Eptinezumab

Eptinezumab (Vyepti) is a prescription medicine used for migraine prevention, to reduce monthly migraine days for chronic migraines and episodic migraines in adults. Eptinezumab is given as an IV infusion every 3 months (four times a year).

Eptinezumab is from a class of medicines called calcitonin gene-related peptide antagonists.

Eptinezumab infusion works by blocking a protein called calcitonin gene-related peptide (CGRP), which is involved in migraines. CGRP levels increase during a migraine attack and may also be involved in the start of a migraine. It is thought that by blocking CGRP, eptinezumab reduces monthly migraine days.

Eptinezumab brand name is Vyepti, by Lundbeck Seattle BioPharmaceuticals.

Eptinezumab-jjmr infusion received FDA approval on February 22, 2020.

Eptinezumab is given by intravenous (IV) infusion into your vein by a healthcare provider in a healthcare setting.

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 this infusion if you are allergic to the active ingredient eptinezumab-jjmr or any of the ingredients in this infusion. See the end of this page for a complete list of ingredients.

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Pregnancy

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

There is a pregnancy registry for women who take this medicine. The purpose of this registry is to collect information about you and your baby's health. You may enroll yourself by calling 1-855-810-8549 or talk 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 eptinezumab side effects are a stuffy nose, scratchy throat, and allergic reactions.

Serious side effects

Allergic reactions can happen after receiving eptinezumab. 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 eptinezumab. In some cases, people have been hospitalized. Contact your healthcare provider if you have severe constipation or constipation 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 eptinezumab. 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 eptinezumab. 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 an eptinezumab 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 eptinezumab dosage is 100mg IV infusion every 3 months. Some patients may benefit from a 300 mg intravenous infusion every 3 months.

Dilution Instructions

Eptinezumab requires dilution prior to 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: 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, 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. 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

Vyepti 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.