Vyepti (Eptinezumab-Jjmr)

Brand Name

Vyepti

Generic Name

Eptinezumab-Jjmr

View Brand Information

FDA approval date: February 21, 2020

Classification: Calcitonin Gene-related Peptide Antagonist

Form: Injection

What is Vyepti (Eptinezumab-Jjmr)?

For people who live with chronic migraines, even simple daily activities can feel impossible. The unpredictable pain, light sensitivity, and nausea can interfere with work, relationships, and mental well-being. Vyepti (eptinezumab-jjmr) offers new hope for those who have tried traditional treatments without success. As one of the newest preventive therapies for migraine, it helps reduce the number and severity of migraine attacks, allowing many patients to reclaim control over their lives.

Vyepti belongs to a class of drugs known as CGRP monoclonal antibodies, which represent a modern, targeted approach to migraine prevention. Approved by the U.S. Food and Drug Administration (FDA) in 2020, it’s administered through an intravenous (IV) infusion rather than a pill or injection at home. This innovative design allows for rapid delivery and sustained effectiveness over several months.

What does Vyepti do?

Vyepti is prescribed to prevent migraine headaches in adults, it is not intended to treat a migraine once it starts, but rather to stop attacks from occurring as often.

In clinical trials, patients receiving Vyepti experienced significant reductions in monthly migraine days, often within the first month after treatment (FDA, 2020). Many participants reported improved productivity, less disability, and better overall quality of life.

Unlike acute migraine medications that provide short-term relief, Vyepti works on an ongoing basis to reduce the frequency, duration, and intensity of migraines. This can be life-changing for those who experience chronic migraines, defined as 15 or more headache days per month.

How does Vyepti work?

Migraines are thought to involve complex interactions between nerves and blood vessels in the brain, with a key role played by a molecule called calcitonin gene-related peptide (CGRP). CGRP levels rise during migraine attacks, causing blood vessels to dilate and triggering pain pathways.

Vyepti is a monoclonal antibody that binds to CGRP, blocking its activity before it can initiate the chain reaction that leads to migraine symptoms. By neutralizing CGRP, Vyepti helps prevent the inflammatory and vascular changes that drive migraine pain.

Clinically, this targeted approach matters because it addresses the root cause of migraine attacks rather than just treating symptoms. Patients who respond well often experience fewer severe migraines and require less rescue medication over time (Mayo Clinic, 2023).

Vyepti side effects

Vyepti is generally well tolerated, with most side effects being mild to moderate.

Common side effects include:

Runny nose or sore throat (nasopharyngitis)
Fatigue
Mild allergic reactions such as itching or rash

Serious but uncommon side effects:

Hypersensitivity reactions, which may include swelling, flushing, or shortness of breath
Infusion-related reactions, typically occurring during or shortly after the IV infusion

Most reactions resolve without intervention, but patients should notify their healthcare team if they experience persistent or severe symptoms.

Those with a known allergy to eptinezumab or its components should not receive Vyepti. Pregnant or breastfeeding women should discuss potential risks and benefits with their doctor, as safety data in these populations are still limited (MedlinePlus, 2024).

Vyepti dosage

Vyepti is given as an intravenous infusion every 12 weeks in a clinical setting, typically a doctor’s office or infusion center. The infusion usually takes about 30 minutes.

One of the key advantages of Vyepti is its quarterly dosing schedule, which minimizes the need for frequent treatments. Because it is administered under medical supervision, healthcare professionals can monitor any infusion-related reactions during and after the procedure.

Routine laboratory testing is not usually required, but doctors may evaluate:

Treatment response, such as changes in migraine frequency
Adverse reactions or allergic symptoms over time

Patients are encouraged to keep a migraine diary to track the frequency and intensity of their headaches, which helps their provider assess how well the therapy works.

Does Vyepti have a generic version?

As of 2025, there is no generic version of Vyepti available. It is currently only offered as the brand-name product manufactured by Lundbeck Pharmaceuticals.

Because Vyepti is a biologic drug, a large, complex protein molecule produced through living cells, creating a generic equivalent is not straightforward. Instead, similar versions called biosimilars may be developed in the future once Vyepti’s exclusivity period expires.

Patients concerned about cost should speak with their healthcare provider or pharmacist about insurance coverage and manufacturer assistance programs, as many companies offer financial support for eligible individuals.

Conclusion

Vyepti (eptinezumab-jjmr) represents a major advancement in migraine prevention. By targeting CGRP, the key molecule involved in migraine activation, it helps reduce the frequency of attacks and gives patients a chance to live more freely and confidently.

While not every patient responds the same way, many report meaningful improvements in their ability to function, sleep, and engage in daily activities. The quarterly infusion schedule also makes adherence easier and provides sustained migraine protection between treatments.

When prescribed and monitored by a qualified healthcare provider, Vyepti is a safe and effective preventive option for adults with frequent or disabling migraines. Patients considering this therapy should discuss whether it fits their health history, lifestyle, and long-term goals for migraine management.

