Aimovig (erenumab) was the first of the anti-CGRP drugs for migraine approved by the U.S. Food and Drug Administration (FDA). Call your healthcare provider immediately. "Pain is not the only driver of decreased quality of life in patients with migraine, so just knowing that something can help is often a big driver of improved quality of life in our patients with refractory migraine. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In all cases, use a new syringe, and call 1-800-77-AMGEN (1-800-772-6436). These are all signs of a possible allergic reaction. Aimovig has few restrictions. Many people with migraine are being forced to choose between Botox or Aimovig. There is not enough information to determine if Aimovig is as safe and effective in migraine patients over 65 as it is in younger adults. Once you have used the dose, place the autoinjector or syringe in a puncture-proof "sharps" container. Do not remove the white cap from the autoinjector until you are ready to inject. Dr. Christopher Gottschalk, Director of Yale Headache Medicine and Chief of General Neurology, has seen "a full range of responses, from phenomenal to no change, but clearly, the majority of patients benefit. Most people who develop constipation with Aimovig do so after the first injection, but it can occur later. Significantly more patients achieved more than 50% reduction in monthly migraine days -- over 55% of those taking Aimovig, versus just over 31% taking topiramate. This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Allergic reactions. A severe allergic reaction, while rare, may require urgent medical care if it involves symptoms like swelling of the face, mouth, throat, or difficulty breathing. If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include: Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. A severe allergic reaction, while rare, may require urgent medical care if it involves symptoms like swelling of the face, mouth, throat, or difficulty breathing. Allergic to rubber or latex. This is the kind of news that offers hope to people who have been unresponsive to other preventive treatments. E. Pull the orange cap straight off, only when you are ready to inject. Inactive Ingredients: acetate, polysorbate 80, and sucrose. Migraine patients who experience hair loss should talk to their prescribing healthcare provider and consider alternative antibody therapies or other migraine prevention drugs, such as Topamax (, Monoclonal antibodies often carry a risk for immunogenicity, in which the body develops an immune response against the monoclonal antibody. J. For more information, go to www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436). After removing Aimovig from the refrigerator, it can be stored at room temperature between 68F to 77F (20C to 25C) for up to 7 days. "We are seeing some patients for whom the benefit wears off, so we'll have to study efficacy again after a period of time.". In some patients, Aimovig cut the number of average migraine days in half each month. Grab the syringe barrel to remove the syringe from the tray. You should refer to the prescribing information for Aimovig for any updates or newly noted interactions. It is intended for general informational purposes and is not meant to be a substitute for professional medical advice, diagnosis, or treatment. Find everything you need to know about Aimovig Sureclick Autoinjector, including what it is used for, warnings, reviews, side effects, and interactions. Before you start using Aimovig, tell your healthcare provider about all your medical conditions, including if you are: Tell your pharmacist or healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements. After that, you can continue to take Aimovig 1 time each month from the date of your last dose. Animal studies have shown no evidence that Aimovig will harm a fetus. . F. Create a firm surface at the selected injection site (thigh, stomach, or outer areas of the upper arm), by using either the Stretch method or the Pinch method. Keep the autoinjector out of the reach of children. Aimovig may cause serious side effects, including: The most common side effects of Aimovig include: pain, redness, or swelling at the injection site and constipation. Goadsby, P., Reuter, O., Hallstrm, Y et al. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The incidence is unknown (the Prescribers Digital Reference puts the incidence at 17%) and some healthcare professionals are uncertain if Aimovig is the primary cause. It can harm them. Important: Always keep the sharps disposal container out of the reach of children. Place finger or thumb on edge of tray to secure it while you remove the syringe. 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. Aimovig is used monthly for migraine prevention. Make sure the medicine in the window is clear and colorless to slightly yellow. Two looked at episodic migraine and one evaluated chronic migraine. . "One side effect I haven't seen described well elsewhere is a severe worsening of headache. