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

PIVOTAL TRIAL RESULTS

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PROMISE-1 primary endpoint:

Patients with EM experienced, 

on average, 11.7 (100 mg) and 12.9 (300 mg) fewer migraine days over weeks 1-12 vs 9.6 with placebo (baseline ~8.6 mean monthly migraine days [MMD]; p<0.001

vs placebo).1*†‡ See study design details and learn more about this data.

""

PROMISE-2 primary endpoint:


Patients with CM experienced, on average, 23.1 (100 mg) and 24.6 (300 mg) fewer migraine days over weeks 1-12 vs 16.8 with placebo (baseline ~16 mean MMD; p<0.001 vs placebo).1†‡ See study design details and learn more about this data.

""

Key secondary endpoint:

On average, 22.2% (100 mg) and 29.7% (300 mg) of patients on VYEPTI vs 16.2% on placebo in PROMISE-1, and 26.7% (100 mg) and 33.1% (300 mg) of patients on VYEPTI vs 15.0% on placebo in PROMISE-2 had a ≥75% response rate over weeks 1-12.2§ Learn more about this data.

*100 mg: p=0.018 vs placebo. 300 mg: p<0.001 vs placebo.
 †Calculated by multiplying the mean change from baseline in mean MMD by 3 months (PROMISE-1: 100 mg, 3.9; 300 mg, 4.3; placebo, 3.2. PROMISE-2: 100 mg, 7.7;
300 mg, 8.2; placebo, 5.6).
 ‡Episodic migraine: 4 to 14 headache days per month, of which ≥4 were migraine days. Chronic migraine: ≥15 to ≤26 headache days a month, with ≥8 being
migraine days.
 §75% responder rate was defined as a subject achieving, on average, a ≥75% reduction from baseline in migraine days within the 12-week dosing interval.

EXPLORE THE DATA

VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema. Clinically significant adverse reactions of hypersensitivity, constipation with serious complications, hypertension, and Raynaud’s phenomenon have been reported, some requiring hospitalization. Consider discontinuation of VYEPTI as appropriate.

 

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VYEPTI consistently demonstrated as generally well tolerated in clinical trials

The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the PROMISE-1 & PROMISE-2 clinical trials were nasopharyngitis and hypersensitivity.1

During PREVAIL, the most common study drug-related treatment-emergent adverse events (AEs) were hypersensitivity (3.9%) and fatigue (3.1%) in patients on VYEPTI 300 mg. All other AEs were less than 1%. No new safety signals were seen during the 2-year study.3

Please see Important Safety Information below.

SEE SAFETY DATA

Flexible infusion
options

Coverage
resources

Copay

support

""

VYEPTI can be infused in a variety
of settings and locations. Lundbeck also partners with providers in the VYEPTI Infusion Network to help deliver a consistent VYEPTI treatment experience in a convenient location for your patients. Explore options with our Infusion Locator tool.

""

Your patients may be covered with fewer step requirements than ever before.

Use VYEPTI Coverage Finder to find coverage details for VYEPTI in your area.

""

Eligible commercial patients may pay as little as $0 for each VYEPTI infusion.* For details on the VYEPTI CONNECT Copay Assistance Program, download the brochure.

*Offer includes up to $200 in administration out-of-pocket (OOP) fees per VYEPTI treatment. Eligibility criteria and program maximums apply. Copay assistance for IV administration OOP costs is restricted in MA and RI. This offer is NOT available for patients enrolled in Medicare, Medicaid, or any other government healthcare program. Please see the full Terms and Conditions.

PIVOTAL TRIAL RESULTS

""

PROMISE-1 primary endpoint:

Patients with EM experienced, on average, 11.7 (100 mg) and 12.9 (300 mg) fewer migraine days over weeks 1-12 vs 9.6 with placebo (baseline ~8.6 mean monthly migraine days [MMD]; p<0.001 vs placebo).1*†‡ See study design details and learn more about this data.

""

PROMISE-2 primary endpoint:


Patients with CM experienced, on average, 23.1 (100 mg) and 24.6 (300 mg) fewer migraine days over weeks 1-12 vs 16.8 with placebo (baseline ~16 mean MMD; p<0.001 vs placebo).1†‡ See study design details and learn more about this data.

