VYEPTI is administered as an IV infusion every 3 months1

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VYEPTI is approved for 100 mg and 300 mg doses1

100 mg is the recommended dose. Some patients may benefit from the approved 300 mg dose.

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VYEPTI can be given at an infusion location or at home

Use the VYEPTI Infusion Locator to help your patients find a convenient location to get their 30-minute VYEPTI treatment.

For details and support on administering VYEPTI, download the guide and watch the short video.

Some patients may have payer-mandated or in-network infusion sites.

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The only IV anti-CGRP that is 100% bioavailable2-4

VYEPTI reaches Cmax in 30 minutes, at the end of infusion3

Relationship between the pharmacodynamic activity and effect of eptinezumab-jjmr is unknown.1

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Week 1 and Day 1 post infusion results were evaluated in an FDA-approved label analysis

VYEPTI demonstrated as well tolerated in clinical trials across years

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.

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

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14% of patients reported at least 1 treatment-emergent AE. The most common study drug-related treatment-emergent AEs were hypersensitivity (3.9%) and fatigue (3.1%) in patients on VYEPTI 300 mg. All other AEs were less than 1%, and 6.3% discontinued study drug.5

Across a 2-year clinical study, infusion-site redness (1 patient), itch (1 patient), constipation (1 patient), and hypertension (1 patient) were minimal (n=128).5

No new safety signals were seen during a 2-year study5

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.5

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 treatment5,6†

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.

VYEPTI infusion guide thumbnail

VYEPTI dosing and administration guide

Get step-by-step instructions for administering VYEPTI, dilution instructions, and frequently asked questions.

VYEPTI dosing and administration video

Step-by-step instructions for the preparation and administration of VYEPTI.

VYEPTI Dosing and Administration Video
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.

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.

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. Winner P, McAllister P, Cady R, et al. Migraine-free months in patients with episodic or chronic migraine treated with eptinezumab: results from the PROMISE-1 and PROMISE-2 trials. Poster presented at: 61st Annual Scientific Meeting of the American Headache Society (AHS); July 11-14, 2019; Philadelphia, PA. P217LB.
  3. Baker B, Schaeffler B, Beliveau M, et al. Population pharmacokinetic and exposure-response analysis of eptinezumab in the treatment of episodic and chronic migraine. Pharmacol Res Perspect. 2020;8(2):e00567.
  4. Ong JJY, Wei DY, Goadsby PJ. Recent advances in pharmacotherapy for migraine prevention: from pathophysiology to new drugs. Drugs. 2018;78(4):411-437.
  5. 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.
  6. 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.