SUPPORT RESOURCES FOR YOU

Hello - thanks for joining me today to learn more about long-acting protection against migraine with AJOVY. Before we get into it, allow me to introduce myself. I’m Dr Brad Torphy—Managing Director of Chicago Headache Center and Research Institute.

Something important to consider when prescribing a preventive migraine medication—will it wear off or last to the next dose? That’s why I want to talk to you today about AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine.

As a reminder, AJOVY is indicated for the preventive treatment of migraine in adults. Please note, AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

During this presentation, we’ll take an in-depth look at the clinical trials to review how AJOVY demonstrated sustained efficacy, reductions in use of acute medication, and no evidence of wearing off from one dose to the next. Before reviewing the clinical results, let’s first look at the trial designs for both the HALO trial and the Long-Term Extension study. The HALO study consisted of two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials. Patients were randomized in either AJOVY monthly dosing, AJOVY quarterly dosing, or the placebo arm, after which they underwent a screening visit, a 28-day preintervention, and a run-in period, followed by a 12-week intervention period, with final evaluation at Week 12.

Some of the patients in the 12-week HALO studies rolled over into the Long-Term Extension study—a 12-month, multicenter, randomized, double-blind, parallel-group clinical trial. The Long-Term Extension study was not placebo controlled, but patients were blinded as to the dosing regimen.

Please note, today we will only be looking at the episodic migraine results. If you’d like to see the results for chronic migraine, please visit AJOVYhcp.com.

The primary endpoint in the HALO episodic migraine trial was mean change from baseline in the monthly average number of migraine days for both monthly and quarterly dosing options during the 12-week period. As you can see, AJOVY demonstrated a statistically significant improvement in the mean reduction from baseline of 4.3 migraine days at month 3 versus 3.1 days for placebo. The Long-Term Extension study further demonstrated a mean reduction of 5.1 migraine days with monthly dosing. Similar results were observed for patients taking quarterly dosing.

Important Safety Information

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.

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including AJOVY, in the postmarketing setting. Monitor patients treated with AJOVY for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of AJOVY is warranted.

Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of preexisting Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including AJOVY. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain.

AJOVY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

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

I want to also mention a secondary endpoint of the HALO trial—change in use of acute medication. During the 12-week treatment period, patients with episodic migraine receiving the AJOVY monthly dosing regimen had a 3-day reduction in the average number of days of use of acute headache medication compared with 1.6 days for placebo. Similar results were also seen in chronic migraine. This endpoint tells us that patients taking AJOVY significantly decreased their need for acute medication. What might these data mean for your patients?

Now I want to take you through the post hoc analyses that showed no evidence of AJOVY wearing off from one dose to the next. To assess these dosing periods, data for patients with chronic and episodic migraine from the HALO trials who rolled over into the Long-Term Extension study were included in the post hoc analyses. We will, again, only be discussing the episodic patients.

The analyses looked at the mean number of weekly migraine days in patients on monthly dosing during months 3, 6, 9, and 15. Each of these months—3, 6, 9, and 15—was split into two: weeks 1 through 3, or the beginning of the dosing period, versus week 4, the end of the dosing period. Let’s look at the figures for the weekly average number of migraine days during weeks 1 through 3. And now, let’s compare them with the number of migraine days during week 4. As you can see, the weekly number of migraine days was similar between the beginning and the end of the dosing period, across all months shown. Note, for all post hoc analyses, no determination of statistical significance can be made, and no conclusions should be drawn.

Now, let’s think back to our consideration for preventive migraine therapy, “Will it wear off or last until the next dose?” Wouldn’t you consider AJOVY an appropriate option for your patients needing preventive therapy?

Of course, safety must be considered before making any decisions, so let’s take a look at those results from the HALO and Long-Term Extension studies. Shown here are the adverse reactions reported by at least 2% of patients on AJOVY and greater than placebo from the HALO trial.

In the Long-Term Extension study, you can see the adverse reactions that occurred in more than 6% of patients. It’s important to mention that no new safety signals were identified in the Long-Term Extension study.

Before we wrap things up, I want to remind you that patients have an option to take AJOVY either monthly or quarterly. Having such options may help your patients stay protected—whatever their lifestyle and schedules demand from them. You and your patients should decide together which option would be best.

Thank you for watching my presentation today. I hope the information I’ve shared helps you and your practice.

Remember, AJOVY is the long-acting anti-CGRP injection with lasting protection against migraine. If you need additional details, or the full Prescribing Information, please visit AJOVYhcp.com.

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® (fremanezumab-vfrm) injection 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.

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including AJOVY, in the postmarketing setting.

Monitor patients treated with AJOVY for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of AJOVY is warranted.

Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of preexisting Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including AJOVY. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain.

