Aimovig (Erenumab): Uses, Side Effects and Dosage

What is AIMOVIG?

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

It is not known if AIMOVIG is safe and effective in children under 18 years of age.

Who should not use AIMOVIG?

Do not use AIMOVIG if you are allergic to erenumab-aooe or any of the ingredients in AIMOVIG. See the end of this Patient Information for a complete list of ingredients in AIMOVIG.

Before you start using AIMOVIG, tell your healthcare provider about all your medical conditions, including 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 AIMOVIG will harm your unborn baby.

  • Pregnancy Registry: There is a pregnancy registry for women who take AIMOVIG. The purpose of this registry is to collect information about your health and your baby's health. You may enroll yourself by calling 1-833-244-4083 or visiting https://www.genesispregnancyregistry.com/. Or you may talk to your healthcare provider about how you can take part in this registry.
• are breastfeeding or plan to breastfeed. It is not known if AIMOVIG passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using AIMOVIG.

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

How should I take AIMOVIG?

• See the detailed "Instructions for Use" on complete information on how to take AIMOVIG.
• Take AIMOVIG exactly as your healthcare provider tells you to take it.
• Before you inject, always check the label of your single-dose prefilled autoinjector or single-dose prefilled syringe to make sure you have the correct medicine and the correct dose of AIMOVIG.
• Also, before you inject, leave AIMOVIG at room temperature for at least 30 minutes protected from direct sunlight.
• AIMOVIG is injected under your skin (subcutaneously) 1 time each month.
• AIMOVIG comes in 2 different types of devices: a single-dose (1 time) prefilled autoinjector or a single-dose (1 time) prefilled syringe. Your healthcare provider will prescribe the type and dose that is best for you.
• If you forget to take AIMOVIG or are not able to take the dose at the regular time, take your missed dose as soon as you remember. After that, you can continue to take AIMOVIG 1 time each month from the date of your last dose.

What are possible side effects of AIMOVIG?

AIMOVIG may cause serious side effects, including:

• Allergic reactions. Allergic reactions, including rash or swelling can happen after receiving AIMOVIG. This can happen within hours to days after using AIMOVIG. 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 the face, mouth, tongue, or throat
  • trouble breathing
• Constipation with serious complications. Severe constipation can happen after receiving AIMOVIG. In some cases, people have been hospitalized or needed surgery. Contact your healthcare provider if you have severe constipation or constipation associated with symptoms such as severe or constant belly pain, vomiting, swelling of belly or bloating.
• High blood pressure. High blood pressure or worsening of high blood pressure can happen after receiving AIMOVIG. 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 AIMOVIG. 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 AIMOVIG include: pain, redness, or swelling at the injection site and constipation.

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

These are not all of the possible side effects of AIMOVIG. Ask your pharmacist or healthcare provider for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436).

How should I store AIMOVIG?

• Store AIMOVIG in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep AIMOVIG in the original carton. This will protect the medicine from light.
• After removing AIMOVIG from the refrigerator, it can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days.
• Throw away AIMOVIG that has been left at room temperature for more than 7 days.
• Do not freeze.
• Do not shake.

Keep AIMOVIG and all medicines out of the reach of children.

General information about the safe and effective use of AIMOVIG.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AIMOVIG for a condition for which it is not prescribed. Do not give AIMOVIG to other people, even if they have the same symptoms that you have. It can harm them. You can ask your pharmacist or healthcare provider for information about AIMOVIG that is written for healthcare professionals.

What are the ingredients in AIMOVIG?

• Active Ingredient: erenumab-aooe
• Inactive Ingredients: acetate, polysorbate 80, and sucrose

AIMOVIG prefilled autoinjectors and prefilled syringes are not made with natural rubber latex.

AIMOVIG^® (erenumab-aooe)

Manufactured by:

Amgen Inc.

One Amgen Center Drive

Thousand Oaks, CA 91320-1799 U.S.A.

U.S. License No. 1080

Patent: http://pat.amgen.com/aimovig/

© 2018-2025 Amgen Inc. All rights reserved.