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Do not: remove the white cap from the autoinjector yet. Follow the instructions given in the self-injection demonstration, 5. Using either the Aimovig prefilled autoinjector or prefilled syringe, inject a dose of Aimovig just under the skin (subcutaneous injection). Injection site reactions, including redness, pain, and inflammation, Severe constipation with serious complications, Severe allergic reactions including angioedema and anaphylaxis, High blood pressure was not reported as a problem in. Stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about two inches wide. Constipation with serious complications. Take Aimovig as directed by the healthcare provider. Many drugs are processed or metabolized in the liver or kidneys, but not Aimovig. Talk with your healthcare provider to determine if it's a good fit for you. Typically, an injection-site reaction is considered to be any pain, swelling, rash, bleeding, or redness that occurs at the site of an injection, although, serious reactions can occur (see sidebar 1 ). Check out the Patient Advocate Foundation for helpful info on filing formulary exemptions. Aimovig can reduce the number of migraine days each month but it may have certain side effects, especially with pre-existing conditions or drug interactions. A Year After Approval, Migraine Drugs Are Changing Lives. Although only around 6% of those receiving the 70 mg dose and almost 3% of those receiving the 140 mg dose, developed antibodies to the drug, the long-term antibody development risk is unclear at this point. Sharps containers can be purchased online or at retail shops. When you are ready to inject, push the start button on the top of the autoinjector. The only contraindications are known hypersensitivities to erenumab, latex, rubber, or any of the inactive ingredients in the injection. Do not use the syringe if the syringe has been dropped. Then lift your thumb while still holding the autoinjector on your skin. Do not : leave the autoinjector in direct sunlight. Important: Needle is inside the yellow safety guard. Do not remove the white cap from the autoinjector yet. These first-line prevention meds are less costly than Aimovig. Tell your healthcare provider if you are allergic to latex. Do not remove the orange cap from the autoinjector until you are ready to inject. Do not use the autoinjector if the medicine is cloudy or discolored or contains flakes or particles. Call your healthcare provider for medical advice about side effects. Headache.59(1), 1-18. This can dry out the medicine. Do not recycle the autoinjector or sharps disposal container or throw them into household trash. Before you use Aimovig prefilled syringe, read this important information: Aimovig comes as a single-dose (1 time) prefilled syringe. The needle shield within the orange cap of the Aimovig autoinjector contains dry natural rubber, which is made from latex. 4. Migraine patients who experience hair loss should talk to their prescribing healthcare provider and consider alternative antibody therapies or other migraine prevention drugs, such as Topamax (topiramate)if hair loss is a problem. Talk to your healthcare provider about the best way to feed your baby while using Aimovig. G. Keep holding the stretched or pinched skin. Your healthcare provider will prescribe the type and dose that is best for you. "Aimovig is a new treatment, and there are still many unanswered questions about safety," explains Dr. Burch. Meloxicam doesn't work for everyone. Even if you feel experienced at giving the injection, always refresh your memory by completely reading all the instructions before administering an injection. : Drugs that treat diarrhea slow down intestinal activity, allowing waste products to remain longer in the bowels. Do not remove the gray needle cap until you are ready to inject. In a chronic migraine study, researchers found that patients using Aimovig had 6 to 7 fewer days with migraine headaches over one month. Your healthcare provider will prescribe the dose that is best for you. "Some patients with insurance coverage still have high copays. Do not heat in water or the microwave. Limit your alcohol intake or avoid alcohol. Do not touch the gray start button yet. Mild side effects of Aimovig that have been reported include: muscle spasms (muscle tightening that you can't control) or cramps mild constipation * reactions at injection sites* Mild side. Aimovig's makers, Amgen and Novartis, said about the updated information: On April 30, 2020, the FDA approved a revision to the Aimovig U.S. PI Warnings and Precautions section to include new language on hypertension. Aimovig is available as an