Aimovig Drug Information
Generic name: ERENUMAB-AOOE
Uses of Aimovig
AIMOVIG is indicated for the preventive treatment of migraine in adults.
Dosage & Administration of Aimovig
Recommended Dosing
The recommended dosage of AIMOVIG is 70 mg injected subcutaneously once monthly. Some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly. If a dose of AIMOVIG is missed, administer as soon as possible.
Thereafter, AIMOVIG can be scheduled monthly from the date of the last dose.
Important Administration Instructions AIMOVIG is for subcutaneous use only. AIMOVIG is intended for patient self-administration. Prior to use, provide proper training to patients and/or caregivers on how to prepare and administer AIMOVIG using the single-dose prefilled autoinjector or single-dose prefilled syringe, including aseptic technique: Prior to subcutaneous administration, allow AIMOVIG to sit at room temperature for at least 30 minutes protected from direct sunlight.
This is important for administering the entire dose and helps minimize discomfort. Do not warm by using a heat source such as hot water or a microwave. Do not shake the product.
Inspect visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or discolored or contains flakes or particles. Administer AIMOVIG in the abdomen, thigh, or upper arm subcutaneously.
Do not inject into areas where the skin is tender, bruised, red, or hard. Both prefilled autoinjector and prefilled syringe are single-dose and deliver the entire contents.
Side Effects of Aimovig
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of AIMOVIG has been evaluated in 2537 patients with migraine who received at least one dose of AIMOVIG, representing 3040.2 patient-years of exposure. Approximately 84% were female, 91% were white, and the mean age was 42 years at study entry.
The most common adverse reactions (incidence ≥ 3% and more often than placebo) in the migraine studies were injection site reactions and constipation. The most frequent injection site reactions were injection site pain, injection site erythema, and injection site pruritus.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of AIMOVIG. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis.
Gastrointestinal Disorders: Constipation with serious complications, oral mucosal ulceration. Skin and Subcutaneous Tissue Disorders: Rash, alopecia. Vascular Disorders: Hypertension, Raynaud's Phenomenon.
| Adverse Reaction | AIMOVIG 70 mg Once Monthly N = 787 % | AIMOVIG 140 mg Once Monthly N = 507 % | Placebo N = 890 % |
|---|---|---|---|
| Injection site reactions Injection site reactions include multiple adverse reactions related terms, such as injection site pain and injection site erythema., The rate of injection site reactions reported in Table 1 is with the prefilled syringe. | 6 | 5 | 3 |
| Constipation | 1 | 3 | 1 |
| Cramps, muscle spasms | < 1 | 2 | < 1 |
Warnings & Cautions for Aimovig
Hypersensitivity Reactions
Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with AIMOVIG in postmarketing experience. Most hypersensitivity reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe hypersensitivity reaction occurs, discontinue administration of AIMOVIG and initiate appropriate therapy.
Constipation with Serious Complications Constipation with serious complications has been reported following the use of AIMOVIG in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose of AIMOVIG; however, patients have also presented with constipation later on in treatment.
AIMOVIG was discontinued in most reported cases of constipation with serious complications. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies. Monitor patients treated with AIMOVIG for severe constipation and manage as clinically appropriate.
The concurrent use of medications associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.
Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of AIMOVIG in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization.
Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. AIMOVIG was discontinued in many of the reported cases.
Monitor patients treated with AIMOVIG for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of AIMOVIG is warranted if evaluation fails to establish an alternative etiology.
In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.
AIMOVIG should be discontinued if signs or symptoms of Raynaud's phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud's phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.
Pregnancy Safety for Aimovig
Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AIMOVIG during pregnancy. Patients should be encouraged to enroll by calling 1-833-244-4083 or visiting https://www.genesispregnancyregistry.com/. Risk Summary There are no adequate data on the developmental risk associated with the use of AIMOVIG in pregnant women.
No adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooe throughout gestation. Serum erenumab-aooe exposures in pregnant monkeys were greater than those in humans at clinical doses. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data In a study in which female monkeys were administered erenumab-aooe (0 or 50 mg/kg) twice weekly by subcutaneous injection throughout pregnancy (gestation day 20-22 to parturition), no adverse effects on offspring were observed.
Serum erenumab-aooe exposures (AUC) in pregnant monkeys were approximately 20 times that in humans at a dose of 140 mg once monthly.
Pediatric Use of Aimovig
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Contraindications for Aimovig
AIMOVIG is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.
Clinical Studies of Aimovig
The efficacy of AIMOVIG was evaluated as a preventive treatment of episodic or chronic migraine in three randomized, double-blind, placebo-controlled studies: two studies in patients with episodic migraine (4 to 14 migraine days per month) (Study 1 and Study 2) and one study in patients with chronic migraine (≥ 15 headache days per month with ≥ 8 migraine days per month) (Study 3). The studies enrolled patients with a history of migraine, with or without aura, according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria. Episodic Migraine Study 1 (NCT 02456740) was a randomized, multi-center, 6-month, placebo-controlled, double-blind study evaluating AIMOVIG for the preventive treatment of episodic migraine.
Patients were allowed to use acute headache treatments including migraine-specific medications (i.e., triptans, ergotamine derivatives) and NSAIDs during the study. The study excluded patients with medication overuse headache as well as patients with myocardial infarction, stroke, transient ischemic attacks, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening. The primary efficacy endpoint was the change from baseline in mean monthly migraine days over months 4 to 6.