For more information, go to www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436).

INSTRUCTIONS FOR USE

AIMOVIG^® [AIM-oh-vig]

(erenumab-aooe)

injection, for subcutaneous use

70 mg/mL

single-dose prefilled SureClick^® autoinjector

This Instructions for Use contains information on how to inject AIMOVIG with a SureClick autoinjector.

If your healthcare provider decides that you or a caregiver may be able to give your injections of AIMOVIG at home, you should receive training on the right way to prepare and inject AIMOVIG. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse.

The medicine in the AIMOVIG autoinjector is for injection under the skin (subcutaneous injection). See the AIMOVIG Patient Information for information about AIMOVIG.

Getting to know your prefilled autoinjector

Storing and Preparing to Inject AIMOVIG

1 Refrigerate the autoinjector carton until you are ready to use it.

• Keep the autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep the autoinjector in the original carton to protect it from light or physical damage.
• Do not freeze the autoinjector.
• Do not store the autoinjector in extreme heat or cold. For example, avoid storing in your vehicle's glove box or trunk.

WAIT

2 Wait 30 minutes for the autoinjector to reach room temperature. Let the autoinjector warm up naturally. Do not heat the autoinjector with hot water, a microwave, or direct sunlight. Do not shake the autoinjector at any time. Using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection.

3 You may keep AIMOVIG at room temperature for up to 7 days, if needed.

• For example, when you are traveling, you may keep AIMOVIG at room temperature.

  • Keep it at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not put it back in the refrigerator.
  • Record the date you removed it from the refrigerator and use it within 7 days.

4 Inspect the medicine. It should be clear and colorless to slightly yellow.

• It is okay to see air bubbles.
• Do not use the autoinjector if the medicine is cloudy, discolored, or contains flakes or particles.

5 Check the expiration date (Exp.) and inspect the autoinjector for damage.

• Do not use the autoinjector if the expiration date has passed.

• Do not use the autoinjector if:

  • the white cap is missing or loose in carton.
  • it has cracks or broken parts, or
  • it has been dropped on a hard surface.

Getting Ready to Inject AIMOVIG

6 Gather and place the following items for your injection on a clean, flat, and well-lit surface:

• AIMOVIG autoinjector (room temperature),
• Sharps disposal container [see Completing the Injection and Disposal],
• Alcohol wipe,
• Adhesive bandage, and
• Cotton balls or gauze pads.

7 Select 1 of these injection sites.

• Select the thigh or stomach (except for 2 inches around the belly button).
• Someone else can inject in your thigh, stomach, or back of the upper arm.

8 Wash your hands thoroughly with soap and water.

9 Clean the injection site with an alcohol wipe.

• Let the skin dry on its own.
• Do not touch this area again before injecting.

Injecting AIMOVIG

10 Grasp the autoinjector so you can see the window. Pull the white cap straight off. You may need to pull hard.

• Do not twist, bend, or wiggle the white cap to pull it off.
• Never put the white cap back on. It may damage the needle.
• Do not put your finger inside the dark green safety guard.
• It is normal to see a drop of medicine come out of the needle or dark green safety guard.

11 Stretch or pinch the skin to create a firm surface at the injection site until the injection is finished. Place the dark green safety guard straight against the skin.

• Make sure you can see the window.
• Make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle).

12 Firmly push the autoinjector down until the dark green safety guard stops moving. Hold the autoinjector down, do not lift.

• The dark green safety guard pushes in and unlocks the purple start button.

13 Keep pushing the autoinjector down and press the purple start button to start the injection.

• You may hear or feel a click.
• The window starts to turn yellow.
• It is okay to let go of the purple start button.

14 Keep pushing the autoinjector down. Wait for the window to turn fully yellow.

• The injection may take up to 15 seconds to complete.
• You may hear or feel a click.
• After the window turns fully yellow, lift the autoinjector away from the skin.
• The dark green safety guard locks around the needle.

