Emgality

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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 
 
Emgality 120 mg solution for injection in pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each pre-filled pen contains 120 mg of galcanezumab in 1 mL. 
 
Galcanezumab is a recombinant humanised monoclonal antibody produced in Chinese Hamster Ovary 
cells. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection). 
 
The solution is clear and colourless to slightly yellow. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per 
month. 
 
4.2 Posology and method of administration 
 
Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. 
 
Posology 
 
The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 
240 mg loading dose as the initial dose. 
 
Patients should be instructed to inject a missed dose as soon as possible and then resume monthly 
dosing. 
 
The treatment benefit should be assessed within 3 months after initiation of treatment. Any further 
decision to continue treatment should be taken on an individual patient basis. Evaluation of the need to 
continue treatment is recommended regularly thereafter. 
 
Elderly (≥ 65 years) 
There is limited information in subjects aged ≥ 65 years. No dose adjustment is required as the 
pharmacokinetics of galcanezumab are not affected by age.   
 



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Renal impairment/hepatic impairment 
No dose adjustment is required in patients with mild to moderate renal impairment or hepatic 
impairment (see section 5.2).  
 
Paediatric population 
The safety and efficacy of galcanezumab in children aged 6 to 18 years have not yet been established. 
No data are available.  
 
There is no relevant use of galcanezumab in children below the age of 6 years for the prevention of 
migraine.  
 
Method of administration  
 
Subcutaneous use. 
 
A patient may self-inject galcanezumab by following the Instructions for Use. Galcanezumab is to be 
injected subcutaneously in the abdomen, thigh, back of the upper arm, or in the gluteal region. After 
training, patients may self-inject galcanezumab if a healthcare professional determines that it is 
appropriate. Comprehensive instructions for administration are given in the Package Leaflet. 
 
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 
 
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. 
 
Cardiovascular risk 
 
Patients with certain major cardiovascular diseases were excluded from clinical studies (see 
section 5.1). No safety data are available in these patients. 
 
Serious hypersensitivity 
 
Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been 
reported. If a serious hypersensitivity reaction occurs, administration of galcanezumab should be 
discontinued immediately and appropriate therapy initiated.  
 
Excipients  
 
This medicinal product contains less than 1 mmol sodium (23 mg) per 120 mg dose, i.e., is essentially 
“sodium-free”.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based 
on the characteristics of galcanezumab.  
 



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4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are limited data from the use of galcanezumab in pregnant women. Animal studies do not 
indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
Human immunoglobulin (IgG) is known to cross the placental barrier. As a precautionary measure, it 
is preferable to avoid the use of galcanezumab during pregnancy. 
 
Breast-feeding 
 
It is unknown whether galcanezumab is excreted in human milk. Human IgG is known to be excreted 
in breast milk during the first days after birth, which is decreasing to low concentrations soon 
afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period. 
Afterwards, use of galcanezumab could be considered during breast-feeding only if clinically needed.  
 
Fertility 
 
The effect of galcanezumab on human fertility has not been evaluated. Fertility studies in animals do 
not indicate harmful effects with respect to male and female fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Galcanezumab may have a minor influence on the ability to drive and use machines. Vertigo may 
occur following the administration of galcanezumab (see section 4.8). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Over 2500 patients were exposed to galcanezumab in clinical studies in migraine prophylaxis. Over 
1400 patients were exposed to galcanezumab during the double-blind treatment phase of the placebo-
controlled phase 3 studies. 279  patients were exposed for 12 months. 
 
The reported adverse drug reactions for 120 mg and 240 mg in the migraine clinical trials were injection 
site pain (10.1 %/11.6 %),  injection site reactions (9.9 %/14.5 %), vertigo (0.7 %/1.2 %), constipation 
(1.0 %/1.5 %), pruritus (0.7 %/1.2 %) and urticaria (0.3 %/0.1 %). Most of the reactions were mild or 
moderate in severity. Less than 2.5 % of patients in these studies discontinued due to adverse events. 
 



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Tabulated list of adverse reactions 
 
Table 1. List of adverse reactions in clinical studies and post-marketing reports 
Frequency estimate: 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). 
 

System Organ 
Class 

 

Very common Common Uncommon Rare 

Immune system 
disorders 

   Anaphylaxis 
Angioedema 

Ear and Labyrinth 
System 

 Vertigo   

Gastrointestinal 
System 

 Constipation   

Skin and 
Subcutaneous 
Tissue 

 Pruritus 
Rash 

Urticaria  

General disorders 
and administration 
site conditions 

Injection site 
pain 
Injection site 
reactionsa 

   

a Most frequently reported terms (≥ 1 %) were: Injection site reaction, Injection site erythema, 
Injection site pruritus, Injection site bruising, Injection site swelling. 

 
Description of selected adverse reactions 
 
Injection site pain or reactions  
The majority of events related to the injection site were mild to moderate and less than 0.5 % of 
patients exposed to galcanezumab during the phase 3 studies discontinued the treatment due to an 
injection site reaction. The majority of injection site reactions were reported within 1 day and on 
average resolved within 5 days. In 86 % of the patients reporting injection site pain, the event occurred 
within 1 hour of injection and resolved on average in 1 day. One percent of the patients exposed to 
galcanezumab during the phase 3 studies experienced severe pain at the injection site. 
 
Urticaria 
While urticaria is uncommon, serious cases of urticaria have been reported in galcanezumab clinical 
studies. 
 
Immunogenicity 
In the clinical studies, the incidence of anti-drug antibody development during the double-blind 
treatment phase was 4.8 % in patients receiving galcanezumab once monthly (all but one of whom had 
in vitro neutralizing activity). With 12 months of treatment, up to 12.5 % of galcanezumab-treated 
patients developed anti-drug antibodies, most of which were of low titre and tested positive for 
neutralising activity in vitro. However, the presence of anti-drug antibodies did not affect the 
pharmacokinetics, efficacy, or safety of galcanezumab. 
 
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. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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4.9 Overdose 
 
Doses up to 600 mg have been administered subcutaneously to humans without dose-limiting toxicity. 
In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of 
adverse reactions and appropriate symptomatic treatment be instituted immediately. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: analgesics, calcitonin gene-related peptide (CGRP) antagonists, ATC 
code: N02CD02 
 
Mechanism of action 
 
Galcanezumab is a humanised IgG4 monoclonal antibody that binds calcitonin gene-related peptide 
(CGRP) thus preventing its biological activity. Elevated blood concentrations of CGRP have been 
associated with migraine attacks. Galcanezumab binds to CGRP with high affinity (KD = 31 pM) and 
high specificity (> 10,000-fold vs related peptides adrenomedullin, amylin, calcitonin and intermedin).  
 
Clinical efficacy and safety 
 
The efficacy and safety of galcanezumab has been studied in 3 phase 3, randomized, placebo-
controlled, double-blind studies in adult patients (N = 2886). The 2 episodic migraine studies 
(EVOLVE-1 and EVOLVE-2) enrolled patients who met International Classification of Headache 
Disorders (ICHD) criteria for a diagnosis of migraine with or without aura with 4-14 migraine 
headache days per month. The chronic migraine study (REGAIN) enrolled patients who met ICHD 
criteria for chronic migraine with ≥ 15 headache days per month, of which at least 8 had the features 
of migraine. Patients with recent acute cardiovascular events (including MI, unstable angina, CABG, 
stroke, DVT) and/or those deemed to be at serious cardiovascular risk were excluded from the 
galcanezumab clinical trials. Patients > 65 years of age were also excluded. 
 
Patients received placebo, galcanezumab 120 mg/month (with an initial loading dose of 240 mg for the 
first month) or galcanezumab 240 mg/month and were allowed to use medication for the acute 
treatment of migraine. Across the 3 studies, patients were predominantly female (> 83 %) with a mean 
age of 41 years, and an average migraine history of 20 to 21 years. Approximately one-third of 
patients across the studies had at least 1 prior failure on a migraine prophylactic treatment for efficacy 
reasons and approximately 16 % of patients across the studies had at least 2 prior failure on a 
prophylactic treatment for efficacy reasons. 
 
In all 3 studies, the overall mean change from baseline in number of monthly Migraine Headache 
Days (MHDs) was the primary efficacy measure. Response rate is the mean percentage of patients 
meeting a defined threshold in the reduction of the number of monthly MHDs (≥ 50 %, ≥ 75 % and 
100 %) across the double-blind treatment period. The impact of migraine on functioning was assessed 
by the Role Function-Restrictive domain of the Migraine-Specific Quality of Life Questionnaire 
(MSQ) version 2.1, and by the Migraine Disability Assessment (MIDAS) Questionnaire. The MSQ 
measures impact of migraine on work or daily activities, relationships with family and friends, leisure 
time, productivity, concentration, energy, and tiredness. Scoring ranges from 0 to 100, with higher 
scores indicating less impairment , that is, patients experience fewer restrictions on the performance of 
day-to-day activities. For the MIDAS, higher scores indicate more disability. The baseline scores of 
the MIDAS reflected severe migraine related disability of patients in EVOLVE-1 and EVOLVE-2 
(mean of 33.1) and a very severely disabled population (mean of 67.2) in REGAIN.   
  



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Episodic migraine 
Studies EVOLVE-1 and EVOLVE-2 had a 6 month, double-blind, placebo-controlled treatment 
period. Completion rate of the double-blind treatment phase for patients who received galcanezumab 
ranged from 82.8 % to 87.7 %.  
 
