Indication Aimovig® is indicated for the preventive treatment of migraine in adults.

  • POOLED PIVOTAL STUDIES
  • PH 3 EM AND PH 2 CM AT YEAR 1
  • PH 2 EM AT MONTH 3 AND YEAR 5

Aimovig®: Established safety profile in a broad range of patients

Adverse reactions occurring with an incidence of at least 2% for either dose of Aimovig® and at least 2% greater than placebo through month 31
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Safety across pooled pivotal studies of episodic and chronic migraine—at month 31
  • 90% of patients with episodic migraine completed the 6-month DBTP; <2% of patients receiving Aimovig® discontinued due to AEs1
  • 95% of patients completed the 3-month chronic migraine study; <2% of patients receiving Aimovig® discontinued due to AEs1

*Injection site reactions include multiple preferred terms, such as injection site pain and injection site erythema.1

 †The rate of injection site reactions reported is with the prefilled syringe.1

AE = adverse event; ATP = active treatment phase; CM = chronic migraine; DBTP = double-blind treatment phase; EM = episodic migraine; Ph = phase; QM = once a month; URI = upper respiratory tract infection.

Phase 3 episodic migraine active treatment phase (ATP) safety data and completion rates—6 months to 1 year

  • Treatment-emergent AEs were reported in 57.2% of patients in the 70 mg group (6.2% ≥Grade 3) and 55% in the 140 mg group (4.7% ≥Grade 3)1
  • Serious AEs were observed in 3.3% of patients in both the 70 mg and the 140 mg group1
  • Fatal AEs were reported in 1 patient (0.2%) treated in the 140 mg group1
  • Most frequent AEs were viral URI, URI, UTI, influenza, sinusitis, and arthralgia1
  • 90.2% of patients with episodic migraine completed the STRIVE ATP (6 months to 1 year); 1.9% of patients discontinued due to AEs1,2,*

Phase 2 chronic migraine OLE safety data and completion rates—1 year

  • The exposure-adjusted incidence rate per 100 subject-years for all AEs was 132 in the 70 mg group (6.6 with ≥Grade 3) and 148.5 in the 140 mg group (3.7 with ≥Grade 3)3
  • The exposure-adjusted incidence rate per 100 subject-years for serious AEs was 3.3 in the 70 mg group and 4.7 in the 140 mg group3
  • Most frequent AEs were viral URI, URI, sinusitis, arthralgia, migraine, back pain, injection site pain, fatigue, UTI, influenza, and nausea3,4
  • 77.2% of patients completed the 1-year CM open-label extension study; 2.6% of patients discontinued due to AEs3,†

*The most frequently reported reasons (≥1.0% of total subjects) for discontinuation of Aimovig® were subject request (6.5%), lost to follow-up (2.0%), adverse event (1.9%), and protocol-specific criteria (1.2%).1,2

†The most frequently reported reasons (≥1.0% of total subjects) for discontinuation of Aimovig® were subject request (10.5%), lack of efficacy (6.4%), adverse event (2.6%), and lost to follow-up (1.5%).4

AE = adverse event; ATP = active treatment phase; CM = chronic migraine; EM = episodic migraine; OLE = open-label extension; Ph = phase; URI = upper respiratory tract infection; UTI = urinary tract infection.

Consistent safety profile established year-over-year for 5 years

Phase 2 Episodic Migraine Open-Label Treatment Phase (OLTP) Safety Data—Through 5 Years1

The safety profile observed in the OLTP was consistent with what was observed in the double-blind treatment phase (DBTP)1

  • After a median 2.0 years of exposure to 70 mg in the OLTP, patients increased dose to 140 mg monthly1
  • Most frequent AEs in OLTP were nasopharyngitis, upper respiratory tract infection, influenza, and sinusitis4,†
  • 56.4% of patients completed the 5-year phase 2 EM open-label treatment phase; 4.7% of patients discontinued due to AEs1,‡

Patient-years of exposure was used in this calculation to account for different lengths of treatment periods experienced by each patient.

*One fatality, previously reported, due to arteriosclerosis occurred in a patient with history of hypertension and left anterior hemiblock (ECG), who on autopsy showed evidence of severe coronary artery disease and presence of cardiac stimulants (liver tissue)—considered not related to investigational product by investigator. The other fatality was attributed to death unattended.2,3

†Events with ≥4.2 patients per 100 patient-years in the Aimovig® 70 mg/140 mg group.

‡Phase 2 EM OLTP: The most frequently reported reasons (≥1.0% of total subjects) for discontinuation of Aimovig® were subject request (21.9%), other (8.1%), adverse event (4.7%), lost to follow-up (3.4%), lack of efficacy (3.1%), and non-compliance (1.8%).1

AE = adverse event; ATP = active treatment phase; CM = chronic migraine; ECG = electrocardiogram; EM = episodic migraine; n = number of patients reporting at least 1 occurrence of event; OLTP = open-label treatment phase; Ph = phase; QM = once a month; r = exposure-adjusted rate per 100 patient-years (n/e x 100).

Indication

Aimovig® (erenumab-aooe) is indicated for the preventive treatment of migraine in adults.

Important Safety Information

Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe reaction occurs, discontinue 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. The onset of constipation was reported after the first dose in a majority of these cases, but patients also reported later on in treatment. Aimovig® was discontinued in most reported cases. 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. 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.

Adverse Reactions: The most common adverse reactions in clinical studies (≥ 3% of Aimovig®-treated patients and more often than placebo) were injection site reactions and constipation.

Please see Aimovig® full Prescribing Information.

Important Safety Information

Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe 

Reference: 1. Aimovig® (erenumab-aooe) Prescribing Information. Thousand Oaks, CA: Amgen Inc; 2021.

References: 1. Goadsby PJ, Reuter U, Hallström Y, et al. One-year sustained efficacy of erenumab for episodic migraine: Results of the STRIVE study. Neurology. 2020;95:e469-e479. doi:10.1212/WNL.0000000000010019. 2. Data on file, Amgen; [Ph 3 EM CSR, July 16, 2018]. 3. Tepper SJ, Ashina M, Reuter U, et al. Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study. Cephalalgia. 2020;40(6):543-553. 4. Data on file, Amgen; [Ph 2 CM CSR, February 16, 2018].

References: 1. Ashina M, Goadsby PJ, Reuter U, et al. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021;28:1716-1725. doi:10.1111/ene.14175. 2. Ashina M, Goadsby PJ, Reuter U, et al. Long-term safety and tolerability of erenumab: three-plus year results from an ongoing open-label extension study in episodic migraine. Presented at: American Headache Society 60th Annual Meeting; June 28-July 1, 2018; San Francisco, CA. 3. Data on file, Amgen; [Ph 2 EM CSR Table 14-6.1.405, September 2, 2021]. 4. Data on file, Amgen; [Ph 2 EM CSR, Table 9-3, June 16, 2020].