Ubrogepant: uses, appearance and warnings

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 )

UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side. UBRELVY 100 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U100” on one side. Tablets: 50 mg and 100 mg ( 3 )

UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side in unit-dose packets (each packet contains 1 tablet): Box of 1 Packet, NDC: 85766-280-01 (relabeled from NDC 0023-6498-02) Box of 10 Packets, NDC: 85766-280-10 (relabeled from NDC 0023-6498-10) Box of 16 Packets, NDC: 85766-280-16 (relabeled from NDC 0023-6498-16) Box of 30 Packets, NDC: 85766-280-30 (relabeled from NDC 0023-6498-30) UBRELVY 100 mg is supplied as white to off-white capsule-shaped, biconvex tablets debossed with “U100” on one side in unit-dose packets (each packet contains 1 tablet): Box of 1 Packet, NDC: 85766-281-01 (relabeled from NDC 0023-6501-02) Box of 10 Packets, NDC: 85766-281-10 (relabeled from NDC 0023-6501-10) Box of 16 Packets, NDC: 85766-281-16 (relabeled from NDC 0023-6501-16) Box of 30 Packets, NDC: 85766-281-30 (relabeled from NDC 0023-6501-30) 16.2 Storage and Handling Store between 20°C and 25°C (68°F and 77°F): excursions permitted between 15°C and 30°C (59°F and 86°F) [ see USP Controlled Room Temperature ] .

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 )

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue UBRELVY and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis and dyspnea. These reactions can occur within minutes, hours, or days after administration. ( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) Raynaud’s phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.3 ) 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 )] . 5. 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. 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.

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. …

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 ) ] . …