This guide includes everything you need to know about erenumab-aooe (Aimovig, Amgen/Novartis) for the preventive treatment of migraine in adults.
In May 2018, erenumab-aooe (Aimovig, Amgen/Novartis) was approved by the FDA for the preventive treatment of migraine in adults.1
Migraines are ranked the third most prevalent illness and sixth most disabling illness in the world according to Migraine Research Foundation. They are severe throbbing, recurring pain, usually on one side of the head. Patients with migraines do not only have headaches, but also other debilitating symptoms such as nausea, vomiting, dizziness, sensitivity to light, touch and sound. Migraines usually last anywhere between 4 to 72 hours. They affect quality of life, leading to early disability, depression, anxiety, and sleep disturbances.2
Erenumab is administered subcutaneously at a dosage of either 70 mg or 140 mg once monthly in the abdomen, thigh, or upper arm.3 It is self-administered by the patient. Before administering, keep erenumab at room temperature for at least 30 minutes, protected from direct sunlight. Let it warm up naturally, without using other heat sources. Do not shake the solution.
Visually inspect the solution for any discoloration or particulate matters before administering. Do not use if the solution is cloudy or contains particles.
One administration of either the autoinjector or syringe will deliver the entire dose of 70 mg. Two prefilled syringes or autoinjectors will be needed for a 140 mg dose. See instructions for use for full administration directions.
Erenumab is human monoclonal antibody that is a calcitonin gene-related peptide (CGRP) antagonist.3
Table 1. Method of Supply
Erenumab injection comes as a clear and colorless to light yellow solution. The needle shield from the autoinjector and the needle cap of the syringe contains dry natural rubber, a type of latex.3
Pack of 1 autoinjector 70 mg/ml
Pack of 2 autoinjectors 140 mg/ml (2 x 70 mg/ml)
Pack of 1 syringe 70 mg/ml
Pack of 2 syringes 140 mg/ml (2 x 70 mg/ml)
NDC indicates National Drug Code.
Erenumab is to be refrigerated at 2°C to 8°C (36°F-46°F) in its original container and protected from light. erenumab must be used within 7 days if kept at room temperature, 25°C (77°F), in its original container. Do not store in the freezer and do not shake.3
There are no drug interactions or contraindications reported on the packaging label of erenumab. Of note, erenumab is not metabolized by CYP450 enzymes, and does not affect oral contraceptive or sumatriptan pharmacokinetics.3
Belimumab should be not used together with erenumab because erenumab will increase the toxicity of belimumab.4
Adverse reactions listed below were observed from placebo-controlled clinical trials from both doses of erenumab (70 mg and 140 mg).3
Table 2. Adverse Reactions Observed From Placebo-controlled Clinical Trials
Injection site reactions (pain, erythema, pruritus)
Cramps and muscle spasms
There are no data on the effect that erenumab has on human pregnancy or lactation.3 Erenumab did not have any adverse effects on female monkey’s offspring. Studies have shown that women with migraine may be predisposed to an increased risk of preeclampsia during pregnancy.
Erenumab has not been tested in pediatrics. Patients 65 years and older should start erenumab treatment at the lower dose (70 mg).3
Erenumab was evaluated in 3 different clinical studies, 2 studies in patients with episodic migraine and 1 study in patients with chronic migraine. In the first study evaluating patients with episodic migraine, erenumab 70 mg and 140 mg had significantly lower mean monthly migraine days (3-4 migraine day difference from baseline), increased the proportion of patients with a ≥50% reduction from baseline in mean monthly migraine days (43.3% to 50% responders in erenumab), lowered monthly acute migraine-specific medication days (1-2 day difference from baseline), and saw improvements in migraine physical function impact diary (MPFID), a measurement of the impacts that migraine has on everyday activities and physical impairment.
Similarly, in the second study conducted on patients with episodic migraine, erenumab 70 mg was shown to significantly lower monthly migraine days, increased the proportion of patients with ≥50% reduction from baseline in mean monthly migraine days, and lowered monthly acute migraine-specific medication days. MFPID improvements in scores of at least a 5-point reduction, as a predetermined outcome, was not achieved by erenumab compared to placebo.
