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

VYEPTI consistently demonstrated as well tolerated in clinical trials

PIVOTAL TRIALS Read full PROMISE-1 clinical publication Link out iconRead full PROMISE-2 clinical publicationLink out icon

Adverse reactions occurring in PROMISE-1 and PROMISE-2 pivotal phase 3 trials of over 1,700 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.

1.9% pie chart icon

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

PREVAIL Read full clinical publicationLink out icon

Adverse reactions occurring in the PREVAIL 2-year, open-label, phase 3 trial2

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 that 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 TEAE.

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

landing safety

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

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

High treatment persistency was demonstrated over 2 years†

†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 (week 84); 100 patients (78.1%) remained on VYEPTI 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 to receive treatment2,3

†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 (week 84); 100 patients (78.1%) remained on VYEPTI 20 weeks after administration of the final study dose (week 104), and 6.3% discontinued study drug due to adverse events.

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Image of 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

Lealani was compensated for her time.

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.

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.

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 Neurology. 2021;21(126):1-12.
  3. Blumenfeld A, Ettrup A, Hirman J, et al. Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab. BMC Neurology. 2022;22(251):1-9.
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