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 is an anti-CGRP mAb administered as an IV infusion every 3 months1*

IV administration of VYEPTI was chosen based on results from phase 1 research for determining the safety, tolerability, and pharmacokinetics (PK) for eptinezumab 100 mg administered intravenously vs subcutaneously over 12 weeks. At the point of administration, IV eptinezumab resulted in higher levels of eptinezumab in serum compared with subcutaneous eptinezumab.2

PK parameters for IV vs SubQ eptinezumab 100 mg following 1 dose1-3*

IV eptinezumab 100 mg (n=13)SubQ eptinezumab 100 mg (n=12)

Line chart of PK parameters for weeks 1-12 for both 100 mg IV administered eptinezumab and 100 mg subcutaneous (subQ) administered eptinezumab. Inset highlights days 1-7 post administration with callouts highlighting that after administration, IV eptinezumab reached Tmax in 1.2 hours and was 100% bioavailable compared to subQ eptinezumab which reached Tmax in 6.0 days and was 73% bioavailable. At every point on the chart (weeks 1-12), eptinezumab demonstrated a higher maximum concentration in a shorter maximum time.

IV eptinezumab reached a mean maximum concentration (Cmax) of 36.0 (6.7) µg/mL (SD) compared to a Cmax of 11.0 (3.2) for eptinezumab administered subcutaneously.

 

*Phase 1 study results. PK study 2 results shown here.

CGRP, calcitonin gene-related peptide; mAb, monoclonal antibody; SD, standard deviation; SubQ, subcutaneous; Tmax, time to maximum concentration.

IV infusion bag icon

Total administered dose is 100% bioavailable immediately post infusion, allowing for rapid onset of action.3

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

See the science behind VYEPTI

See the science behind VYEPTI

100% icon

The only IV anti-CGRP that is 100% bioavailable3-5 

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

Selective binding6,7

With no known off-target activity, VYEPTI is high selective, binding to both the ⍺- and β-forms of the CGRP ligand

Sustained duration of action1,8,9

VYEPTI has a high affinity for the CGRP ligand and has a terminal half-life of 27 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.

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. Baker B, Shen V, Cady R, Ettrup A, Larsen F. Eptinezumab administered intravenously, subcutaneously, or intramuscularly in healthy subjects and/or patients with migraine: early development studies. Cephalalgia Reports. 2022:5;1-11.

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. 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.

5. Ong JJY, Wei DY, Goadsby PJ. Recent advances in pharmacotherapy for migraine prevention: from pathophysiology to new drugs. Drugs. 2018;78(4):411-437.

6. 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.

7. Baker B, Schaeffler B, Cady R, Latham J, Whitaker T, Smith J. Rational design of a monoclonal antibody (mAb) inhibiting calcitonin gene-related peptide, ALD403 (eptinezumab), intended for the prevention of migraine. Poster presented at: 59th American Headache Society Annual Meeting; June 8-11, 2017; Boston, MA.

8. 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.

9. Dodick DW, Lipton RB, Silberstein S, et al. Eptinezumab for prevention of chronic migraine: a randomized phase 2b clinical trial. Cephalalgia. 2019;39(9):1075-1085.

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