""

Key secondary endpoint:

On average, 22.2% (100 mg) and 29.7% (300 mg) of patients on VYEPTI vs 16.2% on placebo in PROMISE-1, and 26.7% (100 mg) and 33.1% (300 mg) of patients on VYEPTI vs 15.0% on placebo in PROMISE-2 had a ≥75% response rate over weeks 1-12.2§ Learn more about this data.

*100 mg: p=0.018 vs placebo. 300 mg: p<0.001 vs placebo.
 †Calculated by multiplying the mean change from baseline in mean MMD by 3 months (PROMISE-1: 100 mg, 3.9; 300 mg, 4.3; placebo, 3.2. PROMISE-2: 100 mg, 7.7; 300 mg, 8.2; placebo, 5.6).
 ‡Episodic migraine: 4 to 14 headache days per month, of which ≥4 were migraine days. Chronic migraine: ≥15 to ≤26 headache days a month, with ≥8 being migraine days.
 §75% responder rate was defined as a subject achieving, on average, a ≥75% reduction from baseline in migraine days within the 12-week dosing interval.

EXPLORE THE DATA

VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema. Clinically significant adverse reactions of hypersensitivity, constipation with serious complications, hypertension, and Raynaud’s phenomenon have been reported, some requiring hospitalization. Consider discontinuation of VYEPTI as appropriate.

 

""

VYEPTI consistently demonstrated as generally well tolerated in clinical trials

The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the PROMISE-1 & PROMISE-2 clinical trials were nasopharyngitis and hypersensitivity.1

During PREVAIL, the most common study drug-related treatment-emergent adverse events (AEs) were hypersensitivity (3.9%) and fatigue (3.1%) in patients on VYEPTI 300 mg. All other AEs were less than 1%. No new safety signals were seen during the 2-year study.4,5

Please see Important Safety Information below.

SEE SAFETY DATA

Flexible infusion
options

""

VYEPTI can be infused in a variety
of settings and locations. Lundbeck also partners with providers in the VYEPTI Infusion Network to help deliver a consistent VYEPTI treatment experience in a convenient location for your patients.Explore options with our Infusion Locator tool.

Coverage
resources

""

Your patients may be covered with fewer step requirements than ever before.

Use VYEPTI Coverage Finder to find coverage details for VYEPTI in your area.

Copay Support

""

Eligible commercial patients may pay as little as $0 for each VYEPTI infusion.* For details on the VYEPTI CONNECT Copay Assistance Program, download the brochure.

*Offer includes up to $200 in administration out-of-pocket (OOP) fees per VYEPTI treatment. Eligibility criteria and program maximums apply. Copay assistance for IV administration OOP costs is restricted in MA and RI. This offer is NOT available for patients enrolled in Medicare, Medicaid, or any other government healthcare program. Please see the full Terms and Conditions.

Lealani, real VYEPTI patient, sitting during her infusion.

VYEPTI was generally well tolerated in pivotal clinical trials, and no new safety signals were seen during the PREVAIL 2-year study.1,3

SAFETY PROFILE

In their 2024 position statement, the American Headache Society recommended that CGRP-targeting therapies should be a first-line treatment option for migraine prevention4

READ THE FULL POSITION STATEMENT
VYEPTI® Copay Support card.

Copay support for VYEPTI and IV administration costs

The VYEPTI CONNECT® Copay Assistance Program can help eligible patients with commercial insurance:

  • Pay as little as $0 for VYEPTI*
  • Save up to $200 per infusion on their administration out-of-pocket cost*

Offer includes 100 mg and up to 300 mg doses.

ENROLL YOUR PATIENTS NOW

*Your patient's out-of-pocket cost may vary depending on their dose, insurance coverage, and eligibility. Eligibility criteria and program maximums apply. Copay assistance for IV administration costs is restricted in MA and RI. This offer is NOT available for patients enrolled in Medicare, Medicaid, or any other government healthcare program. Please see the full Terms and Conditions.

CGRP, calcitonin gene-related peptide; CM, chronic migraine; EM, episodic migraine; IV, intravenous.

""
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. Silberstein S, Diamond M, Hindiyeh NA, et al. Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy-2) study. J Headache Pain. 2020;21(1):120-132.
  3. Kudrow D, Cady RK, Allan B, et al. Long-term safety and tolerability of eptinezumab in patients with chronic migraine following preventive treatment with eptinezumab. BMC Neurol. 2022;22(1):251.
  4. Charles AC, Digre KB, Goadsby PJ, Robbins MS, Hershey A; American Headache Society. Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: an American Headache Society position statement update. Headache. 2024;64(4):333-341.