What to Know About Vyepti (Eptinezumab)

Vyepti (eptinezumab) is the first intravenous (IV) medication approved for preventing migraines. Vyepti is a monoclonal antibody that targets and blocks the binding site of a protein called calcitonin gene-related peptide (CGRP). This protein is believed to be the cause behind the pain of most migraine attacks.

While Vyepti is administered as an IV infusion every three months, other approved CGRP monoclonal antibodies for migraine prevention—Aimovig (erenumab), Ajovy (fremanezumab), and Emgality (galcanezumab)—are administered as a shot, either monthly or once every three months (depending on the drug). The latest CGRP to get approval for this condition, Nurtec ODT (rimegepant), is taken in pill form once every other day for migraine prevention.

Uses

Vyepti was approved by the U.S. Food and Drug Administration (FDA) in 2020 for the preventive treatment of migraines in adults. The drug's safety and effectiveness have not been established in children or patients over the age of 65.

Traditional oral migraine preventive medications (OMPMs) were initially developed to treat other medical conditions, like depression or seizures. CGRP monoclonal antibodies, like Vyepti, are the first drugs designed specifically to prevent migraines.

CGRP is a protein that plays a role in migraines by causing cranial blood vessels to relax. When released around the brain, CGRP also promotes a phenomenon called neurogenic inflammation.

Studies have found that blocking the function of CGRP (what Vyepti does) can reduce the number of migraine attacks a person experiences. For some people, CGRP monoclonal antibodies may even stop their migraine attacks altogether.

Research on Vyepti shows that it reduced migraines by an average of four days per month in patients with episodic migraine (compared to approximately three days in placebo).

In patients with chronic migraine, Vyepti reduced the average monthly migraine days by eight days (compared to approximately six days in placebo).

Before Taking

Before taking Vyepti, it's important to tell your healthcare provider all of the medications you are taking, including prescription and over-the-counter drugs, herbal supplements, and vitamins. Also, please review all of your health conditions with your practitioner. You want to ensure that taking this medication is the best and safest fit for you.

Precautions and Contraindications

Vyepti is contraindicated in patients with serious hypersensitivity to eptinezumab or any of its ingredients.

For people who are pregnant, the safety of Vyepti has not been established. Also, it is not known if Vyepti is present in breast milk. Therefore, be sure to tell your healthcare provider if you are pregnant, breastfeeding, or planning on becoming pregnant or breastfeeding.

You and your practitioner will need to carefully weigh the benefits versus the potential infant and maternal risks of taking the drug during this time. If you are pregnant, your healthcare provider will likely recommend other medications (most notably, propranolol) for migraine prevention.

Dosage

Vyepti is administered at a dose of 100 milligrams (mg) as an intravenous infusion over approximately 30 minutes every three months. Per the manufacturer, some people may benefit from a dosage of 300 mg administered by intravenous infusion every three months.

Modifications

There is no dose adjustment required for people with kidney or liver impairment.

How To Take and Store

Vyepti is administered by a healthcare provider at a healthcare facility, like an infusion center or your healthcare provider's clinic.

Before receiving the infusion, a healthcare provider (commonly, a nurse) will first dilute Vypeti. The dilution process for a typical 100-mg dose involves the following steps:

• Withdraw 1 milliliter (mL) of Vyepti from a single-dose vial using a sterile needle and syringe.
• Inject the resulting 1 mL of the drug into a 100 mL bag of 0.9% sodium chloride injection.
• Gently invert the Vyepti solution to mix completely (no shaking).

Following the dilution process, Vyepti must be infused within eight hours. During this time, the drug is stored at room temperature.

No other medications can be mixed with Vyepti. After administration, the IV line should be flushed with 20 mL of 0.9% sodium chloride injection.

In terms of storage before dilution and use, Vyepti is refrigerated at 2°C to 8°C in its original carton to protect it from light (until its time of use). The manufacturer warns not to freeze or shake the medication.

Side Effects

The most common side effects associated with Vyepti include a stuffy nose, sore throat, and allergic reactions.

According to the reported data, most allergic reactions occurred during the patient's infusion and were not serious; however, they did lead to discontinuation of the drug and/or required treatment.

Also, serious allergic reactions can occur. Be sure to call your healthcare provider or seek emergency medical attention if you have any symptoms of an allergic reaction such as hives or another rash, swelling of your face, lips, tongue, or throat, trouble breathing, or redness in your face.

Warnings and Interactions

You should not take Vyepti if you have had an allergic reaction in the past to the drug or any of its ingredients. Allergic reactions have included angioedema, urticaria, facial flushing, and rash.

The active ingredient of Vyepti is eptinezumab-jjmr. Inactive ingredients include L- histidine, L- histidine hydrochloride monohydrate, polysorbate 80, sorbitol, and water for injection.

The vial stopper for Vyepti is not made with natural rubber latex.