Both galcanezumab 120 mg and 240 mg treatment groups demonstrated statistically significant and 
clinically meaningful improvements from baseline compared to placebo on mean change in MHD (see 
Table 2). Patients treated with galcanezumab had greater response rates and greater reductions in the 
number of monthly MHDs that acute medication was taken compared with placebo-treated patients. 
Galcanezumab-treated patients had a greater improvement in functioning (as measured by the MSQ 
Role Function-Restrictive domain score) compared with placebo-treated patients, beginning at 
month 1. More patients treated with galcanezumab achieved clinically significant levels of 
improvement in functioning (responder rate based on MSQ Role Function Restrictive domain) 
compared with those treated with placebo. Galcanezumab was associated with a statistically 
significant reduction in disability over placebo. 
 
Compared with placebo-treated patients, patients treated with galcanezumab 120 mg or 240 mg had 
significantly greater mean decreases from baseline in the number of monthly MHDs at month 1 and at 
all subsequent months up to month 6 (see Figure 1). Additionally, in month 1, patients treated with 
galcanezumab (loading dose of 240 mg) demonstrated significantly fewer weekly MHDs compared 
with placebo-treated patients, at week 1 and each subsequent week.  
 

Figure 1 Reduction in monthly migraine headache days over time in studies EVOLVE-1 and 
EVOLVE-2 

 

 
 



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Table 2. Efficacy and patient reported outcome measures 
 

  EVOLVE-1 – Episodic Migraine EVOLVE-2 - Episodic Migraine 
 Emgality  

Placebo  
Emgality  

Placebo   120 mg 240 mg 120 mg  240 mg 
  N = 210 N = 208 N = 425 N = 226 N = 220 N = 450 

Efficacy Outcomesa 
MHD             

Baseline 9.21 9.14 9.08 9.07 9.06 9.19 
Mean Change -4.73 -4.57 -2.81 -4.29 -4.18 -2.28 
    Treatment Difference -1.92 -1.76  -2.02 -1.90  
    CI95 % (-2.48, -1.37) (-2.31, -1.20)  (-2.55, -1.48) (-2.44, -1.36)  
    P-value < .001d < .001d   < .001d < .001d   

≥ 50 % MHD Responders              
Percentage, %  62.3 60.9 38.6 59.3 56.5 36.0 
P-value < .001d < .001d   < .001d < .001d   

≥ 75 % MHD Responders             
Percentage, % 38.8 38.5 19.3 33.5 34.3 17.8 
P-value < .001d < .001d   < .001d < .001d   

100 % MHD Responders             
Percentage, % 15.6 14.6 6.2 11.5 13.8 5.7 
P-value < .001d < .001d   < .001d < .001d   

MHD with Acute 
Medication Use             

Baseline 7.42 7.34 7.38 7.47 7.47 7.62 
Mean Change -3.96 -3.76 -2.15 -3.67 -3.63 -1.85 
    Treatment Difference -1.81 -1.61  -1.82 -1.78  
    CI95 % (-2.28, -1.33) (-2.09, -1.14)  (-2.29, -1.36) (-2.25, -1.31)  
    P-value < .001d < .001d   < .001d < .001d   

Patient-reported Outcome Measures 
MSQ Role Function-
Restrictive Domainb             

N 189 184 377 213 210 396 
Baseline 51.39 48.76 52.92 52.47 51.71 51.35 
Mean Change 32.43 32.09 24.69 28.47 27.04 19.65 
    Treatment Difference 7.74 7.40  8.82 7.39  
    CI95 % (5.20, 10.28) (4.83, 9.97)  (6.33, 11.31) (4.88, 9.90)  
    P-value < .001d < .001d   < .001d < .001d   

MSQ Role Function 
Restrictive Domain 
Respondersc             

N 189 184 377 213 210 396 
Percentage, % 63.5 69.6 47.2 58.2 60.0 43.4 
P-value < .001f < .001f   < .001f < .001f   

MIDAS Total Scoree             
N 177  170 345 202 194 374  
Baseline 32.93 36.09 31.84 30.87 32.75 34.25 
Mean Change -21.16 -20.06 -14.87 -21.17 -20.24 -12.02 
    Treatment Difference -6.29 -5.19  -9.15 -8.22  
    CI95% (-9.45, -3.13) (-8.39, -1.98)  (-12.61, -5.69) (-11.71, -4.72)  
    P-value < .001f .002f    < .001f < .001f   

 

N = number of patients; CI95 % = 95 % confidence interval.  
aEfficacy outcomes were evaluated across Months 1-6. 
bEvaluated across Months 4-6. 
cDefined as those with an improvement of ≥ 25 points for Episodic Migraine at Months 4-6 average.  



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dStatistically significant after adjustment for multiple comparisons.  
eEvaluated at Month 6.  
fNot adjusted for multiple comparisons. 
 
In pooled data from studies EVOLVE-1 and EVOLVE-2, in patients who failed one or more 
prophylactic treatments for efficacy reasons, the treatment difference for the reduction of mean 
monthly MHDs observed between galcanezumab 120 mg and placebo was -2.69 days (p < 0.001) and 
between galcanezumab 240 mg and placebo -2.78 days (p < 0.001). In patients failing two or more 
prophylactic treatments, the treatment difference was -2.64 days (p < 0.001) between 120 mg and 
placebo and -3.04 days (p < 0.001) between 240 mg and placebo.  
 
Chronic Migraine 
Study REGAIN had a 3 month, double-blind, placebo-controlled treatment period followed by a 
9 month open-label extension. Approximately 15 % of the patients continued concurrent treatment 
with topiramate or propranolol as allowed by the protocol for prophylaxis of migraine. Completion 
rate of the double-blind treatment phase for patients who received galcanezumab was 95.3 %.  
 
Both galcanezumab 120 mg and 240 mg treatment groups demonstrated statistically significant and 
clinically meaningful improvements from baseline compared to placebo on mean change in MHD (see 
Table 3). Patients treated with galcanezumab had greater response rates and greater reductions in the 
number of monthly MHDs that acute medication was taken compared with placebo-treated patients. 
Galcanezumab-treated patients had a greater improvement in functioning (as measured by the MSQ 
Role Function-Restrictive domain score) compared with placebo-treated patients, beginning at 
month 1. More patients treated with galcanezumab achieved clinically significant levels of 
improvement in functioning (responder rate based on MSQ Role Function Restrictive domain) 
compared with those treated with placebo. The 120 mg dose was associated with a statistically 
significant reduction in disability over placebo.  
 
Compared with placebo-treated patients, patients treated with galcanezumab 120 mg or 240 mg had 
significantly greater mean decreases from baseline in the number of monthly MHDs at the first month 
and at all subsequent months up to month 3 (see Figure 2). Additionally, in month 1, patients treated 
with galcanezumab (loading dose of 240 mg) demonstrated significantly fewer weekly MHDs 
compared with placebo-treated patients, at week 1 and each subsequent week.  
 

Figure 2 Reduction in monthly migraine headache days over time in study REGAIN 
 

 
 
 



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Table 3. Efficacy and patient reported outcome measures 
 

  REGAIN – Chronic Migraine 
  Emgality  

Placebo  
  120 mg  240 mg  
  N = 273 N = 274 N = 538 
Efficacy Outcomesa       
MHD       

Baseline 19.36 19.17 19.55 
Mean Change -4.83 -4.62 -2.74 
    Treatment Difference -2.09 -1.88  
    CI95 % (-2.92, -1.26) (-2.71, -1.05)  
    P-value < .001c < .001c   

≥ 50 % MHD Responders        
Percentage, %  27.6 27.5 15.4 
P-value < .001c < .001c   

≥ 75 % MHD Responders       
Percentage, % 7.0 8.8 4.5 
P-value .031d < .001c   

100 % MHD Responders       
Percentage, % 0.7 1.3 0.5 
P-value > .05d > .05d   

MHD with Acute Medication Use       
Baseline 15.12 14.49 15.51 
Mean Change -4.74 -4.25 -2.23 
    Treatment Difference -2.51 -2.01  
    CI95 % (-3.27, -1.76) (-2.77, -1.26)  
    P-value < .001d < .001 c   

Patient-reported Outcome Measuresb       
MSQ Role Function-Restrictive Domain       

N 252 253 494 
Baseline 39.29 38.93 38.37 
Mean Change 21.81 23.05 16.76 
    Treatment Difference 5.06 6.29  
    CI95 % (2.12, 7.99) (3.03, 9.55)  
    P-value < .001d < .001c   

MSQ Role Function Restrictive Domain 
Responders        

N 252 253 494 
Percentage, % 64.3 64.8 54.1 
P-value .003e .002e   

MIDAS Total Score       
N 254 258 504 
Baseline 62.46 69.17 68.66 
Mean Change -20.27 -17.02 -11.53 
    Treatment Difference -8.74 -5.49  
    CI95 % (-16.39, -1.08) (-13.10, 2.12)  
    P-value .025e > .05e   

N = number of patients; CI95 % = 95 % confidence interval. 
aEfficacy outcomes were evaluated across Months 1-3.  
bPatient-reported outcomes were evaluated at Month 3. MSQ role function restrictive domain responders were 
defined as those with an improvement of ≥ 17.14 points for Chronic Migraine at Month 3.  
cStatistically significant after adjustment for multiple comparisons.  
dNot statistically significant after adjustment for multiple comparisons.  
eNot adjusted for multiple comparisons. 



