunavir; Cobicistat: (Contraindicated) Coadministration of ubrogepant and cobicistat is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; cobicistat is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant. (Contraindicated) Coadministration of ubrogepant and darunavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; darunavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: (Contraindicated) Coadministration of ubrogepant and cobicistat is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; cobicistat is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant. (Contraindicated) Coadministration of ubrogepant and darunavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; darunavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir: (Contraindicated) Coadministration of ubrogepant and ritonavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ritonavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant. (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with dasabuvir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; dasabuvir is a BCRP inhibitor. (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with paritaprevir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; paritaprevir is a BCRP inhibitor.
    Deferasirox: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with deferasirox as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; deferasirox is a weak CYP3A4 inducer.
    Delavirdine: (Contraindicated) Coadministration of ubrogepant and delavirdine is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; delavirdine is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Dexamethasone: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with dexamethasone as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; dexamethasone is a moderate CYP3A4 inducer.
    Dextromethorphan; Quinidine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with quinidine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; quinidine is a P-gp inhibitor.
    Diltiazem: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with diltiazem. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; diltiazem is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Dronedarone: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with dronedarone. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; dronedarone is a moderate CYP3A4 inhibitor and a P-gp inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Duvelisib: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with duvelisib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; duvelisib is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Efavirenz: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with efavirenz as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; efavirenz is a moderate CYP3A4 inducer.
    Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with efavirenz as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; efavirenz is a moderate CYP3A4 inducer.
    Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with efavirenz as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; efavirenz is a moderate CYP3A4 inducer.
    Elagolix: (Major) Ubrogepant dose adjustment is necessary if coadministered with elagolix as concurrent use may decrease ubrogepant exposure and efficacy or increase ubrogepant exposure and side effects. Ubrogepant is a CYP3A4 and P-gp substrate; elagolix is a moderate CYP3A4 inducer and a P-gp inhibitor.
    Elagolix; Estradiol; Norethindrone acetate: (Major) Ubrogepant dose adjustment is necessary if coadministered with elagolix as concurrent use may decrease ubrogepant exposure and efficacy or increase ubrogepant exposure and side effects. Ubrogepant is a CYP3A4 and P-gp substrate; elagolix is a moderate CYP3A4 inducer and a P-gp inhibitor.
    Elbasvir; Grazoprevir: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with elbasvir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; elbasvir is a BCRP inhibitor. (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with grazoprevir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and BCRP substrate; grazoprevir is a weak CYP3A4 inhibitor and a BCRP inhibitor.
    Elexacaftor; tezacaftor; ivacaftor: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with ivacaftor. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; ivacaftor is a weak CYP3A4 inhibitor and a P-gp inhibitor.
    Eliglustat: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with eliglustat. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; eliglustat is a P-gp inhibitor.
    Eltrombopag: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with eltrombopag. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; eltrombopag is a BCRP inhibitor.
    Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide: (Contraindicated) Coadministration of ubrogepant and cobicistat is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; cobicistat is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate: (Contraindicated) Coadministration of ubrogepant and cobicistat is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; cobicistat is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Enasidenib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with enasidenib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; enasidenib is a BCRP and P-gp inhibitor.
    Encorafenib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with encorafenib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; encorafenib is a BCRP inhibitor.
    Enzalutamide: (Major) Avoid the coadministration of ubrogepant and enzalutamide as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; enzalutamide is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Erythromycin: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with erythromycin. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; erythromycin is a moderate CYP3A4 inhibitor and a P-gp inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Eslicarbazepine: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with eslicarbazepine as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; eslicarbazepine is a moderate CYP3A4 inducer.
    Etravirine: (Major) Ubrogepant dose adjustment is necessary if coadministered with etravirine as concurrent use may decrease ubrogepant exposure and efficacy or increase ubrogepant exposure and side effects. Ubrogepant is a CYP3A4 and P-gp substrate; etravirine is a moderate CYP3A4 inducer and P-gp inhibitor.
    Everolimus: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with everolimus. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; everolimus is a weak CYP3A4 inhibitor.
    Fedratinib: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with fedratinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; fedratinib is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Flibanserin: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with flibanserin. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; flibanserin is a P-gp inhibitor.
    Fluconazole: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with fluconazole. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; fluconazole is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Fluoxetine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with fluoxetine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; fluoxetine is a weak CYP3A4 inhibitor.
