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VYEPTI permanent J-code (J3032) is now available. Learn more
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Eptinezumab-jjmr tightly binds and stays bound to CGRP, designed for sustained suppression of the CGRP signaling pathway1
Specifically designed with high selectivity and affinity for the CGRP ligand1
- Binds to both α- and β-forms of the CGRP ligand1
- No known off-target activity1
- Strong binding with minimal dissociation (Kd = 4 pM)1
- Relationship between pharmacodynamic activity and mechanism(s) by which eptinezumab-jjmr exerts its clinical effects is unknown2
- The interaction and contact of CGRP to all 6 CDRs of eptinezumab-jjmr is consistent with the properties of specificity, durability, and strength of binding3
CDR, complementarity-determining region; CGRP, calcitonin gene-related peptide; Kd, dissociation constant; pM, picomolar.
Video of VYEPTI mechanism of action
Eptinezumab-jjmr IV is the only anti-CGRP that is 100% bioavailable—reaching Cmax in 30 minutes (at end of infusion).4
VYEPTI is designed for fast, powerful, and sustained response1,4
Immediate availability post-infusion4
100% bioavailability post-IV administration4
Designed for rapid onset of activity4
Selective binding1
High selectivity for CGRP ligand1
Designed for no off-target activity1
Strong binding1
High affinity for CGRP ligand1
Designed for sustained duration of action1
Eptinezumab-jjmr features were designed for rapid onset and sustained duration of action.1,4
Relationship between pharmacodynamic activity and the mechanism(s) by which eptinezumab-jjmr exerts its clinical effects is unknown.2
VYEPTI clinical trial data
Chronic and episodic migraine
VYEPTI IV treatment was evaluated for prevention of migraine in two phase 3 pivotal trials.2 See the changes from baseline in mean MMD (Months 1-3), Day 1 to Day 7, and more.
Dosing and administration
One 30-minute IV infusion every 3 months2
VYEPTI is the only anti-CGRP given as an IV treatment.2 See the administration details, including supplies, storage, and available doses.
MMD, monthly migraine days.
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.
INDICATION
VYEPTI is indicated for the preventive treatment of migraine in adults.
Warnings and Precautions
Hypersensitivity reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, and rash, have occurred with VYEPTI in clinical trials. 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.
For more information, please see the 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.
INDICATION
VYEPTI is indicated for the preventive treatment of migraine in adults.
Warnings and Precautions
Hypersensitivity reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, and rash, have occurred with VYEPTI in clinical trials. 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.
For more information, please see the Prescribing Information and Patient Information.
References:
- Garcia-Martinez LF, Raport CJ, Ojala EW, et al. Pharmacologic characterization of ALD403, a potent neutralizing humanized monoclonal antibody against the calcitonin gene-related peptide. J Pharmacol Exp Ther. 2020;374(1):93-103.
- VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
- Misura K, Scalley-Kim M, Olland A, White A, Latham J. The eptinezumab: CGRP complex structure and characterization of the ligand binding interface. Poster presented at: 61st Annual Scientific Meeting of the American Headache Society (AHS); July 11-14, 2019; Philadelphia, PA. P220LB.
- 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. 8(2):e00567.
© 2021 Lundbeck. All rights reserved. VYEPTI, VYEPTI CONNECT, and VYEPTI GO are registered trademarks of Lundbeck Seattle BioPharmaceuticals, Inc. EPT-B-100032v7
This website is intended for US healthcare professionals only.