The third study on erenumab efficacy was assessed in patients with chronic migraine. erenumab 70 mg and 140 mg had significantly lower mean monthly migraine days (6.6 migraine day difference from baseline), increased proportion of patients with ≥50% reduction from baseline in mean monthly migraine days (39.9% to 41.2% responders in erenumab), and lower monthly acute migraine-specific medication days (approximately 4-day difference from baseline).
Classification of migraine preventative therapies are done through medications with established efficacy in trials. Level A medications with established efficacy (≥2 Class I trials) include antiepileptic drugs (valproate, topiramate), β-blockers (metoprolol, propranolol, timolol) and frovatriptan. Level B medications with probable efficacy (1 class I or 2 class II studies) include amitriptyline, venlafaxine, β-blockers (atenolol, nadolol) and triptans (naratriptan, zolmitriptan). Level C medications with possible efficacy (1 class II study) include lisinopril, candesartan, α-agonists (clonidine, guanfacine), carbamazepine, β-blockers (nebivolol, pindolol) and cyproheptadine. Selective serotonin reuptake inhibitors, calcium channel blockers and other drugs in the same drug class as the ones listed in Level A to C either have inadequate data to support use or are ineffective.5
The most recent update for the prevention of episodic migraines was the 2012 guidelines from the American Headache Society. Because erenumab was just approved in 2018, it does not have a recommendation on usage in this guideline.
The cost for erenumab 70-mg and 140-mg autoinjectors are listed below (see TABLE 3). There is a co-pay card that commercially insured patients may be eligible for. There is also a service request form that can be submitted by the clinician to help cover the cost of the drug. Both are available online at www.aimovig.com/co-pay-and-support.5
Table 3. Costs of Erenumab from Red Book Online6
Wholesale Acquisition Cost
Average Wholesale Price
Erenumab 70 mg
Erenumab 140 mg
2 autoinjectors 70 mg/ml x 2
Erenumab is a prescription drug used for the preventative treatment of migraine in adults 18 years and older. Inject erenumab subcutaneously once a month in the abdomen, thigh, or upper arm. If the dose taken is 70 mg, use one injection only. If the dose is 140 mg, 2 separate injections will need to be administered at the same body site, or at different locations. If injecting at the same body site, the second injection cannot be the same spot as the first injection. Inform patients to check for discoloration, particulates, and the expiration date prior to use. Missed doses should be taken as soon as the patient remembers. The next dose after the missed dose should be spaced from 1 month of the missed dose. Eerenumab should be stored in the refrigerator in its original container. Erenumab can stay at room temperature in its original container for up to 7 days, then it must be discarded. Patients should be advised not to freeze or shake the medication.3
Common adverse events (AE) include injection site reactions (pain, swelling, redness) and constipation. AEs should be reported to the clinician if they do not go away or if they bother the patient. The needle shield from the autoinjector and the needle cap of the syringe contains latex. Caution should be taken if a patient is allergic to latex.
1. FDA approves novel preventive treatment for migraines. FDA website. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm608120.htm?rel=0" . Updated May 17, 2018. Accessed August 23, 2018.
2. Migraine Facts. Migraine Research Foundation. http://migraineresearchfoundation.org/about-migraine/migraine-facts/?rel=0" . Accessed August 23, 2018.
3. Erenumab [prescribing information]. Thousand Oaks, California: Amgen; 2018. https://pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/erenumab/erenumab_pi_hcp_english.pdf?rel=0" . Accessed August 23, 2018.
4. Erenumab. Lexicomp [online database]. Wolters Kluwer Health, Inc: Riverwoods, IL; 2018. Accessed August 23, 2018.
5. Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E; Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society [published correction appears in Neurology. 2013;80(9):871. doi:10.1212/WNL.0b013e318287dc4e]. Neurology. 2012;78(17):1337-1345. doi:10.1212/WNL.0b013e3182535d20.
6. Erenumab. Red Book Online. Micromedex Healthcare Series [online database]. Greenwood Village, CO: Truven Health Analytics; 2018. Accessed August 22, 2018.