UBRELVY 100 mg/1
ubrogepant · TABLET · Allergan, Inc.
UBRELVY is a tablet containing ubrogepant at 100 mg/1, taken oral. Manufactured by Allergan, Inc..
Key Facts
- Brand Name
- UBRELVY
- Generic Name
- ubrogepant
- NDC Code (Product)
0023-6501- Manufacturer
- Allergan, Inc.
- Strength
- 100 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA211765
- Drug Class
- Calcitonin Gene-related Peptide Receptor Antagonist [EPC]
- Marketing Start
- 12/23/2019
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine. UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dose is 50 mg or 100 mg taken orally, as needed. ( 2.1 ) If needed, a second dose may be administered at least 2 hours after the initial dose. ( 2.1 ) The maximum dose in a 24-hour period is 200 mg. ( 2.1 ) 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 , 8.6 , 8.7 ) 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. 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 …
Contraindications
4 CONTRAINDICATIONS UBRELVY is contraindicated: With concomitant use of strong CYP3A4 inhibitors [see Drug Interactions ( 7.1 )] 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 )] Concomitant use with strong CYP3A4 inhibitors. ( 4 ) History of serious hypersensitivity to ubrogepant or any component of UBRELVY. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A4 Inducers: Should be avoided as concomitant use will result in reduction of ubrogepant exposure. ( 2.2 , 7.2 ) For additional dose modifications for moderate or weak CYP3A4 inhibitors and inducers or BCRP and/or P-gp only inhibitors, refer to section 2.2 . ( 7.1 , 7.2 , 7.3 ) 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…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypertension [see Warnings and Precautions ( 5.2 )] Raynaud’s Phenomenon [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (at least 2% and greater than placebo) were nausea and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 ( 14 )] . Of the UBRELVY-treated patients in these 2 studies, approximately 89% were fe…
Frequently Asked Questions
What is UBRELVY used for?
UBRELVY contains ubrogepant. It is a tablet taken oral. Consult your doctor for specific uses.
Is UBRELVY a controlled substance?
UBRELVY is not classified as a controlled substance by the DEA.
What is the generic name for UBRELVY?
The generic name for UBRELVY is ubrogepant. There are no other listed brand versions of ubrogepant.
What is the NDC code for UBRELVY 100 mg/1?
The NDC (National Drug Code) for UBRELVY 100 mg/1 is 0023-6501, listed by Allergan, Inc..
Other UBRELVY Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)