VYEPTI is indicated for the preventive treatment of migraine in adults.
VYEPTI is indicated for the preventive treatment of migraine in adults.

VYEPTI consistently demonstrated as generally well tolerated in clinical trials

PIVOTAL TRIALSRead full PROMISE-1 clinical publicationRead full PROMISE-2 clinical publication

From PROMISE-1 and PROMISE-2 pivotal phase 3 trials of over 1700 patients1

Most common adverse reactions (incidence of ≥2% for VYEPTI and ≥2% greater than placebo)1

   

VYEPTI 100 mg (n=579)

  

VYEPTI 300 mg (n=574)

  

Placebo (n=588)
Nasophar-yngitis   6%   8%   6%
Hypersen-sitivity reactions*   1%   2%   0%

*Hypersensitivity reactions included multiple related adverse event (AE) terms, such as hypersensitivity, pruritus, and flushing/hot flush, that occurred on the day of dosing.

Chart showing 1.9% of patients treated with VYEPTI discontinued the PROMISE-1 and PROMISE-2 pivotal trials due to adverse events.

of patients treated with VYEPTI discontinued the study due to AEs.1

PREVAIL Read full clinical publication Read full clinical post hoc analysis

From the PREVAIL 2-year, open-label, phase 3 trial in patients with chronic migraine2

Most common study drug-related treatment-emergent adverse events (TEAEs)2

   

VYEPTI 300 mg (n=128)
Hypersensitivity reaction   4%
Fatigue   3%

There were 21 study drug-related TEAEs; the most common were hypersensitivity and fatigue.

  • All other study drug-related TEAEs were less than 1%, including anaphylaxis, back pain, blood pressure systolic increased, constipation, etc
  • The full alphabetical listing is available within the full 2-year study publication

6.3% of participants discontinued treatment due to a TEAE.

14% of patients reported at least 1 study drug-related TEAE.2

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No new safety signals were seen during the PREVAIL 2-year study2,3

Immunogenicity: In an open-label study with 84 weeks of treatment, 18% (23/128) of patients developed anti­­­­­­­­­­­­–eptinezumab-jjmr antibodies, and 39% (9/23) of those patients developed anti–eptinezumab-jjmr neutralizing antibodies. Formation of antibodies did not affect efficacy or the safety profile of eptinezumab.2

Read full 2-year study publication Read full 2-year study post hoc analysis
Chart showing PREVAIL 2-year study design for chronic migraine.

PREVAIL2-4

A Phase-3, multicenter, open-label, single-arm study designed to evaluate the long-term safety and tolerability of VYEPTI 300 mg in adults with chronic migraine over 2 years.

  • Adults with chronic migraine received VYEPTI 300 mg every 12 weeks for up to 8 doses. Patients who received the first 4 doses (112/128 [87.5%]) could continue to receive the remaining 4 doses. Patients were followed for 20 weeks after final infusion (end-of-study visit at week 104)
  • Primary objective: Evaluate the long-term safety and tolerability of VYEPTI 300 mg
  • Exploratory assessments of patient-reported outcome measures included the Migraine Disability Assessment (MIDAS) questionnaire, patient-identified most bothersome symptom (MBS) associated with migraine, Patient Global Impression of Change (PGIC), and the 6-item Headache Impact Test (HIT-6)

Limitations:

  • Patient-reported outcomes (PRO) were exploratory in nature. Findings are descriptive and not confirmatory
  • Open-label study designs may introduce bias in patients and investigators which can influence symptom reporting, outcome assessment, and perceived treatment benefits
  • Without an appropriate comparator, there is no control for type 1 error (a false positive) and it is not possible to determine if the effect observed is attributable to VYEPTI or other factors

The study included:

  • Adults (18-65 years old) with an ICHD-3β diagnosis of migraine at or before age 50 with ≥12-month history of chronic migraine advised by a healthcare professional to use medication to treat their migraine
    • Migraine prophylactic medications had to be stable for 3 months prior
    • Limited use of barbiturate or prescription opiates was allowed

The study excluded patients who:

  • Required botulinum toxin injections for any reason within 4 months prior to screening
  • Received any monoclonal antibody targeting the CGRP pathway within 6 months prior to screening
  • Had pre-existing significant cardiovascular disease
  • Had clinically significant pain syndromes

CGRP, calcitonin gene-related peptide; ICHD, International Classification of Headache Disorders.

High persistency was observed in a 2-year study2,3†

Post hoc analysis is exploratory and hypothesis-generating. Due to the lack of randomization or control group or control for type 1 error rate, it is not possible to determine if the observed effect is attributable to VYEPTI or to other factors.

 

† In the 2-year PREVAIL study, a total of 118 patients (92.2%) completed the primary treatment phase (week 48), and 101 (78.9%) completed the secondary phase (week 84); 100 patients (78.1%) remained in the study 20 weeks after administration of the final study dose (week 104), and 6.3% discontinued study drug due to adverse events.

~80% of patients treated with

VYEPTI 300 mg continued in the study2,3

Collage of VYEPTI patients.

Real VYEPTI patients. Patients were compensated for their time. They did not participate in the study.

Post hoc analysis is exploratory and hypothesis-generating. Due to the lack of randomization or control group or control for type 1 error rate, it is not possible to determine if the observed effect is attributable to VYEPTI or to other factors.

† In the 2-year PREVAIL study, a total of 118 patients (92.2%) completed the primary treatment phase (week 48), and 101 (78.9%) completed the secondary phase (week 84); 100 patients (78.1%) remained in the study 20 weeks after administration of the final study dose (week 104), and 6.3% discontinued study drug due to adverse events.

Lealani, a real VYEPTI patient, receiving her VYEPTI infusion.

Get dosing and administration information

VYEPTI is just one 30-minute infusion, 4 times a year (every 12 weeks).1

LEARN MORE
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IMPORTANT SAFETY INFORMATION AND INDICATION
CONTRAINDICATIONS

VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.

WARNINGS AND PRECAUTIONS

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.

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.

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.

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.

ADVERSE REACTIONS

The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.

INDICATION

VYEPTI is indicated for the preventive treatment of migraine in adults.

For more information, please see the Full Prescribing Information and Patient Information.

IMPORTANT SAFETY INFORMATION AND INDICATION
CONTRAINDICATIONS

VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.

WARNINGS AND PRECAUTIONS

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.

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.

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.

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.

ADVERSE REACTIONS

The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.

INDICATION

VYEPTI is indicated for the preventive treatment of migraine in adults.

For more information, please see the Full Prescribing Information and Patient Information.

References:

  1. VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  2. Kudrow D, Cady RK, Allan B, et al. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurol. 2021;21(126):1-12.
  3. Blumenfeld A, Ettrup A, Hirman J, Ebert B, Cady R. Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab. BMC Neurol. 2022;22(1):251.
  4. Supplement to: Kudrow D, Cady RK, Allan B, et al. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurol. 2021;21(126):1-12.