    Fluvoxamine: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with fluvoxamine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; fluvoxamine is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Fosamprenavir: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with fosamprenavir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A substrate; fosamprenavir is a moderate CYP3A inhibitor. Coadministration with another moderate CYP3A inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Fosphenytoin: (Major) Avoid the coadministration of ubrogepant and fosphenytoin as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; fosphenytoin is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Fostamatinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with fostamatinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4, BCRP, and P-gp substrate; fostamatinib is a weak CYP3A4 inhibitor and a BCRP and P-gp inhibitor.
    Fostemsavir: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with fostemsavir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; fostemsavir is a BCRP inhibitor.
    Futibatinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with futibatinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a P-gp and BCRP substrate and futibatinib is a P-gp and BCRP inhibitor.
    Gilteritinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with gilteritinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; gilteritinib is a BCRP and P-gp inhibitor.
    Glecaprevir; Pibrentasvir: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with glecaprevir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; glecaprevir is a BCRP and P-gp inhibitor. (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with pibrentasvir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; pibrentasvir is a BCRP and P-gp inhibitor.
    Grapefruit juice: (Contraindicated) Coadministration of ubrogepant and grapefruit juice is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; grapefruit juice is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Ibrutinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with ibrutinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; ibrutinib is a BCRP and P-gp inhibitor.
    Idelalisib: (Contraindicated) Coadministration of ubrogepant and idelalisib is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; idelalisib is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Imatinib: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with imatinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; imatinib is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Indinavir: (Contraindicated) Coadministration of ubrogepant and indinavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; indinavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Isavuconazonium: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with isavuconazonium. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; isavuconazonium is a moderate CYP3A4 inhibitor and a P-gp inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Isoniazid, INH: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with isoniazid. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; isoniazid is a weak CYP3A4 inhibitor.
    Isoniazid, INH; Pyrazinamide, PZA; Rifampin: (Major) Avoid the coadministration of ubrogepant and rifampin as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; rifampin is a strong CYP3A4 inducer. Coadministration with rifampin resulted in an 80% reduction in ubrogepant exposure. (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with isoniazid. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; isoniazid is a weak CYP3A4 inhibitor.
    Isoniazid, INH; Rifampin: (Major) Avoid the coadministration of ubrogepant and rifampin as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; rifampin is a strong CYP3A4 inducer. Coadministration with rifampin resulted in an 80% reduction in ubrogepant exposure. (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with isoniazid. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; isoniazid is a weak CYP3A4 inhibitor.
    Istradefylline: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with istradefylline. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; istradefylline is a weak CYP3A4 inhibitor and a P-gp inhibitor.
    Itraconazole: (Contraindicated) Coadministration of ubrogepant and itraconazole is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; itraconazole is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Ivacaftor: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with ivacaftor. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; ivacaftor is a weak CYP3A4 inhibitor and a P-gp inhibitor.
    Ketoconazole: (Contraindicated) Coadministration of ubrogepant and ketoconazole is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ketoconazole is a strong CYP3A4 inhibitor. Coadministration with ketoconazole resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Lansoprazole; Amoxicillin; Clarithromycin: (Contraindicated) Coadministration of ubrogepant and clarithromycin is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; clarithromycin is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Lapatinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with lapatinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; lapatinib is a weak CYP3A4 inhibitor and a P-gp inhibitor.
    Larotrectinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with larotrectinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; larotrectinib is a weak CYP3A4 inhibitor.
    Lasmiditan: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with lasmiditan. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a P-gp substrate and lasmiditan is a P-gp inhibitor.
    Ledipasvir; Sofosbuvir: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with ledipasvir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; ledipasvir is a BCRP and P-gp inhibitor.
    Lefamulin: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with oral lefamulin. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate, and oral lefamulin is a moderate CYP3A4 inhibitor; an interaction is not expected with intravenous lefamulin. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Leflunomide: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with leflunomide. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; leflunomide is a BCRP inhibitor.
    Lesinurad: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with lesinurad as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; lesinurad is a weak CYP3A4 inducer.
    Lesinurad; Allopurinol: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with lesinurad as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; lesinurad is a weak CYP3A4 inducer.
    Letermovir: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with letermovir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; letermovir is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Levoketoconazole: (Contraindicated) Coadministration of ubrogepant and ketoconazole is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ketoconazole is a strong CYP3A4 inhibitor. Coadministration with ketoconazole resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Lomitapide: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with lomitapide. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; lomitapide is a P-gp inhibitor.