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In patients who failed one or more prophylactic treatments for efficacy reasons, the treatment 
difference for the reduction of mean monthly MHDs observed between galcanezumab 120 mg and 
placebo was -3.54 days (p < 0.001) and between galcanezumab 240 mg and placebo -1.37 days 
(p < 0.05). In patients failing two or more prophylactic treatments, the treatment difference was -
4.48 days (p < 0.001) between 120 mg and placebo and -1.86 days (p < 0.01) between 240 mg and 
placebo. 
 
Sixty-four percent of the patients had acute headache medication overuse at baseline. In these patients, 
the treatment difference observed between galcanezumab 120 mg and placebo and between 
galcanezumab 240 mg and placebo for the reduction of MHDs in these patients was respectively -
2.53 days (p < 0.001) and -2.26 days (p < 0.001).  
 
Long term efficacy 
Efficacy was sustained for up to 1 year in an open-label study in which patients with either episodic or 
chronic migraine (with an average baseline of 10.6 monthly MHDs) received galcanezumab 
120 mg/month (with an initial loading dose of 240 mg for the first month) or galcanezumab 
240 mg/month. 77.8 % of patients completed the treatment period. The overall mean reduction from 
baseline in the number of monthly MHDs averaged over the treatment phase was 5.6 days for the 
120 mg dose group and 6.5 days for the 240 mg dose group. Over 72 % of patients completing the 
study reported a 50 % reduction in MHDs at month 12. In pooled data from studies EVOLVE-1 and 
EVOLVE-2, more than 19 % of the patients treated with galcanezumab maintained a ≥ 50 % response 
from Month 1 to Month 6 versus 8 % of the patients on placebo (p < 0.001). 
 
Phase 3 study in a population with previous failure to 2 to 4 migraine preventive medication 
categories  
Study CONQUER, in episodic and chronic migraine patients that experienced previous failures to 2 to 
4 prophylactic medication categories in the past 10 years, supports the main findings of the previous 
migraine efficacy studies, i.e. galcanezumab treatment led to a mean reduction in monthly migraine 
headache days (4.1 days compared to 1.0 days in the placebo group; p<.0001).  Mean reduction in 
monthly migraine headache days was also observed within the subpopulations of episodic migraine 
(2.9 days for galcanezumab compared with 0.3 days for placebo; p<.0001) and chronic migraine 
(5.9 days for galcanezumab compared with 2.2 days for placebo; p<.0001). 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
galcanezumab in one or more subsets of the paediatric population in the prophylaxis of migraine 
headaches (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Based on a population pharmacokinetic (PK) analysis, following a loading dose of 240 mg the 
maximum serum concentration (Cmax) of galcanezumab was approximately 30 μg/mL 
(27 % coefficient of variation, (CV)) and the time to Cmax was 5 days postdose.  
 
Monthly doses of 120 mg or 240 mg achieved a steady-state Cmax (Cmax, ss) of approximately 28 μg/mL 
(35 % CV) or 54 μg/mL (31 % CV), respectively. The galcanezumab Cmax, ss at monthly doses of 
120 mg is achieved after the 240 mg loading dose. 
 
Injection site location (abdomen, thigh, buttocks and arm) did not significantly influence the 
absorption of galcanezumab. 
 



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Distribution 
 
Based on a population PK analysis, the apparent volume of distribution of galcanezumab was 7.3 L. 
 
Biotransformation 
 
As a humanised IgG4 monoclonal antibody, galcanezumab is expected to be degraded into small 
peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. 
 
Elimination 
 
Based on a population PK analysis, the apparent clearance of galcanezumab was approximately 
0.008 L/hour and the half life of galcanezumab was 27 days.  
 
Linearity/non-linearity 
 
Galcanezumab exposure increases proportionally with dose. 
 
Based on a population PK analysis that included doses ranging from 5 – 300 mg, the rate of 
absorption, apparent clearance and apparent volume of distribution was independent of dose. 
 
Age, sex, weight, race, ethnicity 
 
No dose adjustment is needed on the basis of age (18 to 65 years), sex, weight, race or ethnicity as 
there was no clinically meaningful effect of these factors on the apparent clearance or apparent volume 
of distribution of galcanezumab.  
 
Renal or hepatic impairment 
 
Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic 
impairment on the PK of galcanezumab have not been conducted. Renal elimination of IgG 
monoclonal antibody is low. Similarly, IgG monoclonal antibodies are mainly eliminated via 
intracellular catabolism and hepatic impairment is not expected to influence the clearance of 
galcanezumab. Based on a population PK analysis, bilirubin concentration or Cockcroft-Gault 
creatinine clearance (range: 24 to 308 mL/min) did not significantly influence the apparent clearance 
of galcanezumab. 
 
5.3 Preclinical safety data 
 
Non-clinical data revealed no special hazards for humans based on repeat-dose toxicity studies 
conducted in rats and cynomolgus monkeys and safety pharmacology evaluations conducted in 
cynomolgus monkeys at exposures approximately 10 to 80 times higher than clinical exposures in 
patients receiving 240 mg. 
 
Nonclinical studies have not been conducted to evaluate the carcinogenic or mutagenic potential of 
galcanezumab. There is no evidence to suggest that chronic treatment with galcanezumab would 
increase the risk of carcinogenesis based on data from pharmacology and chronic toxicology studies 
with galcanezumab, as well as an assessment of the literature regarding CGRP.  
 
No effects on fertility parameters such as oestrous cycle, sperm analysis, or mating and reproductive 
performance were observed in rats that were administered galcanezumab (exposures approximately 4 
to 20 times the human exposure at 240 mg). In male fertility study, right testis weight was 
significantly reduced at exposures to 4 times the human exposure at 240 mg. 
 
At Gestational Day 20, an increase in the number of foetuses and litters with short ribs and a decrease 
in the mean number of ossified caudal vertebrae occurred in the rat embryo-foetal toxicity 
development study at an exposure approximately 20 times the human exposure at 240 mg. These 



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findings were noted at no maternal toxicity and were considered to be related to galcanezumab but 
non-adverse.  
 
At Gestational Day 29, in rabbit embryo-foetal development toxicity study skull anomaly was found in 
one male foetus from mother treated with galcanezumab at an exposure approximately 33 times the 
human exposure at 240 mg. 
 
In a juvenile toxicology study in which rats were administered galcanezumab twice weekly from 
Postnatal Day 21 through 90, systemic effects were limited to reversible, minimal, nonadverse 
decreases in total bone mineral content and bone mineral density at exposures approximately 50 times 
the human exposure at 240 mg.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
L-histidine  
L-histidine hydrochloride monohydrate  
Polysorbate 80 
Sodium chloride   
Water for injections 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2 ºC – 8 ºC).  
Do not freeze.  
Store in the original package in order to protect from light. 
 
Emgality may be stored unrefrigerated for up to 7 days when stored at temperatures up to 30 °C. If 
these conditions are exceeded, the pre-filled pen must be discarded.  
 
6.5 Nature and contents of container  
 
1 mL of solution in a type I clear glass syringe. The syringe is encased in a disposable, single-dose 
pen. Packs of 1, 2 or 3 pre-filled pens. Not all pack sizes may be marketed. 
 
The needle included in the pack is only suitable for sub-cutaneous injection. 
 
6.6 Special precautions for disposal and other handling 
 
Instructions for use  
 
The instructions for using the pen included with the Package Leaflet, must be followed carefully. The 
pre-filled pen is for total use only.  
 
The pre-filled pen should be inspected visually prior to administration. Emgality should not be used if 
the solution is cloudy, discoloured or contains particles, or if any part of the device appears to be 
damaged.  



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Do not shake. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands  
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1330/001 
EU/1/18/1330/002 
EU/1/18/1330/005 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation:  14 November 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. 
 

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


15 

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 
 
Emgality 120 mg solution for injection in pre-filled syringe 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each pre-filled syringe contains 120 mg of galcanezumab in 1 mL. 
 
Galcanezumab is a recombinant humanised monoclonal antibody produced in Chinese Hamster Ovary 
cells. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection). 
 
The solution is clear and colourless to slightly yellow. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per 
month. 
 
4.2 Posology and method of administration 
 
Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. 
 
Posology 
 
The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 
240 mg loading dose as the initial dose. 
 
Patients should be instructed to inject a missed dose as soon as possible and then resume monthly 
dosing. 
 
The treatment benefit should be assessed within 3 months after initiation of treatment. Any further 
decision to continue treatment should be taken on an individual patient basis. Evaluation of the need to 
continue treatment is recommended regularly thereafter. 
 
Elderly (≥ 65 years) 
There is limited information in subjects aged ≥ 65 years. No dose adjustment is required as the 
pharmacokinetics of galcanezumab are not affected by age.   
 



16 

Renal impairment/hepatic impairment 
No dose adjustment is required in patients with mild to moderate renal impairment or hepatic 
impairment (see section 5.2).  
 
Paediatric population 
The safety and efficacy of galcanezumab in children aged 6 to 18 years have not yet been established. 
No data are available.  
 
There is no relevant use of galcanezumab in children below the age of 6 years for the prevention of 
migraine.  
 
Method of administration  
 
Subcutaneous use. 
 
A patient may self-inject galcanezumab by following the Instructions for Use. Galcanezumab is to be 
injected subcutaneously in the abdomen, thigh, back of the upper arm, or in the gluteal region. After 
training, patients may self-inject galcanezumab if a healthcare professional determines that it is 
appropriate. Comprehensive instructions for administration are given in the Package Leaflet. 
 
