Aimovig

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

 

1. NAME OF THE MEDICINAL PRODUCT 
 

Aimovig 70 mg solution for injection in pre-filled syringe 

Aimovig 140 mg solution for injection in pre-filled syringe 

Aimovig 70 mg solution for injection in pre-filled pen 

Aimovig 140 mg solution for injection in pre-filled pen 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Aimovig 70 mg solution for injection in pre-filled syringe 

 

Each pre-filled syringe contains 70 mg erenumab. 

 

Aimovig 140 mg solution for injection in pre-filled syringe 

 

Each pre-filled syringe contains 140 mg erenumab. 

 

Aimovig 70 mg solution for injection in pre-filled pen 

 

Each pre-filled pen contains 70 mg erenumab. 

 

Aimovig 140 mg solution for injection in pre-filled pen 

 

Each pre-filled pen contains 140 mg erenumab. 

 

Erenumab is a fully human IgG2 monoclonal antibody produced using recombinant DNA technology 

in Chinese hamster ovary (CHO) cells. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Solution for injection (injection) 

 

The solution is clear to opalescent, colourless to light yellow. 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

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

month. 

 



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4.2 Posology and method of administration 

 

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. Some patients may benefit from a dose of 

140 mg every 4 weeks (see section 5.1). 

 

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. 

 

Renal impairment / hepatic impairment 

No dose adjustment is necessary in patients with mild to moderate renal impairment or hepatic 

impairment (see section 5.2). 

 

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. The injection can be administered 

into the abdomen, thigh or into the outer area of the upper arm (the arm should be used only if the 

injection is being given by a person other than the patient; see section 5.2). 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. 

 



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4.3 Contraindications 
 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

4.4 Special warnings and precautions for use 

 

Patients with certain major cardiovascular diseases were excluded from clinical studies (see 

section 5.1). 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. If a serious or severe 

hypersensitivity reaction occurs, initiate appropriate therapy and do not continue treatment with 

erenumab (see section 4.3). 

 

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. 

 

Latex-sensitive individuals 

 

The removable cap of the Aimovig pre-filled syringe/pen contains dry natural rubber latex, which may 

cause allergic reactions in individuals sensitive to latex. 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

No effect on exposure of co-administered medicinal products is expected based on the metabolic 

pathways of monoclonal antibodies. No interaction with oral contraceptives (ethinyl 

estradiol/norgestimate) or sumatriptan was observed in studies with healthy volunteers. 

 

4.6 Fertility, pregnancy and lactation 
 

Pregnancy 

 

There are a limited amount of data from the use of erenumab in pregnant women. Animal studies do 

not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As 

a precautionary measure, it is preferable to avoid the use of Aimovig during pregnancy. 

 

Breast-feeding 

 

It is unknown whether erenumab is excreted in human milk. Human IgGs are known to be excreted in 

breast milk during the first few days after birth, which is decreasing to low concentrations soon 

afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. 

Afterwards, use of Aimovig could be considered during breast-feeding only if clinically needed. 

 

Fertility 

 

Animal studies showed no impact on female and male fertility (see section 5.3). 

 

4.7 Effects on ability to drive and use machines 
 

Aimovig is expected to have no or negligible influence on the ability to drive and use machines. 

 



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4.8 Undesirable effects 

 

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. 

 

The reported adverse drug reactions for 70 mg and 140 mg were injection site reactions (5.6%/4.5%), 

constipation (1.3%/3.2%), muscle spasms (0.1%/2.0%) and pruritus (0.7%/1.8%). Most of the 

reactions were mild or moderate in severity. Less than 2% of patients in these studies discontinued due 

to adverse events. 

 

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). 

 

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 

Skin and subcutaneous tissue disorders Pruritusb Common 

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 Pruritus includes preferred terms of generalised pruritus, pruritus and pruritic rash. 

 

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. 

 

Cases of anaphylaxis and angiodoema were also observed in the post-marketing setting. 

 



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Immunogenicity 

In the clinical studies, the incidence of anti-erenumab antibody development during the double-blind 

treatment phase was 6.3% (56/884) among subjects receiving a 70 mg dose of erenumab (3 of whom 

had in vitro neutralising activity) and 2.6% (13/504) among subjects receiving a 140 mg dose of 

erenumab (none of whom had in vitro neutralising activity). There was no impact of anti-erenumab 

antibody development on efficacy or safety. 

 

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. 

 

4.9 Overdose 

 

No cases of overdose have been reported in clinical studies. 

 

Doses up to 280 mg have been administered subcutaneously in clinical studies with no evidence of 

dose-limiting toxicity. 

 

In the event of an overdose, the patient should be treated symptomatically and supportive measures 

instituted as required. 

 

 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 
 

Pharmacotherapeutic group: Analgesics, antimigraine preparations, ATC code: N02CX07 

 

Mechanism of action 

 

Erenumab is a human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) 

receptor. The CGRP receptor is located at sites that are relevant to migraine pathophysiology, such as 

the trigeminal ganglion. Erenumab potently and specifically competes with the binding of CGRP and 

inhibits its function at the CGRP receptor, and has no significant activity against other calcitonin 

family of receptors. 

 

CGRP is a neuropeptide that modulates nociceptive signalling and a vasodilator that has been 

associated with migraine pathophysiology. In contrast with other neuropeptides, CGRP levels have 

been shown to increase significantly during migraine and return to normal with headache relief. 

Intravenous infusion of CGRP induces migraine-like headache in patients. 

 

Inhibition of the effects of CGRP could theoretically attenuate compensatory vasodilation in 

ischaemic-related conditions. A study evaluated the effect of a single intravenous dose of 140 mg 

Aimovig in subjects with stable angina under controlled exercise conditions. Aimovig showed similar 

exercise duration compared to placebo and did not aggravate myocardial ischaemia in these patients. 

 

Clinical efficacy and safety 

 

Aimovig (erenumab) was evaluated for prophylaxis of migraine in two pivotal studies across the 

migraine spectrum in chronic and episodic migraine. In both studies, the patients enrolled had at least 

a 12-month history of migraine (with or without aura) according to the International Classification of 

Headache Disorders (ICHD-III) diagnostic criteria. Elderly patients (>65 years), patients with opioid 

overuse in study in chronic migraine, patients with medication overuse in study in episodic migraine, 

and also patients with pre-existing myocardial infarction, stroke, transient ischaemic attacks, unstable 



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angina, coronary artery bypass surgery or other re-vascularisation procedures within 12 months prior 

to screening were excluded. Patients with poorly controlled hypertension or BMI >40 were excluded 

from Study 1. 

