Aimovig: Uses, Dosage & Side Effects

What Is Aimovig and What Is It Used For?

Aimovig contains the active substance erenumab, a fully human immunoglobulin G2 (IgG2) monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. As a monoclonal antibody, Aimovig is a highly specialized protein engineered to bind to one specific molecular target in the body. What makes Aimovig unique among the class of anti-CGRP migraine therapies is its target: rather than binding to the CGRP molecule (ligand) itself, erenumab binds directly to the CGRP receptor, preventing CGRP from activating it.

Calcitonin gene-related peptide (CGRP) is one of the most potent vasodilators known and one of the most abundant neuropeptides in the human nervous system. It is found at particularly high concentrations in the trigeminal ganglion and in perivascular nerve fibers surrounding cerebral and meningeal blood vessels. During a migraine attack, CGRP is released in large quantities from trigeminal sensory nerve endings, triggering a cascade of pathological events including vasodilation of intracranial blood vessels, neurogenic inflammation of the meninges, sensitization of pain-processing neurons in the trigeminal nucleus caudalis, and transmission of pain signals to higher cortical brain centers. Elevated CGRP levels have been consistently measured in the jugular venous blood of patients during acute migraine attacks, and intravenous infusion of CGRP has been shown to provoke migraine-like headaches in susceptible individuals, establishing CGRP as a key mediator of migraine pathophysiology.

The CGRP receptor is a heterodimer composed of the calcitonin receptor-like receptor (CLR) and receptor activity-modifying protein 1 (RAMP1). Erenumab binds with high affinity to this receptor complex, sterically blocking CGRP from binding and activating downstream signaling cascades. By targeting the receptor rather than the ligand, erenumab provides a comprehensive blockade of all CGRP-mediated signaling at the receptor level, including signaling that might be mediated by CGRP fragments or related peptides. This receptor-targeted approach is pharmacologically distinct from the ligand-targeting mechanism of fremanezumab (AJOVY) and galcanezumab (Emgality), which bind to the CGRP molecule itself.

Aimovig is indicated for the preventive treatment of migraine in adults who experience at least 4 migraine days per month. This includes patients with both episodic migraine (fewer than 15 headache days per month) and chronic migraine (15 or more headache days per month, of which at least 8 are migraine days). Aimovig was evaluated in multiple pivotal phase III clinical trials:

• STRIVE (Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention): This large, randomized, double-blind, placebo-controlled trial enrolled 955 adults with episodic migraine. Patients treated with erenumab 70 mg or 140 mg monthly experienced statistically significant reductions in mean monthly migraine days compared with placebo over a 6-month treatment period. The 70 mg group had a reduction of 3.2 days per month versus 1.8 for placebo, and the 140 mg group had a reduction of 3.7 days versus 1.8 for placebo.
• ARISE (A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of AMG 334): This trial enrolled 577 adults with episodic migraine and evaluated the 70 mg monthly dose. Patients receiving erenumab experienced a mean reduction of 2.9 monthly migraine days versus 1.8 for placebo over 3 months of treatment.
• Chronic Migraine Study (Study 295): This trial enrolled 667 adults with chronic migraine. Patients treated with erenumab 70 mg or 140 mg monthly experienced significant reductions in monthly migraine days. The 70 mg group showed a reduction of 6.6 days per month versus 4.2 for placebo, and the 140 mg group showed a reduction of 6.6 days versus 4.2 for placebo.

Across all trials, the proportion of patients achieving a 50% or greater reduction in monthly migraine days (a widely used clinical benchmark known as the “50% responder rate”) was significantly higher in the erenumab groups compared with placebo. In the STRIVE trial, for example, approximately 43% of patients on erenumab 70 mg and 50% on 140 mg achieved this threshold, compared with 27% on placebo. Long-term open-label extension studies have demonstrated sustained efficacy over 5 years of continuous treatment, with no evidence of tolerance (loss of effect over time) and a consistent safety profile.

Aimovig was first approved by the U.S. Food and Drug Administration (FDA) in May 2018, making it the first CGRP-pathway therapy to receive regulatory approval. The European Medicines Agency (EMA) subsequently approved Aimovig in July 2018. It is now approved in more than 50 countries worldwide. As the pioneering therapy in the anti-CGRP class, Aimovig represented a paradigm shift in migraine prevention, moving away from older preventive medications (beta-blockers, anticonvulsants, antidepressants, and botulinum toxin) that were originally developed for other conditions and repurposed for migraine.

