Vyepti (eptinezumab)

Vyepti is a new preventive treatment for migraine. It is part of a class of medications called calcitonin gene-related peptide (CGRP) monoclonal antibodies.

Preventive treatments like Vyepti are generally recommended for anyone living with chronic or debilitating migraine attacks. However, there are many different medications available, and it can be hard to decide which one might be best for you. This article covers the essential information about Vyepti to help you better understand your options.

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Medically reviewed by Dr Trudy Cheng. Last updated September 19, 2022.

What is Vyepti?

Vyepti (eptinezumab) is an intravenous (IV) medication for the prevention of migraine. 

Migraine is a neurological disorder that can be debilitating. It causes head pain, nausea,  and light or sound sensitivity, alongside many other symptoms. Preventive treatments like Vyepti are generally recommended for anyone living with chronic or debilitating migraine attacks.

Vyepti is part of a class of medications called calcitonin gene-related peptide (CGRP) monoclonal antibodies. There are several other CGRP monoclonal antibody medications available in Australia.

At a glance

Brand nameVyepti
Active ingredientEptinezumab
ManufacturerLundbeck Australia Pty Limited
Dosage100mg every 12 weeks*
AdministrationIntravenous infusion prepared by a healthcare professional.
CostApprox. $1800 per 100 mg dose
AvailabilityPrescription-only
PBS Status?Recommended for listing by the PBAC (August 19, 2022)

*Guideline only. Consult your doctor for exact dosage recommendations.

Cost & access in Australia

Vyepti is available in Australia for the preventive treatment of migraine in adults. It is currently only available on private access, but it has been recommended for addition to the Pharmaceutical Benefits Scheme (PBS) for the treatment of chronic migraine.

You will need to get a prescription from a neurologist who will assess your medical history to see if this medication is appropriate for you. If you are not seeing a neurologist at the moment, you can find one in our doctor directory.

The price of the medication starts at $1,800 per dose. The total price of the medication and the IV infusion will vary depending on the place of purchase & the infusion clinic.

While this price is high, you can ask your neurologist to contact Lundbeck to see if you qualify for the Coordinated Access Network (CAN). The CAN is a collaboration between Lundbeck and some private hospitals and infusion centres. It allows new patients to receive their first infusion free of charge (for the first 300 patients).

Side effects

Like most medications, Vyepti may cause side effects. If you do experience side effects, they will most likely be minor and temporary (1). However, more serious complications are possible that require immediate medical attention.

Keep in mind that side effects can vary depending on your age, other health conditions you might have, or other medications you take.

Mild side effects (1) 

  • Related to receiving Vyepti: nasal congestion, runny nose, sore throat, cough, sneezing, being short of breath
  • Allergy-related symptoms: hives, rash, itching and hot flushes
  • Infection-related: nose or throat infection

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects (1)

A serious allergic reaction can cause: 

  • Difficulty breathing, a fast or weak pulse, a sudden drop in blood pressure (making you feel dizzy or lightheaded), swelling of the face, lips, tongue, or other body parts.

Call your doctor immediately or seek emergency medical attention in a hospital if you experience any of these serious side effects.

Two studies conducted by Lundbeck (the manufacturer) found that Vyepti is generally well tolerated. Out of more than 1,700 people, the most common side effects were (2):

  • Stuffy nose and scratchy throat (6-8%)
  • Allergic reactions (3-4%)

Other side effects could occur in some people. After receiving medical advice about any side effects you experience, you or your neurologist can report them to the Therapeutic Goods Administration.

How it works

Vyepti is part of a group of drugs called calcitonin gene-related peptide (CGRP) monoclonal antibodies. These are the newest type of preventive migraine medication, and the first preventive treatment to be designed specifically for migraine. You can see how it works in the diagram below (2).

Diagram of CGRP neurotransmitters near a neuron receptor.

1. Inside the body, there is a protein called calcitonin gene-related peptide, or CGRP.

Diagram of CGRP attaching to the receptor, which is thought to play a role in triggering migraine.

2. CGRP attaches to and activates specific receptors, which may play a role in migraine.

Diagram shows how Vyepti attaches to CGRP molecules, preventing them from reaching the receptor.

3. VYEPTI binds to CGRP and prevents it from attaching to and activating the receptors.

We don’t know exactly what the relationship is between CGRP antibodies and migraine prevention. However, studies have shown that if CGRP is injected as an intravenous infusion in patients with migraine, it can cause a migraine-like attack in 57% of patients (3). Researchers wanted to find out if the reverse was true: could they block migraine by blocking CGRP action?

After many years, this research led to the development of CGRP monoclonal antibodies like Vyepti. You can read more about CGRPs here >

Dosage

Your doctor will prescribe the amount of Vyepti that is right for you. Typically, this starts at 100 mg administered via intravenous infusion every 12 weeks (1).

Your dose may be adjusted depending on how you respond to the medication. Clinical trials have tested doses up to 300mg (2).

If you miss a dose, you should try to reschedule your infusion appointment as soon as possible. Your migraine attacks may return if you stop taking Vyepti, as it is designed for long-term use.

How is Vyepti administered?

Vyepti’s route of administration is different to other CGRPs because it is administered via intravenous infusions. Other medications (such as Emgality or Ajovy) are administered as a monthly or 3 monthly subcutaneous injection that you give yourself at home.