 

Chronic migraine 

Study 1 

Aimovig (erenumab) was evaluated as monotherapy for prophylaxis of chronic migraine in a 

randomised, multicentre, 12-week, placebo-controlled, double-blind study in patients suffering from 

migraine with or without aura (≥15 headache days per month with ≥8 migraine days per month). 

 

667 patients were randomised in a 3:2:2 ratio to receive placebo (n = 286) or 70 mg (n = 191) or 

140 mg (n = 190) erenumab, stratified by the presence of acute medication overuse (present in 41% of 

overall patients). Patients were allowed to use acute headache treatments during the study. 

 

Demographics and baseline disease characteristics were balanced and comparable between study arms. 

Patients had a median age of 43 years, 83% were female and 94% were white. The mean migraine 

frequency at baseline was approximately 18 migraine days per month. Overall, 68% had failed one or 

more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability, and 49% 

had failed two or more previous prophylactic pharmacotherapies due to lack of efficacy or poor 

tolerability. A total of 366 (96%) patients in the erenumab arms and 265 (93%) patients in the placebo 

arm completed the study (i.e. completed Week 12 assessment). 

 

Reduction in mean monthly migraine days from placebo was observed in a monthly analysis from 

Month 1 and in a follow-up weekly analysis an onset of erenumab effect was seen from the first week 

of administration. 

 

Figure 1 Change from baseline in monthly migraine days over time in Study 1 (including 

primary endpoint at Month 3) 

 

 



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Table 2 Change from baseline in efficacy and patient-reported outcomes at Week 12 in 

Study 1 

 
 Aimovig 

(erenumab) 

140 mg 

(n = 187) 

Aimovig 

(erenumab) 

70 mg 

(n = 188) 

Placebo 

(n = 281) 

Treatment 

difference 

(95% CI) 

p-value 

Efficacy outcomes 

MMD 

Mean change 

(95% CI) 

Baseline (SD) 

 

-6.6 

(-7.5, -5.8) 

17.8 (4.7) 

 

-6.6 

(-7.5; -5.8) 

17.9 (4.4) 

 

-4.2 

(-4.9, -3.5) 

18.2 (4.7) 

 

Both -2.5 

(-3.5, -1.4) 

 

Both 

<0.001 

≥50% MMD responders 

Percentage [%] 

 

41.2% 

 

39.9% 

 

23.5% 

 

n/a 

 

Both 

<0.001a,d 

≥75% MMD responders 

Percentage [%] 

 

20.9% 

 

17.0% 

 

7.8% 

 

n/a 

 

n/ab 

Monthly acute migraine- 

specific medication days 
Mean change (95% CI) 

 

 

-4.1 

(-4.7, -3.6) 

 

 

-3.5 

(-4.0, -2.9) 

 

 

-1.6 

(-2.1, -1.1) 

 

70 mg: 

-1.9 (-2.6, -1.1) 

140 mg: 

 -2.6 (-3.3, -1.8) 

 

 

Both 

<0.001a 

Baseline (SD) 9.7 (7.0) 8.8 (7.2) 9.5 (7.6)   

Patient-reported outcome measures 

HIT-6 

Mean changec (95% CI) 

 

-5.6 

(-6.5, -4.6) 

 

-5.6 

(-6.5, -4.6) 

 

-3.1 

(-3.9, -2.3) 

70 mg: 

-2.5 (-3.7, -1.2) 

140 mg: 

 -2.5 (-3.7, -1.2) 

 

n/ab 

MIDAS total  

Mean changec (95% CI) 

 

-19.8 

(-25.6, -14.0) 

 

-19.4 

(-25.2, -13.6) 

 

-7.5 

(-12.4, -2.7) 

70 mg: 

-11.9 (-19.3, -4.4) 

140 mg: 

-12.2 (-19.7, -4.8) 

 

n/ab 

CI = confidence interval; MMD = monthly migraine days; HIT-6 = Headache Impact Test; MIDAS = Migraine 

Disability Assessment; n/a = not applicable. 
a For secondary endpoints, all p-values are reported as unadjusted p-values and are statistically significant after 

adjustment for multiple comparisons. 
b For exploratory endpoints, no p-value is presented. 
c For HIT-6: Change and reduction from baseline were evaluated in the last 4 weeks of the 12-week 

double-blind treatment phase. For MIDAS: Change and reduction from baseline were evaluated over 

12 weeks. For data collection a recall period of 3 months has been used. 
d p value was calculated based on the odds ratios. 

 

In patients failing one or more prophylactic pharmacotherapies the treatment difference for the 

reduction of monthly migraine days (MMD) observed between erenumab 140 mg and placebo 

was -3.3 days (95% CI: -4.6, -2.1) and between erenumab 70 mg and placebo -2.5 days (95% 

CI: -3.8, -1.2). In patients failing two or more prophylactic pharmacotherapies the treatment difference 

was -4.3 days (95% CI: -5.8; -2.8) between 140 mg and placebo and -2.7 days (95% CI: -4.2, -1.2) 

between 70 mg and placebo. There was also a higher proportion of subjects treated with erenumab 

who achieved at least 50% reduction of MMD compared to placebo in the patients failing one or more 

prophylactic pharmacotherapies (40.8% for 140 mg, 34.7% for 70 mg versus 17.3% for placebo), with 

an odds ratio of 3.3 (95% CI: 2.0, 5.5) for 140 mg and 2.6 (95% CI: 1.6, 4.5) for 70 mg. In patients 

failing two or more prophylactic pharmacotherapies the proportion was 41.3% for 140 mg and 35.6% 

for 70 mg versus 14.2% for placebo with an odds ratio of 4.2 (95% CI: 2.2, 7.9) and 3.5 (95% CI: 1.8, 

6.6), respectively. 

 

Approximately 41% of patients in the study had medication overuse. The treatment difference 

observed between erenumab 140 mg and placebo and between erenumab 70 mg and placebo for the 

reduction of MMD in these patients was -3.1 days (95% CI: -4.8, -1.4) in both cases, and for the 

reduction of acute migraine-specific medication days was -2.8 (95% CI: -4.2, -1.4) for 140 mg 

and -3.3 (95% CI: -4.7, -1.9) for 70 mg. There was a higher proportion of patients in the erenumab 



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group who achieved at least a 50% reduction of MMD compared to placebo (34.6% for 140 mg, 

36.4% for 70 mg versus 17.7% for placebo), with an odds ratio of 2.5 (95% CI: 1.3, 4.9) and 2.7 (95% 

CI: 1.4, 5.2), respectively. 