AJOVY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

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.

How to use the autoinjector for AJOVY® (fremanezumab-vfrm) injection.

Hi. I’m here to walk you through some instructions on how to use the autoinjector for AJOVY.

This video does not replace the complete Instructions for use included with your autoinjector. Please read and follow the Instructions for use before you start using your autoinjector for AJOVY and each time you get a refill.

If you still have questions after doing so, speak to your healthcare provider.

Preparing to use the autoinjector

Let’s get started. Whether you are injecting your AJOVY quarterly or once monthly, the process is very similar. First, remove your autoinjector from the refrigerator and wait for 30 minutes to allow the medicine to reach room temperature.

If your dose is 225 mg of AJOVY each month, remove one autoinjector.

If your dose is 675 mg of AJOVY every three months, take out three autoinjectors.

Do not shake the autoinjector.

Also, do not leave it in direct sunlight or try to warm it up using a heat source such as hot water or a microwave.

Now, wash your hands with soap and water and dry well with a clean towel.

Next, look closely at your autoinjector to make sure there is no visible damage such as cracks or leaks.

Ensure that the liquid inside is clear and colorless to slightly yellow.

If the liquid has any particles in it or is discolored, cloudy or frozen, do not use the autoinjector and call your healthcare provider or pharmacist.

If you see air bubbles in the autoinjector, don’t worry, as this is normal.

Be sure to check that “AJOVY” appears on the autoinjector and that the expiration date has not passed.

Choosing an injection area

You have a few options on where to inject your dose.

You can choose to inject your stomach area, but make sure to avoid about 2 inches around the belly button.

You can also inject in the front of either of your thighs at least 2 inches above the knee and at least 2 inches below the groin.

Or, you can inject on the fleshy areas at the back of either of your upper arms but you may need someone who has been instructed on how to give your injection to help you. If prescribed the 675 mg dose, avoid injecting in exactly the same place.

Using the autoinjector

To inject your dose of AJOVY, first clean the chosen injection area using a new alcohol swab and let your skin dry.

Now, pick up your autoinjector with one hand and pull the protective cap straight off with the other. Do not twist.

Throw the protective cap away immediately.

To give yourself the injection, place the blue end of the autoinjector at a 90-degree angle against your cleaned skin at the injection site.

Press down firmly on the autoinjector and you will hear a “CLICK” that means the injection has started.

Continue to hold down firmly for about 30 seconds.

As the medicine is being injected, the blue plunger will move to the bottom of the viewing window. After about 15 seconds, you will hear a second "CLICK."

Next, wait about 10 seconds to make sure all the medicine is injected.

Check that the blue plunger has filled the viewing window and remove the autoinjector from the skin by lifting straight up.

Now, use a clean, dry cotton ball or gauze pad to gently press on the injection site for a few seconds.

Put your used autoinjector in an FDA-approved sharps disposal or puncture-resistant container immediately after use.

Alright, there you have it. Please read the Instructions for use. If you still have questions about these steps, I suggest speaking with your healthcare provider. You can also call the Shared Solutions® hotline at 1-800-887-8100.

 

What is AJOVY?

AJOVY is a prescription medicine used for the preventive treatment of migraine in adults.

It is not known if AJOVY is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about AJOVY?

Do not use AJOVY if you are allergic to fremanezumab-vfrm or any of the ingredients in AJOVY.

What should I tell my healthcare provider before taking AJOVY?

Before you use AJOVY, tell your healthcare provider if you:

• have high blood pressure.
• have circulation problems in your fingers and toes.
• are pregnant or plan to become pregnant. It is not known if AJOVY will harm your unborn baby.

Pregnancy Registry: There is a registry for women who become pregnant during treatment with AJOVY. The purpose of this registry is to collect information about the safety of AJOVY during pregnancy. Contact the registry as soon as you learn that you are pregnant, or ask your doctor to contact the registry for you. You or your doctor can get information and enroll you in the registry by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com.

• are breastfeeding or plan to breastfeed. It is not known if AJOVY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using AJOVY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of AJOVY?

AJOVY may cause serious side effects, including:

• Allergic reactions. Allergic reactions, including itching, rash, and hives, can happen within hours and up to 1 month after receiving AJOVY. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction:
• swelling of your face, mouth, tongue, or throat
• trouble breathing
• High blood pressure. High blood pressure or worsening of high blood pressure can happen after receiving AJOVY. Contact your healthcare provider if you have an increase in blood pressure.
• Raynaud’s phenomenon. A type of circulation problem can worsen or happen after receiving AJOVY. 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.

The most common side effects of AJOVY include:

• injection site reactions

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of AJOVY. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Please see the full Prescribing Information at AJOVY.com