What is VYEPTI indicated for?

VYEPTI is indicated for the preventive treatment of migraine in adults.1

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Does VYEPTI have any contraindications?

VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included angioedema.1

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What are the most common adverse reactions for VYEPTI?

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.1

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Are there warnings and precautions associated with VYEPTI?

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. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.1

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How does VYEPTI work?

Eptinezumab-jjmr is a monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.1

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How is VYEPTI different from other anti-CGRP treatments?

VYEPTI is the only CGRP antagonist (anti-CGRP) administered by IV every 3 months.1 It was specifically designed for IV administration and is 100% bioavailable following the 30-minute infusion.2

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How were the VYEPTI clinical studies designed?

VYEPTI was evaluated for prevention of migraine in 2 randomized, multicenter, double-blind, placebo-controlled studies: PROMISE-1 in 665 patients with episodic migraine over a period of 12 months, and PROMISE-2 in 1072 patients with chronic migraine over a period of 6 months. VYEPTI was administered by IV every 3 months in both studies.1

REVIEW EPISODIC MIGRAINE STUDY DESIGNREVIEW CHRONIC MIGRAINE STUDY DESIGN

How were episodic migraine and chronic migraine defined?

Episodic migraine was defined as 4 to 14 headache days per month, of which ≥4 were migraine days.Chronic migraine was defined as ≥15 to ≤26 headache days per month, of which ≥8 were migraine days.1 One month was defined as 28 consecutive days.3,4

RESULTS FOR EPISODIC MIGRAINERESULTS FOR CHRONIC MIGRAINE

What were the VYEPTI results for episodic migraine?

After a single dose of VYEPTI 100 mg, patients had 12 fewer migraine days, on average, over 3 months.1*†‡
  • The most common adverse reactions (incidence ≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity
  • 1.9% of patients treated with VYEPTI discontinued treatment due to adverse events
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice

PROMISE-1 was a parallel-group, double-blind, placebo-controlled global trial to evaluate the efficacy and safety of VYEPTI for the preventive treatment of episodic migraine in adults. A total of 665 patients were randomized and received placebo (n=222), VYEPTI 100 mg (n=221), or VYEPTI 300 mg (n=222) every 3 months for 12 months.5

*Calculated by multiplying the mean change from baseline in mean monthly migraine days (MMD) by 3 months.
†p=0.018 vs placebo.
‡Analysis of covariance model used to test for difference between treatment groups.

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What were the VYEPTI results for chronic migraine?

After a single dose of VYEPTI 100 mg, patients had 23 fewer migraine days, on average, over 3 months.1*†‡
  • 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
  • 1.9% of patients treated with VYEPTI discontinued treatment due to adverse events
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice

PROMISE-2 was a parallel-group, double-blind, placebo-controlled global trial to evaluate the efficacy and safety of VYEPTI for the preventive treatment of chronic migraine in adults. A total of 1072 patients were randomized and received placebo (n=366), VYEPTI 100 mg (n=356), or VYEPTI 300 mg (n=350) every 3 months for 6 months.4

*Calculated by multiplying the mean change from baseline in mean monthly migraine days (MMD) by 3 months.
†p<0.001 vs placebo.
‡Analysis of covariance model used to test for difference between treatment groups.

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Which patient types are right for VYEPTI IV treatment?

VYEPTI is indicated for the preventive treatment of migraine in adults. Every patient has unique needs. Explore the patient profiles1:

EPISODIC MIGRAINE PATIENT PROFILECHRONIC MIGRAINE PATIENT PROFILE

How is VYEPTI administered?

The recommended dosage is 100 mg administered by IV infusion every 3 months. Some patients may benefit from a dosage of 300 mg administered by IV infusion every 3 months.1

VYEPTI is for IV infusion only; infuse over approximately 30 minutes. Do not administer VYEPTI as an IV push or bolus injection. Use an IV infusion set with a 0.2 µm or 0.22 µm in-line or add-on sterile filter. After the infusion is complete, flush the line with 20 mL of 0.9% Sodium Chloride Injection, USP. No other medications should be administered through the infusion set or mixed with VYEPTI.1

For more information on the 300 mg data, please see the Prescribing Information.

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Can VYEPTI be used for the acute treatment of migraine?

VYEPTI is indicated for the preventive treatment of migraine in adults.1

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How do I order VYEPTI?

VYEPTI can be obtained through a network of specialty distributors and specialty pharmacies. Please call 833-4-VYEPTI, for more information.

LEARN HOW TO ORDER VYEPTI

Is the VYEPTI CONNECT support program mandatory?

VYEPTI CONNECT is not mandatory. For enrolled patients, VYEPTI CONNECT offers access and reimbursement information and information about potential financial assistance that may be available for eligible patients. A Field Reimbursement Team is available to help navigate the access process. Please call 833-4-VYEPTI for more information.

LEARN MORE ABOUT VYEPTI CONNECT

Does VYEPTI have a copay program?

Financial assistance is available for eligible commercially insured patients through the VYEPTI Copay Assistance Program. Patients may pay as little as $5 per infusion every 3 months for VYEPTI. A maximum annual benefit limit of $4000 and other restrictions may apply.* Patients can check eligibility requirements and enroll in the program by calling 833-4-VYEPTI, or learn more here.

*Patients are not eligible for financial assistance if they are uninsured or if their prescription is eligible to be reimbursed, in whole or in part, by any state or federal healthcare programs, including but not limited to Medicare or Medicaid, US Department of Veterans Administration, US Department of Defense, or TRICARE. The VYEPTI Copay Assistance Program covers the cost of VYEPTI only. Administration and other fees are not covered by this copay program. Patients must be US residents aged 17 years or older and have a valid VYEPTI prescription. Click here for full Terms and Conditions for the VYEPTI Copay Assistance Program.

What is VYEPTI GO?

VYEPTI GO is a personalized support program designed to help patients through their VYEPTI treatment journey. Eligible patients who have been prescribed VYEPTI can access a range of resources to help them stay on track. Patients can learn more about VYEPTI GO here.

Who should I contact if I have a question about VYEPTI?

Contact a Lundbeck representative or get in touch with us for questions about VYEPTI, access support, and more. You can contact us by phone at 833-4-VYEPTI.

CONNECT WITH US

Where can I get updates about VYEPTI treatment?

How can I enroll my patient for VYEPTI CONNECT?

Does VYEPTI have patient financial assistance available?

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 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. 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 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. 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:
  1. VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  2. 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):1-12.
  3. Data on file. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  4. Lipton RB, Goadsby PJ, Smith J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020;94:e1365-e1377.
  5. Ashina M, Saper J, Cady R, et al. Eptinezumab in episodic migraine: a randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020;40(3):241-254.