Erenumab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 1, 2026🚩 Report this page

Erenumab

Calcitonin Gene-Related Peptide (Cgrp) Antagonists

Sold as AIMOVIG

GB MHRACA Health CanadaEU EMA

Drug class: Calcitonin Gene-Related Peptide (Cgrp) Antagonists
Availability: See label
Routes: Subcutaneous
Markets covered: 3
Products on record: 9

N02CDCalcitonin Gene-Related Peptide (Cgrp) Antagonists

Overview

Erenumab is an active pharmaceutical ingredient in the Calcitonin Gene-Related Peptide (Cgrp) Antagonists group (N02CD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	4	May 1, 2026
CA Canada	Health Canada	4	March 22, 2025
EU European Union	EMA	1	December 10, 2025

GBUnited Kingdom· MHRA

4 products

Uses

GBOfficial regulatory label· revised May 1, 2026[1]

Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

How to take

CACanada· Health Canada

4 products

Uses

CAOfficial regulatory label· revised March 22, 2025[2]

1 Pediatrics Pediatrics (< 18 years of age): Safety and efficacy of Aimovig in patients below the age of 18 have not been studied. Aimovig is not authorized for pediatric use. 2 Geriatrics Geriatrics (≥ 65 years of age): Safety and efficacy of Aimovig has not been studied in patients aged 65 or older.
4 Geriatrics.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised December 10, 2025[3]

Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

How to take

Sources & citations

[1]MHRA (UK) · PLGB001011192 · revised May 1, 2026
[2]Health Canada (DPD) · 02479605 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/004447 · revised December 10, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 1, 2026[1]

Summary of the safety profile A total of over 2,500 patients (more than 2,600 patient years) have been treated with Aimovig in registration studies. Of these, more than 1,300 patients were exposed for at least 12 months and 218 patients were exposed for 5 years.
The overall safety profile of Aimovig remained consistent for 5 years of long-term open-label treatment. 8%). Most of the reactions were mild or moderate in severity. Less than 2% of patients in these studies discontinued due to adverse reactions.
Tabulated list of adverse reactions Table 1 lists all adverse drug reactions that occurred in Aimovig-treated patients during the 12-week placebo-controlled periods of the studies, as well as in the post-marketing setting. Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Table 1 List of adverse reactions System Organ Class Adverse reaction Frequency category Immune system disorders Hypersensitivity reactionsa including anaphylaxis, angioedema, rash, swelling/oedema and urticaria Common Constipation CommonGastrointestinal disorders Oral soresb Not known Pruritusc CommonSkin and subcutaneous tissue disorders Alopecia Rashd Not known Musculoskeletal and connective tissue disorders Muscle spasms Common General disorders and administration site conditions Injection site reactionsa Common a See section “Description of selected adverse reactions” b Oral sores includes preferred terms of stomatitis, mouth ulceration, oral mucosal blistering.
c Pruritus includes preferred terms of generalised pruritus, pruritus and pruritic rash. d Rash includes preferred terms of rash papular, exfoliative rash, rash erythematous, urticaria, blister. Description of selected adverse reactions Injection site reactions In the integrated 12-week placebo-controlled phase of the studies, injection site reactions were mild and mostly transient.
There was one case of discontinuation in a patient receiving the 70 mg dose due to injection site rash. The most frequent injection site reactions were localised pain, erythema and pruritus. Injection site pain typically subsided within 1 hour after administration.
Cutaneous and hypersensitivity reactions In the integrated 12-week placebo-controlled phase of the studies, non-serious cases of rash, pruritus and swelling/oedema were observed, which in the majority of cases were mild and did not lead to treatment discontinuation.
In the post-marketing setting, cases of anaphylaxis and angiodoema were observed. 6% (13/504) among subjects receiving the 140 mg dose of erenumab (none of whom had in vitro neutralising activity). 0% (25/225) among patients who only received 70 mg or 140 mg of Aimovig throughout the entire study (2 of whom had in vitro neutralising activity).
There was no impact of anti-erenumab antibody development on the efficacy or safety of erenumab. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 1, 2026[1]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 1). No safety data are available in these patients. Hypersensitivity reactions Serious hypersensitivity reactions, including rash, angioedema, and anaphylactic reactions, have been reported with erenumab in post-marketing experience.
These reactions may occur within minutes, although some may occur more than one week after treatment. In that context, patients should be warned about the symptoms associated with hypersensitivity reactions. 3). Constipation Constipation is a common adverse reaction of erenumab and is usually mild or moderate in intensity.
In a majority of the cases, the onset was reported after the first dose of erenumab; however patients have also experienced constipation later on in the treatment. In most cases constipation resolved within three months. In the post-marketing setting, constipation with serious complications has been reported with erenumab.
In some of these cases hospitalisation was required, including cases where surgery was necessary. History of constipation or the concurrent use of medicinal products associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.
Patients should be warned about the risk of constipation and advised to seek medical attention in case constipation does not resolve or worsens. Patients should seek medical attention immediately if they develop severe constipation.
Constipation should be managed promptly as clinically appropriate. For severe constipation, discontinuation of treatment should be considered. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
004 mg/kg.