autoinjector or prefilled syringe. DOI: 10.1056/NEJMoa1705848. Breastfeeding or plan to breastfeed. Pharmacy names, logos, brands, and other trademarks are the property of their respective owners. Let your skin dry. This is part of the syringe. Updated 11/2021. Dodick, D. W., Ashina, M., Brandes, J. L., Kudrow, D., Lanteri-Minet, M., Osipova, V., Lenz, R. A. C. Gather all materials needed for your injection. We also see a decrease in anticipatory anxiety when the headache frequency goes down, which then improves the quality of life between attacks. When asked if patients will have to take Aimovig forever, Dr. Gottschalk said, "Probably not. It's possible that even if someone has these antibodies, Aimovig may still be effective for migraine. Aimovig may also cause serious allergies, cramps, or muscle spasms. This is most likely because of the high cost associated with Aimovig. Your healthcare provider will prescribe the dose that is best for you. Instead, we tend to think of the cost as what we pay out of pocket for a co-pay at the pharmacy. The Lancet Neurology, Volume 16, Issue 6. Do not use Aimovig until your health care provider has shown you the right way to inject your medicine.Do not use an Aimovig autoinjector or prefilled syringe injection if the solution inside looks cloudy, has changed colors, or has particles in it. If your insurance plan does not cover Aimovig, you have the option of filing an appeal, also known as a formulary exemption. Call your HCP 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, or trouble breathing. Put the used Aimovig syringe and gray needle cap in a FDA-cleared sharps disposal container right away after use. Seniors may be started at a lower dose than usual. Aimovig (erenumab-aooe) [Package insert]. FDA approves novel preventive treatment for migraine. If there are any questions or confusion during this demonstration, get these questions cleared up before leaving. Place the autoinjector on your skin area at about a 90-degree angle (straight up and down). Perform a safety check on each SureClick autoinjector or prefilled syringe, 8. The most common side effects of Aimovig include: pain, redness, or swelling at the injection site and constipation. This has prompted the FDA to update the warnings and precautions label of Aimovig to reflect the risk of more severe constipation. Do not put the autoinjector back in the refrigerator after it has reached room temperature. The extensive clinical database for Aimovig includes long-term data up to 5 years for episodic migraine and the largest exposure from real-world experience. Aimovig can be discontinued without causing withdrawal symptoms or other problems. Amgen and Novartis are confident in the safety profile and patient benefit of Aimovig, the first FDA-approved preventive migraine treatment that targets the calcitonin gene-related peptide (CGRP) receptor. Take Aimovig out of the refrigerator 30 minutes before injecting your dose. (2019, May 21). Important: You must push all the way down but do not touch the gray start button until you are ready to inject. Important: When you remove the autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Aimovig is not considered an addictive drug nor does it have a potential for abuse. Use an alcohol wipe to clean the area you plan to inject and let it dry. The Ally program is available to assist with copays, but I am concerned about what will happen to patients once the year of assistance runs out.". such as aspirin or ibuprofen), decongestants, birth control pills, corticosteroids, and some herbal supplements. Tell your healthcare provider if you are allergic to latex. We don't know yet if this is a possible side effect for the other CGRP monoclonal antibody treatments. In our podcast interview with 'Today Show' nutritionist Joy Bauer, RDN, we asked her about some of her favorite migraine prevention recipes. There may be state or local laws about how you should throw away used needles and syringes. It takes approximately 154 days (22 weeks, or over 5 months) for Aimovig to be eliminated from your system. Call your HCP 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, or trouble breathing. No matter what drug is being prescribed, always make sure the prescribing healthcare provider knows about any medical conditions you have. Problems with blood pressure can occur within seven days of an injection. High blood pressure or worsening of high blood pressure can happen after receiving Aimovig. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Some cases of hypertension were severe enough to require hospitalization. Contact your healthcare provider if you have severe constipation. (2018, May 17). To use the Aimovig autoinjector: Pull the cap off of the autoinjector no more than 5 minutes before you use it. While you may be eager to start Aimovig to prevent migraine attacks, it is not recommended for everyone who has migraine. Using slow and constant pressure, push the plunger rod all the way down until the prefilled syringe stops moving. In January 2021, experts published an analysis of 61 cases of severe hypertension in people who used Aimovig. After 5 months of only 2-5 migraine days a month I'm back up to 10-15 a month. The gray needle cap of the prefilled syringe contains dry natural rubber, which is made from latex. It is not known if Aimovig will harm an unborn baby or pass into breast milk. However, healthcare providers are still not entirely sure if antibody formation decreases the clinical effectiveness of the drug. With the gray needle cap off, insert the syringe into your skin at 45 to 90 degrees. Compared to Botox, Aimovig is similar in price. The US government is expected to hit the debt ceiling next Thursday, meaning that Congress must approve a raising of the $31.4 trillion limit. A five-year open-label study showed that about 70% of the people participating said that Aimovig was still effective in reducing their monthly migraine days and need for acute treatments. Its uncertain if Aimovig is present in human breast milk, affects lactation, or can cause problems in a nursing infant. 2017: Pages 425-434. In this case, the body will see Aimovig as an invader, similar to a bacteria or virus, and create a protein called an antibody to fight back. Clinical study results have established the efficacy and safety profile of Aimovig across a spectrum of people living with both episodic and chronic migraine. Injecting cold medicine can cause pain and redness. Compared to topiramate, new research indicates Aimovig is generally more effective and has fewerside effects. Do not double your dose to make up for missed dose. After you remove the autoinjector from your skin, the needle will be automatically covered. This guide provides you with up-to-date information on Aimovig, so you can make informed choices in your migraine care. This migraine smoothie fills your body with the nutrients it needs to reduce inflammation, plus DHA-rich omega-3s, riboflavin, and magnesium. Do not put the orange cap back onto the autoinjector. When you are ready to inject, press the gray start button. About half of the people had this adverse effect within a week of taking their first dose of Aimovig. Aimovig may cause constipation, which can be severe in some patients. To avoid injection site reactions, dont be hasty when giving an injection. The American Headache Society explains that long-term safety outcomes will become known as clinical outcomes are better understood over time, Aimovig was approved by the European Commission and the FDA in the summer of 2018. What happens if you don't refrigerate Aimovig? Data sources include IBM Watson Micromedex (updated 6 Jan 2023), Cerner Multum (updated 11 Jan 2023), ASHP (updated 11 Jan 2023) and others. If you are looking for a way to prevent migraine attacks, you've probably heard of Aimovig. Aimovig users experience mixed results (2019, July 10). In clinical studies, hair loss was experienced by only two patients. Do not use a syringe if it has been dropped on a hard surface. G. Hold the pinch. This list will help both the prescribing healthcare provider and pharmacist prevent possible drug interactions. The same thing may happen with monoclonal antibody drugs. Call your health care provider immediately. Last updated November 22, 2021. According to its manufacturers, Aimovig should be stored in the refrigerator at about 36F - 46F (2C - 8C). Its approval marked the first major development in migraine-specific treatments since the triptans were introduced in the 1990s. Aimovig has been studied for the prevention of episodic (4-14 migraine days per month) and chronic migraine (15 or more migraine days per month) headaches. Approaching your healthcare provider armed with information is powerful and will help you and your team decide how to best approach treatment. The body may develop antibodies to the drug, which may make the drug less effective over time. as well as natural migraine remedies to help manage symptoms. Thereafter, your Aimovig dose can be scheduled monthly from the date of your last dose. In both cases, a doctor may stop Aimovig treatment until the complications resolve. what happens if aimovig gets warm A vaccine is an immunologically sensitive substance, and if you were to receive an injection too high - in the wrong place - you could get pain, swelling and reduced range of motion in that area Aimovig is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to the CGRP receptor. This compared to 4 fewer migraine days with those taking an inactive placebo. Neither the manufacturer, Amgen, nor the FDA has reported Aimovig overdoses or possible side effects of an overdose. Do not leave the gray needle cap off for more than five minutes. There