AJOVY CGRP migraine prevention treatment injection

What makes Ajovy different?

Hear from an expert

Dr Susan Hutchinson discusses AJOVY and its metabolism, dosing, and administration.
Show transcript

Hello, I’m Dr Susan Hutchinson, a board-certified, headache specialist and founder of Orange County Migraine & Headache Center.

Thank you for taking the time to join us to learn more about AJOVY (fremanezumab-vfrm) injection, for the preventive treatment of migraine in adults.

In this video, we’ll discuss what makes AJOVY different and other key information for AJOVY, including its metabolism, the AJOVY autoinjector, and the available dosing options. I understand that your time is valuable, but I also think the following information will help you in making more informed treatment decisions, so let’s get started.

As we start talking through the features of AJOVY and considerations for prescribing, please keep in mind that AJOVY is contraindicated in patients with severe hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

So you may be wondering, what makes AJOVY different?

For one, AJOVY is the long-acting anti-CGRP injection with the option of dosing only 4 times a year. While a monthly dosing option is also available, patients who are prescribed quarterly dosing will need as few as 4 injection days per year.

AJOVY is also a fully humanized monoclonal antibody that works through exclusive binding of the calcitonin gene-related peptide. Let’s zoom in on some details.

The antigen-binding fragment of the antibody, termed Fab, is the variable region of the molecule, which recognizes and binds to antigens selectively and with specificity.

There are four subtypes amongst the IgG monoclonal antibodies. These subtypes vary across the class of monoclonal antibodies for the preventive treatment of migraine in adults.

AJOVY was bioengineered to contain 2 amino acid substitutions in the Fc region, a variant referred to as IgG2Δa—designed to reduce unwanted activation of the immune system.

In a published study, Bhakta et al tested the specificity of AJOVY with closely related calcitonin family members. A combination of in vitro binding, functional, and imaging assays demonstrated that AJOVY only antagonizes CGRP signaling at the CGRP receptor, allowing other peptides to signal through this receptor unperturbed. Additionally, these assays indicated that AJOVY shows no binding to human CGRP receptor–expressing cells. No off-site binding of related calcitonin family members was exhibited by AJOVY, further supporting its selectivity.

Now let’s shift gears a bit and take a look at the pharmacokinetic profile of AJOVY, beginning with its half-life.

Here, we see that AJOVY has a long half-life of 31 days. This is part of the reason that AJOVY is the long-acting anti-CGRP injection with the option of dosing just 4 times a year. Once steady state is reached, elimination of AJOVY is similar for monthly and quarterly dosing, which is approximately 5 to 6 half-lives.

Now let’s take a look at the results from a phase 1 study assessing pharmacokinetic parameters for both quarterly and monthly dosing in healthy volunteers. As you can see, these pharmacokinetic data provide further support for either quarterly or monthly dosing options for AJOVY.

Before we move on to the metabolism of AJOVY, it’s important to keep in mind that hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, you should consider discontinuing AJOVY and institute appropriate therapy.

And now for the metabolism of AJOVY. We know this information is critical to you as you are weighing treatment decisions for your patients so let’s get into some details.

You may find it interesting to note that AJOVY is not metabolized by cytochrome P450 enzymes. Therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Please keep in mind that in clinical trials, the most common adverse reactions in clinical trials (greater than or equal to 5% and greater than placebo) were injection-site reactions.

Moving on to administration and how the AJOVY Autoinjector could be helpful to you and your patients.

AJOVY is available in an easy-to-use autoinjector for quarterly and monthly dosing. The autoinjector has no visible needle, has audible cues that signal progress of administration, and a window that displays when the dose has been delivered.

Now that you’re familiar with the autoinjector, let’s get a closer look at the available dosing options for AJOVY.

AJOVY is available in quarterly and monthly dosing options for your patients. Quarterly dosing of AJOVY consists of three 225 mg injections administered subcutaneously on the same day for a total of 675 mg every 3 months. That’s only 4 injection days a year with quarterly dosing. You may also want to prescribe the Triple Pack for your patients, which includes three 225 mg injections in one box.

For your monthly patients, AJOVY is also available in a single pack of one 225 mg injection. Either way, with AJOVY, patients have the option to choose administration by you or your staff, in the office or at home, or by themselves or a caregiver. In addition, AJOVY does not have a loading dose and does not require dose titration. And it’s good to know that the AJOVY Autoinjector is not made with natural rubber latex.

That’s a lot of valuable information about AJOVY.

By now you can see why AJOVY is the long-acting anti-CGRP injection with the option of dosing only 4 times a year.

It is a fully humanized IgG2∆a monoclonal antibody that targets the CGRP ligand with selectivity, has a long half-life and pharmacokinetics that allow for either quarterly or monthly dosing. Also, AJOVY can be administered with an autoinjector at the office or at home. One last thing about safety: the most common adverse reactions were injection-site reactions.

We hope this video has been informative and has given enough background to consider AJOVY as a preventive treatment option for your patients with migraine.

If you would like to know more about AJOVY, please consult the full Prescribing Information available at AJOVYhcp.com, where you can find information about efficacy, safety, and dosing, as well as savings and available support resources. Thank you for your time.

Pharmacokinetic profile that supports quarterly dosing1-4

Phase 1 study assessing pharmacokinetic parameters3*

Month 1Month 3

The relationship between pharmacokinetics and efficacy has not been established.

AJOVY was evaluated in a phase 1 study to assess pharmacokinetic parameters for both quarterly and monthly dosing in healthy volunteers.3

Plasma concentrations of AJOVY were slightly higher at month 3 for quarterly dosing than at month 1 for monthly dosing.2

Washout period defined as time until plasma concentrations of AJOVY are below a clinically relevant concentration and thus considered eliminated.

AJOVY has a long half-life of 31 days1

This information should not be construed to imply any difference in safety, efficacy, or other clinical outcome. View the safety profile of AJOVY.

AJOVY is a fully humanized (IgG2Δa) monoclonal antibody that selectively targets the CGRP ligand1,5

MOA of AJOVY involves the selective binding of CGRP

CGRP ligand binding5

The mechanism of action for AJOVY works through exclusive binding of the CGRP

MOA of AJOVY shows no off-site binding

Off-site binding5

AJOVY does not exhibit off-site binding of related calcitonin family members

Watch the MOA video of AJOVY

Introducing AJOVY (fremanezumab-vfrm) injection, indicated for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

AJOVY (fremanezumab-vfrm) injection is a monoclonal antibody targeting the calcitonin gene-related peptide, or CGRP, ligand.

Patients experiencing migraine have increased levels of CGRP, a neuropeptide present in both the central and peripheral nervous system.

When CGRP binds to its receptor, a cascade of events result, which contribute to neurogenic inflammation that is associated with migraine pain.

This involves mast cell degranulation, vasodilation, and protein extravasation.

AJOVY selectively binds the CGRP ligand, which is believed to block this cascade of events, thereby preventing the activation of the trigeminal system.

CGRP plays an important role in the pathophysiology of migraine.

INDICATION
AJOVY is indicated for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION
Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection-site reactions.

Please see the full Prescribing Information at AJOVYhcp.com.

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