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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and initiate appropriate therapy ( 5.1 ) Constipation with Serious Complications: Serious complications of constipation may occur ( 5.2 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur ( 5.3 ) Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur ( 5.4 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy [see Contraindications (4) and Patient Counseling Information (17) ] . 5.2 Constipation with Serious Complications Constipation with serious complications has been reported following the use of monoclonal antibody CGRP antagonists, including VYEPTI, in the postmarketing setting. There were cases with monoclonal antibody CGRP antagonists that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose; however, patients have also presented with constipation later on in treatment. The monoclonal antibody CGRP antagonist was discontinued in many of the reported cases of constipation with serious complications. Monitor patients treated with VYEPTI for severe constipation and manage as clinically appropriate. The concurrent use of medications that reduce gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications. 5.3 Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, 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 VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. 5.4 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. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 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. VYEPTI 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.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] . Constipation with Serious Complications [see Warnings and Precautions (5.2)] Hypertension [see Warnings and Precautions (5.3) ] Raynaud’s Phenomenon [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 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 clinical practice. The safety of VYEPTI was evaluated in 2076 patients with migraine who received at least one dose of VYEPTI, representing 1615 patient-years of exposure; of these, 1524 patients were exposed to 100 mg or 300 mg. Across all doses, 1872 patients were exposed for at least 6 months and 991 patients were exposed for 12 months. In the placebo-controlled clinical studies (Study 1 and Study 2) of 1372 patients, 579 patients received at least one dose of VYEPTI 100 mg, 574 patients received at least one dose of VYEPTI 300 mg, and 588 patients received placebo [see Clinical Studies (14) ] . Approximately 86% were female, 89% were white, and the mean age was 40.4 years at study entry. The most common (incidence at least 2% and at least 2% greater than placebo) adverse reactions in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. Table 1 summarizes the adverse reactions that occurred during Study 1 and Study 2. Table 1. Adverse Reactions Occurring with an Incidence of at Least 2% for VYEPTI and at Least 2% Greater than Placebo in Studies 1 and 2 Adverse Reactions VYEPTI 100 mg N=579% VYEPTI 300 mg N=574% Placebo N=588% Nasopharyngitis 6 8 6 Hypersensitivity reactions* 1 2 0 * Hypersensitivity reactions includes multiple related adverse event terms, such as hypersensitivity, pruritus, and flushing/hot flush that occurred on the day of dosing. In Study 1 and Study 2, 1.9% of patients treated with VYEPTI discontinued treatment because of adverse reactions [see Warnings and Precautions (5.1) ] . In study 3, the safety profile observed in 480 patients who were randomized and treated (238 to VYEPTI 100 mg and 242 to placebo) was consistent with the safety profile observed in the two pivotal placebo-controlled studies with VYEPTI (Study 1 and 2). 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of VYEPTI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: Constipation [see Warnings and Precautions (5.2) ] General Disorders and Administration Site Conditions: Fatigue Immune System Disorders: Anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.1) ] Vascular Disorders: Hypertension [see Warnings and Precautions (5.3) ] , Raynaud’s phenomenon [see Warnings and Precautions (5.4) ]