 

Efficacy was sustained for up to 1 year in the open-label extension of Study 1 in which patients 

received 70 mg and/or 140 mg erenumab. 74.1% of patients completed the 52-week extension. Pooled 

across the two doses, a reduction of -9.3 MMD was observed after 52 weeks relative to core study 

baseline. 59% of patients completing the study achieved a 50% response in the last month of the study. 

 

Episodic migraine 

Study 2 

Aimovig (erenumab) was evaluated for prophylaxis of episodic migraine in a randomised, multicentre, 

24-week, placebo-controlled, double-blind study in patients suffering from migraine with or without 

aura (4-14 migraine days per month). 

 

955 patients were randomised in a 1:1:1 ratio to receive 140 mg (n = 319) or 70 mg (n = 317) 

erenumab or placebo (n = 319). Patients were allowed to use acute headache treatments during the 

study. 

 

Demographics and baseline disease characteristics were balanced and comparable between study arms. 

Patients had a median age of 42 years, 85% were female and 89% were white. The mean migraine 

frequency at baseline was approximately 8 migraine days per month. Overall, 39% had failed one or 

more previous prophylactic pharmacotherapies due to lack of efficacy or poor tolerability. A total of 

294 patients (92%) for 140 mg, 287 (91%) patients for 70 mg and 284 patients (89%) in the placebo 

arm completed the double-blind phase. 

 

Patients treated with erenumab had a clinically relevant and statistically significant reduction from 

baseline in the frequency of migraine days from Months 4 to 6 (Figure 2) compared to patients 

receiving placebo. Differences from placebo were observed from Month 1 onwards. 

 

Figure 2 Change from baseline in monthly migraine days over time in Study 2 (including 

primary endpoint over Months 4, 5 and 6) 

 

 



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Table 3 Change from baseline in efficacy and patient-reported outcomes at Weeks 13-24 in 

Study 2 

 
 Aimovig 

(erenumab) 

140 mg 

(n = 318) 

Aimovig 

(erenumab) 

70 mg 

(n = 312) 

Placebo 

(n = 316) 
Treatment difference 

(95% CI) 
p-value 

Efficacy outcomes 

MMD 

Mean change 

(95% CI) 

Baseline (SD) 

 

-3.7 

(-4.0, -3.3) 

8.3 (2.5) 

 

-3.2 

(-3.6, -2.9) 

8.3 (2.5) 

 

-1.8 

(-2.2, -1.5) 

8.2 (2.5) 

 

70 mg: -1.4 (-1.9, -0.9) 

140 mg: -1.9 (-2.3, -1.4) 

 

Both 

<0.001a 

≥50% MMD 

responders 

Percentage [%] 

 

 

50.0% 

 

 

43.3% 

 

 

26.6% 

 

 

n/a 

 

Both 

<0.001a,d 

≥75% MMD 
responders 
Percentage [%] 

 

 

22.0% 

 

 

20.8% 

 

 

7.9% 

 

 

n/a 

 

 

n/ab 

Monthly acute 

migraine-specific 

medication days 

Mean change 

(95% CI) 

 

 

 

-1.6 

(-1.8, -1.4) 

 

 

 

-1.1 

(-1.3, -0.9) 

 

 

 

-0.2 

(-0.4, 0.0) 

 

 

70 mg: -0.9(-1.2, -0.6) 

140 mg: -1.4 (-1.7, -1.1) 

 

 

Both 

<0.001a 

Baseline (SD) 3.4 (3.5) 3.2 (3.4) 3.4 (3.4)   

Patient-reported outcome measures 

HIT-6 

Mean changec 

(95% CI) 

 

-6.9 

(-7.6, -6.3) 

 

-6.7 

(-7.4, -6.0) 

 

-4.6 

(-5.3, -4.0) 

 

70 mg: -2.1 (-3.0, -1.1) 

140 mg: -2.3 (-3.2, -1.3) 

 

n/ab 

MIDAS 

(modified) total 

Mean changec 

(95% CI) 

 

 

-7.5 

(-8.3, -6.6) 

 

 

-6.7 

(-7.6, -5.9) 

 

 

-4.6 

(-5.5, -3.8) 

 

 

70 mg: -2.1 (-3.3, -0.9) 

140 mg: -2.8 (-4.0, -1.7) 

 

n/ab 

CI = confidence interval; MMD = monthly migraine days; HIT-6 = Headache Impact Test; MIDAS = Migraine 

Disability Assessment; n/a = not applicable. 
a For the secondary endpoints, all p-values are reported as unadjusted p-values and are statistically 

significant after adjustment for multiple comparisons. 
b For exploratory endpoints, no p-value was presented. 
c For HIT-6: Change and reduction from baseline were evaluated in the last 4 weeks of the 12-week 

double-blind treatment phase. For MIDAS: Change and reduction from baseline were evaluated over 

24 weeks. For data collection a recall period of 1 month has been used. 
d p value is calculated based on the odds ratios. 

 

In patients failing one or more prophylactic pharmacotherapies the treatment difference for the 

reduction of MMD observed between erenumab 140 mg and placebo was -2.5 (95% CI: -3.4, -1.7) and 

between erenumab 70 mg and placebo -2.0 (95% CI: -2.8, -1.2). There was also a higher proportion of 

subjects treated with erenumab who achieved at least 50% reduction of MMD compared to placebo 

(39.7% for 140 mg and 38.6% for 70 mg, with an odds ratio of 3.1 [95% CI: 1.7, 5.5] and 2.9 [95% 

CI: 1.6, 5.3], respectively). 

 

Efficacy was sustained up to 1 year in the active re-randomisation part of Study 2. Patients were 

re-randomised in the active treatment phase (ATP) to 70 mg or 140 mg erenumab. 79.8% completed 

the entire study out to 52 weeks. The reduction in monthly migraine days from baseline to Week 52 

was -4.22 in the 70 mg ATP group and -4.64 days in the 140 mg ATP group. At Week 52, the 

proportion of subjects who achieved a ≥50% reduction in MMD from baseline was 61.0% in the 

70 mg ATP and 64.9% in the 140 mg ATP group. 

 



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Paediatric population 

 

The European Medicines Agency has deferred the obligation to submit the results of studies with 

Aimovig in prevention of migraine headaches in one or more subsets of the paediatric population (see 

section 4.2 for information on paediatric use). 

 

5.2 Pharmacokinetic properties 

 

Erenumab exhibits non-linear kinetics as a result of binding to the CGRP-R receptor. However, at 

therapeutically relevant doses, the pharmacokinetics of erenumab following subcutaneous dosing 

every 4 weeks are predominantly linear due to saturation of binding to CGRP-R. Subcutaneous 

administration of a 140 mg once monthly dose and a 70 mg once monthly dose in healthy volunteers 

resulted in a Cmax mean (standard deviation [SD]) of 15.8 (4.8) µg/ml and 6.1 (2.1) µg/ml, 

respectively, and AUClast mean (SD) of 505 (139) day*µg/ml and 159 (58) day*µg/ml, respectively. 

