Erenumab-aooe (Subcutaneous)

Erenumab-aooe injection is used to stop migraine headaches from happening.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

The needle shield inside the white or orange cap of the autoinjector and the gray needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Erenumab-aooe may increase your risk of having severe constipation, especially when given with medicines that decrease bowel movement. Talk with your doctor if this is a concern for you.

Check with your doctor right away if you have blurred vision, dizziness, nervousness, headache, pounding in the ears, or slow or fast heartbeat. These could be symptoms of high blood pressure.

In deciding to use a medicine, you and your doctor will need to weigh the risks of taking the medicine against the benefits it may provide. For this medicine, you should consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other types of allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how erenumab-aooe injection affects children. Safety and effectiveness have not been established in this age group.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the usefulness of erenumab-aooe injection. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may require caution and a dose adjustment for those receiving this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain foods, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect your use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Hypertension (high blood pressure)—Use with caution. This condition may worsen.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Constipation

Incidence not known

• Blurred vision
• cough
• dizziness
• fast heartbeat
• fever
• headache
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• nervousness
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• slow or fast heartbeat
• tightness in the chest
• trouble breathing or swallowing
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Less common

• Muscle cramp or spasm

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Aimovig

Available Dosage Forms:

• Solution

Therapeutic Class: Antimigraine

Pharmacologic Class: Erenumab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine. It is given through a needle given as a shot under your skin, usually in the stomach, thighs, or upper arm. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, or hard.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is available in two forms: a a prefilled syringe or an autoinjector.

Check the liquid in the prefilled syringe or autoinjector. It should be clear and colorless to slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Do not shake.

Allow the medicine to warm to room temperature for at least 30 minutes, away from direct sunlight, before you use it. Do not warm it in any other way.

Do not remove the needle cap from the prefilled syringe or autoinjector until you are ready to use it.

You might not use all of the medicine in each prefilled syringe or autoinjector. Use each prefilled syringe and autoinjector only one time. Do not save an open syringe or autoinjector.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):For migraine headaches: Adults—70 milligrams (mg) injected under the skin once a month. Some patients may be given 140 mg injected under the skin once a month. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Continue to use this medicine each month from the date of your last dose.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in its original carton. You may store it at room temperature for up to 7 days after removing it from the refrigerator. Throw away any unused medicine kept at room temperature after 7 days.

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