    Lonafarnib: (Contraindicated) Coadministration of ubrogepant and lonafarnib is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; lonafarnib is a P-gp and strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Lopinavir; Ritonavir: (Contraindicated) Coadministration of ubrogepant and ritonavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ritonavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Lorlatinib: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with lorlatinib as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; lorlatinib is a moderate CYP3A4 inducer.
    Lumacaftor; Ivacaftor: (Major) Avoid the coadministration of ubrogepant and lumacaftor as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; lumacaftor is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure. (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with ivacaftor. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; ivacaftor is a weak CYP3A4 inhibitor and a P-gp inhibitor.
    Lumacaftor; Ivacaftor: (Major) Avoid the coadministration of ubrogepant and lumacaftor as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; lumacaftor is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Maribavir: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with maribavir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A, P-gp, and BCRP substrate; maribavir is a P-gp, BCRP, and weak CYP3A inhibitor.
    Mavacamten: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with mavacamten as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A substrate; mavacamten is a moderate CYP3A inducer.
    Mefloquine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with mefloquine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; mefloquine is a P-gp inhibitor.
    Methohexital: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with methohexital as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; methohexital is a moderate CYP3A4 inducer.
    Midostaurin: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with midostaurin. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; midostaurin is a BCRP inhibitor.
    Mifepristone: (Contraindicated) Coadministration of ubrogepant and mifepristone is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; mifepristone is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Mitapivat: (Major) Ubrogepant dose adjustment is necessary if coadministered with mitapivat as concurrent use may decrease ubrogepant exposure and efficacy or increase ubrogepant exposure and side effects. Ubrogepant is a CYP3A and P-gp substrate and mitapivat is a weak CYP3A inducer and P-gp inhibitor.
    Mitotane: (Major) Avoid the coadministration of ubrogepant and mitotane as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; mitotane is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Mobocertinib: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with mobocertinib as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A substrate; mobocertinib is a weak CYP3A inducer.
    Modafinil: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with modafinil as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; modafinil is a moderate CYP3A4 inducer.
    Nafcillin: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with nafcillin as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; nafcillin is a moderate CYP3A4 inducer.
    Nanoparticle Albumin-Bound Sirolimus: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with sirolimus. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; sirolimus is a BCRP inhibitor.
    Nefazodone: (Contraindicated) Coadministration of ubrogepant and nefazodone is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; nefazodone is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Nelfinavir: (Contraindicated) Coadministration of ubrogepant and nelfinavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; nelfinavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Neratinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with neratinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; neratinib is a P-gp inhibitor.
    Netupitant, Fosnetupitant; Palonosetron: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with netupitant. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; netupitant is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Nevirapine: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with nevirapine as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; nevirapine is a weak CYP3A4 inducer.
    Nicardipine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with nicardipine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; nicardipine is a weak CYP3A4 inhibitor.
    Nilotinib: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with nilotinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; nilotinib is a moderate CYP3A4 inhibitor. Coadministration with another moderate CYP3A4 inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Nirmatrelvir; Ritonavir: (Contraindicated) Coadministration of ubrogepant and ritonavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ritonavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant. (Contraindicated) Concomitant use of ritonavir-boosted nirmatrelvir and ubrogepant is contraindicated due to the potential for serious adverse reactions; consider an alternative COVID-19 therapy. Coadministration may increase ubrogepant exposure resulting in increased toxicity. Ubrogepant is a CYP3A4 substrate and nirmatrelvir is a CYP3A inhibitor.
    Odevixibat: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with odevixibat as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A substrate; odevixibat is a weak CYP3A inducer.
    Olanzapine; Fluoxetine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with fluoxetine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; fluoxetine is a weak CYP3A4 inhibitor.
    Ombitasvir; Paritaprevir; Ritonavir: (Contraindicated) Coadministration of ubrogepant and ritonavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ritonavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant. (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with paritaprevir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; paritaprevir is a BCRP inhibitor.
    Omeprazole; Amoxicillin; Rifabutin: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with rifabutin as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; rifabutin is a moderate CYP3A4 inducer.
    Oritavancin: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with oritavancin as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; oritavancin is a weak CYP3A4 inducer.
    Osilodrostat: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with osilodrostat. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; osilodrostat is a weak CYP3A4 inhibitor.
    Osimertinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with osimertinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; osimertinib is a BCRP and P-gp inhibitor.
    Oteseconazole: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with oteseconazole. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of BCRP; oteseconazole is a BCRP inhibitor.
    Oxcarbazepine: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with oxcarbazepine as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; oxcarbazepine is a weak CYP3A4 inducer.
    Pacritinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with pacritinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of CYP3A4, P-gp, and BCRP; pacritinib is a weak CYP3A4 inhibitor, a P-gp inhibitor, and a BCRP inhibitor.
    Palbociclib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with palbociclib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; palbociclib is a weak CYP3A4 inhibitor.
    Pazopanib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with pazopanib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; pazopanib is a weak CYP3A4 inhibitor.
    Pexidartinib: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with pexidartinib as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; pexidartinib is a moderate CYP3A4 inducer.
    Phenobarbital: (Major) Avoid the coadministration of ubrogepant and phenobarbital as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; phenobarbital is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Phenobarbital; Hyoscyamine; Atropine; Scopolamine: (Major) Avoid the coadministration of ubrogepant and phenobarbital as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; phenobarbital is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Phenytoin: (Major) Avoid the coadministration of ubrogepant and phenytoin as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; phenytoin is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Posaconazole: (Contraindicated) Coadministration of ubrogepant and posaconazole is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; posaconazole is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Primidone: (Major) Avoid the coadministration of ubrogepant and primidone as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; primidone is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Propafenone: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with propafenone. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; propafenone is a P-gp inhibitor.
    Quinidine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with quinidine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; quinidine is a P-gp inhibitor.
    Quinine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with quinine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; quinine is a P-gp inhibitor.
    Ranolazine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with ranolazine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; ranolazine is a weak CYP3A4 inhibitor and a P-gp inhibitor.
    Regorafenib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with regorafenib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; regorafenib is a BCRP inhibitor.
    Ribociclib: (Contraindicated) Coadministration of ubrogepant and ribociclib is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ribociclib is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Ribociclib; Letrozole: (Contraindicated) Coadministration of ubrogepant and ribociclib is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ribociclib is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Rifabutin: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with rifabutin as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; rifabutin is a moderate CYP3A4 inducer.
    Rifampin: (Major) Avoid the coadministration of ubrogepant and rifampin as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; rifampin is a strong CYP3A4 inducer. Coadministration with rifampin resulted in an 80% reduction in ubrogepant exposure.
    Rifapentine: (Major) Avoid the coadministration of ubrogepant and rifapentine as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; rifapentine is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Ritonavir: (Contraindicated) Coadministration of ubrogepant and ritonavir is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; ritonavir is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Rucaparib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with rucaparib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; rucaparib is a weak CYP3A4 inhibitor.
    Safinamide: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with safinamide. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; safinamide is a BCRP and P-gp inhibitor.
    Saquinavir: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with saquinavir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; saquinavir is a P-gp inhibitor.
    Sarecycline: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with sarecycline. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; sarecycline is a P-gp inhibitor.
    Secobarbital: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with secobarbital as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; secobarbital is a moderate CYP3A4 inducer.
    Selpercatinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with selpercatinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; selpercatinib is a weak CYP3A4 inhibitor and a P-gp inhibitor.
    Simeprevir: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with simeprevir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4, BCRP, and P-gp substrate; simeprevir is a weak CYP3A4 inhibitor and a BCRP and P-gp inhibitor.
    Sirolimus: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with sirolimus. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; sirolimus is a BCRP inhibitor.
    Sofosbuvir; Velpatasvir: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with velpatasvir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; velpatasvir is a BCRP and P-gp inhibitor.
    Sofosbuvir; Velpatasvir; Voxilaprevir: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with velpatasvir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; velpatasvir is a BCRP and P-gp inhibitor. (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with voxilaprevir. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; voxilaprevir is a BCRP and P-gp inhibitor.
    Sorafenib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with sorafenib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; sorafenib is a P-gp inhibitor.
    Sotorasib: (Major) Avoid concurrent use of sotorasib and ubrogepant due to unpredictable effects. Coadministration may alter the exposure of ubrogepant resulting in decreased efficacy or increased toxicity. Ubrogepant is a CYP3A4 and P-gp substrate; sotorasib is a moderate CYP3A4 inducer and P-gp inhibitor.
