Aimovig

Aimovig (erenumab-aooe) is a once-monthly, self-administered injection used to prevent migraines in adults. It helps prevent migraines before they start and reduces the number of migraine days per month. Aimovig is given as an injection under the skin (subcutaneous injection) using an Aimovig autoinjector or a single-dose prefilled syringe.

Aimovig works by blocking the effect of calcitonin gene-related peptide (CGRP), a small protein involved in migraines that increases during a migraine attack. By blocking CGRP, Aimovig stops interaction between CGRP and the CGRP receptor which helps to prevent migraines. Aimovig is from a class of medicines called CGRP inhibitors.

Aimovig FDA approval was granted on May 17, 2018, for Amgen Inc. There is no generic available.

Use the Aimovig autoinjector or prefilled syringe exactly as directed by your healthcare provider. Follow all directions on your prescription label and read all medication guides or instruction sheets.

• 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.
• It is injected under your skin (subcutaneously) once a month. Do not inject it yourself until a healthcare provider has shown you how to do so.

Take the injection out of the refrigerator and allow it to warm up to room temperature for 30 minutes before injecting it. Protect from sunlight. Do not heat the medicine in hot water or a microwave. Do not use it if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

• Inject it subcutaneously (under the skin) of the abdomen (but not within 2 inches of the belly button), thigh, or upper arm.
• Each single-use prefilled syringe or autoinjector is for one use only. Throw it away after one use, even if there is still medicine left inside.
• Do not shake the syringe or autoinjector or you may ruin the medicine.

Only use the form and strength your doctor prescribes.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

This medicine may cause allergic reactions. If a serious allergic reaction occurs, stop injecting and go to the emergency room. Hypersensitivity reactions can occur within hours to more than one week after administration. Do not use this medicine if you are allergic to the active ingredient erenumab or any of the inactive ingredients.

May also cause constipation with serious complications, and new-onset or worsening of pre-existing high blood pressure may occur.

Before you inject this medicine, 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.

Aimovig may cause new-onset or worsening of pre-existing Raynaud's phenomenon. Raynaud's phenomenon is a condition where blood vessels, usually in the fingers and toes, over-constrict, causing skin color changes, sometimes white, then blue, then red, along with numbness, pain, or tingling.

Aimovig autoinjector and prefilled syringe do not treat an acute migraine (one that is happening right now).

The list cost price of Aimovig is $767.67 per month, but most patients do not pay this price.

The cost of Aimovig for the patient depends on whether you have insurance, your insurance plan type and which pharmacy you use.

With the Aimovig Copay Card, you may pay as little as $5 out-of-pocket if you qualify. The Aimovig Coupon or Copay Card helps you save money on prescriptions.

You are eligible for the Aimovig Copay Card if you have commercial or private insurance, a valid prescription and live in the US, Puerto Rico, or US territories. There is no income requirement to participate in this program.

For more information see Aimovig copay card or coupon: Do I qualify and how much can I save?

Refer to our Aimovig price guide page for more information about cost, coupons, copay cards, and rebates

You should not use this medicine if you are allergic to the active ingredient erenumab or any of the inactive ingredients in the injection.

Before you start using this injection, tell your doctor about all your medical conditions, including if you are:

• Have circulation problems in your fingers and toes
• Have high blood pressure

• Pregnant or plan to become pregnant
• Breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Aimovig autoinjector or prefilled syringe will harm your unborn baby. However, having migraine headaches during pregnancy may cause complications such as preeclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of preventing migraines may outweigh any risks to the baby.

There is a pregnancy registry for women who take this medicine. 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 doctor about how you can take part in this registry.

Breastfeeding

It is not known if this medicine passes into your breast milk. It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

Talk to your healthcare provider about the best way to feed your baby while using this medicine.

Common Aimovig side effects

The most common Aimovig side effects include:

• Injection site reactions including pain, redness, or swelling at the injection site (6%)
• constipation (1%)
• cramps, muscle spasms (<1%).

These common side effects occurred in 2% or more of patients using a 70mg dose in the first 3 months of clinical trials called Studies 1, 2, and 3.

The Aimovig 140mg dose side effects injection side reactions 5%, constipation 3%, and cramps and muscle spasms 2%. These side effects occurred in 2% or more of patients in the first 3 months of Studies 1, 2, and 3.

Serious Aimovig side effects

Aimovig autoinjector or prefilled syringe may cause serious side effects, including:

• Allergic reactions, including a rash or swelling. This can happen within hours to days after using the medicine. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction: hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
• Severe constipation. 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 the belly, or bloating.
• High blood pressure or worsening of high blood pressure. Ask your healthcare provider to monitor your blood pressure or call them immediately if you develop severe headaches, blurred vision, or pounding in your neck or ears.
• Raynaud's phenomenon. A type of circulation problem can worsen or happen after receiving this medicine. This 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.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of this injection. Ask your pharmacist or doctor 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).

Recommended Aimovig dose: 70mg once a month given as a subcutaneous injection.

Aimovig 140mg dose may benefit some patients. Aimovig 140mg is given once a month.

• Aimovig autoinjector 70 mg/mL in a single-dose prefilled SureClick autoinjector
• Aimovig injection 70 mg/mL solution in a single-dose prefilled syringe
• Aimovig 140 mg/mL (autoinjector) in a single-dose prefilled SureClick autoinjector
• Aimovig 140 mg/mL ( injection) solution in a single-dose prefilled syringe.

If you forget to take your dose 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 this injection once a month from the date of your last dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid injecting this medicine into skin that is red, bruised, tender, or hard.

Other drugs may interact with Aimovig, including prescription and over-the-counter medicines, vitamins, and herbal products.

Tell your pharmacist or healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements. See the prescribing information for a full list of interactions.

• Store refrigerator between 36°F to 46°F (2°C to 8°C).
• After removing 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 the medicine if kept at room temperature for more than 7 days.
• Keep it in the original carton. This will protect the medicine from light.
• Do not freeze. Do not shake.
• Keep out of the reach of children.

Active: erenumab-aooe

Inactive: acetate, polysorbate 80, and sucrose

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

Aimovig Amgen Inc., One Amgen Center Drive Thousand Oaks, CA 91320-1799 U.S.A.