This is not medical advice. Consult a qualified healthcare professional.

1 Dosing Considerations  Aimovig is administered subcutaneously through single-dose pre-filled autoinjector or single-dose pre-filled syringe.  Aimovig is intended for patient self-administration.  Administration should be performed by an individual who has been trained to ad minister the product  Aimovig should be initiated by health professionals experienced in the diagnosis and treatment of migraine.
2 Recommended Dose and Dosage Adjustment The recommended dose of Aimovig is 70 mg administered once monthly. Some patients may benefit from a dose of 140 mg once monthly administered as one subcutaneous injection of 140 mg. See Part II- 14 CLINICAL TRIALS.
Aimovig is not approved for pediatric use. 4 Administration To administer the recommended dose of 70 mg, give one subcutaneous injection. To administer the recommended dose of 140 mg, give one subcutaneous injection of 140 mg. Prior to subcutaneous administration, allow Aimovig to sit at room temperature for at least 30 minutes and protect from direct sunlight.
Do not warm by using a heat source such as hot water or microwave. Do not shake the product. Visually inspect the solution for particles and discolouration. Aimovig is a clear to opalescent, colourless to light yellow solution. Do not use if the solution is cloudy, discoloured or if flakes or particles are present.
Administer Aimovig subcutaneously in the abdomen, thigh, or upper arm. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red, or hard. Both the pre-filled syringe and the pre-filled SureClick® autoinjector are single-dose and designed to deliver the entire contents with no residual content.
The grey needle cover of the Aimovig pre-filled syringe and the needle shield within the white or orange cap of the Aimovig pre-filled autoinjector contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
Comprehensive instructions for the administration of Aimovig are provided in the Patient Medication Information. 5 Missed Dose If an Aimovig dose is missed, administer as soon as possible. Thereafter, Aimovig can be scheduled monthly from the date of the last dose.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]

1 Adverse Reaction Overview A total of over 2,500 patients (more than 2,600 patient years) have been treated with AIMOVIG in registration studies. Of these, more than 1,300 patients were exposed for at least 12 months. The adverse reactions reported in the placebo-controlled trials of Aimovig were injection site reactions, constipation, muscle spasm and pruritus.
5%) AIMOVIG® (erenumab) Page 9 of 63 System Organ Class Preferred Term Aimovig 70 mg N = 893 n (%) Aimovig 140 mg N = 507 n (%) Placebo N = 1043 n (%) a Injection Site Reactions includes multiple preferred terms, such as injection site pain and injection site erythema.
b Pruritus includes generalized pruritus, pruritus, and pruritic rash. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 2%) muscle spasm was reported in subjects treated with Aimovig 140 mg. This subject had a history of muscle spasms and experienced worsening of back spasms.
All other adverse reactions were grade 1 (mild) or moderate (grade 2) in severity. In the pivotal studies, the following adverse events were observed to occur at or above 1% during the double-blind treatment phase. 7) Upper […]

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]

, Constipation with Serious Complications 09/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pregnant Women ..........................................................................................
2 Breast-feeding............................................................................................... 3 Pediatrics ...................................................................................................... 4 Geriatrics ......................................................................................................
3 Less Common Clinical Trial Adverse Reactions .................................................... 5 Post-Market Adverse Reactions.......................................................................... 15 9 DRUG INTERACTIONS..................................................................................................
2 Drug Interactions Overview................................................................................ 4 Drug-Drug Interactions ...................................................................................... 5 Drug-Food Interactions ......................................................................................
6 Drug-Herb Interactions ...................................................................................... 7 Drug-Laboratory Test Interactions ...................................................................... 16 10 CLINICAL PHARMACOLOGY .........................................................................................
1 Mechanism of Action.................................................................................... 2 Pharmacodynamics ...................................................................................... 3 Pharmacokinetics.........................................................................................
16 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 18 12 SPECIAL HANDLING INSTRUCTIONS............................................................................. 18 PART II: SCIENTIFIC INFORMATION ........................................................................................
19 13 PHARMACEUTICAL INFORMATION.............................................................................. 19 14 CLINICAL TRIALS..........................................................................................................
1 Trial Design and Study Demographics Clinical Trials by Indication .................. 2 Comparative Bioavailability Studies .............................................................. 3 Immunogenicity ...........................................................................................

This is not medical advice. Consult a qualified healthcare professional.

Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. Posology Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with erenumab. The recommended dose is 70 mg erenumab every 4 weeks.
1). 3 Each 140 mg dose is given either as one subcutaneous injection of 140 mg or as two subcutaneous injections of 70 mg. Clinical studies have demonstrated that the majority of patients responding to therapy showed clinical benefit within 3 months.
Consideration should be given to discontinuing treatment in patients who have shown no response after 3 months of treatment. Evaluation of the need to continue treatment is recommended regularly thereafter. Special populations Elderly (aged 65 years and over) Aimovig has not been studied in elderly patients.
No dose adjustment is required as the pharmacokinetics of erenumab are not affected by age. 2). Paediatric population The safety and efficacy of Aimovig in children below the age of 18 years have not yet been established. No data are available.
Method of administration Aimovig is for subcutaneous use. Aimovig is intended for patient self-administration after proper training. The injections can also be given by another individual who has been appropriately instructed. 2). Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard.
Pre-filled syringe The entire contents of the Aimovig pre-filled syringe should be injected. Each pre-filled syringe is for single use only and designed to deliver the entire contents with no residual content remaining. Comprehensive instructions for administration are given in the instructions for use in the package leaflet.
Pre-filled pen The entire contents of the Aimovig pre-filled pen should be injected. Each pre-filled pen is for single use only and designed to deliver the entire contents with no residual content remaining. Comprehensive instructions for administration are given in the instructions for use in the package leaflet.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised December 10, 2025[3]

Summary of the safety profile A total of over 2 500 patients (more than 2 600 patient years) have been treated with Aimovig in registration studies. Of these, more than 1 300 patients were exposed for at least 12 months and 218 patients were exposed for 5 years.
The overall safety profile of Aimovig remained consistent for 5 years of long-term open-label treatment. 8%). Most of the reactions were mild or moderate in severity. Less than 2% of patients in these studies discontinued due to adverse reactions.
Tabulated list of adverse reactions Table 1 lists all adverse drug reactions that occurred in Aimovig-treated patients during the 12-week placebo-controlled periods of the studies, as well as in the post-marketing setting. Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); not known (cannot be estimated from the available data).
6 Table 1 List of adverse reactions System Organ Class Adverse reaction Frequency category Immune system disorders Hypersensitivity reactionsa including anaphylaxis, angioedema, rash, swelling/oedema and urticaria Common Gastrointestinal disorders Constipation Common Oral soresb Not known Skin and subcutaneous tissue disorders Pruritusc Common Alopecia Rashd Not known Musculoskeletal and connective tissue disorders Muscle spasms Common General disorders and administration site conditions Injection site reactionsa Common a See section “Description of selected adverse reactions” b Oral sores includes preferred terms of stomatitis, mouth ulceration, oral mucosal blistering.
c Pruritus includes preferred terms of generalised pruritus, pruritus and pruritic rash. d Rash includes preferred terms of rash papular, exfoliative rash, rash erythematous, urticaria, blister. Description of selected adverse reactions Injection site reactions In the integrated 12-week placebo-controlled phase of the studies, injection site reactions were mild and mostly transient.
There was one case of discontinuation in a patient receiving the 70 mg dose due to injection site rash. The most frequent injection site reactions were localised pain, erythema and pruritus. Injection site pain typically subsided within 1 hour after administration.
Cutaneous and hypersensitivity reactions In the integrated 12-week placebo-controlled phase of the studies, non-serious cases of rash, pruritus and swelling/oedema were observed, which in the majority of cases were mild and did not lead to treatment discontinuation.
In the post-marketing setting, cases of anaphylaxis and angiodoema were observed. 6% (13/504) among subjects receiving the 140 mg dose of erenumab (none of whom had in vitro neutralising activity). 0% (25/225) among patients who only received 70 mg or 140 mg of Aimovig throughout the entire study (2 of whom had in vitro neutralising activity).
There was no impact of anti-erenumab antibody development on the efficacy or safety of erenumab. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 7

EUOfficial regulatory label· Warnings and precautions· revised December 10, 2025[3]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 1). No safety data are available in these patients. Hypersensitivity reactions Serious hypersensitivity reactions, including rash, angioedema, and anaphylactic reactions, have been reported with erenumab in post-marketing experience.
These reactions may occur within minutes, although some may occur more than one week after treatment. In that context, patients should be warned about the symptoms associated with hypersensitivity reactions. 3). Constipation Constipation is a common adverse reaction of erenumab and is usually mild or moderate in intensity.
In a majority of the cases, the onset was reported after the first dose of erenumab; however patients have also experienced constipation later on in the treatment. In most cases constipation resolved within three months. In the post-marketing setting, constipation with serious complications has been reported with erenumab.
In some of these cases hospitalisation was required, including cases where surgery was necessary. History of constipation or the concurrent use of medicinal products associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.
Patients should be warned about the risk of constipation and advised to seek medical attention in case constipation does not resolve or worsens. Patients should seek medical attention immediately if they develop severe constipation.
Constipation should be managed promptly as clinically appropriate. For severe constipation, discontinuation of treatment should be considered. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
004 mg/kg.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

CACanada· Health Canada

EUEuropean Union· EMA

Drugs in the same class

Sources & citations