Vyepti® Infusion Therapy for Chronic Migraine

Vyepti is a CGRP-targeted migraine preventive medication. CGRP — calcitonin gene-related peptide — is a protein involved in the biology of migraine. Vyepti is a monoclonal antibody that binds to CGRP and prevents it from activating its receptor.

By targeting CGRP, Vyepti is designed specifically to help prevent migraine attacks rather than simply treat symptoms after an attack has already started. Unlike medications taken every day, it is administered by IV infusion once every three months.

Chronic migraine is generally defined as:

• ✦15 or more headache days per month, occurring for more than three months, with
• ✦At least 8 days per month having migraine features or responding to migraine-specific treatment

Your physician will determine whether your headache pattern meets the diagnostic criteria for chronic migraine and whether Vyepti is appropriate for you.

Clinical trials have demonstrated that Vyepti can reduce the number of monthly migraine days in adults with migraine.

In a large trial of patients with chronic migraine who averaged roughly 16 migraine days per month, those receiving Vyepti 100 mg or 300 mg experienced an average reduction of approximately 8 migraine days per month over the three-month treatment period, compared with about 6 fewer days with placebo. Individual results vary.

Some patients experience improvement relatively soon after the first infusion, with benefit continuing through the treatment period. However, not everyone responds, and the degree of improvement varies from person to person.

For patients who respond to treatment, Vyepti may:

• ✦Reduce the number of migraine days each month
• ✦Reduce the frequency of migraine attacks
• ✦Reduce the severity of attacks
• ✦Reduce the amount of time affected by migraine
• ✦Decrease the need for acute migraine medications
• ✦Improve ability to work and participate in daily activities
• ✦Improve overall quality of life

The goal of preventive therapy is not necessarily to eliminate every migraine, but to achieve a meaningful reduction in migraine frequency and disability.

Vyepti is administered through a small IV placed in your arm or hand, given by a healthcare professional over approximately 30 minutes. You remain awake, and your medical team monitors you during and after the infusion.

The entire visit may take longer than the 30-minute infusion itself because of check-in, medication preparation, IV placement, observation, and discharge. For most patients, Vyepti does not require sedation.

One of the advantages of Vyepti is its dosing schedule. The FDA-recommended dose is 100 mg IV every 3 months, and some patients may benefit from 300 mg IV every 3 months — generally four treatments per year.

Your physician will determine which dose is appropriate based on your migraine history, treatment response, and individual circumstances.

Vyepti is designed to provide prevention across the three-month dosing interval. Some patients notice improvement early after the first infusion, while others need more time or additional treatments to determine the full benefit.

We typically evaluate your response by tracking:

• ✦Number of migraine days
• ✦Number of headache days
• ✦Migraine severity
• ✦Duration of attacks
• ✦Acute medication use
• ✦Functional impairment
• ✦Quality of life

Keeping a headache diary can be extremely helpful in determining how well Vyepti is working.

Most people tolerate Vyepti well. In clinical studies, commonly reported adverse reactions included stuffy nose, scratchy throat, and hypersensitivity or allergic reactions. The prescribing information also warns about potentially serious hypersensitivity reactions that can require immediate medical treatment.

More recent FDA labeling has added warnings regarding:

• ✦Constipation with serious complications
• ✦New or worsening hypertension
• ✦New or worsening Raynaud's phenomenon

Tell your physician if you have a history of significant constipation, high blood pressure, circulation problems involving the fingers or toes, or previous reactions to monoclonal antibody medications.

Although serious reactions are uncommon, an allergic or hypersensitivity reaction can occur. Seek immediate medical attention if you develop symptoms such as:

• ✦Difficulty breathing
• ✦Swelling of the face, lips, tongue, or throat
• ✦Hives or significant rash
• ✦Severe dizziness
• ✦Facial flushing or other symptoms suggesting an allergic reaction

Also notify your healthcare provider if you develop severe or persistent constipation, particularly with significant abdominal pain, vomiting, abdominal swelling, or bloating.

Vyepti is a preventive treatment and does not necessarily replace medications used to treat an acute attack. Depending on your plan, you may continue to use an appropriate acute migraine medication when an attack occurs.

Your physician will determine which medications should be continued, adjusted, or discontinued based on your response to Vyepti and your overall migraine-management plan.

For many patients, the biggest advantage of Vyepti is convenience. Instead of taking a preventive medication every day, Vyepti is administered approximately once every three months — one 30-minute infusion, roughly three months of prevention, four treatments per year.

For patients who struggle with daily medication schedules, side effects from oral preventives, or inadequate control with other therapies, an IV option may be an attractive alternative.