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 
 
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. 
 
Cardiovascular risk 
 
Patients with certain major cardiovascular diseases were excluded from clinical studies (see 
section 5.1). No safety data are available in these patients. 
 
Serious hypersensitivity 
 
Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been 
reported. If a serious hypersensitivity reaction occurs, administration of galcanezumab should be 
discontinued immediately and appropriate therapy initiated.  
 
Excipients  
 
This medicinal product contains less than 1 mmol sodium (23 mg) per 120 mg dose, i.e., is essentially 
“sodium-free”.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based 
on the characteristics of galcanezumab.  
 



17 

4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are limited data from the use of galcanezumab in pregnant women. Animal studies do not 
indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
Human immunoglobulin (IgG) is known to cross the placental barrier. As a precautionary measure, it 
is preferable to avoid the use of galcanezumab during pregnancy. 
 
Breast-feeding 
 
It is unknown whether galcanezumab is excreted in human milk. Human IgG is known to be excreted 
in breast milk during the first days after birth, which is decreasing to low concentrations soon 
afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period. 
Afterwards, use of galcanezumab could be considered during breast-feeding only if clinically needed.  
 
Fertility 
 
The effect of galcanezumab on human fertility has not been evaluated. Fertility studies in animals do 
not indicate harmful effects with respect to male and female fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Galcanezumab may have a minor influence on the ability to drive and use machines. Vertigo may 
occur following the administration of galcanezumab (see section 4.8). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Over 2500 patients were exposed to galcanezumab in clinical studies in migraine prophylaxis. Over 
1400 patients were exposed to galcanezumab during the double-blind treatment phase of the placebo-
controlled phase 3 studies. 279  patients were exposed for 12 months. 
 
The reported adverse drug reactions for 120 mg and 240 mg in the migraine clinical trials were injection 
site pain (10.1 %/11.6 %),  injection site reactions (9.9 %/14.5 %), vertigo (0.7 %/1.2 %), constipation 
(1.0 %/1.5 %), pruritus (0.7 %/1.2 %) and urticaria (0.3 %/0.1 %). Most of the reactions were mild or 
moderate in severity. Less than 2.5 % of patients in these studies discontinued due to adverse events. 
 



18 

Tabulated list of adverse reactions 
 
Table 1. List of adverse reactions in clinical studies and post-marketing reports 
Frequency estimate: 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). 
 

System Organ 
Class 

 

Very common Common Uncommon Rare 

Immune system 
disorders 

   Anaphylaxis 
Angioedema 

Ear and Labyrinth 
System 

 Vertigo   

Gastrointestinal 
System 

 Constipation   

Skin and 
Subcutaneous 
Tissue 

 Pruritus 
Rash 

Urticaria  

General disorders 
and administration 
site conditions 

Injection site 
pain 
Injection site 
reactionsa 

   

a Most frequently reported terms (≥ 1 %) were: Injection site reaction, Injection site erythema, 
Injection site pruritus, Injection site bruising, Injection site swelling. 

 
Description of selected adverse reactions 
 
Injection site pain or reactions  
The majority of events related to the injection site were mild to moderate and less than 0.5 % of 
patients exposed to galcanezumab during the phase 3 studies discontinued the treatment due to an 
injection site reaction. The majority of injection site reactions were reported within 1 day and on 
average resolved within 5 days. In 86 % of the patients reporting injection site pain, the event occurred 
within 1 hour of injection and resolved on average in 1 day. One percent of the patients exposed to 
galcanezumab during the phase 3 studies experienced severe pain at the injection site. 
 
Urticaria 
While urticaria is uncommon, serious cases of urticaria have been reported in galcanezumab clinical 
studies. 
 
Immunogenicity 
In the clinical studies, the incidence of anti-drug antibody development during the double-blind 
treatment phase was 4.8 % in patients receiving galcanezumab once monthly (all but one of whom had 
in vitro neutralizing activity). With 12 months of treatment, up to 12.5 % of galcanezumab-treated 
patients developed anti-drug antibodies, most of which were of low titre and tested positive for 
neutralising activity in vitro. However, the presence of anti-drug antibodies did not affect the 
pharmacokinetics, efficacy, or safety of galcanezumab. 
 
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. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


19 

4.9 Overdose 
 
Doses up to 600 mg have been administered subcutaneously to humans without dose-limiting toxicity. 
In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of 
adverse reactions and appropriate symptomatic treatment be instituted immediately. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: analgesics, calcitonin gene-related peptide (CGRP) antagonists, ATC 
code: N02CD02 
 
Mechanism of action 
 
Galcanezumab is a humanised IgG4 monoclonal antibody that binds calcitonin gene-related peptide 
(CGRP) thus preventing its biological activity. Elevated blood concentrations of CGRP have been 
associated with migraine attacks. Galcanezumab binds to CGRP with high affinity (KD = 31 pM) and 
high specificity (> 10,000-fold vs related peptides adrenomedullin, amylin, calcitonin and intermedin).  
 
Clinical efficacy and safety 
 
The efficacy and safety of galcanezumab has been studied in 3 phase 3, randomized, placebo-
controlled, double-blind studies in adult patients (N = 2886). The 2 episodic migraine studies 
(EVOLVE-1 and EVOLVE-2) enrolled patients who met International Classification of Headache 
Disorders (ICHD) criteria for a diagnosis of migraine with or without aura with 4-14 migraine 
headache days per month. The chronic migraine study (REGAIN) enrolled patients who met ICHD 
criteria for chronic migraine with ≥ 15 headache days per month, of which at least 8 had the features 
of migraine. Patients with recent acute cardiovascular events (including MI, unstable angina, CABG, 
stroke, DVT) and/or those deemed to be at serious cardiovascular risk were excluded from the 
galcanezumab clinical trials. Patients > 65 years of age were also excluded. 
 
Patients received placebo, galcanezumab 120 mg/month (with an initial loading dose of 240 mg for the 
first month) or galcanezumab 240 mg/month and were allowed to use medication for the acute 
treatment of migraine. Across the 3 studies, patients were predominantly female (> 83 %) with a mean 
age of 41 years, and an average migraine history of 20 to 21 years. Approximately one-third of 
patients across the studies had at least 1 prior failure on a migraine prophylactic treatment for efficacy 
reasons and approximately 16 % of patients across the studies had at least 2 prior failure on a 
prophylactic treatment for efficacy reasons. 
 
In all 3 studies, the overall mean change from baseline in number of monthly Migraine Headache 
Days (MHDs) was the primary efficacy measure. Response rate is the mean percentage of patients 
meeting a defined threshold in the reduction of the number of monthly MHDs (≥ 50 %, ≥ 75 % and 
100 %) across the double-blind treatment period. The impact of migraine on functioning was assessed 
by the Role Function-Restrictive domain of the Migraine-Specific Quality of Life Questionnaire 
(MSQ) version 2.1, and by the Migraine Disability Assessment (MIDAS) Questionnaire. The MSQ 
measures impact of migraine on work or daily activities, relationships with family and friends, leisure 
time, productivity, concentration, energy, and tiredness. Scoring ranges from 0 to 100, with higher 
scores indicating less impairment , that is, patients experience fewer restrictions on the performance of 
day-to-day activities. For the MIDAS, higher scores indicate more disability. The baseline scores of 
the MIDAS reflected severe migraine related disability of patients in EVOLVE-1 and EVOLVE-2 
(mean of 33.1) and a very severely disabled population (mean of 67.2) in REGAIN.   
  



20 

Episodic migraine 
Studies EVOLVE-1 and EVOLVE-2 had a 6 month, double-blind, placebo-controlled treatment 
period. Completion rate of the double-blind treatment phase for patients who received galcanezumab 
ranged from 82.8 % to 87.7 %.  
 
Both galcanezumab 120 mg and 240 mg treatment groups demonstrated statistically significant and 
clinically meaningful improvements from baseline compared to placebo on mean change in MHD (see 
Table 2). Patients treated with galcanezumab had greater response rates and greater reductions in the 
number of monthly MHDs that acute medication was taken compared with placebo-treated patients. 
Galcanezumab-treated patients had a greater improvement in functioning (as measured by the MSQ 
Role Function-Restrictive domain score) compared with placebo-treated patients, beginning at 
month 1. More patients treated with galcanezumab achieved clinically significant levels of 
improvement in functioning (responder rate based on MSQ Role Function Restrictive domain) 
compared with those treated with placebo. Galcanezumab was associated with a statistically 
significant reduction in disability over placebo. 
 
Compared with placebo-treated patients, patients treated with galcanezumab 120 mg or 240 mg had 
significantly greater mean decreases from baseline in the number of monthly MHDs at month 1 and at 
all subsequent months up to month 6 (see Figure 1). Additionally, in month 1, patients treated with 
galcanezumab (loading dose of 240 mg) demonstrated significantly fewer weekly MHDs compared 
with placebo-treated patients, at week 1 and each subsequent week.  
 