 

Less than 2-fold accumulation was observed in trough serum concentrations following 140 mg doses 

administered subcutaneously every 4 weeks and serum trough concentrations approached steady state 

by 12 weeks of dosing. 

 

Absorption 

 

Following a single subcutaneous dose of 140 mg or 70 mg erenumab administered to healthy adults, 

median peak serum concentrations were attained in 4 to 6 days, and estimated absolute bioavailability 

was 82%. 

 

Distribution 

 

Following a single 140 mg intravenous dose, the mean (SD) volume of distribution during the terminal 

phase (Vz) was estimated to be 3.86 (0.77) l. 

 

Biotransformation / Elimination 

 

Two elimination phases were observed for erenumab. At low concentrations, the elimination is 

predominately through saturable binding to target (CGRP-R), while at higher concentrations the 

elimination of erenumab is largely through a non-specific proteolytic pathway. Throughout the dosing 

period erenumab is predominantly eliminated via a non-specific proteolytic pathway with the effective 

half-life of 28 days. 

 

Special populations 

 

Patients with renal impairment 

Patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) have not been studied. Population 

pharmacokinetic analysis of integrated data from the Aimovig clinical studies did not reveal a 

difference in the pharmacokinetics of erenumab in patients with mild or moderate renal impairment 

relative to those with normal renal function (see section 4.2). 

 

Patients with hepatic impairment 

No studies have been performed in patients with hepatic impairment. Erenumab, as a human 

monoclonal antibody, is not metabolised by cytochrome P450 enzymes and hepatic clearance is not a 

major clearance pathway for erenumab (see section 4.2). 

 

  



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5.3 Preclinical safety data 
 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated-dose toxicity, toxicity to reproduction and development. 

 

Carcinogenicity studies have not been conducted with erenumab. Erenumab is not pharmacologically 

active in rodents. It has biological activity in cynomolgus monkeys, but this species is not an 

appropriate model for evaluation of tumorigenic risk. The mutagenic potential of erenumab has not 

been evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes. 

 

In repeated-dose toxicology studies there were no adverse effects in sexually mature monkeys dosed 

up to 150 mg/kg subcutaneously twice weekly for up to 6 months at systemic exposures up to 123-fold 

and 246-fold higher than the clinical dose of 140 mg and 70 mg, respectively, every 4 weeks, based on 

serum AUC. There were also no adverse effects on surrogate markers of fertility (anatomical 

pathology or histopathology changes in reproductive organs) in these studies. 

 

In a reproduction study in cynomolgus monkeys there were no effects on pregnancy, embryo-foetal or 

post-natal development (up to 6 months of age) when erenumab was dosed throughout pregnancy at 

exposure levels approximately 17-fold and 34-fold higher than those achieved in patients receiving 

erenumab 140 mg and 70 mg, respectively, every 4 weeks dosing regimen based on AUC. Measurable 

erenumab serum concentrations were observed in the infant monkeys at birth, confirming that 

erenumab, like other IgG antibodies, crosses the placental barrier. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Sucrose 

Polysorbate 80 

Sodium hydroxide (for pH adjustment) 

Glacial acetic acid 

Water for injections 

 

6.2 Incompatibilities 
 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 

products. 

 

6.3 Shelf life 
 

2 years 

 

6.4 Special precautions for storage 

 

Pre-filled syringe 

 

Store in a refrigerator (2°C - 8°C). Do not freeze. 

Keep the pre-filled syringe in the outer carton in order to protect from light. 

After removal from the refrigerator, Aimovig must be used within 14 days when stored at room 

temperature (up to 25°C), or discarded. If it is stored at a higher temperature or for a longer period it 

must be discarded. 

 



13 

Pre-filled pen 

 

Store in a refrigerator (2°C - 8°C). Do not freeze. 

Keep the pre-filled pen in the outer carton in order to protect from light. 

After removal from the refrigerator, Aimovig must be used within 14 days when stored at room 

temperature (up to 25°C), or discarded. If it is stored at a higher temperature or for a longer period it 

must be discarded. 

 

6.5 Nature and contents of container 

 

Pre-filled syringe 

 

Aimovig is supplied in a pre-filled syringe (1 ml, Type 1 glass) with a stainless steel needle and a 

needle cover (rubber containing latex). 

 

Aimovig is available in packs containing 1 pre-filled syringe. 

 

Pre-filled pen 

 

Aimovig is supplied in a pre-filled pen (1 ml, Type 1 glass) with a stainless steel needle and a needle 

cover (rubber containing latex). 

 

Aimovig is available in packs containing 1 pre-filled pen and in multipacks containing 

3 (3x1) pre-filled pens. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal and other handling 
 

Before administration, the solution should be inspected visually. The solution should not be injected if 

it is cloudy, distinctly yellow or contains flakes or particles. 

 

Pre-filled syringe 

 

To avoid discomfort at the site of injection, the pre-filled syringe(s) should be left to stand at room 

temperature (up to 25°C) for at least 30 minutes before injecting. It should also be protected from 

direct sunlight. The entire contents of the pre-filled syringe(s) must be injected. The syringe(s) must 

not be warmed by using a heat source such as hot water or microwave and must not be shaken. 

 

Pre-filled pen 

 

To avoid discomfort at the site of injection, the pre-filled pen(s) should be left to stand at room 

temperature (up to 25°C) for at least 30 minutes before injecting. It should also be protected from 

direct sunlight. The entire contents of the pre-filled pen(s) must be injected. The pen(s) must not be 

warmed by using a heat source such as hot water or microwave and must not be shaken. 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 



14 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/18/1293/001-006 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

26 July 2018 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

  



15 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 

SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE 

FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 



16 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 

MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 

Name and address of the manufacturer(s) of the biological active substance(s) 

 

Amgen, Inc. 

One Amgen Center Drive 

Thousand Oaks 

CA 

91320 

United States 

 

Amgen Singapore Manufacturing Pte. Ltd. 