References

U.S. Food and Drug Administration (FDA). Vyepti (Eptinezumab-jjmr) Prescribing Information, 2020. https://www.fda.gov/
Mayo Clinic. Eptinezumab (Intravenous Route) Description and Side Effects, 2023. https://www.mayoclinic.org/
MedlinePlus. Eptinezumab Injection – Drug Information, National Library of Medicine, 2024. https://medlineplus.gov/

Approved To Treat

Migraine

Top Global Experts

Amaal J. Starling

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Brand Information

Vyepti (eptinezumab-jjmr)

1INDICATIONS AND USAGE

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

2DOSAGE FORMS AND STRENGTHS

VYEPTI is a clear to slightly opalescent, colorless to brownish-yellow solution available as follows:

Injection: 100 mg/mL in a single-dose vial

3CONTRAINDICATIONS

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

4ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Hypersensitivity Reactions
Hypertension
Raynaud’s Phenomenon

4.1ClinicalTrials Experience

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.

The safety of VYEPTI was evaluated in 2076 patients with migraine who received at least one dose of VYEPTI, representing 1615 patient-years of exposure; of these, 1524

The most common (incidence at least 2% and at least 2% greater than placebo) adverse reactions in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.

Table 1 summarizes the adverse reactions that occurred during Study 1 and Study 2.

Table 1. Adverse Reactions Occurring with an Incidence of at Least 2% for VYEPTI and at Least 2% Greater than Placebo in Studies 1 and 2

* Hypersensitivity reactions includes multiple related adverse event terms, such as hypersensitivity, pruritus, and flushing/hot flush that occurred on the day of dosing.

In Study 1 and Study 2, 1.9% of patients treated with VYEPTI discontinued treatment because of adverse reactions

In study 3, the safety profile observed in 480 patients who were randomized and treated (238 to VYEPTI 100 mg and 242 to placebo) was consistent with the safety profile observed in the two pivotal placebo-controlled studies with VYEPTI (Study 1 and 2).

4.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of VYEPTI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Anaphylaxis [see

General Disorders and Administration Site Conditions: Fatigue

Vascular Disorders: Hypertension [see , Raynaud’s phenomenon [see

5DESCRIPTION

Eptinezumab-jjmr is a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Eptinezumab-jjmr has an approximate molecular weight of 143 kD. Eptinezumab-jjmr is produced in

VYEPTI (eptinezumab-jjmr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to brownish-yellow solution, for intravenous infusion. VYEPTI is supplied as a 100 mg/mL single-dose vial. Each mL contains 100 mg eptinezumab-jjmr formulated in L-histidine (1 mg), L-histidine hydrochloride monohydrate (2.8 mg), polysorbate 80 (0.15 mg), sorbitol (40.5 mg), and Water for Injection, USP, at a pH of 5.8.

6CLINICAL STUDIES

The efficacy of VYEPTI was evaluated in three randomized, multicenter, placebo-controlled double-blind studies that enrolled patients with episodic and chronic migraine who were eligible for preventive treatment of migraine. In Study 1, which included patients with episodic migraine, and Study 2, which included patients with chronic migraine, either 100 mg or 300 mg VYEPTI was administered by intravenous infusion every 3 months. In Study 3, 100 mg VYEPTI was administered as a single intravenous infusion to patients with episodic or chronic migraine who were eligible for preventive migraine treatment and who had a concurrent migraine.

Study 1: Episodic Migraine

Study 1 (NCT02559895) included adults with a history of episodic migraine (4 to 14 headache days per month, of which at least 4 were migraine days). A total of 665 patients were randomized to receive placebo (N=222), 100 mg VYEPTI (N=221), or 300 mg VYEPTI (N=222) every 3 months for 12 months. Patients were allowed to use concurrent acute migraine or headache medications, including migraine-specific medications (i.e., triptans, ergotamine derivatives), during the trial.

The study excluded patients with a history of cardiovascular disease (hypertension, ischemic heart disease), neurological disease, or cerebrovascular disease.

The primary efficacy endpoint was the change from baseline in mean monthly migraine days over Months 1-3. Secondary endpoints included the percentages of patients with 50% or greater, and 75% or greater reductions from baseline in monthly migraine days over Months 1-3.

Patients had a median age of 39 years (range: 18 to 71 years), 84% were female, and 84% were white. The mean migraine frequency at baseline was approximately 8.6 migraine days per month and was similar across treatment groups.

VYEPTI treatment demonstrated statistically significant improvements compared to placebo for the primary efficacy endpoint, as shown in Table 2; secondary endpoints are also summarized in Table 2.

Table 2. Efficacy Endpoint Results in Study 1

* Nominal statistical significance

** NS = Not statistically significant

Figure 1 shows the mean change from baseline in average monthly migraine days in Study 1. Patients treated with VYEPTI at both doses had greater mean decreases from baseline in mean monthly migraine days over Months 1-3 compared to placebo-treated patients.