    Spironolactone: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with spironolactone. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; spironolactone is a weak CYP3A4 inhibitor.
    Spironolactone; Hydrochlorothiazide, HCTZ: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with spironolactone. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; spironolactone is a weak CYP3A4 inhibitor.
    St. John's Wort, Hypericum perforatum: (Major) Avoid the coadministration of ubrogepant and St. John's Wort as concurrent use may decrease ubrogepant exposure and reduce the efficacy. Ubrogepant is a CYP3A4 substrate; St. John's Wort is a strong CYP3A4 inducer. Coadministration with another strong CYP3A4 inducer resulted in an 80% reduction in ubrogepant exposure.
    Streptogramins: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with quinupristin. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; quinupristin is a weak CYP3A4 inhibitor.
    Sulfasalazine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with sulfasalazine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; sulfasalazine is a BCRP inhibitor.
    Tacrolimus: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with tacrolimus. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; tacrolimus is a BCRP inhibitor.
    Tafamidis: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with tafamidis. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; tafamidis is a BCRP inhibitor.
    Tazemetostat: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with tazemetostat as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; tazemetostat is a weak CYP3A4 inducer.
    Tecovirimat: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with tecovirimat as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; tecovirimat is a weak CYP3A4 inducer.
    Tedizolid: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with tedizolid. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; tedizolid is a BCRP inhibitor.
    Telithromycin: (Contraindicated) Coadministration of ubrogepant and telithromycin is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; telithromycin is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Telotristat Ethyl: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with telotristat as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; telotristat is a weak CYP3A4 inducer.
    Temsirolimus: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with temsirolimus. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; temsirolimus is a P-gp inhibitor.
    Tepotinib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with tepotinib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; tepotinib is a P-gp inhibitor.
    Teriflunomide: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with teriflunomide. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP drug transporter; teriflunomide is a BCRP inhibitor.
    Tezacaftor; Ivacaftor: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with ivacaftor. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; ivacaftor is a weak CYP3A4 inhibitor and a P-gp inhibitor.
    Ticagrelor: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with ticagrelor. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; ticagrelor is a weak CYP3A4 inhibitor and a P-gp inhibitor.
    Trandolapril; Verapamil: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with verapamil. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; verapamil is a moderate CYP3A4 inhibitor and a P-gp inhibitor. Coadministration with verapamil resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Tucatinib: (Contraindicated) Coadministration of ubrogepant and tucatinib is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-glycoprotein (P-gp) substrate; tucatinib is a strong CYP3A4 inhibitor and P-gp inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Valproic Acid, Divalproex Sodium: (Major) Ubrogepant dose adjustment is necessary if coadministered with valproic acid as concurrent use may decrease ubrogepant exposure and efficacy or increase ubrogepant exposure and side effects. Ubrogepant is a CYP3A4 substrate; valproic acid is a weak CYP3A4 inhibitor and inducer.
    Vemurafenib: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with vemurafenib. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the BCRP and P-gp drug transporters; vemurafenib is a BCRP and P-gp inhibitor.
    Venetoclax: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with venetoclax. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; venetoclax is a P-gp inhibitor.
    Verapamil: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with verapamil. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 and P-gp substrate; verapamil is a moderate CYP3A4 inhibitor and a P-gp inhibitor. Coadministration with verapamil resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Viloxazine: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with viloxazine. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; viloxazine is a weak CYP3A4 inhibitor.
    Voclosporin: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with voclosporin. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a P-gp substrate; voclosporin is a P-gp inhibitor.
    Vonoprazan; Amoxicillin: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with vonoprazan. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A substrate and vonoprazan is a weak CYP3A inhibitor.
    Vonoprazan; Amoxicillin; Clarithromycin: (Contraindicated) Coadministration of ubrogepant and clarithromycin is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; clarithromycin is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant. (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with vonoprazan. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A substrate and vonoprazan is a weak CYP3A inhibitor.
    Voriconazole: (Contraindicated) Coadministration of ubrogepant and voriconazole is contraindicated as concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; voriconazole is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor resulted in a 9.7-fold increase in the exposure of ubrogepant.
    Voxelotor: (Major) Limit the initial dose of ubrogepant to 50 mg and avoid a second dose within 24 hours if coadministered with voxelotor. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A substrate; voxelotor is a moderate CYP3A inhibitor. Coadministration with another moderate CYP3A inhibitor resulted in a 3.5-fold increase in the exposure of ubrogepant.