1 Tuas View Drive 

Singapore 637026 

Singapore 

 

Name and address of the manufacturer(s) responsible for batch release 

 

Aimovig 70 mg, 140 mg solution for injection in pre-filled syringe: 

 

Alcon-Couvreur 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

Novartis Pharma GmbH 

Roonstrasse 25 

D-90429 Nuremberg 

Germany 

 

Aimovig 70 mg, 140 mg solution for injection in pre-filled pen: 

 

Sandoz GmbH 

Biochemiestrasse 10 

6336 Langkampfen 

Austria 

 

Novartis Pharma GmbH 

Roonstrasse 25 

D-90429 Nuremberg 

Germany 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 



17 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

 Periodic Safety Update Reports 
 

The requirements for submission of periodic safety update reports for this medicinal product are 

set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 

Directive 2001/83/EC and any subsequent updates published on the European medicines 

web-portal. 

 

The marketing authorisation holder shall submit the first periodic safety update report for this product 

within 6 months following authorisation. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in 

the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 

subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 

 Whenever the risk management system is modified, especially as the result of new information 
being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 

  



18 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



19 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 
  



20 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK – pre-filled syringe 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aimovig 70 mg solution for injection in pre-filled syringe 

erenumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe contains 70 mg erenumab. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections. 

Needle cap contains latex. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled syringe 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled syringe in the outer carton in order to protect from light. 



21 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/18/1293/003 Pack containing 1 pre-filled syringe 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Aimovig 70 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



22 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SYRINGE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Aimovig 70 mg injection 

erenumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

  



23 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK – pre-filled syringe 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aimovig 140 mg solution for injection in pre-filled syringe 

erenumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled syringe contains 140 mg erenumab. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections. 

Needle cap contains latex. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled syringe 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled syringe in the outer carton in order to protect from light. 



24 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/18/1293/006 Pack containing 1 pre-filled syringe 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Aimovig 140 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



25 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

SYRINGE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Aimovig 140 mg injection 

erenumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

  



26 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aimovig 70 mg solution for injection in pre-filled pen 

erenumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 70 mg erenumab. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections. 

Needle cap contains latex. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled pen 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pen in the outer carton in order to protect from light. 



27 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1293/001 Pack containing 1 pre-filled pen 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Aimovig 70 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



28 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aimovig 70 mg solution for injection in pre-filled pen 

erenumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 70 mg erenumab. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections. 

Needle cap contains latex. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

Multipack: 3 (3 packs of 1) pre-filled pens 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pens in the outer carton in order to protect from light. 



29 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1293/002 Multipack containing 3 (3x 1) pre-filled pens 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Aimovig 70 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



30 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aimovig 70 mg solution for injection in pre-filled pen 

erenumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 70 mg erenumab. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections. 

Needle cap contains latex. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled pen 

Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



31 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1293/002 Multipack containing 3 (3x 1) pre-filled pens 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Aimovig 70 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

  



32 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

PEN LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Aimovig 70 mg injection 

erenumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

  



33 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON OF UNIT PACK – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aimovig 140 mg solution for injection in pre-filled pen 

erenumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 140 mg erenumab. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections. 

Needle cap contains latex. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled pen 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pen in the outer carton in order to protect from light. 



34 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1293/004 Pack containing 1 pre-filled pen 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Aimovig 140 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



35 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aimovig 140 mg solution for injection in pre-filled pen 

erenumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 140 mg erenumab. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections. 

Needle cap contains latex. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

Multipack: 3 (3 packs of 1) pre-filled pens 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pens in the outer carton in order to protect from light. 



36 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1293/005 Multipack containing 3 (3x 1) pre-filled pens 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Aimovig 140 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



37 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) – pre-filled pen 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Aimovig 140 mg solution for injection in pre-filled pen 

erenumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One pre-filled pen contains 140 mg erenumab. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains: sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections. 

Needle cap contains latex. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1 pre-filled pen 

Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Subcutaneous use 

Single use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



38 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. Do not freeze. 

Keep the pre-filled pen in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1293/005 Multipack containing 3 (3x 1) pre-filled pens 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Aimovig 140 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

  



39 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

PEN LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Aimovig 140 mg injection 

erenumab 

SC 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6. OTHER 

 

  



40 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



41 

Package leaflet: Information for the user 
 

Aimovig 70 mg solution for injection in pre-filled syringe 

Aimovig 140 mg solution for injection in pre-filled syringe 

erenumab 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What Aimovig is and what it is used for 

2. What you need to know before you use Aimovig 

3. How to use Aimovig 

4. Possible side effects 

5. How to store Aimovig 

6. Contents of the pack and other information 

 

 

1. What Aimovig is and what it is used for 

 

Aimovig contains the active substance erenumab. It belongs to a group of medicines called 

monoclonal antibodies. 

 

Aimovig works by blocking the activity of the CGRP molecule, which has been linked to migraine 

(CGRP stands for calcitonin gene-related peptide). 

 

Aimovig is used to prevent migraine in adults who have at least 4 migraine days per month when 

starting treatment with Aimovig. 

 

 

2. What you need to know before you use Aimovig 

 

Do not use Aimovig: 
- if you are allergic to erenumab or any of the other ingredients of this medicine (listed in 

section 6). 

 

Warnings and precautions 

Talk to your doctor before using Aimovig: 

- if you have ever had an allergic reaction to rubber latex. The container of this medicinal product 
contains latex rubber within the cap. 

- if you suffer from a cardiovascular disease. Aimovig has not been studied in patients with 
certain cardiovascular diseases. 

 



42 

Talk to your doctor or get emergency medical help immediately: 

- if you get any symptoms of a serious allergic reaction, such as rash or swelling usually of the 
face, mouth, tongue, or throat; or difficulty breathing. Serious allergic reactions can happen 

within minutes, but some may happen more than one week after using Aimovig. 

 

Children and adolescents 

Do not give this medicine to children or adolescents (under 18 years old) because the use of Aimovig 

has not been studied in this age group. 

 

Other medicines and Aimovig 

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor for advice before using this medicine. 

 

Pregnancy 

Your doctor will decide whether you should stop using Aimovig during pregnancy. 

 

Breast-feeding 

Monoclonal antibodies like Aimovig are known to pass into breast milk during the first few days after 

birth, but after this first period Aimovig can be used. Talk to your doctor about using Aimovig while 

breast-feeding in order to help you decide whether you should stop breast-feeding or stop using 

Aimovig. 

 

Driving and using machines 

Aimovig is unlikely to affect your ability to drive and use machines. 

 

Aimovig contains sodium 

Aimovig contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”. 

 

 

3. How to use Aimovig 

 

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not 

sure. 

 

If you have not noticed any treatment effect after 3 months, tell your doctor who will decide whether 

you should continue treatment. 

 

Use Aimovig exactly as prescribed by your doctor. If your doctor prescribes the 70 mg dose you 

should have one injection once every 4 weeks. If your doctor prescribes the 140 mg dose you should 

have either one injection of Aimovig 140 mg or two injections of Aimovig 70 mg once every 4 weeks. 