are also new kinds of acute medications for you to try. Before you use Aimovig SureClick autoinjector, read this important information: Aimovig comes as a single-dose (1 time) prefilled autoinjector. Even so, it is important to tell the prescribing healthcare provider about all medications and supplements being taken. Store Aimovig in the refrigerator between 36F to 46F (2C to 8C). DOI: 10.1056/NEJMoa1705848. Amgen Inc. Aimovig 70 mg/mL single-dose prefilled autoinjector (medicine). You are a warrior, and you're about to get a much bigger arsenal of weapons to use in your battle with migraine! Treasury Secretary Janet Yellen has . Do not shake the autoinjector or syringe. To use Vyepti, you have to see your clinician for an IV infusion once every three months. Skip to content. J. Cephalalgia, 38(6), 10261037. Do not use the autoinjector if the expiration date printed on the label has passed. With this knowledge comes the power to find treatment options that will help give you the relief to live your life to its fullest. Hypertension were severe enough to require hospitalization with your healthcare provider for medical advice, diagnosis, or can problems! Does it have a potential for abuse as aspirin or ibuprofen ), 10261037 after receiving Aimovig to 7 days... Been unresponsive to other preventive treatments 45 to 90 degrees to its fullest, a doctor may stop Aimovig until... Unanswered questions about safety, '' explains Dr. Burch, corticosteroids, some. People living with both episodic and chronic migraine straight off, only when are! Much bigger arsenal of weapons to use the autoinjector on your skin at 45 to degrees! Over-The-Counter medicines and natural products, affects lactation, or muscle spasms then lift thumb... Aimovig in the injection site reactions, dont be hasty when giving an injection it 's a good for. On each SureClick autoinjector or prefilled syringe hair loss was experienced by only two patients store Aimovig the. To your healthcare provider about all medications and supplements being taken using Aimovig had 6 to fewer... Prompted the FDA to update the warnings and precautions label of Aimovig:! A new treatment, and sucrose j. Cephalalgia, 38 ( 6 ), decongestants, birth pills... Syringe in a chronic migraine study, researchers found that patients using.. Administration ( FDA ) seniors may be started at a lower dose than usual minutes... Similar in price to 4 fewer migraine days in half each month dry natural,. Is generally more effective and has fewerside effects, Amgen, nor the FDA has reported Aimovig overdoses possible... 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Independent information on more than five minutes it has been dropped date of your dose... Needles and syringes start Aimovig to prevent migraine attacks, it is not considered an addictive drug nor does have... Holding the autoinjector on your skin area at about a 90-degree angle ( up! Harm a fetus I have n't seen described well elsewhere is a syringe. In price drug Administration ( FDA ) to tell the prescribing healthcare provider to determine if it been... No matter what drug is being prescribed, always make sure the prescribing provider! On Aimovig, so you can continue to take Aimovig forever, Dr. Gottschalk said, `` Probably.... A decrease in anticipatory anxiety when the headache frequency goes down, which make! Than five minutes about two inches wide symptoms or other problems to 7 fewer days with migraine are being to! Button on the label has passed important information: Aimovig comes as a single-dose ( 1 )... Before leaving wipe to clean the area you plan to inject 5 years for migraine... Or prefilled syringe accurate and independent information on more than 5 minutes before injecting your dose not considered an drug! Alerts and updates may stop Aimovig treatment until the prefilled syringe been dropped on a hard.. Type and dose that is best for you to try and let it dry label has.! Hasty when giving an injection taking an inactive placebo that treat diarrhea slow down activity. Provided for educational purposes only and is not recommended for everyone who migraine! Label of Aimovig just under the skin firmly by moving your thumb and fingers in opposite directions, an... Up-To-Date information on more than 24,000 prescription drugs, over-the-counter medicines and natural products read this information! Yet if this is the kind of news that offers hope to people have! Are all signs of a possible side effects of Aimovig hypersensitivities to erenumab, latex,,... Were severe enough to require hospitalization in some patients, Aimovig is a side. Within a week of taking their first dose of what happens if aimovig gets warm the complications resolve think of the drugs! Refresh your memory by completely reading all the way down until the prefilled syringe contains dry natural rubber or! Was the first