Figure 1 Reduction in monthly migraine headache days over time in studies EVOLVE-1 and 
EVOLVE-2 

 

 
 



21 

Table 2. Efficacy and patient reported outcome measures 
 

  EVOLVE-1 – Episodic Migraine EVOLVE-2 - Episodic Migraine 
 Emgality  

Placebo  
Emgality  

Placebo   120 mg 240 mg 120 mg  240 mg 
  N = 210 N = 208 N = 425 N = 226 N = 220 N = 450 

Efficacy Outcomesa 
MHD             

Baseline 9.21 9.14 9.08 9.07 9.06 9.19 
Mean Change -4.73 -4.57 -2.81 -4.29 -4.18 -2.28 
    Treatment Difference -1.92 -1.76  -2.02 -1.90  
    CI95 % (-2.48, -1.37) (-2.31, -1.20)  (-2.55, -1.48) (-2.44, -1.36)  
    P-value < .001d < .001d   < .001d < .001d   

≥ 50 % MHD Responders              
Percentage, %  62.3 60.9 38.6 59.3 56.5 36.0 
P-value < .001d < .001d   < .001d < .001d   

≥ 75 % MHD Responders             
Percentage, % 38.8 38.5 19.3 33.5 34.3 17.8 
P-value < .001d < .001d   < .001d < .001d   

100 % MHD Responders             
Percentage, % 15.6 14.6 6.2 11.5 13.8 5.7 
P-value < .001d < .001d   < .001d < .001d   

MHD with Acute 
Medication Use             

Baseline 7.42 7.34 7.38 7.47 7.47 7.62 
Mean Change -3.96 -3.76 -2.15 -3.67 -3.63 -1.85 
    Treatment Difference -1.81 -1.61  -1.82 -1.78  
    CI95 % (-2.28, -1.33) (-2.09, -1.14)  (-2.29, -1.36) (-2.25, -1.31)  
    P-value < .001d < .001d   < .001d < .001d   

Patient-reported Outcome Measures 
MSQ Role Function-
Restrictive Domainb             

N 189 184 377 213 210 396 
Baseline 51.39 48.76 52.92 52.47 51.71 51.35 
Mean Change 32.43 32.09 24.69 28.47 27.04 19.65 
    Treatment Difference 7.74 7.40  8.82 7.39  
    CI95 % (5.20, 10.28) (4.83, 9.97)  (6.33, 11.31) (4.88, 9.90)  
    P-value < .001d < .001d   < .001d < .001d   

MSQ Role Function 
Restrictive Domain 
Respondersc             

N 189 184 377 213 210 396 
Percentage, % 63.5 69.6 47.2 58.2 60.0 43.4 
P-value < .001f < .001f   < .001f < .001f   

MIDAS Total Scoree             
N 177  170 345 202 194 374  
Baseline 32.93 36.09 31.84 30.87 32.75 34.25 
Mean Change -21.16 -20.06 -14.87 -21.17 -20.24 -12.02 
    Treatment Difference -6.29 -5.19  -9.15 -8.22  
    CI95% (-9.45, -3.13) (-8.39, -1.98)  (-12.61, -5.69) (-11.71, -4.72)  
    P-value < .001f .002f    < .001f < .001f   

 

N = number of patients; CI95 % = 95 % confidence interval.  
aEfficacy outcomes were evaluated across Months 1-6. 
bEvaluated across Months 4-6. 
cDefined as those with an improvement of ≥ 25 points for Episodic Migraine at Months 4-6 average.  



22 

dStatistically significant after adjustment for multiple comparisons.  
eEvaluated at Month 6.  
fNot adjusted for multiple comparisons. 
 
In pooled data from studies EVOLVE-1 and EVOLVE-2, in patients who failed one or more 
prophylactic treatments for efficacy reasons, the treatment difference for the reduction of mean 
monthly MHDs observed between galcanezumab 120 mg and placebo was -2.69 days (p < 0.001) and 
between galcanezumab 240 mg and placebo -2.78 days (p < 0.001). In patients failing two or more 
prophylactic treatments, the treatment difference was -2.64 days (p < 0.001) between 120 mg and 
placebo and -3.04 days (p < 0.001) between 240 mg and placebo.  
 
Chronic Migraine 
Study REGAIN had a 3 month, double-blind, placebo-controlled treatment period followed by a 
9 month open-label extension. Approximately 15 % of the patients continued concurrent treatment 
with topiramate or propranolol as allowed by the protocol for prophylaxis of migraine. Completion 
rate of the double-blind treatment phase for patients who received galcanezumab was 95.3 %.  
 
Both galcanezumab 120 mg and 240 mg treatment groups demonstrated statistically significant and 
clinically meaningful improvements from baseline compared to placebo on mean change in MHD (see 
Table 3). Patients treated with galcanezumab had greater response rates and greater reductions in the 
number of monthly MHDs that acute medication was taken compared with placebo-treated patients. 
Galcanezumab-treated patients had a greater improvement in functioning (as measured by the MSQ 
Role Function-Restrictive domain score) compared with placebo-treated patients, beginning at 
month 1. More patients treated with galcanezumab achieved clinically significant levels of 
improvement in functioning (responder rate based on MSQ Role Function Restrictive domain) 
compared with those treated with placebo. The 120 mg dose was associated with a statistically 
significant reduction in disability over placebo.  
 
Compared with placebo-treated patients, patients treated with galcanezumab 120 mg or 240 mg had 
significantly greater mean decreases from baseline in the number of monthly MHDs at the first month 
and at all subsequent months up to month 3 (see Figure 2). Additionally, in month 1, patients treated 
with galcanezumab (loading dose of 240 mg) demonstrated significantly fewer weekly MHDs 
compared with placebo-treated patients, at week 1 and each subsequent week.  
 

Figure 2 Reduction in monthly migraine headache days over time in study REGAIN 
 

 
 
 



23 

Table 3. Efficacy and patient reported outcome measures 
 

  REGAIN – Chronic Migraine 
  Emgality  

Placebo  
  120 mg  240 mg  
  N = 273 N = 274 N = 538 
Efficacy Outcomesa       
MHD       

Baseline 19.36 19.17 19.55 
Mean Change -4.83 -4.62 -2.74 
    Treatment Difference -2.09 -1.88  
    CI95 % (-2.92, -1.26) (-2.71, -1.05)  
    P-value < .001c < .001c   

≥ 50 % MHD Responders        
Percentage, %  27.6 27.5 15.4 
P-value < .001c < .001c   

≥ 75 % MHD Responders       
Percentage, % 7.0 8.8 4.5 
P-value .031d < .001c   

100 % MHD Responders       
Percentage, % 0.7 1.3 0.5 
P-value > .05d > .05d   

MHD with Acute Medication Use       
Baseline 15.12 14.49 15.51 
Mean Change -4.74 -4.25 -2.23 
    Treatment Difference -2.51 -2.01  
    CI95 % (-3.27, -1.76) (-2.77, -1.26)  
    P-value < .001d < .001 c   

Patient-reported Outcome Measuresb       
MSQ Role Function-Restrictive Domain       

N 252 253 494 
Baseline 39.29 38.93 38.37 
Mean Change 21.81 23.05 16.76 
    Treatment Difference 5.06 6.29  
    CI95 % (2.12, 7.99) (3.03, 9.55)  
    P-value < .001d < .001c   

MSQ Role Function Restrictive Domain 
Responders        

N 252 253 494 
Percentage, % 64.3 64.8 54.1 
P-value .003e .002e   

MIDAS Total Score       
N 254 258 504 
Baseline 62.46 69.17 68.66 
Mean Change -20.27 -17.02 -11.53 
    Treatment Difference -8.74 -5.49  
    CI95 % (-16.39, -1.08) (-13.10, 2.12)  
    P-value .025e > .05e   

N = number of patients; CI95 % = 95 % confidence interval. 
aEfficacy outcomes were evaluated across Months 1-3.  
bPatient-reported outcomes were evaluated at Month 3. MSQ role function restrictive domain responders were 
defined as those with an improvement of ≥ 17.14 points for Chronic Migraine at Month 3.  
cStatistically significant after adjustment for multiple comparisons.  
dNot statistically significant after adjustment for multiple comparisons.  
eNot adjusted for multiple comparisons. 



24 

 
In patients who failed one or more prophylactic treatments for efficacy reasons, the treatment 
difference for the reduction of mean monthly MHDs observed between galcanezumab 120 mg and 
placebo was -3.54 days (p < 0.001) and between galcanezumab 240 mg and placebo -1.37 days 
(p < 0.05). In patients failing two or more prophylactic treatments, the treatment difference was -
4.48 days (p < 0.001) between 120 mg and placebo and -1.86 days (p < 0.01) between 240 mg and 
placebo. 
 
Sixty-four percent of the patients had acute headache medication overuse at baseline. In these patients, 
the treatment difference observed between galcanezumab 120 mg and placebo and between 
galcanezumab 240 mg and placebo for the reduction of MHDs in these patients was respectively -
2.53 days (p < 0.001) and -2.26 days (p < 0.001).  
 
Long term efficacy 
Efficacy was sustained for up to 1 year in an open-label study in which patients with either episodic or 
chronic migraine (with an average baseline of 10.6 monthly MHDs) received galcanezumab 
120 mg/month (with an initial loading dose of 240 mg for the first month) or galcanezumab 
240 mg/month. 77.8 % of patients completed the treatment period. The overall mean reduction from 
baseline in the number of monthly MHDs averaged over the treatment phase was 5.6 days for the 
120 mg dose group and 6.5 days for the 240 mg dose group. Over 72 % of patients completing the 
study reported a 50 % reduction in MHDs at month 12. In pooled data from studies EVOLVE-1 and 
EVOLVE-2, more than 19 % of the patients treated with galcanezumab maintained a ≥ 50 % response 
from Month 1 to Month 6 versus 8 % of the patients on placebo (p < 0.001). 
 