The MPFID measures the impact of migraine on everyday activities (EA) and physical impairment (PI) using an electronic diary administered daily. Monthly MPFID scores are averaged over 28 days, including days with and without migraine; scores are scaled from 0 to 100. Higher scores indicate worse impact on EA and PI.
Reductions from baseline in MPFID scores indicate improvement. A total of 858 (90%) patients completed the 6-month double-blind study. Three percent of patients were taking concomitant preventive treatments for migraine.
The mean migraine frequency at baseline was approximately 8 migraine days per month and was similar across treatment groups. AIMOVIG treatment demonstrated statistically significant improvements for key efficacy endpoints compared to placebo, as summarized in Table 3. A treatment benefit over placebo for both doses of AIMOVIG is seen across a range of changes from baseline in monthly migraine days.
Study 2 (NCT 02483585) was a randomized, multi-center, 3-month, placebo-controlled, double-blind study evaluating AIMOVIG for the preventive treatment of episodic migraine. The primary efficacy endpoint was the change from baseline in monthly migraine days at month 3. Secondary endpoints included the achievement of a ≥ 50% reduction from baseline in monthly migraine days ("≥ 50% MMD responders"), the change from baseline in monthly acute migraine-specific medication days at month 3, and the proportion of patients with at least a 5-point score reduction from baseline in MPFID at month 3.
A total of 546 (95%) patients completed the 3-month double-blind study. Six to seven percent of patients were taking concomitant preventive migraine treatment. Figure 4 shows the distribution of change from baseline in monthly migraine days at month 3 in bins of 2 days by treatment group.
Figure 4: Distribution of Change from Baseline in Monthly Migraine Days at Month 3 by Treatment Group in Study 2 Figure excludes patients with missing data. The pre-specified analysis for the MPFID was based on at least a 5-point reduction within-patient responder definition. AIMOVIG 70 mg once monthly was not significantly better than placebo for the proportion of responders for everyday activity and physical impairment.
In an exploratory analysis of the change from baseline in the mean MPFID scores at month 3, patients treated with AIMOVIG 70 mg, as compared to placebo, showed nominally greater reductions of physical impairment scores, but not of everyday activities scores. The study excluded patients with medication overuse headache caused by opiate overuse and patients with concurrent use of migraine preventive treatments. AIMOVIG treatment demonstrated statistically significant improvements for key efficacy outcomes compared to placebo, as summarized in Table 5.
Figure 5 Figure 6
| AIMOVIG 70 mg Once Monthly | AIMOVIG 140 mg Once Monthly | Placebo | |
|---|---|---|---|
| N = 312 | N = 318 | N = 316 | |
| Monthly Migraine Days (MMD) | |||
| Change from baseline | −3.2 | −3.7 | −1.8 |
| Difference from placebo | −1.4 | −1.9 | |
| p- value | < 0.001 | < 0.001 | |
| ≥ 50% MMD responders | |||
| % Responders | 43.3% | 50.0% | 26.6% |
| Difference from placebo | 16.7% | 23.4% | |
| Odds ratio relative to placebo | 2.1 | 2.8 | |
| p- value | < 0.001 | < 0.001 | |
| Monthly acute migraine-specific medication days | |||
| Change from baseline | −1.1 | −1.6 | −0.2 |
| Difference from placebo | −0.9 | −1.4 | |
| p- value | < 0.001 | < 0.001 | |
| AIMOVIG 70 mg Once Monthly | Placebo | |
|---|---|---|
| N = 282 | N = 288 | |
| Monthly Migraine Days (MMD) | ||
| Change from baseline | −2.9 | −1.8 |
| Difference from placebo | −1.0 | |
| p- value | < 0.001 | |
| ≥ 50% MMD responders | ||
| % Responders | 39.7% | 29.5% |
| Difference from placebo | 10.2% | |
| Odds ratio relative to placebo | 1.6 | |
| p- value | 0.010 | |
| Monthly acute migraine-specific medication days | ||
| Change from baseline | −1.2 | −0.6 |
| Difference from placebo | −0.6 | |
| p- value | 0.002 | |
| AIMOVIG 70 mg Once Monthly | AIMOVIG 140 mg Once Monthly | Placebo | |
|---|---|---|---|
| N = 188 | N = 187 | N = 281 | |
| Monthly Migraine Days (MMD) | |||
| Change from baseline | −6.6 | −6.6 | −4.2 |
| Difference from placebo | −2.5 | −2.5 | |
| p- value | < 0.001 | < 0.001 | |
| ≥ 50% MMD responders | |||
| % Responders | 39.9% | 41.2% | 23.5% |
| Difference from placebo | 16.4% | 17.7% | |
| Odds ratio relative to placebo | 2.2 | 2.3 | |
| p- value | < 0.001 | < 0.001 | |
| Monthly acute migraine-specific medication days | |||
| Change from baseline | −3.5 | −4.1 | −1.6 |
| Difference from placebo | −1.9 | −2.6 | |
| p- value | < 0.001 | < 0.001 | |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
Ready to save on Aimovig?
Compare prescription prices at over 70,000 pharmacies and start saving today—no enrollment required.
Compare Aimovig Prices