Figure 1. Change from Baseline in Monthly Migraine Days in Study 1

Figure 2 shows the distribution of change from baseline in mean monthly migraine days through Month 3 by treatment group in 2-day increments.

Figure 2. Distribution of Change from Baseline in Mean Monthly Migraine Days over Months 1 to 3 by Treatment Group in Study 1

Figure 3 demonstrates that greater percentages of placebo-treated patients had migraines on most days during the first 7 days of treatment compared to VYEPTI-treated patients in Study 1.

Figure 3. Percentage of Patients with a Migraine from Day -1 (Day Prior to Infusion) to Day 7 in Study 1

Study 2: Chronic Migraine

Study 2 (NCT02974153) included adults with a history of chronic migraine (15 to 26 headache days per month, of which at least 8 were migraine days). A total of 1072 patients were randomized and received placebo (N=366), 100 mg VYEPTI (N=356), or 300 mg VYEPTI (N=350) every 3 months for 6 months. Patients were allowed to use and to continue an established stable regimen of acute migraine or headache preventive medication (except onabotulinumtoxinA). Patients with a dual diagnosis of chronic migraine and medication overuse headache attributable to acute medication overuse (triptans, ergotamine, or combination analgesics greater than 10 days per month) were included in the study population. Patients using opioids or butalbital-containing products greater than 4 days per month were not allowed.

The study excluded patients with a history of cardiovascular disease (hypertension, ischemic heart disease), neurological disease, or cerebrovascular disease.

The primary efficacy endpoint was the change from baseline in mean monthly migraine days over Months 1-3. Secondary endpoints included the percentages of patients with 50% or greater and 75% or greater reductions from baseline in monthly migraine days over Months 1-3.

Patients had a median age of 41 years (range: 18 to 65 years), 88% were female, and 91% were white. Forty-one percent of patients were taking concomitant preventive medication for migraine. The mean migraine frequency at baseline was approximately 16.1 migraine days per month and was similar across treatment groups.

VYEPTI treatment demonstrated statistically significant improvements compared to placebo for the primary efficacy endpoint, as shown in Table 3; secondary endpoints are also summarized in Table 3.

Table 3. Efficacy Endpoint Results in Study 2

Figure 4 shows the mean change from baseline in average monthly migraine days for Study 2. Patients treated with VYEPTI at both doses had greater mean decreases from baseline in mean monthly migraine days over Month 1-3 compared to placebo-treated patients.

Figure 4. Change from Baseline in Monthly Migraine Days in Study 2

Figure 5 shows the distribution of change from baseline in mean monthly migraine days through Month 3 by treatment group in 3-day increments.

Figure 5. Distribution of Change from Baseline in Mean Monthly Migraine Days over Months 1-3 by Treatment Group in Study 2

Figure 6 demonstrates that greater percentages of placebo-treated patients had migraines on individual days during the first 7 days of treatment compared to VYEPTI-treated patients in Study 2.

Figure 6. Percentage of Patients with a Migraine from Day -1 (Day Prior to Infusion) to Day 7 in Study 2

Study 3: Episodic Migraine or Chronic Migraine

Study 3 (NCT01719055) included adults who were candidates for preventive migraine therapy with VYEPTI and presented with a concurrent moderate to severe migraine on the day of infusion. A total of 480 patients were randomized to receive 100 mg VYEPTI (n=238) or placebo (n=242) as a single dose. VYEPTI demonstrated statistically significant improvements in headache pain freedom at 2 hours (VYEPTI 23.5% vs placebo 12%; p<0.001) and absence of most bothersome symptom (such as nausea, photophobia, or phonophobia) at 2 hours (VYEPTI 55.5% vs placebo 35.8%; p< 0.001) as compared to placebo. The dose of 300 mg VYEPTI was not evaluated in Study 3.

7PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions

Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur with VYEPTI. Advise patients to contact their healthcare provider immediately if signs or symptoms of hypersensitivity reactions occur

Hypertension

Inform patients that hypertension can develop or pre-existing hypertension can worsen with VYEPTI, and that they should contact their healthcare provider if they experience elevation in their blood pressure

Raynaud’s Phenomenon

Inform patients that Raynaud’s phenomenon can develop or worsen with VYEPTI. Advise patients to discontinue VYEPTI treatment and contact their healthcare provider if they experience signs or symptoms of Raynaud’s phenomenon

Pregnancy Exposure Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYEPTI during pregnancy

Lactation

Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed

Manufactured by:

Lundbeck Seattle BioPharmaceuticals, Inc.

11804 North Creek Parkway South

Bothell, WA 98011 USA

U.S. License No. 2097

Vyepti is a registered trademark of Lundbeck Seattle BioPharmaceuticals, Inc.

8PATIENT PACKAGE INSERT

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 10/2025

9PRINCIPAL DISPLAY PANEL

NDC 67386-130-51

VYEPTITM (vye ep' tee)

(eptinezumab-jjmr)

injection, for intravenous use

100 mg/mL

10PRINCIPAL DISPLAY PANEL

NDC 67386-130-91

Professional Sample