Completing the Injection and Disposal

CONFIRM

15 Confirm a full dose of medicine was injected.

• Do not touch the dark green safety guard.
• A small drop of liquid on the injection site is okay.

16 Check the injection site.

• Do not rub the injection site.
• If there is blood, press a cotton ball or gauze pad on your injection site.
• Apply an adhesive bandage if necessary.

For more information or help call 1-800-77-AMGEN (1-800-772-6436).

17 Place the used autoinjector and white cap in an FDA-cleared sharps disposal.

• Do not reuse the autoinjector.
• Do not touch the dark green safety guard.

Additional information about your sharps disposal container

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labeled to warn of hazardous waste inside the container.

Disposing of sharps disposal containers:

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.

There may be state or local laws about how you should throw away used needles and syringes.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:

http://www.fda.gov/safesharpsdisposal

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

Do not recycle your used sharps disposal container.

Keep the autoinjector and sharps disposal container out of the sight and reach of children.

AIMOVIG^® (AIM-oh-vig)

Manufactured by:

Amgen Inc.

One Amgen Center Drive

Thousand Oaks, California 91320-1799

U.S. License Number 1080

© 2018 – 2025 Amgen Inc.

All rights reserved.

1XXXXXX

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 6/2025

v12

INSTRUCTIONS FOR USE

AIMOVIG^® [AIM-oh-vig]

(erenumab-aooe)

injection, for subcutaneous use

140 mg/mL

single-dose prefilled SureClick^® autoinjector

This Instructions for Use contains information on how to inject AIMOVIG with a SureClick autoinjector.

If your healthcare provider decides that you or a caregiver may be able to give your injections of AIMOVIG at home, you should receive training on the right way to prepare and inject AIMOVIG. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse.

The medicine in the AIMOVIG autoinjector is for injection under the skin (subcutaneous injection). See the AIMOVIG Patient Information for information about AIMOVIG.

Getting to know your prefilled autoinjector

Storing and Preparing to Inject AIMOVIG

1 Refrigerate the autoinjector carton until you are ready to use it.

• Keep the autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep the autoinjector in the original carton to protect it from light or physical damage.
• Do not freeze the autoinjector.
• Do not store the autoinjector in extreme heat or cold. For example, avoid storing in your vehicle's glove box or trunk.

WAIT

2 Wait 30 minutes for the autoinjector to reach room temperature. Let the autoinjector warm up naturally. Do not heat the autoinjector with hot water, a microwave, or direct sunlight. Do not shake the autoinjector at any time. Using the autoinjector at room temperature makes sure the full dose is delivered and allows for a more comfortable injection.

3 You may keep AIMOVIG at room temperature for up to 7 days, if needed.

• For example, when you are traveling, you may keep AIMOVIG at room temperature.

  • Keep it at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not put it back in the refrigerator.
  • Record the date you removed it from the refrigerator and use it within 7 days.

4 Inspect the medicine. It should be clear and colorless to slightly yellow.

• It is okay to see air bubbles.
• Do not use the autoinjector if the medicine is cloudy, discolored, or contains flakes or particles.

5 Check the expiration date (Exp.) and inspect the autoinjector for damage.

• Do not use the autoinjector if the expiration date has passed.

• Do not use the autoinjector if:

  • the orange cap is missing or loose in carton.
  • it has cracks or broken parts, or
  • it has been dropped on a hard surface.

Getting Ready to Inject AIMOVIG

6 Gather and place the following items for your injection on a clean, flat, and well-lit surface:

• AIMOVIG autoinjector (room temperature),
• Sharps disposal container [see Completing the Injection and Disposal],
• Alcohol wipe,
• Adhesive bandage, and
• Cotton balls or gauze pads

7 Select 1 of these injection sites.

• Select the thigh or stomach (except for 2 inches around the belly button).
• Someone else can inject in your thigh, stomach, or back of the upper arm.

8 Wash your hands thoroughly with soap and water.

9 Clean the injection site with an alcohol wipe.

• Let the skin dry on its own.
• Do not touch this area again before injecting.