What Should You Know Before Taking Aimovig?

Contraindications

The primary contraindication to Aimovig use is hypersensitivity (allergy) to erenumab or to any of the other ingredients in the formulation. The excipients in Aimovig include sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, and water for injections. If you have a known allergy to any of these substances, you must not use Aimovig.

Serious hypersensitivity reactions have been reported in post-marketing experience, including anaphylaxis, angioedema (swelling of the face, lips, tongue, or throat), urticaria (hives), and rash. These reactions can occur within minutes of injection but have also been reported with delayed onset, occurring more than one week after administration. If you experience signs of a severe allergic reaction after using Aimovig, seek immediate medical attention and do not administer further doses until you have consulted your healthcare provider.

Warnings and Precautions

Before starting Aimovig, discuss the following with your healthcare provider:

• Cardiovascular disease: Aimovig has not been studied in patients with certain cardiovascular conditions, including uncontrolled hypertension, recent myocardial infarction (heart attack), unstable angina, heart failure, or a history of stroke or transient ischemic attack. CGRP plays a role in cardiovascular protection, including vasodilation and cardioprotection during ischemic events. While clinical trial data and post-marketing surveillance have not identified significant cardiovascular safety signals with Aimovig, patients with established cardiovascular disease should be carefully monitored and should discuss potential risks with their doctor.
• Constipation: Constipation is a recognized side effect of Aimovig and can be severe in some cases. Post-marketing reports have described cases of constipation with serious complications, including hospitalization and, in rare instances, surgical intervention. CGRP plays a role in gastrointestinal motility, and blocking the CGRP receptor may reduce gut peristalsis. Patients with a history of chronic constipation or conditions that predispose to constipation should discuss this risk with their doctor before starting treatment. If you develop constipation while taking Aimovig, especially if accompanied by severe or persistent abdominal pain, vomiting, or abdominal bloating, seek medical attention promptly.
• History of allergic reactions: If you have a history of significant allergic reactions to medications or biological products, inform your doctor before starting Aimovig. Hypersensitivity reactions have been reported, including rare cases of anaphylaxis.

Children and Adolescents

Aimovig is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of erenumab have not been established in this age group, and there are currently no clinical data to support its use in pediatric patients. Migraine in children and adolescents may require different treatment approaches, and healthcare providers should consider age-appropriate alternatives. Pediatric studies are underway, and dosing recommendations for younger patients may become available in the future.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using Aimovig. The effects of erenumab on human pregnancy have not been adequately studied. As a monoclonal antibody (IgG2), erenumab is expected to cross the placental barrier, particularly during the second and third trimesters, when active transport of maternal IgG antibodies to the fetus is at its highest. Animal reproductive studies in cynomolgus monkeys did not reveal adverse developmental effects when erenumab was administered during organogenesis and throughout pregnancy at exposures exceeding the clinical dose, but animal data are not always predictive of human outcomes. As a precaution, Aimovig should be avoided during pregnancy unless the potential benefit to the mother clearly justifies the potential risk to the fetus.

It is known that monoclonal antibodies such as erenumab pass into breast milk during the first few days after birth, but after this initial period, concentrations are expected to be very low. A risk to the breastfed infant cannot be excluded, particularly in the neonatal period. The decision to breastfeed during Aimovig treatment should be made in consultation with your doctor, weighing the developmental and health benefits of breastfeeding for the infant against the clinical need for Aimovig treatment and any potential adverse effects on the breastfed child.

Driving and Operating Machinery

Aimovig is unlikely to affect your ability to drive or operate machinery. No specific studies on the effects of erenumab on driving ability have been performed, but based on its pharmacological properties and the known side effect profile from clinical trials, no impairment of these abilities is expected. However, if you experience any adverse effects that could affect your concentration or reaction time, refrain from driving or operating machinery until you feel well again.

Important Information About Ingredients

Aimovig contains less than 1 mmol (23 mg) of sodium per dose, meaning it is essentially sodium-free. This information is relevant for patients on a sodium-restricted diet. The formulation also contains polysorbate 80 (0.1 mg per mL, equivalent to 0.004 mg/kg), which may cause allergic reactions in some individuals. If you have any known allergies or sensitivities to these components, inform your healthcare provider before starting treatment.

