Vyepti

Vyepti (eptinezumab-jjmr) is an FDA-approved prescription medicine for migraine prevention in adults. It is administered as an IV infusion every 3 months. Vyepti is used to help prevent both episodic migraine and chronic migraine by reducing the number of monthly migraine days and increasing the number of migraine-free days.

Vyepti works by targeting and blocking calcitonin gene-related peptide (CGRP), a protein involved in migraine attacks. Because CGRP is believed to play an important role in the development of migraine, blocking it can help prevent migraine episodes before they begin.

Vyepti is a CGRP inhibitor and received FDA approval in February 2020.

Episodic migraine

In adults with episodic migraine, Vyepti reduced monthly migraine days more than placebo over the first 3 months of treatment. In Study 1 (NCT02559895), patients started with an average baseline of about 8.6 monthly migraine days.

Compared with placebo, Vyepti 100 mg provided a net benefit of 0.7 fewer migraine days per month, while Vyepti 300 mg provided a net benefit of 1.1 fewer migraine days per month, for episodic migraine.

Chronic migraine

In adults with chronic migraine, Vyepti reduced monthly migraine days more than placebo in clinical trials. In Study 2 (NCT02974153), which evaluated 3 months of treatment in patients with a baseline average of about 16.1 monthly migraine days, Vyepti 100 mg reduced monthly migraine days by 7.7 days and Vyepti 300 mg reduced them by 8.2 days, compared with 5.6 days for placebo.

The net benefit versus placebo was 2.1 fewer migraine days per month with Vyepti 100 mg and 2.6 fewer migraine days per month with Vyepti 300 mg for chronic migraine.

• Vyepti is given by intravenous (IV) infusion in your vein by a healthcare provider in a healthcare setting.
• Vyepti infusions take approximately 30 minutes and are given every 3 months.

If you have questions about your infusion schedule, ask your healthcare provider.

Before using this medicine, tell your healthcare professional about all of your medical conditions, especially if you have:

• high blood pressure
• circulation problems in your fingers and toes

You should not receive Vyepti infusion if you are allergic to the active ingredient eptinezumab-jjmr or any of the ingredients in Vyepti. See the end of this page for a complete list of ingredients.

Pregnancy

Tell your healthcare provider if you are pregnant, plan to become pregnant, or become pregnant, as it is not known if Vyepti infusion will harm your unborn baby.

There is a pregnancy registry for women who take Vyepti. The purpose of this registry is to collect information about your and your baby's health. You may enroll yourself by calling 1-855-810-8549 or by talking to your healthcare provider about how you can participate in this registry.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed, as it is not known if Vyepti passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby while using this medicine.

The most common Vyepti side effects are a stuffy nose, scratchy throat, and allergic reactions.

Serious side effects

Allergic reactions can happen after receiving Vyepti. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction:

• rash
• swelling of your face, lips, tongue, or throat
• trouble breathing
• hives
• redness in your face.

Constipation with serious complications. Severe constipation can happen after receiving Vyepti. In somecases, people have been hospitalized. Contact your healthcare provider if you have severe constipation orconstipation is associated with symptoms such as severe or constant belly pain, vomiting, swelling of the belly, or bloating.

High blood pressure or worsening of high blood pressure can happen after receiving Vyepti. Contact your healthcare provider if you have an increase in blood pressure.

Raynaud’s phenomenon is a type of circulation problem that can worsen or happen after receiving Vyepti. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale to blue to red. Contact your healthcare provider if these symptoms occur.

These are not all of the possible side effects of Vyepti infusion. Ask your pharmacist or healthcare provider for more information. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The recommended Vyepti dosage is 100mg IV infusion every 3 months. Some patients may benefit from a 300 mg intravenous infusion every 3 months.

Dilution Instructions

Vyepti requires dilution before administration. Dilute only in 100 mL 0.9% Sodium Chloride Injection, USP. The infusion bags must be made of polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO). Use appropriate aseptic technique when preparing Vyepti solution for intravenous infusion. Vyepti single-dose vials contain no preservative; discard the unused portion remaining in the vial.

Vyepti is available as a 100 mg/mL solution in a single-dose vial, which needs to be diluted.

Dilution for 100 mg dose:

To prepare the solution, withdraw 1 mL of Vyepti from a single-dose vial using a sterile needle and syringe. Inject the 1 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP.

Dilution for 300 mg dose:

To prepare the solution, withdraw 1 mL of Vyepti from each of 3 single-dose vials using a sterile needle and syringe. Inject the resulting 3 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP.

Storage and Handling of Diluted Product

Gently invert the Vyepti solution to mix completely. Do not shake. Following dilution, Vyepti solution must be infused within 8 hours. During this time, the solution should be stored at room temperature, 20°C to 25°C (68°F to 77°F). Do not freeze.

Store a single-dose vial at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light until the time of use. Do not freeze or shake.

Store diluted solution at 0°C to 25°C (68°F to 77°F). Do not freeze. The diluted solution must be infused within 8 hours

Manufactured by: Lundbeck Seattle BioPharmaceuticals, Inc., 11804 North Creek Parkway South, Bothell, WA 98011

Active ingredient: eptinezumab-jjmr

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sorbitol, and Water for Injection.The vial stopper is not made with natural rubber latex.