Erenumab

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

Erenumab mechanism of action is 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, erenumab stops interaction between CGRP and the CGRP receptor which helps to prevent migraines. Erenumab is from a class of medicines called CGRP inhibitors.

Erenumab FDA approval was granted on May 17, 2018, under the brand name Aimovig after positive results from clinical trials. Research has shown that people receiving erenumab-aooe experienced, on average, 7 fewer migraine days per month, 3 less than those receiving a placebo (an inactive treatment). Approximately 40% of people on erenumab had their monthly migraine days cut in half.

Erenumab brand name is Aimovig, there is no generic available.

Use erenumab exactly as directed by your healthcare provider. Follow all directions on your prescription label and read all medication guides or instruction sheets.

• Erenumab is available under the brand name Aimovig which comes in 2 different types of devices:
• Erenumab is injected subcutaneously (SC), which means under your skin, 1 time each month.
• Do not inject it yourself until a healthcare provider has shown you how to do so.

Take erenumab 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 medicine is still 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.

Erenumab 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.

This medicine may also cause constipation with serious complications, new-onset or worsening of pre-existing high blood pressure, and new-onset or worsening of Raynaud's phenomenon.

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.

Erenumab does not treat an acute migraine (one that is happening right now).

The cost of erenumab (Aimovig brand) varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about Aimovig's cost.

You may also be eligible for an Aimovig coupon, an Aimovig access card, or an Aimovig copay card. See Aimovig copay card or coupon: Do I qualify and how much can I save?.

Do not use erenumab if you are allergic to erenumab-aooe, Aimovig, or any inactive ingredients in the injection.

Before you start using erenumab, tell your healthcare provider about all your medical conditions, including if you are:

• pregnant or intending to become pregnant
• breastfeeding or intend to breastfeed.

Pregnancy

It is not known if erenumab 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 erenumab. 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 erenumab 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 when using erenumab.

Common erenumab side effects

The most common erenumab side effects are:

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

These common side effects are for the 70mg dose.

Serious erenumab side effects

Erenumab 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.

High blood pressure or constipation are possible long-term side effects of erenumab.

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 erenumab-aooe. 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).

The recommended dosage of erenumab is 70 mg SC once a month.

• Some people may benefit from increasing the dosage to erenumab 140 mg SC once a month.

Erenumab formulations

Aimovig brand of erenumab is available as a:

• Aimovig prefilled erenumab-aooe 70 mg/ml auto-injector
• Aimovig prefilled erenumab-aooe 140 mg/ml auto-injector
• Aimovig prefilled erenumab-aooe 70 mg/mL solution in a single-dose prefilled syringe
• Aimovig prefilled erenumab-aooe 140 mg/mL solution in a single-dose prefilled syringe.

If you forget to take your dose of erenumab 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 erenumab one time each 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 erenumab into skin that is red, bruised, tender, or hard.

Other drugs may interact with erenumab, 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.

Drug interaction studies have not found any interactions between erenumab-aooe and inducers or inhibitors of cytochrome P450 enzymes, oral contraceptives, and sumatriptan.

Erenumab-aooe is only available under the brand name Aimovig. Store Aimovig in the 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.

Erenumab is only available under the brand name Aimovig.

Active ingredients: erenumab-aooe

Inactive ingredients: acetate, polysorbate 80, and sucrose.

Amgen Inc. makes erenumab-aooe under the brand name Aimovig.