If you are having two injections of Aimovig 70 mg, the second injection must be given immediately 

after the first one at a different injection site. Make sure that you inject the entire contents of both 

syringes. 

 

Aimovig is given as an injection under your skin (known as a subcutaneous injection). You or your 

caregiver can give the injection into your abdomen or your thigh. The outer area of your upper arm can 

also be used as an injection site, but only if someone else is giving you the injection. If you need 

2 injections, they should be given in different sites to avoid hardening of the skin and should not be 

given into areas where the skin is tender, bruised, red or hard. 

 

Your doctor or nurse will give you or your caregiver training in the right way to prepare and inject 

Aimovig. Do not try to inject Aimovig until this training has been given. 

 

Aimovig syringes are for single use only. 



43 

 

For detailed instructions on how to inject Aimovig, see “Instructions for use of Aimovig pre-filled 

syringe” at the end of this leaflet. 

 

If you use more Aimovig than you should 
If you have received more Aimovig than you should or if the dose has been given earlier than it should 

have been, tell your doctor. 

 

If you forget to use Aimovig 
- If you forget an Aimovig dose, take it as soon as possible after you realise. 
- Then contact your doctor, who will tell you when you should schedule your next dose. Follow 

the new schedule exactly as your doctor has told you. 

 

If you stop using Aimovig 

Do not stop using Aimovig without talking to your doctor first. Your symptoms may return if you stop 

the treatment. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Possible side effects are listed below. Most of these side effects are mild to moderate. 

 

Common: may affect up to 1 in 10 people 

- allergic reactions such as rash, swelling, hives or difficulty breathing (see section 2) 
- constipation 
- itching 
- muscle spasms 
- injection site reactions, such as pain, redness and swelling where the injection is given. 
 

Aimovig may cause skin reactions such as rash or itching. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Aimovig 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 

expiry date refers to the last day of that month. 

 

Keep the syringe(s) in the outer carton in order to protect from light. Store in a refrigerator (2°C – 

8°C). Do not freeze. 

 

After Aimovig has been taken out of the refrigerator, it must be kept at room temperature (up to 25°C) 

in the outer carton and must be used within 14 days, or else discarded. Do not put Aimovig back in the 

refrigerator once it has been removed. 

 



44 

Do not use this medicine if you notice that the solution contains particles, is cloudy or is distinctly 

yellow. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Aimovig contains 

- The active substance is erenumab. 
- Aimovig 70 mg solution for injection in pre-filled syringe contains 70 mg erenumab. 
- Aimovig 140 mg solution for injection in pre-filled syringe contains 140 mg erenumab. 
- The other ingredients are sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water 

for injections. 

 

What Aimovig looks like and contents of the pack 

Aimovig solution for injection is clear to opalescent, colourless to light yellow, and practically free 

from particles. 

 

Each pack contains one single-use pre-filled syringe. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Alcon-Couvreur 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

Novartis Pharma GmbH 

Roonstrasse 25 

90429 Nuremberg 

Germany 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 
Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 



45 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

This leaflet was last revised in 
 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

 



46 

Instructions for use of Aimovig pre-filled syringe 

 

Illustration of the syringe 

    Before use  After use 

 

 

 

 

 

 

 

 

 
 

 

 

  

 

 

 

 

 

Note: Needle is inside the grey needle cap. 

 

 

General 

 

Before you use the Aimovig pre-filled syringe, read this important 

information: 

 
 

 

 

Step 1: Prepare 
Note: The prescribed dose of Aimovig is either 70 mg or 140 mg. This means that for the 70 mg dose 

you must inject the contents of one 70 mg single-use syringe. For the 140 mg dose you must inject the 

contents of either one 140 mg single-use syringe or two 70 mg single-use syringes, one after the other. 

 

(A) 

 

Remove Aimovig pre-filled syringe(s) from the carton by holding it/them at the barrel. You may need 

to use either one or two syringes based on your prescribed dose. Do not shake. 

 

To avoid discomfort at the site of injection, leave the syringe(s) at room temperature for at least 

30 minutes before injecting. 

 

Note: Do not try to warm the syringe(s) by using a heat source such as hot water or microwave. 

Plunger Plunger 

Finger flange 

Label and expiry date 

Barrel 

Solution 

Grey needle cap on 

(needle inside) 

Used plunger 

Finger flange 

Label and expiry date 

Used barrel 

Used needle 

Grey needle cap off 



47 

(B) 
 

Inspect the syringe(s). Make sure the solution you see in the syringe is clear and colourless to light 

yellow. 

 

Note: 

- Do not use the syringe if any part of it appears cracked or broken. 
- Do not use the syringe if it has been dropped. 
- Do not use the syringe if the needle cap is missing or is not securely attached. 
 

In all cases described above, use a new syringe, and if you are unsure contact your doctor or 

pharmacist. 

 

(C) 

 

Gather all materials needed for the 

injections: 

 

Wash your hands thoroughly with 

soap and water. 

 

On a clean, well-lit work surface, 

place the: 

- New syringe(s) 
- Alcohol wipes 
- Cotton balls or gauze pads 
- Adhesive plasters 
- Sharps disposal container 

 

 

 



48 

(D) 
 

Prepare and clean the injection site(s). 

 

 
Only use the following injection sites: 

- Thigh 
- Stomach area (abdomen) (except for a 5 cm area around the navel) 
- Outer area of upper arm (only if someone else is giving you the injection) 
 

Clean the injection site with an alcohol wipe and let the skin dry. 

 

Choose a different site each time you give yourself an injection. If you need to use the same injection 

site, just make sure it is not the same spot on that site you used last time. 

 

Note: 

- After you have cleaned the area, do not touch it again before injecting. 
- Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas 

with scars or stretch marks. 
 

Step 2: Get ready 

 

(E) 
 

Pull the grey needle cap straight off and away from your body, only when you are ready to inject. The 

injection must be administered within 5 minutes. It is normal to see a drop of liquid at the end of the 

needle. 

 

 
Note: 

- Do not leave the grey needle cap off for more than 5 minutes. This can dry out the medicine. 
- Do not twist or bend the grey needle cap. 
- Do not put the grey needle cap back onto the syringe once it has been removed. 

 

Upper 

arm 

Stomach area 

(abdomen) 

Thigh 



49 

(F) 
 

Firmly pinch the skin at the injection site. 

 

 
Note: Keep skin pinched while injecting. 

 

Step 3: Inject 

 

(G) 
 

While pinching, insert the syringe needle into the skin at an angle of 45 to 90 degrees. 

 

 
Do not place your finger on the plunger while inserting the needle. 