How Does Aimovig Interact with Other Drugs?

One of the important practical advantages of Aimovig in the preventive treatment of migraine is its favorable drug interaction profile. Unlike many traditional oral preventive medications for migraine (such as topiramate, valproate, propranolol, or amitriptyline), which are metabolized by hepatic cytochrome P450 enzymes and can interact with a wide range of other medications, erenumab is a monoclonal antibody that is degraded through general protein catabolic pathways rather than through CYP enzyme-mediated metabolism.

No formal drug interaction studies have been conducted with erenumab. However, based on its mechanism of clearance, no clinically significant pharmacokinetic interactions are expected. Population pharmacokinetic analyses from the clinical trial program have confirmed that concomitant medications commonly used by migraine patients do not meaningfully affect erenumab pharmacokinetics. Similarly, erenumab is not expected to affect the metabolism or pharmacokinetics of other drugs.

In clinical trials, Aimovig was used concomitantly with a wide variety of medications commonly used by migraine patients, with no evidence of clinically relevant interactions:

Although no formal drug-drug interactions have been identified, it is always important to inform your doctor or pharmacist about all medications, herbal supplements, and over-the-counter products you are currently using. This standard recommendation for any prescription medication helps ensure comprehensive monitoring of your health and treatment outcomes.

There is a theoretical pharmacodynamic consideration when combining Aimovig with other CGRP pathway-targeting therapies. Since small-molecule CGRP receptor antagonists (gepants such as rimegepant and ubrogepant) also target the CGRP receptor, combining them with erenumab means both agents are competing for the same target. While co-administration has been reported in clinical practice and emerging data suggest it may be safe, the long-term implications of dual CGRP receptor blockade have not been fully characterized. Combining Aimovig with ligand-targeting anti-CGRP antibodies (fremanezumab or galcanezumab) is generally considered unnecessary, as both approaches aim to prevent CGRP signaling, and the combined benefit is unlikely to exceed that of either agent alone. Discuss with your headache specialist if you are considering or already using other CGRP-targeted treatments.

What Is the Correct Dosage of Aimovig?

Aimovig should always be used exactly as your doctor has instructed. The medication is administered as a subcutaneous injection (under the skin) using pre-filled autoinjector pens. Your doctor will determine the most appropriate dose based on your migraine pattern, response to treatment, and individual clinical circumstances.

Adults

There are two available dosing options for Aimovig in adult patients:

The recommended starting dose is 70 mg administered subcutaneously once every 4 weeks. Some patients may benefit from the higher dose of 140 mg every 4 weeks. If your doctor prescribes the 140 mg dose, it can be administered as a single injection using a 140 mg pen, or as two consecutive injections using two 70 mg pens. When two 70 mg injections are required, the second injection must be given immediately after the first but at a different injection site. Ensure that the entire contents of both pens are injected.

Aimovig is injected subcutaneously into one of the following body areas:

• Abdomen (belly): Avoid the area within approximately 5 cm (2 inches) of the navel.
• Front of the thighs: Choose the middle area of the thigh, away from the knee and groin.
• Back of the upper arms: This site can only be used if another person is giving you the injection, as it is difficult to reach yourself.

Rotate injection sites between administrations. Do not inject into areas where the skin is tender, red, hard, bruised, or scarred. If two injections are required for the 140 mg dose, they must be given at different sites to avoid skin hardening.

Children and Adolescents

Aimovig is not recommended for use in patients under 18 years of age. Safety and efficacy have not been established in this age group. Pediatric clinical trials are ongoing, and dosing recommendations for children may become available in the future.

Elderly Patients

No dose adjustment is required for elderly patients. Clinical trials included patients up to 65 years of age, and population pharmacokinetic analyses did not identify age as a significant factor affecting erenumab clearance. Limited data are available for patients aged over 65, as migraine typically decreases in prevalence with advancing age. However, no specific precautions are necessary, and standard dosing can be used.

Missed Dose

If you forget to take a dose of Aimovig, administer it as soon as you remember. Then contact your doctor, who will advise you when to take your next scheduled dose. Follow the new schedule as directed. Do not take a double dose to make up for a missed injection. Using a calendar, diary, or mobile phone reminder can help you keep track of your 4-weekly dosing schedule.