Injecting AIMOVIG

10 Grasp the autoinjector so you can see the window. Pull the orange cap straight off. You may need to pull hard.

• Do not twist, bend, or wiggle the orange cap to pull it off.
• Never put the orange cap back on. It may damage the needle.
• Do not put your finger inside the yellow safety guard.
• It is normal to see a drop of medicine come out of the needle or yellow safety guard.

11 Stretch or pinch the skin to create a firm surface at the injection site until the injection is finished. Place the yellow safety guard straight against the skin.

• Make sure you can see the window.
• Make sure the autoinjector is positioned straight on the injection site (at a 90-degree angle).

12 Firmly push the autoinjector down until the yellow safety guard stops moving. Hold the autoinjector down, do not lift.

• The yellow safety guard pushes in and unlocks the gray start button.

13 Keep pushing the autoinjector down and press the gray start button to start the injection.

• You may hear or feel a click.
• The window starts to turn yellow.
• It is okay to let go of the gray start button.

14 Keep pushing the autoinjector down. Wait for the window to turn fully yellow.

• The injection may take up to 15 seconds to complete.
• You may hear or feel a click.
• After the window turns fully yellow, lift the autoinjector away from the skin.
• The yellow safety guard locks around the needle.

Completing the Injection and Disposal

CONFIRM

15 Confirm a full dose of medicine was injected.

• Do not touch the yellow safety guard.
• A small drop of liquid on the injection site is okay.

16 Check the injection site.

• Do not rub the injection site.
• If there is blood, press a cotton ball or gauze pad on your injection site.
• Apply an adhesive bandage if necessary.

For more information or help call 1-800-77-AMGEN (1-800-772-6436).

17 Place the used autoinjector and orange cap in an FDA-cleared sharps disposal.

• Do not reuse the autoinjector.
• Do not touch the yellow safety guard.

Additional information about your sharps disposal container

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labeled to warn of hazardous waste inside the container.

Disposing of sharps disposal containers:

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.

There may be state or local laws about how you should throw away used needles and syringes.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:

http://www.fda.gov/safesharpsdisposal

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

Do not recycle your used sharps disposal container.

Keep the autoinjector and sharps disposal container out of the sight and reach of children.

AIMOVIG^® (AIM-oh-vig)

Manufactured by:

Amgen Inc.

One Amgen Center Drive

Thousand Oaks, California 91320-1799

U.S. License Number 1080

© 2019 – 2025 Amgen Inc. All rights reserved.

1XXXXXX

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 6/2025

V11

Instructions for Use

AIMOVIG^® (AIM-oh-vig) (erenumab-aooe)

Injection, For Subcutaneous Use

Single-Dose Prefilled Syringe

70 mg/mL and 140 mg/mL

Important: Needle is inside the gray needle cap.

Important

Before you use AIMOVIG prefilled syringe, read this important information:

Storing your AIMOVIG prefilled syringe

• Keep the syringe out of the reach of children.
• Keep the syringe in the original carton to protect from light.
• The syringe should be kept in the refrigerator at 36°F to 46°F (2°C to 8°C).
• After removing AIMOVIG from the refrigerator, it can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days.
• Throw away AIMOVIG that has been left at room temperature for more than 7 days.
• Do not freeze.

Using your AIMOVIG prefilled syringe

• It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.
• Do not use a syringe after the expiration date on the label.
• Do not shake the syringe.
• Do not remove the gray needle cap from the syringe until you are ready to inject.
• Do not use the syringe if it has been frozen.
• Do not use a syringe if it has been dropped on a hard surface. Part of the syringe may be broken even if you cannot see the break. Use a new syringe, and call 1-800-77-AMGEN (1-800-772-6436).
• The prefilled syringe is not made with natural rubber latex.

Step 1: Prepare

AIMOVIG comes as a single-dose (1 time) prefilled syringe. Your healthcare provider will prescribe the dose that is best for you.

Before you inject, always check the label of your single-dose prefilled syringe to make sure you have the correct medicine and the correct dose of AIMOVIG.