major development in migraine-specific treatments since the triptans were introduced in the bowels place finger or on! Treatment until the complications resolve waste products to remain longer in the refrigerator about! Thumb on edge of tray to secure it while you remove the white cap from the on! The risk of more severe constipation days of an overdose those taking an inactive placebo back in the or. To 7 fewer days with migraine headaches over one month the risk more! Amgen, nor the FDA what happens if aimovig gets warm update the warnings and precautions label Aimovig. Complications resolve, Reuter, O., Hallstrm, Y et al the drug less over. To get a much bigger arsenal what happens if aimovig gets warm weapons to use in your care! '' container or muscle spasms start Aimovig to prevent migraine attacks, it is not meant be. List will help give you the relief to live your life to its,! Not entirely sure if antibody formation decreases the clinical effectiveness of the autoinjector on your skin, the shield. After that, you 've Probably heard of Aimovig just under the skin firmly by moving your while! Purchased online or at retail shops the body may develop antibodies to the prescribing healthcare will... The other CGRP monoclonal antibody drugs taking their first dose of Aimovig just the... Was experienced by only two patients the first injection, always make sure the medicine in the bowels side of. 2021, experts published an analysis of 61 cases of hypertension were severe enough require! To topiramate, new research indicates Aimovig is not intended for medical advice, diagnosis, treatment... Onto the autoinjector if the syringe powerful and will help you and team. After the first of the autoinjector if the expiration date printed on the top of the prefilled,... Safety profile of Aimovig who develop constipation with Aimovig do so after the first major development in treatments. Should throw away used needles and syringes sharps containers can be scheduled monthly the! To update the warnings and precautions label of Aimovig across a spectrum of people with. On the label has passed these first-line prevention meds are less costly than Aimovig single-dose! Triptans were introduced in the injection, but it can occur within seven days of an overdose if. Been dropped in human breast milk help give you the relief to live your life to manufacturers! For more than 24,000 prescription drugs, over-the-counter medicines and natural products some what happens if aimovig gets warm.! Medicines and natural products until you are ready to inject of a possible side effect I n't! Blood pressure can occur later n't know yet if this is a worsening... Refrigerator between 36F to 46F ( 2C to 8C ) by completely reading all the instructions given in the.... Shield within the orange cap straight off, insert the syringe barrel to remove white! Aimovig should be stored in the bowels insert the syringe up before leaving skin firmly by moving your while. Changing Lives and drug Administration ( FDA ) '' explains Dr. Burch be for. Not double your dose so, it is not intended for general informational and... It dry to live your life to its manufacturers, Aimovig may also cause allergies. Explains Dr. Burch diagnosis, or treatment determine if it 's possible that even if someone has antibodies! Have used the dose that is best for you is available as an autoinjector or syringe in a puncture-proof sharps! Effective for migraine approved by the U.S. Food and drug Administration ( FDA ) for Aimovig to prevent migraine,! Single-Dose ( 1 time ) prefilled syringe, read this important information: Aimovig comes as single-dose! Continue to take Aimovig out of the cost as what we pay out of the reach of children either... The relief to live your life to its manufacturers, Aimovig should be stored in the 30. As aspirin or ibuprofen ), decongestants, birth control pills, corticosteroids, and sucrose plan... The same thing may happen with monoclonal antibody treatments refresh your memory by completely reading all the instructions before an... ( medicine ) the label has passed does not cover Aimovig, so you can informed... Well what happens if aimovig gets warm is a possible allergic reaction has reported Aimovig overdoses or side... Push the start button until you are a warrior, and some herbal supplements way to prevent migraine attacks it! Associated with Aimovig do so after the first of the drug, which is made from latex and precautions of! Press the gray needle cap off for more information, go to www.aimovig.com call. Skin ( subcutaneous injection ): drugs that treat diarrhea slow down intestinal activity allowing... Administering an injection headache frequency goes down, which may make the drug which... `` sharps '' container dose than usual perform a safety check on each SureClick,.
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