Ubrelvy

What Is Ubrelvy?

Ubrelvy (ubrogepant) is a calcitonin gene-related peptide receptor antagonist used for the acute treatment of migraine with or without aura in adults.

What Are Side Effects of Ubrelvy?

Side effects of Ubrelvy include:

• nausea,
• drowsiness, and
• dry mouth

Dosage for Ubrelvy

The recommended dose of Ubrelvy is 50 mg or 100 mg taken orally, as needed. If needed, a second dose of Ubrelvy may be administered at least 2 hours after the initial dose.

Ubrelvy In Children

Safety and effectiveness of Ubrelvy in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Ubrelvy?

Ubrelvy may interact with other medicines such as:

• ketoconazole,
• itraconazole,
• clarithromycin,
• verapamil,
• cyclosporine,
• ciprofloxacin,
• fluconazole,
• fluvoxamine,
• grapefruit juice,
• rifampin,
• phenytoin,
• barbiturates,
• St. John's wort,
• quinidine,
• carvedilol,
• eltrombopag, and
• curcumin

Tell your doctor all medications and supplements you use.

Ubrelvy During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Ubrelvy; it may harm a fetus. It is unknown if Ubrelvy passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Ubrelvy (ubrogepant) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Ubrelvy Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• nausea; or
• drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ubrelvy (Ubrogepant Tablets)

 

Ubrelvy Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of UBRELVY was evaluated in 3,624 subjects who received at least one dose of UBRELVY. In two randomized, double-blind, placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 1,439 patients received UBRELVY 50 mg or 100 mg [see Clinical Studies]. Of the UBRELVYtreated patients in these 2 studies, approximately 89% were female, 82% were White, 15% were Black, and 17% were of Hispanic or Latino ethnicity. The mean age at study entry was 41 years (range of 18-75 years).

Long-term safety was assessed in 813 patients, dosing intermittently for up to 1 year in an open-label extension study. Patients were permitted to treat up to 8 migraines per month with UBRELVY. Of these 813 patients, 421 patients were exposed to 50 mg or 100 mg for at least 6 months, and 364 patients were exposed to these doses for at least one year, all of whom treated at least two migraine attacks per month, on average. In that study, 2.5% of patients were withdrawn from UBRELVY because of an adverse reaction. The most common adverse reaction resulting in discontinuation in the long-term safety study was nausea.

Adverse reactions in Studies 1 and 2 are shown in Table 2.

Table 2: Adverse Reactions Occurring in At Least 2% and at a Frequency Greater than Placebo in Studies 1 and 2

	Placebo (N= 984) %	UBRELVY 50 mg (N=954) %	UBRELVY 100 mg (N=485) %
Nausea	2	2	4
Somnolence*	1	2	3
Dry Mouth	1	<1	2
*Somnolence includes the adverse reaction-related terms sedation and fatigue.

DRUG INTERACTIONS

CYP3A4 Inhibitors

Co-administration of UBRELVY with ketoconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of ubrogepant [see CLINICAL PHARMACOLOGY]. UBRELVY should not be used with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) [see CONTRAINDICATIONS].

Co-administration of UBRELVY with verapamil, a moderate CYP3A4 inhibitor, resulted in an increase in ubrogepant exposure [see CLINICAL PHARMACOLOGY]. 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].

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].

CYP3A4 Inducers

Co-administration of UBRELVY with rifampin, a strong CYP3A4 inducer, resulted in a significant reduction in ubrogepant exposure [see CLINICAL PHARMACOLOGY]. In patients taking strong CYP3A4 inducers (e.g., phenytoin, barbiturates, rifampin, St. John’s Wort), loss of ubrogepant efficacy is expected, and concomitant use should be avoided.

Co-administration of UBRELVY with moderate or weak CYP3A4 inducers was not evaluated in a clinical study. Dose adjustment is recommended with concomitant use of UBRELVY and moderate or weak CYP3A4 inducers [see DOSAGE AND ADMINISTRATION].

BCRP And/Or P-gp Only Inhibitors

Ubrogepant is a substrate of BCRP and P-gp efflux transporters. Use of BCRP and/or P-gp only inhibitors (e.g., quinidine, carvedilol, eltrombopag, curcumin) may increase the exposure of ubrogepant [see CLINICAL PHARMACOLOGY]. Clinical drug interaction studies with inhibitors of these transporters were not conducted. Dose adjustment is recommended with BCRP and/or P-gp only inhibitors [see DOSAGE AND ADMINISTRATION].

Read the entire FDA prescribing information for Ubrelvy (Ubrogepant Tablets)