 

(H) 
 

Using slow and constant pressure, push the plunger rod all the way down until it stops moving. 

 

 
 

(I) 
 

When done, release your thumb, and gently lift the syringe off of the skin and then release the pinched 

skin. 

 

Note: When you remove the syringe, if it looks like there is still medicine in the syringe barrel this 

means you have not received a full dose. Contact your doctor. 

 



50 

Step 4: Finish 

 

(J) 

 

Discard the used syringe and the grey needle cap. 

Put the used syringe in a sharps disposal container immediately 

after use. Talk to your doctor or pharmacist about proper disposal. 

There may be local regulations for disposal. 

 

Note: 

- Do not reuse the syringe. 
- Do not recycle the syringe or sharps disposal container, or 

throw them into household waste. 

Always keep the sharps disposal container out of the reach of 

children. 
 

 

(K) 

 

Examine the injection site. 

If there is any blood on the skin, press a cotton ball or gauze pad onto the injection site. Do not rub the 

injection site. Apply an adhesive plaster if needed. 

 

If your dose is 140 mg and you are using two Aimovig 70 mg syringes, 

repeat steps 1(D) to 4 with the second syringe to inject the full dose. 

 



51 

Package leaflet: Information for the user 
 

Aimovig 70 mg solution for injection in pre-filled pen 

Aimovig 140 mg solution for injection in pre-filled pen 

erenumab 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What Aimovig is and what it is used for 

2. What you need to know before you use Aimovig 

3. How to use Aimovig 

4. Possible side effects 

5. How to store Aimovig 

6. Contents of the pack and other information 

 

 

1. What Aimovig is and what it is used for 

 

Aimovig contains the active substance erenumab. It belongs to a group of medicines called 

monoclonal antibodies. 

 

Aimovig works by blocking the activity of the CGRP molecule, which has been linked to migraine 

(CGRP stands for calcitonin gene-related peptide). 

 

Aimovig is used to prevent migraine in adults who have at least 4 migraine days per month when 

starting treatment with Aimovig. 

 

 

2. What you need to know before you use Aimovig 

 

Do not use Aimovig: 
- if you are allergic to erenumab or any of the other ingredients of this medicine (listed in 

section 6). 

 

Warnings and precautions 

Talk to your doctor before using Aimovig: 

- if you have ever had an allergic reaction to rubber latex. The container of this medicinal product 
contains latex rubber within the cap. 

- if you suffer from a cardiovascular disease. Aimovig has not been studied in patients with 
certain cardiovascular diseases. 

 



52 

Talk to your doctor or get emergency medical help immediately: 

- if you get any symptoms of a serious allergic reaction, such as rash or swelling usually of the 
face, mouth, tongue, or throat; or difficulty breathing. Serious allergic reactions can happen 

within minutes, but some may happen more than one week after using Aimovig. 

 

Children and adolescents 

Do not give this medicine to children or adolescents (under 18 years old) because the use of Aimovig 

has not been studied in this age group. 

 

Other medicines and Aimovig 

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor for advice before using this medicine. 

 

Pregnancy 

Your doctor will decide whether you should stop using Aimovig during pregnancy. 

 

Breast-feeding 

Monoclonal antibodies like Aimovig are known to pass into breast milk during the first few days after 

birth, but after this first period Aimovig can be used. Talk to your doctor about using Aimovig while 

breast-feeding in order to help you decide whether you should stop breast-feeding or stop using 

Aimovig. 

 

Driving and using machines 

Aimovig is unlikely to affect your ability to drive and use machines. 

 

Aimovig contains sodium 

Aimovig contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”. 

 

 

3. How to use Aimovig 

 

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not 

sure. 

 

If you have not noticed any treatment effect after 3 months, tell your doctor who will decide whether 

you should continue treatment. 

 

Use Aimovig exactly as prescribed by your doctor. If your doctor prescribes the 70 mg dose you 

should have one injection once every 4 weeks. If your doctor prescribes the 140 mg dose you should 

have either one injection of Aimovig 140 mg or two injections of Aimovig 70 mg once every 4 weeks. 

If you are having two injections of Aimovig 70 mg, the second injection must be given immediately 

after the first one at a different injection site. Make sure that you inject the entire contents of both 

pens. 

 

Aimovig is given as an injection under your skin (known as a subcutaneous injection). You or your 

caregiver can give the injection into your abdomen or your thigh. The outer area of your upper arm can 

also be used as an injection site, but only if someone else is giving you the injection. If you need 

2 injections, they should be given in different sites to avoid hardening of the skin and should not be 

given into areas where the skin is tender, bruised, red or hard. 

 

Your doctor or nurse will give you or your caregiver training in the right way to prepare and inject 

Aimovig. Do not try to inject Aimovig until this training has been given. 

 

Aimovig pens are for single use only. 



53 

 

For detailed instructions on how to inject Aimovig, see “Instructions for use of Aimovig pre-filled 

pen” at the end of this leaflet. 

 

If you use more Aimovig than you should 
If you have received more Aimovig than you should or if the dose has been given earlier than it should 

have been, tell your doctor. 

 

If you forget to use Aimovig 
- If you forget an Aimovig dose, take it as soon as possible after you realise. 
- Then contact your doctor, who will tell you when you should schedule your next dose. Follow 

the new schedule exactly as your doctor has told you. 

 

If you stop using Aimovig 

Do not stop using Aimovig without talking to your doctor first. Your symptoms may return if you stop 

the treatment. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Possible side effects are listed below. Most of these side effects are mild to moderate. 

 

Common: may affect up to 1 in 10 people 

- allergic reactions such as rash, swelling, hives or difficulty breathing (see section 2) 
- constipation 
- itching 
- muscle spasms 
- injection site reactions, such as pain, redness and swelling where the injection is given. 
 

Aimovig may cause skin reactions such as rash or itching. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store Aimovig 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 

expiry date refers to the last day of that month. 

 

Keep the pen(s) in the outer carton in order to protect from light. Store in a refrigerator (2°C – 8°C). 

Do not freeze. 

 

After Aimovig has been taken out of the refrigerator, it must be kept at room temperature (up to 25°C) 

in the outer carton and must be used within 14 days, or else discarded. Do not put Aimovig back in the 

refrigerator once it has been removed. 

 



54 

Do not use this medicine if you notice that the solution contains particles, is cloudy or is distinctly 

yellow. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Aimovig contains 

- The active substance is erenumab. 
- Aimovig 70 mg solution for injection in pre-filled pen contains 70 mg erenumab. 
- Aimovig 140 mg solution for injection in pre-filled pen contains 140 mg erenumab. 
- The other ingredients are sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water 

for injections. 