Phase 3 study in a population with previous failure to 2 to 4 migraine preventive medication 
categories  
Study CONQUER, in episodic and chronic migraine patients that experienced previous failures to 2 to 
4 prophylactic medication categories in the past 10 years, supports the main findings of the previous 
migraine efficacy studies, i.e. galcanezumab treatment led to a mean reduction in monthly migraine 
headache days (4.1 days compared to 1.0 days in the placebo group; p<.0001).  Mean reduction in 
monthly migraine headache days was also observed within the subpopulations of episodic migraine 
(2.9 days for galcanezumab compared with 0.3 days for placebo; p<.0001) and chronic migraine 
(5.9 days for galcanezumab compared with 2.2 days for placebo; p<.0001). 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
galcanezumab in one or more subsets of the paediatric population in the prophylaxis of migraine 
headaches (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Based on a population pharmacokinetic (PK) analysis, following a loading dose of 240 mg the 
maximum serum concentration (Cmax) of galcanezumab was approximately 30 μg/mL 
(27 % coefficient of variation, (CV)) and the time to Cmax was 5 days postdose.  
 
Monthly doses of 120 mg or 240 mg achieved a steady-state Cmax (Cmax, ss) of approximately 28 μg/mL 
(35 % CV) or 54 μg/mL (31 % CV), respectively. The galcanezumab Cmax, ss at monthly doses of 
120 mg is achieved after the 240 mg loading dose. 
 
Injection site location (abdomen, thigh, buttocks and arm) did not significantly influence the 
absorption of galcanezumab. 
 



25 

Distribution 
 
Based on a population PK analysis, the apparent volume of distribution of galcanezumab was 7.3 L. 
 
Biotransformation 
 
As a humanised IgG4 monoclonal antibody, galcanezumab is expected to be degraded into small 
peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. 
 
Elimination 
 
Based on a population PK analysis, the apparent clearance of galcanezumab was approximately 
0.008 L/hour and the half life of galcanezumab was 27 days.  
 
Linearity/non-linearity 
 
Galcanezumab exposure increases proportionally with dose. 
 
Based on a population PK analysis that included doses ranging from 5 – 300 mg, the rate of 
absorption, apparent clearance and apparent volume of distribution was independent of dose. 
 
Age, sex, weight, race, ethnicity 
 
No dose adjustment is needed on the basis of age (18 to 65 years), sex, weight, race or ethnicity as 
there was no clinically meaningful effect of these factors on the apparent clearance or apparent volume 
of distribution of galcanezumab.  
 
Renal or hepatic impairment 
 
Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic 
impairment on the PK of galcanezumab have not been conducted. Renal elimination of IgG 
monoclonal antibody is low. Similarly, IgG monoclonal antibodies are mainly eliminated via 
intracellular catabolism and hepatic impairment is not expected to influence the clearance of 
galcanezumab. Based on a population PK analysis, bilirubin concentration or Cockcroft-Gault 
creatinine clearance (range: 24 to 308 mL/min) did not significantly influence the apparent clearance 
of galcanezumab. 
 
5.3 Preclinical safety data 
 
Non-clinical data revealed no special hazards for humans based on repeat-dose toxicity studies 
conducted in rats and cynomolgus monkeys and safety pharmacology evaluations conducted in 
cynomolgus monkeys at exposures approximately 10 to 80 times higher than clinical exposures in 
patients receiving 240 mg. 
 
Nonclinical studies have not been conducted to evaluate the carcinogenic or mutagenic potential of 
galcanezumab. There is no evidence to suggest that chronic treatment with galcanezumab would 
increase the risk of carcinogenesis based on data from pharmacology and chronic toxicology studies 
with galcanezumab, as well as an assessment of the literature regarding CGRP.  
 
No effects on fertility parameters such as oestrous cycle, sperm analysis, or mating and reproductive 
performance were observed in rats that were administered galcanezumab (exposures approximately 4 
to 20 times the human exposure at 240 mg). In male fertility study, right testis weight was 
significantly reduced at exposures to 4 times the human exposure at 240 mg. 
 
At Gestational Day 20, an increase in the number of foetuses and litters with short ribs and a decrease 
in the mean number of ossified caudal vertebrae occurred in the rat embryo-foetal toxicity 
development study at an exposure approximately 20 times the human exposure at 240 mg. These 



26 

findings were noted at no maternal toxicity and were considered to be related to galcanezumab but 
non-adverse.  
 
At Gestational Day 29, in rabbit embryo-foetal development toxicity study skull anomaly was found in 
one male foetus from mother treated with galcanezumab at an exposure approximately 33 times the 
human exposure at 240 mg. 
 
In a juvenile toxicology study in which rats were administered galcanezumab twice weekly from 
Postnatal Day 21 through 90, systemic effects were limited to reversible, minimal, nonadverse 
decreases in total bone mineral content and bone mineral density at exposures approximately 50 times 
the human exposure at 240 mg.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
L-histidine  
L-histidine hydrochloride monohydrate  
Polysorbate 80 
Sodium chloride   
Water for injections 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2 ºC – 8 ºC).  
Do not freeze.  
Store in the original package in order to protect from light. 
 
Emgality may be stored unrefrigerated for up to 7 days when stored at temperatures up to 30 °C. If 
these conditions are exceeded, the pre-filled syringe must be discarded.  
 
6.5 Nature and contents of container  
 
1 mL of solution in a type I clear glass single-dose syringe. Pack sizes of 1, 2 or 3 pre-filled syringes. 
Not all pack sizes may be marketed. 
 
The needle included in the pack is only suitable for sub-cutaneous injection. 
 
6.6 Special precautions for disposal and other handling 
 
Instructions for use  
 
The instructions for using the syringe included with the Package Leaflet, must be followed carefully. 
The pre-filled syringe is for total use only.  
 
The pre-filled syringe should be inspected visually prior to administration. Emgality should not be 
used if the solution is cloudy, discoloured or contains particles, or if any part of the device appears to 
be damaged.  



27 

 
Do not shake. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands  
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1330/003 
EU/1/18/1330/004 
EU/1/18/1330/006 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation:  14 November 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. 
 
  

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


28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 

 



29 

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)  
 
ImClone Systems LLC 
33 ImClone Drive 
Branchburg 
New Jersey 
NJ 08876 
United States 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Eli Lilly Italia S.p.A. 
Via Gramsci, 731-733 
50019 
Sesto Fiorentino (FI) 
Italy 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription. 

 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports (PSURs) 

 
The requirements for submission of PSURs 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. 
 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 

 
The marketing authorisation holder (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.  

  



30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 

  



31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
A. LABELLING 

  



32 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON - PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Emgality 120 mg solution for injection in pre-filled syringe  
galcanezumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 120 mg of galcanezumab  
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: L-histidine, L-histidine hydrochloride monohydrate, sodium chloride, polysorbate 80,  
water for injections. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
1 pre-filled syringe 
3 pre-filled syringes 
2 pre-filled syringes 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use. 
For single use only.  
Do not shake. 
 
 
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.  



33 

Do not freeze.  
Store in the original package in order to protect from light. 
Emgality may be stored unrefrigerated for a single period up to 7 days when stored at temperatures up 
to 30 °C. 
 
 
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 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1330/003 (1 pre-filled syringe) 
EU/1/18/1330/004 (3 pre-filled syringes) 
EU/1/18/1330/006 (2 pre-filled syringes) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Emgality 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



34 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL   
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Emgality 120 mg injection  
galcanezumab  
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 mL 
 
 
6. OTHER 
 
 
  



35 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - PRE-FILLED PEN 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Emgality 120 mg solution for injection in pre-filled pen 
galcanezumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 120 mg of galcanezumab  
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: L-histidine, L-histidine hydrochloride monohydrate, sodium chloride, polysorbate 80,  
water for injections. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
1 pre-filled pen  
3 pre-filled pens  
2 pre-filled pens  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use. 
For single use only.  
Do not shake. 
 
 
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.  



36 

Do not freeze.  
Store in the original package in order to protect from light. 
Emgality may be stored unrefrigerated for a single period up to 7 days when stored at temperatures up 
to 30 °C 
 
 
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 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1330/001 (1 pre-filled pen) 
EU/1/18/1330/002 (3 pre-filled pens) 
EU/1/18/1330/005 (2 pre-filled pens) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Emgality 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



37 

 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL   
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Emgality 120 mg injection  
galcanezumab  
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 mL 
 
 
6. OTHER 
 
 
  



38 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



39 

Package leaflet: Information for the patient 
 

Emgality 120 mg solution for injection in pre-filled pen 
 

galcanezumab 
 

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 Emgality is and what it is used for  
2. What you need to know before you use Emgality  
3. How to use Emgality  
4. Possible side effects  
5. How to store Emgality  
6. Contents of the pack and other information 
 
 
1. What Emgality is and what it is used for 
 
Emgality contains galcanezumab, a medicine that stops the activity of a naturally occurring substance 
in the body called calcitonin gene-related peptide (CGRP). People with migraine may have increased 
levels of CGRP.  
 
Emgality is used to prevent migraine in adult patients who have at least 4 migraines days per month.  
 
Emgality can reduce the frequency of migraine headache and improve your quality of life. It starts 
working in about a week. 
 
 
2. What you need to know before you use Emgality 
 
Do not use Emgality: 
- if you are allergic to galcanezumab or any of the other ingredients of this medicine (listed in 

section 6).   
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before or during treatment with Emgality if: 

- you have a serious cardiovascular disease. Emgality has not been studied in patients with 
serious cardiovascular diseases. 

 
Look out for allergic reactions 
Emgality can potentially cause serious allergic reactions. You must look out for signs of these 
reactions while you are using Emgality. Stop using Emgality and tell your doctor or seek medical help 



40 

immediately if you notice any signs of a serious allergic reaction. Such signs are listed under “Serious 
side effects” in section 4.  
 
Children and adolescents 
This medicine should not be given to children and adolescents under 18 years of age because it has not 
been studied in this age group. 
 
Other medicines and Emgality  
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other 
medicines. 
 
Pregnancy and breast-feeding  
If you are a woman able to have children, you are advised to avoid becoming pregnant while using 
Emgality.  
 
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for 
advice before taking this medicine. It is preferable to avoid the use of Emgality in pregnancy as the 
effects of this medicine in pregnant women are not known.  
 
If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. 
You and your doctor should decide if you should breast feed and use Emgality .    
 
Driving and using machines 
Galcanezumab could have a minor effect on your ability to drive and use machines. Some patients 
have had vertigo whilst using Emgality. 
 
Emgality contains sodium  
This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say it is 
essentially “sodium-free”. 
 
 
3. How to use Emgality 
 
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your 
doctor, pharmacist or nurse if you are not sure.  
 
Emgality pre-filled pen is for single use only and contains one dose of Emgality (120 mg).    

- The first time you receive Emgality your doctor or nurse will inject two pens (total 240 mg).  
- After the first dose, you will use one pen (120 mg) every month. 

 
Your doctor will decide for how long you should use Emgality. 
 
Emgality is given by injection under your skin (subcutaneous injection). You and your doctor or nurse 
should decide if you can inject Emgality yourself. 
 
It is important not to try to inject yourself until you have been trained by your doctor or nurse. A 
caregiver may also give you your Emgality injection after proper training.  
 
The pen must not be shaken. 
 
Read the “Instructions for Use” for the pen carefully before using Emgality. 
 
If you use more Emgality than you should 
If you have injected more Emgality than you should, e.g. if after the first dose of 240 mg, you have 
injected it twice in a single month, or if anyone else has accidentally used Emgality, contact your 
doctor immediately. 
 



41 

If you forget to use Emgality 
Do not take a double dose to make up for forgotten injection   
 
If you have forgotten to inject a dose of Emgality, inject the missed dose as soon as possible and then 
inject the next dose after a month from that date.  
 
If you stop using Emgality 
You should not stop using Emgality without speaking to your doctor first. 
 
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.   
  
Serious side effects 
 
Allergic reactions with Emgality are usually mild to moderate (such as rash or itching). Serious 
allergic reactions may occur rarely (may affect up to 1 in 1,000 people) and the signs may include:  

- difficulty breathing or swallowing, 
- low blood pressure, which can cause dizziness or light-headedness, 
- swelling of the neck, face, mouth, lips, tongue or throat which may develop rapidly, 
- severe itching of the skin, with a red rash or raised bumps. 

 
Tell your doctor or get emergency medical help straight away if you notice any of those signs. 
 
Other side effects that have been reported. 
 
Very common side effects (may affect more than 1 in 10 people): 

- Injection site pain 
- Injection site reactions (e.g. red skin, itching, bruising, swelling) 

 
Common side effects (may affect up to 1 in 10 people): 

- Vertigo (a feeling of dizziness or “spinning”) 
- Constipation 
- Itching 
- Rash 

 
Uncommon side effects (may affect up to 1 in 100 people): 

- Hives (raised itchy areas of skin) 
 
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 Emgality 
 
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 on the carton after 
“EXP.”  The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2 °C to 8 °C). Do not freeze. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


42 

 
Store in the original package in order to protect from light. 
 
Emgality may be stored unrefrigerated for single period up to 7 days when stored at temperatures up to 
30 °C. If the pen is stored at a higher temperature or for a longer period it must be discarded.  
 
Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy or has 
particles in it.   
 
Do not throw away any medicines via wastewater or household waste. Ask your doctor, nurse or 
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 Emgality contains  
The active substance is galcanezumab.  Each pre-filled pen contains 120 mg of galcanezumab in 1 mL 
solution.  
 
The other ingredients are: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium 
chloride and water for injections. 
 
What Emgality looks like and contents of the pack 
Emgality is a solution for injection in a clear glass syringe.  Its colour may vary from colourless to 
slightly yellow. 
 
The syringe is encased in a disposable, single-dose pen. Pack sizes of 1, 2 or 3 pre-filled pens.   
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
Eli Lilly Nederland B. V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.  
 
Manufacturer: 
Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
  
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 

 
България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 

 
Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

 
Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 60 00 

 
Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 



43 

 
Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 

 
Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

 
Eesti 
Eli Lilly Nederland B. V. 
Tel: +372 6 817 280 

 
Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

 
Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 

 
Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 

 
España 
Lilly S.A. 
Tel: + 34-91 663 50 00 

 
Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

 
France 
Lilly France 
Tél: +33-(0) 1 55 49 34 34 
 

 
Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

 
Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 

 
Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 

 
Ísland 
Icepharma hf. 
Sími + 354 540 8000 

 
Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 

 
Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 

 
Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 

 
Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 

 
Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

 
Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: 
+371 67364000 

 
United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
 
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 



44 

Package leaflet: Information for the patient 
 

Emgality 120 mg solution for injection in pre-filled syringe  
 

galcanezumab 
 

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 Emgality is and what it is used for  
2. What you need to know before you use Emgality  
3. How to use Emgality  
4. Possible side effects  
5. How to store Emgality  
6. Contents of the pack and other information 
 
 
1. What Emgality is and what it is used for 
 
Emgality contains galcanezumab, a medicine that stops the activity of a naturally occurring substance 
in the body called calcitonin gene-related peptide (CGRP). People with migraine may have increased 
levels of CGRP.  
 
Emgality is used to prevent migraine in adult patients who have at least 4 migraines days per month.  
 
Emgality can reduce the frequency of migraine headache and improve your quality of life. It starts 
working in about a week. 
 
 
2. What you need to know before you use Emgality 
 
Do not use Emgality: 
- if you are allergic to galcanezumab or any of the other ingredients of this medicine (listed in 

section 6).   
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before or during treatment with Emgality if: 

- you have a serious cardiovascular disease. Emgality has not been studied in patients with 
serious cardiovascular diseases. 

 
Look out for allergic reactions 
Emgality can potentially cause serious allergic reactions. You must look out for signs of these 
reactions while you are using Emgality. Stop using Emgality and tell your doctor or seek medical help 



45 

immediately if you notice any signs of a serious allergic reaction. Such signs are listed under “Serious 
side effects” in section 4.  
 
Children and adolescents 
This medicine should not be given to children and adolescents under 18 years of age because it has not 
been studied in this age group. 
 
Other medicines and Emgality  
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other 
medicines. 
 
Pregnancy and breast-feeding  
If you are a woman able to have children, you are advised to avoid becoming pregnant while using 
Emgality.  
 
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for 
advice before taking this medicine. It is preferable to avoid the use of Emgality in pregnancy as the 
effects of this medicine in pregnant women are not known.  
 
If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. 
You and your doctor should decide if you should breast feed and use Emgality .    
 
Driving and using machines 
Galcanezumab could have a minor effect on your ability to drive and use machines. Some patients 
have had vertigo whilst using Emgality. 
 
Emgality contains sodium  
This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say it is 
essentially “sodium-free”. 
 
 
3. How to use Emgality 
 
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your 
doctor, pharmacist or nurse if you are not sure.  
 
Emgality pre-filled syringe is for single use only and contains one dose of Emgality (120 mg).    

- The first time you receive Emgality your doctor or nurse will inject two syringes (total 240 mg).  
- After the first dose, you will use one syringe (120 mg) every month. 

 
Your doctor will decide for how long you should use Emgality. 
 
Emgality is given by injection under your skin (subcutaneous injection). You and your doctor or nurse 
should decide if you can inject Emgality yourself. 
 
It is important not to try to inject yourself until you have been trained by your doctor or nurse. A 
caregiver may also give you your Emgality injection after proper training.  
 
The syringe must not be shaken. 
 
Read the “Instructions for Use” for the syringe carefully before using Emgality. 
 
If you use more Emgality than you should 
If you have injected more Emgality than you should, e.g. if after the first dose of 240 mg, you have 
injected it twice in a single month, or if anyone else has accidentally used Emgality, contact your 
doctor immediately. 
 



46 

If you forget to use Emgality 
Do not take a double dose to make up for forgotten injection   
 
If you have forgotten to inject a dose of Emgality, inject the missed dose as soon as possible and then 
inject the next dose after a month from that date.  
 
If you stop using Emgality 
You should not stop using Emgality without speaking to your doctor first. 
 
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.   
  
Serious side effects 
 
Allergic reactions with Emgality are usually mild to moderate (such as rash or itching). Serious 
allergic reaction may occur rarely (may affect up to 1 in 1,000 people) and the signs may include: 

- difficulty breathing or swallowing, 
- low blood pressure, which can cause dizziness or light-headedness, 
- swelling of the neck, face, mouth, lips, tongue or throat which may develop rapidly, 
- severe itching of the skin, with a red rash or raised bumps. 

 
Tell your doctor or get emergency medical help straight away if you notice any of those signs. 
 
Other side effects that have been reported. 
 
