What is mechanism of action?

mechanism of action is Calcitonin Gene-related Peptide Receptor Antagonists [MoA]

Ubrelvy

(Ubrogepant)

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Dosage & Administration

* The recommended dose is 50 mg or 100 mg taken orally, as needed. (

2.1
Recommended Dosage

The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food.

If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.

)

* If needed, a second dose may be administered at least 2 hours after the initial dose. (

2.1
Recommended Dosage

The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food.

)

* The maximum dose in a 24-hour period is 200 mg. (

2.1
Recommended Dosage

The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food.

)

* Severe Hepatic or Severe Renal Impairment: Recommended dose is 50 mg; if needed, a second 50 mg dose may be taken at least 2 hours after the initial dose. (

2.2
Dosage
Modification
s

Dosing modifications for concomitant use of specific drugs and for patients with hepatic or renal impairment are provided in Table 1.

Table 1: Dose Modifications for Drug Interactions and for Specific Populations
Dosage Modifications	Initi a l Dose	Second Dose ^a (if needed)
Concomitant Drug [see Drug Interactions ( 7 )]
Moderate CYP3A4 Inhibitors ( 7.1 )	50 mg	Avoid within 24 hours
Weak CYP3A4 Inhibitors ( 7.1 )	50 mg	50 mg
Strong CYP3A4 Inducers ( 7.2 )	Avoid concomitant use
Weak & Moderate CYP3A4 Inducers ( 7.2 )	100 mg	100 mg
BCRP and/or P-gp only Inhibitors ( 7.3 )	50 mg	50 mg
Spec i fic Populations [see Use in Specific Populations ( 8 )]
Severe Hepatic Impairment (Child-Pugh Class C) ( 8.6 )	50 mg	50 mg
Severe Renal Impairment (CLcr 15-29 mL/min) ( 8.7 )	50 mg	50 mg
End-Stage Renal Disease (CLcr <15 mL/min) ( 8.7 )	Avoid use
^aSecond dose may be taken at least 2 hours after the initial dose

8.6
Hepatic Impairment

In patients with pre-existing 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

No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Dose adjustment for UBRELVY is recommended for patients with severe hepatic impairment

[

Dosage and Administration (

2.2

)

]

8.7
Renal Impairment

The renal route of elimination plays a minor role in the clearance of ubrogepant

[see Clinical Pharmacology (

12.3

)]

No dose adjustment is recommended for patients with mild or moderate renal impairment. Dose adjustment is recommended for patients with severe renal impairment (CLcr 15-29 mL/min)

[see Dosage and Administration (

2.2

) and Clinical Pharmacology (

12.3

)]

. Avoid use of UBRELVY in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min).

)

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Ubrelvy Prescribing Information

Warnings and Precautions (

5.000000000000000e+00
2
Hyper
tension

Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including UBRELVY, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases.

Monitor patients treated with UBRELVY for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of UBRELVY is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

5.000000000000000e+00
3
Raynaud’s Phenomenon

Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including UBRELVY. In reported cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.

UBRELVY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

)

3/2025

The recommended dose is 50 mg or 100 mg taken orally, as needed. (
2.1
Recommended Dosage
The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food.
If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.
)
If needed, a second dose may be administered at least 2 hours after the initial dose. (
2.1
Recommended Dosage
The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food.
If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.
)
The maximum dose in a 24-hour period is 200 mg. (
2.1
Recommended Dosage
The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food.
If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.
)

Severe Hepatic or Severe Renal Impairment: Recommended dose is 50 mg; if needed, a second 50 mg dose may be taken at least 2 hours after the initial dose. (

2.2
Dosage
Modification
s

Dosing modifications for concomitant use of specific drugs and for patients with hepatic or renal impairment are provided in Table 1.

Table 1: Dose Modifications for Drug Interactions and for Specific Populations
Dosage Modifications	Initi a l Dose	Second Dose ^a (if needed)
Concomitant Drug [see Drug Interactions ( 7 )]
Moderate CYP3A4 Inhibitors ( 7.1 )	50 mg	Avoid within 24 hours
Weak CYP3A4 Inhibitors ( 7.1 )	50 mg	50 mg
Strong CYP3A4 Inducers ( 7.2 )	Avoid concomitant use
Weak & Moderate CYP3A4 Inducers ( 7.2 )	100 mg	100 mg
BCRP and/or P-gp only Inhibitors ( 7.3 )	50 mg	50 mg
Spec i fic Populations [see Use in Specific Populations ( 8 )]
Severe Hepatic Impairment (Child-Pugh Class C) ( 8.6 )	50 mg	50 mg
Severe Renal Impairment (CLcr 15-29 mL/min) ( 8.7 )	50 mg	50 mg
End-Stage Renal Disease (CLcr <15 mL/min) ( 8.7 )	Avoid use
^aSecond dose may be taken at least 2 hours after the initial dose

8.6
Hepatic Impairment

No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Dose adjustment for UBRELVY is recommended for patients with severe hepatic impairment

[

Dosage and Administration (

2.2

)

]

8.7
Renal Impairment

The renal route of elimination plays a minor role in the clearance of ubrogepant

[see Clinical Pharmacology (

12.3

)]

No dose adjustment is recommended for patients with mild or moderate renal impairment. Dose adjustment is recommended for patients with severe renal impairment (CLcr 15-29 mL/min)

[see Dosage and Administration (

2.2

) and Clinical Pharmacology (

12.3

)]

. Avoid use of UBRELVY in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min).

)

Pregnancy: Based on animal data, may cause fetal harm. (
8.1
Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while taking UBRELVY. Patients should be encouraged to enroll by calling 1-833-277-0206 or visiting http://empresspregnancyregistry.com.
Risk Summary
There are no adequate data on the developmental risk associated with the use of UBRELVY in pregnant women. In animal studies, adverse effects on embryofetal development were observed following administration of ubrogepant during pregnancy (increased embryofetal mortality in rabbits) or during pregnancy and lactation (decreased body weight in offspring in rats) at doses greater than those used clinically and which were associated with maternal toxicity
(
see
Data
)
.
In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2% -2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.
Clinical Considerations
Disease-Associated Maternal and/or Embryo/Fetal Risk
Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.
Data
Animal
Data
Oral administration of ubrogepant (0, 1.5, 5, 25, 125 mg/kg/day) to pregnant rats during the period of organogenesis resulted in no adverse effects on embryofetal development. Plasma exposure (AUC) at the highest dose tested is approximately 45 times that in humans at the maximum recommended human dose (MRHD) of 200 mg/day.
In pregnant rabbits, ubrogepant (0, 15, 45, 75, or 250 mg/kg/day) was administered orally throughout organogenesis in two separate studies. In both studies, the highest dose tested (250 mg/kg/day) was associated with maternal toxicity. In the first study, ubrogepant produced abortion and increased embryofetal mortality in surviving litters at the high dose (250 mg/kg/day). In the second study, excessive maternal toxicity at the high dose (250 mg/kg/day) resulted in early termination and lack of fetal data for that dose group. Plasma exposure (AUC) at the highest no-effect dose (75 mg/kg/day) for adverse effects on embryofetal development in rabbit is approximately 8 times that in humans at the MRHD.
Oral administration of ubrogepant (0, 25, 60, or 160 mg/kg/day) to rats throughout gestation and lactation resulted in decreased body weight in offspring at birth and during the lactation period at the mid and high doses, which were associated with maternal toxicity. 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.
)
Avoid use in patients with end-stage renal disease. (
8.7
Renal Impairment
The renal route of elimination plays a minor role in the clearance of ubrogepant
[see Clinical Pharmacology (
12.3
)]
.
No dose adjustment is recommended for patients with mild or moderate renal impairment. Dose adjustment is recommended for patients with severe renal impairment (CLcr 15-29 mL/min)
[see Dosage and Administration (
2.2
) and Clinical Pharmacology (
12.3
)]
. Avoid use of UBRELVY in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min).
)

UBRELVY is contraindicated:

With concomitant use of strong CYP3A4 inhibitors
[see Drug Interactions (
7.1
CYP3A4
I
nhibitors
Co-administration of UBRELVY with ketoconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of ubrogepant
[see
Clinical Pharmacology
(
12.3
)
]
. UBRELVY should not be used with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
[see
Contraindication
s
(
4
)]
.
Co-administration of UBRELVY with verapamil, a moderate CYP3A4 inhibitor, resulted in an increase in ubrogepant exposure
[see
Clinical Pharmacology
(
12.3
)
]
. Dose adjustment is recommended with concomitant use of UBRELVY and moderate CYP3A4 inhibitors (e.g., cyclosporine, ciprofloxacin, fluconazole, fluvoxamine, grapefruit juice)
[see
Dosage and Administration
(
2.2
)]
.
No dedicated drug interaction study was conducted with ubrogepant and weak CYP3A4 inhibitors. Dose adjustment is recommended with concomitant use of UBRELVY with weak CYP3A4 inhibitors
[see Dosage and Administration (
2.2
)]
.
)]
In patients with a history of serious hypersensitivity to ubrogepant or any component of UBRELVY. Reactions have included anaphylaxis, dyspnea, and facial or throat edema
[see Warnings and Precautions (
5
.1
Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported with use of UBRELVY. Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions occurred within hours after dosing and were not serious, and some reactions led to discontinuation. If a serious or severe hypersensitivity reaction occurs, discontinue UBRELVY and institute appropriate therapy
[see Contraindications (
4
) and Adverse Reactions (
6.2
)]
.
)]

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