 

What Aimovig looks like and contents of the pack 

Aimovig solution for injection is clear to opalescent, colourless to light yellow, and practically free 

from particles. 

 

Aimovig is available in packs containing one single-use pre-filled pen and in multipacks containing 

3 (3x1) pre-filled pens. 

 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Sandoz GmbH 

Biochemiestrasse 10 

6336 Langkampfen 

Austria 

 

Novartis Pharma GmbH 

Roonstrasse 25 

90429 Nuremberg 

Germany 

 

  



55 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 
Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 



56 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

This leaflet was last revised in 
 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

 



57 

Instructions for use of Aimovig pre-filled pens 

 

Illustration of the Aimovig 70 mg pen (with light blue body, purple start button, white cap and 

green safety guard) 

     Before use  After use 

 

 

 

 

 

 

 

Note: Needle is inside the green safety guard.  

 

Purple start button 

Expiry date 

Window 

Solution 

Green safety guard 

(needle inside) 

White cap on 

Expiry date 

Yellow window  

(injection complete) 

Green safety guard 

(needle inside) 

White cap off 



58 

Illustration of the Aimovig 140 mg pen (with dark blue body, grey start button, orange cap and yellow 

safety guard) 

     Before use  After use 

 

 

 

 

 

 

 

Note: Needle is inside the yellow safety guard. 

 
  

Expiry date 

Window 

Solution 

Yellow safety guard 

(needle inside) 

Orange cap on 

Expiry date 

Yellow window 

(injection 

complete) 

Yellow safety guard 

(needle inside) 

Orange cap off 

Grey start button 



59 

 

General 

 

Before you use the Aimovig pre-filled pen, read this 

information. 
 

 

Step 1: Prepare 
Note: The prescribed dose of Aimovig is either 70 mg or 140 mg. This means that for the 70 mg dose 

you must inject the contents of one 70 mg single-use pen. For the 140 mg dose you must inject the 

contents of either one 140 mg single-use pen or two 70 mg single-use pens, one after the other. 

 

(A) 
 

Carefully lift Aimovig pre-filled pen(s) out of the carton. You may need to use either one or two pens 

based on your prescribed dose. Do not shake. 

 

To avoid discomfort at the site of injection, leave the pen(s) at room temperature for at least 

30 minutes before injecting. 

 

Note: Do not try to warm the pen(s) by using a heat source such as hot water or microwave. 

 

(B) 
 

Inspect the pen(s). Make sure the solution you see in the window is clear and colourless to light 

yellow. 

 

Note: 

- Do not use the pen(s) if any part appears cracked or broken. 
- Do not use any pen that has been dropped. 
- Do not use the pen if the cap is missing or is not securely attached. 
 

In all cases described above, use a new pen, and if you are unsure contact your doctor or pharmacist. 

 

(C) 

 

Gather all materials needed for the 

injection(s). 

 

Wash your hands thoroughly with 

soap and water. 

 

On a clean, well-lit work surface, 

place the: 

- New pen(s) 
- Alcohol wipe(s) 
- Cotton ball(s) or gauze 

pad(s) 

- Adhesive plaster(s) 
- Sharps disposal container 

 
 

 



60 

(D) 
 

Prepare and clean the injection site(s). 

 

 
Only use the following injection sites: 

- Thigh 
- Stomach area (abdomen) (except for a 5 cm area around the navel) 
- Outer area of upper arm (only if someone else is giving you the injection) 
 

Clean the injection site with an alcohol wipe and let the skin dry. 

 

Choose a different site each time you give yourself an injection. If you need to use the same injection 

site, just make sure it is not the same spot on that site you used last time. 

 

Note: 

- After you have cleaned the area, do not touch it again before injecting. 
- Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas 

with scars or stretch marks. 

 

Step 2: Get ready 

 

(E) 
 

Pull the cap straight off, only when you are ready to inject. The injection must be administered within 

5 minutes. It is normal to see a drop of liquid at the end of the needle or safety guard. 

 

 
 

Note: 

- Do not leave the cap off for more than 5 minutes. This can dry out the medicine. 
- Do not twist or bend the cap. 
- Do not put the cap back onto the pen once it has been removed. 
- Do not put your fingers into the safety guard. 

 

Upper 

arm 

Stomach 

area 

(abdomen) 

Thigh 



61 

(F) 
 

Create a firm surface at the selected injection site (thigh, stomach, or outer areas of the upper arm), by 

using either the Stretch method or the Pinch method. 

 

Stretch method 

Stretch skin firmly by moving your thumb and fingers in opposite directions, creating an area about 

five cm wide. 

 

 

Pinch method 

Pinch skin firmly between your thumb and fingers, creating an area about five cm wide. 

 

Note: It is important to keep skin stretched or pinched while injecting. 

 

  



62 

Step 3: Inject 

 

(G) 
 

Keep holding the stretched/pinched skin. With the cap off, put the safety guard of the pen on the skin 

at an angle of 90 degrees. The needle is inside the safety guard. 

 

Note: Do not touch the start button yet. 

 

  

Safety guard 

(needle inside) 



63 

(H) 
 

Firmly push the pen down onto the skin until it stops moving. 

 

 
Note: You must push all the way down but do not touch the start button until you are ready to inject. 

 

(I) 
 

Press the start button. You will hear a click. 

 

 

click 

Push down 



64 

(J) 
 

Remove your thumb from the button, but keep pushing down on the skin. The injection could take 

about 15 seconds. 

 
 

15 seconds 

 

 
 

Note: When the injection is completed, the window will turn from clear to yellow and you may hear a 

second click. 

 

 
Note: 

- After you remove the pen from the skin, the needle will automatically be covered by the safety 
guard. 

- When you remove the pen, if the window has not turned yellow, or if it looks like the medicine 
is still injecting, this means you have not received a full dose. Contact your doctor immediately. 

 

click 



65 

Step 4: Finish 
 

(K) 

 

Discard the used pen and the cap. 

Put the used pen in a sharps disposal container immediately after use. Talk to your doctor or 

pharmacist about proper disposal. There may be local regulations for disposal. 

 

Note: 

- Do not reuse the pen. 
- Do not recycle the pen or sharps disposal container, or throw them into household waste. 
- Always keep the sharps disposal container out of the reach of children. 

 

 
 

(L) 

 

Examine the injection site. 

If there is any blood on the skin, press a cotton ball or gauze pad onto the injection site. Do not rub 

the injection site. Apply an adhesive plaster if needed. 

 

If your dose is 140 mg and you are using two Aimovig 70 mg pens, repeat 

steps 1(D) to 4 with the second pen to inject the full dose. 

 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET