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VYEPTI is indicated for the preventive treatment of migraine in adults.1
GET THE FULL PRESCRIBING INFORMATIONSEE THE FULL PATIENT INFORMATION
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included angioedema.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
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
Eptinezumab-jjmr is a monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.1
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
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
Episodic migraine was defined as 4 to 14 headache days per month, of which ≥4 were migraine days.1 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
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.
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.
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
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.
VYEPTI is indicated for the preventive treatment of migraine in adults.1
VYEPTI can be obtained through a network of specialty distributors and specialty pharmacies. Please call 833-4-VYEPTI, for more information.
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.
Financial assistance is available for eligible commercially insured patients through the VYEPTI Copay Assistance Program. Your patients may pay as little as $0 for their VYEPTI infusion.*
- Offer includes up to $200 in administration fees per VYEPTI treatment
- Includes 100 mg and up to 300 mg doses
- Applies to eligible commercial patients only
Patients can check eligibility requirements and enroll in the program by calling 833-4-VYEPTI, option 1, or learn more here.
*Your patient’s out-of-pocket cost may vary depending on their dose, insurance coverage, and eligibility. Eligibility criteria and program maximums apply. This offer is NOT available for patients enrolled in Medicare, Medicaid, or any other government healthcare program. Please see the full Terms and Conditions.
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.
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.
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, 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.
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.
INDICATION
VYEPTI is indicated for the preventive treatment of migraine in adults.
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.
For more information, please see the Full Prescribing Information and Patient Information.
References:
- VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
- 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.
- Data on file. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
- 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.
- 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.
© 2022 Lundbeck. All rights reserved. VYEPTI, VYEPTI CONNECT, and VYEPTI GO are registered trademarks of Lundbeck Seattle BioPharmaceuticals, Inc. EPT-B-100032v13
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