Overdose

If you have received more Aimovig than prescribed, or if the dose has been given earlier than scheduled, inform your doctor. In clinical trials, single doses of up to 280 mg subcutaneously have been administered without dose-limiting toxicity. There is no specific antidote for erenumab overdose. Treatment of overdose should be supportive, including monitoring of vital signs and observation of clinical status. Given the half-life of approximately 28 days, monitoring after overdose may need to continue for an extended period.

How to Use the Pre-Filled Pen

Before using Aimovig, your doctor or nurse should train you or your caregiver on the proper injection technique. Do not attempt to inject Aimovig until you have received this training. The following is a general overview of the injection process:

1. Preparation: Remove the pre-filled pen from the refrigerator and allow it to reach room temperature for at least 30 minutes before injection. Do not warm it using any heat source such as hot water or a microwave. Do not shake the pen.
2. Inspection: Check the viewing window: the solution should be clear to opalescent, colorless to slightly yellow, and practically free from particles. Do not use the pen if it appears cracked or damaged, has been dropped, or if the needle shield cap is missing or not securely attached.
3. Site preparation: Wash your hands thoroughly with soap and water. Clean the chosen injection site with an alcohol swab and let it dry. Choose a well-lit location and a clean, flat surface.
4. Injection: Remove the needle shield cap by pulling it straight off (do not twist or bend it). Place the pen against the skin at a 90-degree angle. Press the pen firmly against the skin, then press the start button. You will hear a click. Keep the pen pressed against the skin for approximately 15 seconds until the viewing window turns yellow and you may hear a second click, indicating the injection is complete.
5. Disposal: After removing the pen from the skin, the needle is automatically covered by the safety guard. Place the used pen immediately into an approved sharps disposal container. Do not reuse the pen or put it in household waste.

If the viewing window has not turned yellow, or if it appears that medication is still being injected when you remove the pen, you may not have received the full dose. Contact your doctor immediately. After injection, if there is slight bleeding at the injection site, press a cotton ball or gauze pad over the site for a few seconds. Do not rub the injection site. Apply a plaster (adhesive bandage) if needed.

What Are the Side Effects of Aimovig?

Like all medicines, Aimovig can cause side effects, although not everyone who takes it will experience them. The side effects observed during clinical trials and post-marketing surveillance are categorized below by their frequency of occurrence. Overall, Aimovig has been shown to have a favorable tolerability profile, with the discontinuation rate due to adverse events being low and comparable to placebo in clinical trials.

Clinical data from the STRIVE, ARISE, and chronic migraine trials, along with long-term open-label extension studies and post-marketing pharmacovigilance, form the basis of the known safety profile of Aimovig. In the pivotal trials, the overall incidence of adverse events was similar between Aimovig and placebo groups, with constipation and injection site reactions being the primary exceptions.

Constipation is a notable side effect that distinguishes Aimovig from other anti-CGRP monoclonal antibodies. CGRP plays a physiological role in regulating gastrointestinal motility, and blocking the CGRP receptor with erenumab can reduce peristaltic activity in the gut. In clinical trials, constipation was reported in approximately 1–3% of patients receiving Aimovig compared with less than 1% on placebo. While constipation is usually mild or moderate in intensity, post-marketing reports have documented cases of constipation with serious complications, including bowel obstruction, fecal impaction, and hospitalization. Some cases have required surgical intervention. If you experience constipation while taking Aimovig, especially if accompanied by severe or persistent abdominal pain, bloating, vomiting, or an inability to pass stool, seek medical attention immediately.

Injection site reactions are generally mild and transient, typically resolving within a few days without specific treatment. Common injection site symptoms include pain, redness (erythema), and swelling at the point of injection. Rotating injection sites between administrations and allowing the pen to reach room temperature before injection can help minimize discomfort.

Allergic reactions to Aimovig have been reported during clinical trials and in post-marketing experience. Most allergic reactions have been mild to moderate, presenting as localized or generalized skin rash, hives (urticaria), or swelling. In rare cases, more severe hypersensitivity reactions have occurred, including anaphylaxis. Importantly, serious allergic reactions can have a delayed onset, occurring more than one week after injection. If you develop symptoms such as difficulty breathing, facial or throat swelling, widespread rash, or a rapid drop in blood pressure after using Aimovig, seek emergency medical care immediately and do not use further doses until you have consulted your doctor.

Muscle cramps (muscle spasms) have been reported as a common side effect in clinical trials, typically affecting the legs. These are generally mild and self-limiting. Adequate hydration and regular stretching may help reduce the frequency of muscle cramps.

Long-term safety data from open-label extension studies spanning up to 5 years of continuous treatment have been consistent with the known safety profile. No new safety signals have emerged with prolonged use. The incidence of anti-drug antibodies (immunogenicity) has been observed in approximately 6–8% of patients, with neutralizing antibodies detected in approximately 1%. In the majority of cases, the presence of anti-drug antibodies did not appear to meaningfully affect the efficacy or safety of Aimovig. However, in a small number of patients with neutralizing antibodies, reduced efficacy has been observed.

How Should You Store Aimovig?

Proper storage of Aimovig is essential to maintain the quality, safety, and efficacy of the medication. As a biological product (monoclonal antibody), erenumab is sensitive to temperature extremes, light exposure, and physical agitation, all of which can compromise its structural integrity and reduce its therapeutic effectiveness.

Follow these storage guidelines carefully:

• Refrigerated storage: Store Aimovig in the refrigerator at 2–8 °C (36–46 °F). This is the primary storage condition for the pre-filled pens. Keep the pens in the outer carton to protect them from light.
• Do not freeze: Freezing can damage the protein structure of the monoclonal antibody and render the medication ineffective. If Aimovig has been accidentally frozen, do not use it — discard the pen and use a new one.
• Temporary room temperature storage: Aimovig can be taken out of the refrigerator and stored at room temperature (up to 25 °C / 77 °F) for a single period of up to 7 days. After 7 days at room temperature, the pen must be discarded. Do not return Aimovig to the refrigerator once it has been removed.
• Keep out of reach of children: Store Aimovig in a safe location where children cannot access it.
• Check expiration date: Do not use Aimovig after the expiration date printed on the pen label and outer carton after “EXP.” The expiration date refers to the last day of that month.
• Inspect before use: Before each injection, visually inspect the solution through the viewing window. The solution should be clear to opalescent and colorless to slightly yellow. Do not use Aimovig if the solution contains particles, is cloudy, or is distinctly yellow.
• Single use only: Each pre-filled pen is for single use only. Do not reuse or share pens between patients.
• Proper disposal: After use, place the pen immediately into an approved sharps disposal container. Do not dispose of pens in household waste. Ask your pharmacist or local authority about proper disposal procedures. There may be local regulations regarding the disposal of sharps containers.

When traveling with Aimovig, use an insulated bag with a cold pack to maintain the appropriate temperature during transport. Avoid exposing the medication to excessive heat, direct sunlight, or extreme cold. Carry Aimovig in your hand luggage during air travel to avoid temperature extremes in the cargo hold. Airport security screening (x-ray machines) should not damage the medication.

What Does Aimovig Contain?

Understanding what your medication contains is important, particularly if you have known allergies or sensitivities to specific pharmaceutical ingredients. Below is a detailed breakdown of the composition of Aimovig.

Active Ingredient

The active substance is erenumab, a fully human IgG2 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Aimovig is available in two strengths:

• Aimovig 70 mg: Each pre-filled pen contains 70 mg of erenumab in 1 mL of solution (concentration: 70 mg/mL).
• Aimovig 140 mg: Each pre-filled pen contains 140 mg of erenumab in 1 mL of solution (concentration: 140 mg/mL).

Inactive Ingredients (Excipients)

Appearance and Pack Sizes

Aimovig is supplied as a clear to opalescent, colorless to slightly yellow solution for injection in a single-use pre-filled autoinjector pen. Each pen contains 1 mL of solution. Aimovig is available in packs of 1 pre-filled pen (for the 70 mg or 140 mg dose) and in multipacks containing 3 (3 × 1) pre-filled pens. Not all pack sizes may be marketed in every country.

Marketing Authorization Holder and Manufacturer

The marketing authorization holder for Aimovig in the European Union is Novartis Europharm Limited (Dublin, Ireland). Aimovig is manufactured by Sandoz GmbH and Novartis Pharmaceutical Manufacturing GmbH (Langkampfen, Austria), as well as Novartis Pharma GmbH (Nürnberg, Germany). In the United States, Aimovig is co-marketed by Amgen and Novartis. Aimovig was initially developed by Amgen and is now available in more than 50 countries worldwide.