Example of IV infusion bag used for Vyepti

The infusion can only be administered in a medical practice by a doctor, nurse, or neurologist. The medication is reconstituted in a bag of sterile infusion liquid of 0.95 normal saline, which is injected into your vein over 30 minutes.

Pros & cons of intravenous delivery

ProsCons
Rapid absorption into the bloodstream means it can take effect fasterExtra costs of the infusion, depending on where your infusion is being administered (private clinic fees, etc)
Booking consistent appointments ensures regular dosingUnable to be self-administered, requires seeing a healthcare professional to administer
Only required every 3 months versus monthly or daily for other preventivesActual infusion is more time-consuming than auto-injectors or oral tablets
Potential to reduce injection site reactions

Before your appointment, make sure to drink plenty of water and wear comfortable clothing. You can ask your doctor if you have any questions or concerns about the infusion process.

How effective is Vyepti?

Just like any medication, Vyepti will not be perfect for everyone. One person may find it very effective, while someone else might find that it doesn’t really make a difference.

A clinical trial measured the safety and efficacy of Vyepti in adults with chronic migraine over a 12 week period (between the first and second infusion). There were 1072 participants in the trial who received either 100mg, 300mg, or a placebo dose.

 100mg dose (n = 356)300mg dose (n = 350)Placebo (n = 366)
Average migraine days at baseline16.116.116.2
Average migraine days during treatment8.57.910.5
Average reduction in migraine days‒7.7‒8.2‒5.6
Percentage of patients with 50% or more reduction in migraine days57.6%61.4%39.3%
Percentage of patients with 75% or more reduction in migraine days26.7%33.1%15.0%

This study shows a clinically significant reduction in migraine days, giving Vyepti Class I evidence for use in migraine prevention. Class I evidence is the highest evidence rating a treatment can receive. It means that the trial was randomised, controlled, objectively assessed, and had statistically significant results (6).

Why is the placebo effect so strong?

The placebo rate in this trial might seem high, with almost 40% of trial participants experiencing a significant 50% improvement with the placebo infusion, but this actually happens quite often. The ‘placebo effect’ is a well-documented phenomenon in which people see an improvement in their disease even if they aren’t receiving the actual drug.

There are many different theories about why the placebo effect works, such as high expectations, conditioned responses, and visual, verbal, & social cues (5). These can elicit real physiological responses in your central nervous system such as reduced activity in brain regions associated with pain processing (5).

The authors of the study said the placebo effect could be attributed to (4):

  • The novelty of the treatment (and CGRPs in general)
  • Route of administration
  • High percentage of people receiving the actual medication, meaning people had higher expectations
  • Number of patients who hadn’t tried preventive therapy before

Patients also were in regular contact with migraine care experts throughout the trial. They went to professionally supervised IV infusions, and had frequent follow-up contact via telephone & in-person visits (4). This ongoing support can improve mental health and behavioural management of migraine.

Other considerations & interactions

When taking a new medication it is important to consider your overall health, including lifestyle factors, health conditions, or other medications. Certain foods, vaccines, or other factors can affect how a medication works. These are called interactions.

Sometimes, interactions just cause the drug to be less effective. But in some cases, these interactions can be harmful or unsafe.

At this stage, Vyepti has no known interactions with other medications, foods, or health conditions. However, this doesn’t mean that they don’t exist. Please speak to your doctor before taking any new medications or supplements during your Vyepti treatment.

There is also very little research about Vyepti and (1):

  • Cardiovascular disease (i.e. hypertension or ischemic heart disease)
  • Pregnancy
  • Breastfeeding

Please consult your doctor if any of the above applies to you.

PBS listing update

On the 19th of August 2022, Vyepti received a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) to be listed on the PBS. The government and manufacturer will now enter into negotiations to finalise pricing details before the listing is made available to patients eligible for PBS access.

The PBAC has recommended that Vyepti should be available on the PBS for chronic migraine patients who have found at least three other preventive medications to be ineffective or intolerable. They have also recommended that it should be added to the risk-sharing arrangement that exists for Ajovy and Emgality. This means that all three medications would share the same expenditure cap.

In the past negotiations can take anywhere from several months to several years. To be alerted when Vyepti is added to the PBS, sign up to the Migraine & Headache Australia newsletter.

Further information & resources

If you’d like to learn more about anything in this article, you can check out the following resources:

References:

  1. Therapeutic Goods Administration, 2022, ARTG ID 335256 [VYEPTI Consumer Medicine Information (CMI) Summary]. Retrieved from: https://www.tga.gov.au/resources/artg/335256 
  2. Lundbeck, 2021, About VYEPTI. Retrieved from: https://www.vyepti.com/about-vyepti 
  3. JM Hansen et al, 2010, Calcitonin gene-related peptide triggers migraine- like attacks in patients with migraine with aura. DOI: 10.1177/0333102410368444
  4. RB Lipton et al, 2020, Efficacy and safety of eptinezumab in patients with chronic migraine. DOI: 10.1212/WNL.0000000000009169
  5. B Colagiuri et al, 2015, The placebo effect: From concepts to genes. DOI: 10.1016/j.neuroscience.2015.08.017
  6. American Academy of Neurology, 2010, American Academy of Neurology Classification of Evidence. Retrieved from: https://qibawiki.rsna.org/images/3/33/American_Academy_of_Neurology_Classification_of_Evidence-20100504.doc
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