    Zafirlukast: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with zafirlukast. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a CYP3A4 substrate; zafirlukast is a weak CYP3A4 inhibitor.
    Zanubrutinib: (Major) Increase the initial and second dose of ubrogepant to 100 mg if coadministered with zanubrutinib as concurrent use may decrease ubrogepant exposure and reduce its efficacy. Ubrogepant is a CYP3A4 substrate; zanubrutinib is a weak CYP3A4 inducer.
    Zonisamide: (Major) Limit the initial and second dose of ubrogepant to 50 mg if coadministered with zonisamide. Concurrent use may increase ubrogepant exposure and the risk of adverse effects. Ubrogepant is a substrate of the P-gp drug transporter; zonisamide is a P-gp inhibitor.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no adequate data on the developmental risk associated with ubrogepant use during human pregnancy. Women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. In pregnant rabbits, ubrogepant (0, 15, 45, 75, or 250 mg/kg/day) administered orally throughout organogenesis resulted in abortion and increased embryofetal mortality in surviving offspring at the highest dose tested (250 mg/kg/day). Plasma exposure (AUC) at the highest no-effect dose (75 mg/kg/day) for adverse effects on embryofetal development in rabbits is approximately 8 times that in humans at the maximum recommended human dose (MRHD). Oral administration of ubrogepant (0, 25, 60, or 160 mg/kg/day) throughout gestation and lactation resulted in decreased body weight in the offspring of pregnant rats at birth and during the lactation period at the mid and high doses. Plasma exposure (AUC) at the no-effect dose for adverse effects on pre- and postnatal development in rats (25 mg/kg/day) is approximately 15 times that in humans at the MRHD.

    There are no data on the presence of ubrogepant in human milk, the effects on the breast-fed infant, or the effects on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for ubrogepant and any potential adverse effects on the breast-fed infant from ubrogepant or the underlying maternal condition. In lactating rats, oral dosing with ubrogepant resulted in concentrations of ubrogepant in milk comparable to peak plasma concentrations.

    MECHANISM OF ACTION

    Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP is distributed throughout the nervous system, and it is concentrated at anatomical sites, such as the trigeminovascular system, which are involved in migraine pathophysiology. Centrally, CGRP is involved in nociceptive transmission through second and third-order neurons and pain modulation in the brainstem. Peripherally, CGRP mediates vasodilation through smooth muscle receptors. CGRP concentrations are elevated during acute migraine attacks and may be chronically elevated in chronic migraineurs.

    PHARMACOKINETICS

    Ubrogepant is administered orally. Plasma protein binding of ubrogepant is 87% in vitro. The mean apparent central volume of distribution of ubrogepant after single dose administration is approximately 350 L. Ubrogepant is eliminated mainly through metabolism, primarily by CYP3A4. The parent compound and 2 glucuronide conjugate metabolites are the most prevalent circulating components in human plasma. The glucuronide metabolites are unlikely to contribute to the pharmacologic activity of ubrogepant. The mean apparent oral clearance (CL/F) of ubrogepant is approximately 87 L/hour. Approximately 42% and 6% of the dose is excreted unchanged in feces and urine, respectively. The elimination half-life of ubrogepant is 5 to 7 hours.
     
    Affected cytochrome P450 isoenzymes and drug transporters: CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, BCRP, MAO-A, OAT1, OATP1B1, OATP1B3, OCT2, P-gp, UGT1A1
    Ubrogepant is a substrate for CYP3A4, BCRP, and P-gp. In vitro, ubrogepant is a weak substrate of OATP1B1, OATP1B3, and OAT1 and a weak inhibitor of CYP2C8, CYP2C9, CYP2C19, CYP2D6, MAO-A, OATP1B1, OATP1B3, OCT2, and UGT1A1. Dose adjustments are needed only for CYP3A4 inhibitors/inducers and BCRP or P-gp inhibitors; no clinical drug interactions are expected for other enzymes and drug transporters.

    Oral Route

    Ubrogepant displays dose-proportional pharmacokinetics within the recommended dose range. Peak plasma concentrations occur at approximately 1.5 hours after oral administration. When ubrogepant was administered with a high-fat meal, Tmax was delayed by 2 hours and resulted in a 22% reduction in Cmax with no change in AUC.