Description
Erenumab-aooe injection is used to prevent migraine headaches.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, 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 performed on the relationship of age to the effects of erenumab-aooe injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of erenumab-aooe injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Hypertension (high blood pressure) or
- Raynaud's phenomenon (blood vessel disease), history of—Use with caution. May make these conditions worse.
Proper Use
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 raised, thick, red, scaly skin patch or lesion, or areas with scars or stretch marks.
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 2 forms: a prefilled syringe and a prefilled Sure Click® autoinjector. Before you inject this medicine, always check the label of the device to make sure you have the correct medicine and the correct dose.
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. Do not use it if it is cracked, broken, or has been dropped.
Allow 30 minutes for the medicine to warm up to room temperature. Do not warm it by using a heat source (eg, hot water, microwave, direct sunlight) or in any other way.
Do not remove the needle cap from the prefilled syringe or autoinjector until you are ready to use it.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Do not grab the plunger rod or gray needle cap. Do not remove the gray needle cap until you are ready to inject.
- Pull the gray needle cap straight out. Do not leave the cap off for more than 5 minutes. Do not twist or bend the gray needle cap.
- Pinch the skin firmly. Insert the syringe into your skin at 45 to 90 degree angle. Place your finger on the plunger rod. Push the plunger rod all the way down until the syringe stops moving.
To use the prefilled Sure Click® autoinjector:
- Wash your hands with soap and water before and after using this medicine.
- Pull the cap straight off. Do not twist, bend, or wiggle the cap to pull it off. Never put the cap back on. Do not put your finger inside the safety guard.
- Stretch or pinch the skin. Place the safety guard straight against the skin. Make sure you can see the window.
- Firmly push the autoinjector down until the safety guard stops moving. Hold the autoinjector down, do not lift. Keep pushing the autoinjector down and press the start button to start the injection. You may hear or feel a "click". The window will start to turn yellow.
- The injection may take up to 15 seconds to complete. When the window is fully yellow, the injection is complete. The safety guard locks around the needle.
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.
- For migraine headaches:
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to receive it. Blood tests will be needed to check for unwanted effects.
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.
This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Check with your doctor right away if you have tingling or pain in the fingers or toes when exposed to cold temperatures, paleness or a cold feeling in the fingertips and toes, or a skin color change in your fingers.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Constipation
Incidence not known
- Blurred vision
- chest tightness
- 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
- paleness or cold feeling in the fingertips and toes
- 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
- tingling or pain in the fingers or toes when exposed to cold
- 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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 cramps or spasms
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.
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