A Remove AIMOVIG prefilled syringe from the carton.

Grab the syringe barrel to remove the syringe from the tray.

Place finger or thumb on edge of tray to secure it while you remove the syringe.		Grab Here

For safety reasons:

• Do not grab the plunger rod.
• Do not grab the gray needle cap.
• Do not remove the gray needle cap until you are ready to inject.
• Do not remove the finger flange. This is part of the syringe.

Leave the syringe at room temperature for at least 30 minutes before injecting.

• Do not put the syringe back in the refrigerator after it has reached room temperature.
• Do not try to warm the syringe by using a heat source such as hot water or microwave.
• Do not leave the syringe in direct sunlight.
• Do not shake the syringe.

Important: Always hold the prefilled syringe by the syringe barrel.

B Inspect the AIMOVIG prefilled syringe.

Always hold the syringe by the syringe barrel.

Make sure the medicine in the syringe is clear and colorless to slightly yellow.

• Do not use the syringe if the medicine is cloudy or discolored or contains flakes or particles.
• Do not use the syringe if any part appears cracked or broken.
• Do not use the syringe if the syringe has been dropped.
• Do not use the syringe if the gray needle cap is missing or not securely attached.
• Do not use the syringe if the expiration date printed on the label has passed.

In all cases, use a new syringe, and call 1-800-77-AMGEN (1-800-772-6436).

C Gather all materials needed for your injection.

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place the:

• New syringe
• Alcohol wipes
• Cotton balls or gauze pads
• Adhesive bandages
• Sharps disposal container

D Prepare and clean your injection site.

Only use these injection sites:

• Your thigh
• Stomach area (abdomen), except for a two inch area right around your navel
• Outer area of upper arm (only if someone else is giving you the injection)

Clean your injection site with an alcohol wipe. Let your skin dry.

• Do not touch this area again before injecting.

• Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting directly into raised, thick, red, or scaly skin patch or lesion, or areas with scars or stretch marks.

  

Step 2: Get ready

E Pull gray needle cap straight out and away from your body, only when you are ready to inject. Do not leave the gray needle cap off for more than five minutes. This can dry out the medicine.

It is normal to see a drop of liquid at the end of the needle.

• Do not twist or bend the gray needle cap.
• Do not put the gray needle cap back onto the syringe.
• Do not remove the gray needle cap from the syringe until you are ready to inject.

Important: Throw the gray needle cap into the sharps disposal container.

F Pinch your injection site to create a firm surface.

Pinch skin firmly between your thumb and fingers, creating an area about two inches wide.

Important: Keep skin pinched while injecting.

Step 3: Inject

G Hold the pinch. With the gray needle cap off, insert the syringe into your skin at 45 to 90 degrees.

Do not place your finger on the plunger rod while inserting the needle.

H Place your finger on the plunger rod. Using slow and constant pressure, push the plunger rod all the way down until the prefilled syringe stops moving.

I When done, release your thumb, and gently lift the syringe off of your skin.

Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare provider immediately.

Step 4: Finish

J Discard the used syringe and the gray needle cap.

Put the used AIMOVIG syringe and gray needle cap in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the syringe in your household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

• Made of a heavy-duty plastic
• Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
• Upright and stable during use
• Leak-resistant
• Properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

• Do not reuse the syringe.
• Do not recycle the syringe or sharps disposal container or throw them into household trash.

Important: Always keep the sharps disposal container out of the reach of children.

K Examine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply an adhesive bandage if needed.

For more information, go to www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436).

AIMOVIG^® (erenumab-aooe)

Manufactured by:

Amgen Inc.

One Amgen Center Drive

Thousand Oaks, CA 91320-1799 USA

U.S. License No. 1080

© 2018-2022, 2024 Amgen Inc. All rights reserved.

Symbol table

Do not reuse	CAUTION, Prior to use, read the enclosed Instructions For Use for administration information and see package insert for full Prescribing Information	Lot number

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Approved: 8/2024

[partnumber] v7