THE EASY-TO-USE AUTOINJECTOR FOR AJOVY¹*

Features of the AJOVY Autoinjector

No visible needle

Window displays when dose has been delivered

Audible cues signal progress of injection

Button-free, push-down mechanism

of HCP and patient evaluators found the AJOVY Autoinjector easy to use in two Human Factor studies (N=77)¹*

*Two Human Factor studies assessed evaluators’ ability to complete critical tasks in order to demonstrate use of the AJOVY Autoinjector in simulated-use sessions. When asked, “Was the autoinjector easy to use?”, 97% in study 1 (N=30) and 98% in study 2 (N=47) answered “Yes”.¹

Administration of AJOVY

AJOVY may be administered in office by a healthcare professional or at home by the patient or caregiver.¹ AJOVY is available in an autoinjector. Guidance on proper subcutaneous techniques should be provided.

AJOVY Autoinjector administration video

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 and episodic migraine in children who are 6 to 17 years of age and who weigh 99 pounds (45 kg) or more.

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 healthcare provider to contact the registry for you. You or your healthcare provider 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 happen or worsen after receiving AJOVY. Symptoms may include:
- fingers or toes may feel numb, cool, or painful
- fingers and toes may change color from pale, to blue, to red

Stop taking AJOVY and 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

Please read the Patient Information Leaflet in the full Prescribing Information at AJOVY.com

How to use the AJOVY Autoinjector

Step 1

Uncap the autoinjector

With one hand, firmly pull the cap straight off the autoinjector (don’t twist) and throw the cap away immediately.

Step 2

Place at a 90° angle

Place the autoinjector at a 90° angle against your skin at your chosen injection site.

Step 3

Press down and hold autoinjector until 10 seconds after second click

Press down on the autoinjector. You will hear a click. This means the injection has started and you should see the blue plunger move down. You will hear a second click. Remove autoinjector 10 seconds after.

The above steps do not include the full administration instructions for the AJOVY Autoinjector.

Follow the links below to read the full Instructions for Use prior to administering AJOVY.

READ FULL INSTRUCTIONS FOR USE FOR AUTOINJECTOR

READ FULL INSTRUCTIONS FOR USE FOR PREFILLED SYRINGE

Storage and handling²

Store AJOVY in the refrigerator between 36°F to 46°F (2°C to 8°C).
Do not freeze.

Storage and handling PDF

Important

AJOVY prefilled autoinjector is for single time (one-time) use only. Put AJOVY in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) your used sharps disposal container in your household trash
Before injecting, let AJOVY sit at room temperature for 30 minutes. Do not warm up the AJOVY prefilled autoinjector using a heat source such as hot water or a microwave
Keep AJOVY prefilled autoinjector out of the reach of small children
After you remove the protective cap from AJOVY, to prevent infection, do not touch the needle
Do not inject AJOVY in your veins (intravenously)
Do not re-use your AJOVY prefilled autoinjector, as this could cause injury or infection
Do not share your AJOVY prefilled autoinjector with another person. You may give another person an infection or get an infection from them

Sharps disposal PDF

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 pre-existing 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.

AJOVY is indicated for:

The preventive treatment of migraine in adults, and
The preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.

Please see the full Prescribing Information.

Reference: 1. Data on file. Parsippany, NJ: Teva Pharmaceuticals USA, Inc. 2. AJOVY® (fremanezumab-vfrm) injection Current Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.

THE EASY-TO-USE AUTOINJECTOR FOR AJOVY1*