Very common side effects (may affect more than 1 in 10 people): 

- Injection site pain 
- Injection site reactions (e.g. red skin, itching, bruising, swelling) 

 
Common side effects (may affect up to 1 in 10 people): 

- Vertigo (a feeling of dizziness or “spinning”) 
- Constipation 
- Itching 
- Rash 

 
Uncommon side effects (may affect up to 1 in 100 people): 

- Hives (raised itchy areas of skin) 
 
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 Emgality 
 
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 on the carton after 
“EXP.”  The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2 °C to 8 °C). Do not freeze. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


47 

 
Store in the original package in order to protect from light. 
 
Emgality may be stored unrefrigerated for a single period up to 7 days when stored at temperatures up 
to 30 °C. If the syringe is stored at a higher temperature or for a longer period it must be discarded. 
 
Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy or has 
particles in it.   
 
Do not throw away any medicines via wastewater or household waste. Ask your doctor, nurse or 
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 Emgality contains  
The active substance is galcanezumab. . Each pre-filled syringe contains 120 mg of galcanezumab in 
1 mL solution. 
 
The other ingredients are: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium 
chloride and water for injections. 
 
What Emgality looks like and contents of the pack 
Emgality is a solution for injection in a clear glass single-dose syringe. Its colour may vary from 
colourless to slightly yellow. Pack sizes of 1, 2 or 3 pre-filled syringes.  
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
Eli Lilly Nederland B. V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.  
 
Manufacturer: 
Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
  
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 

 
България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

 
Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

 
Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 60 00 

 
Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 



48 

 
Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

 
Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B. V. 
Tel: +372 6 817 280 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

 
Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 

 
Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 

 
España 
Lilly S.A. 
Tel: + 34-91 663 50 00 

 
Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

 
France 
Lilly France 
Tél: +33-(0) 1 55 49 34 34 
 

 
Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

 
Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 

 
Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 

 
Ísland 
Icepharma hf. 
Sími + 354 540 8000 

 
Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 

 
Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 

 
Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 

 
Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 

 
Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

 
Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: 
+371 67364000 

 
United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
 
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 
  



49 

 
Instructions for use 

 
Emgality 120 mg solution for injection in pre-filled pen 

 
Galcanezumab 

 
For subcutaneous use 

 

 
 
 
Before using your pre-filled pen (pen): 
 
Important Information 
 

• Your doctor or nurse should show you how to prepare and inject Emgality using the pen. 
Do not inject yourself or someone else until you have been shown how to inject Emgality. 

• Keep these instructions and refer to them as needed. 
• Each pen is for ONE-TIME USE ONLY. Do not share or reuse your pen. Otherwise, you 

may give or get an infection. 

• The pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not 
use it. Use a new pen for your injection. 

• Your doctor, pharmacist or nurse can help you decide where on your body to inject your 
dose. You can also read the “Choose your injection site” section of these instructions to 
help you choose which area can work best for you. 

• If you have vision or hearing problems, do not use the pen without help from a caregiver. 

 
 
INSTRUCTIONS FOR USE 
 
Before you use the EMGALITY pen, read and carefully follow all the step-by-step 
instructions.



50 

 

 

  

Parts of the Emgality pen 
 

 
Bottom/ Needle end 

Base Cap 

Teal 
Injection 
Button 

Lock Ring 

Lock/Unlock 
Symbols 

Medicine 

Clear Base 

Top 



51 

 
 
 
 
  

Before You Get Started 
Take the pen from the 
refrigerator 

Put the original package with any unused pens back in the 
refrigerator. 
Leave the base cap on until you are ready to inject. 
Do not shake. 
For a more comfortable injection, leave the pen at room 
temperature for 30 minutes before injecting. 
Do not microwave the pen, run hot water over it, or leave it in 
direct sunlight. 
 
 
 

 

Inspect the pen and the 
medicine 

Make sure you have the right medicine. The medicine inside 
should be clear. It may be colourless to slightly yellow. 
 
Do not use the pen, and dispose of as directed by your doctor, 
pharmacist or nurse if: 

• it looks damaged 
• the medicine is cloudy, is discolored, or has small particles 
• the expiration date printed on the label has passed 
• the medicine is frozen 
 

 
 

 
Expiration Date 



52 

 
 
1 Uncap the Pen 

 

 
Make sure the pen is locked. Leave the base 
cap on until you are ready to inject. 

• When you are ready to inject, twist off the base 
cap and throw it away in the bin. 

• Do not put the base cap back on – this could 
damage the needle. 

• Do not touch the needle. 

   
2 Place and Unlock 

 

 • Place and hold the clear base flat and firmly 
against your skin. 

 
 

Turn the lock ring to the unlock position. 

  
 

 

Prepare for injection Wash your hands with soap and water before you inject 
Emgality. Make sure a sharps disposal container is close 
by. 
 

Choose your injection site Your doctor, pharmacist or nurse can help you choose 
the injection site that is best for you. 

 
 

• You may inject the medicine into your stomach 
area (abdomen) or thigh. Do not inject within 
5 centimeters of the belly button (navel). 

• Another person may give you the injection in 
the back of your upper arm or buttock. 

• Do not inject in the same spot as before. For 
example, if your first injection was in your 
abdomen, your next injection could be in another 
area of your abdomen. 

• Clean and dry the injection site before you 
inject. 

 

Buttock 

Thigh 

Abdomen 

Back of arm 



53 

3 Press and Hold  

 

• Press and hold the teal injection button; you 
will hear a loud click. 

 
• Keep holding the clear base firmly against 

your skin. You will hear a second click in 
about 5 to 10 seconds after the first one. This 
second click tells you that your injection is 
complete.  

 
• Remove the pen from your skin. 

You will know your 
injection is 
complete when you 
can see the grey 
plunger. 

 
After You Inject Your Medicine  
 
Dispose of the pen 

DO NOT put the base cap back on. Dispose of 
the pen in a sharps disposal container or as 
directed by your doctor, pharmacist or nurse.  

 

 

When you dispose of the pen and the sharps disposal container: 
• Do not recycle the filled sharps container. 
• Ask your doctor, pharmacist or nurse about how to dispose of medicines you no 

longer use. 
 
 

 
Commonly Asked Questions 
 
Q. What if I see air bubbles in my pen? 

A. It is normal to have air bubbles in the pen. Emgality is injected under your skin (subcutaneous 
injection). 

  
Q. What if there is a drop of liquid on the tip of the needle when I remove the base cap? 

A. It is okay to see a drop of liquid on the tip of the needle. 
  
Q. What if I unlocked the pen and pressed the teal injection button before I twisted off the 

base cap? 
A. Do not remove the base cap. Dispose of the pen and get a new one. 
  

10 
seconds 

Click 



54 

Q. Do I need to hold the injection button down until the injection is complete? 
A. This is not necessary, but it may help you keep the pen steady and firm against your skin. 
  
Q. What if the needle did not retract after my injection? 
A. Do not touch the needle or replace the base cap. Store in a safe place to avoid an accidental 

needlestick. Contact your doctor, pharmacist or nurse for instructions on how to return the pen. 
  
Q. What if there is a drop of liquid or blood on my skin after my injection? 
A. This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site. 
  
Q. What if I hear more than 2 clicks during my injection – 2 loud clicks and a soft one. Did I 

get my complete injection? 
A. Some patients may hear a soft click right before the second loud click. That is the normal 

operation of the pen. Do not remove the pen from your skin until you hear the second loud 
click. 

  
Q. How can I tell if my injection is complete? 
A. After you press the teal injection button, you will hear 2 loud clicks. The second click tells you 

that your injection is complete. You will also see the grey plunger at the top of the clear base. 
  
 
Read the full Package Leaflet for Emgality inside this box to learn more about your medicine.  

 
  



55 

Instructions for use 
 

Emgality 120 mg solution for injection in pre-filled syringe 
 

Galcanezumab 
 

For subcutaneous use 
 

 
 
Before using your pre-filled syringe: 
 
Important Information 
 

• Your doctor or nurse should show you how to prepare and inject Emgality using the syringe. 
Do not inject yourself or someone else until you have been shown how to inject Emgality. 

•   Keep these instructions and refer to them as needed. 

• Each syringe is for ONE-TIME USE ONLY. Do not share or reuse your syringe. 
Otherwise, you may give or get an infection. 

• Your doctor, pharmacist or nurse can help you decide where on your body to inject your 
dose. You can also read the “Choose your injection site” section of these instructions to 
help you choose which area can work best for you. 

• If you have vision problems, do not use Emgality syringe without help from a caregiver. 
 

INSTRUCTIONS FOR USE 
 
Before you use the EMGALITY syringe, read and carefully follow all the step-by-step 
instructions.



56 

 
 

 
  

Parts of the Emgality Syringe 

 

Thumb Pad 

Teal Plunger Rod 

Finger Grips 

Syringe 
Body with 
Medicine 

Grey Syringe 
Plunger 

Needle Cap 

Needle 



57 

 
Before You Get Started 
Take the syringe from the 
refrigerator 

Put the original package with any unused syringes back in 
the refrigerator. 

Leave the needle cap on until you are ready to inject. 
 
Do not shake. 
 
For a more comfortable injection, leave the syringe at 
room temperature for 30 minutes before injecting. 
 
Do not microwave the syringe, run hot water over it, or 
leave it in direct sunlight. 
 
 
 

Inspect the syringe and the medicine Make sure you have the right medicine. The medicine 
inside should be clear. It may be colourless to slightly 
yellow. 
 
Do not use the syringe, and dispose of as directed by 
your  doctor, pharmacist or nurse if: 

•  it looks damaged 
• the medicine is cloudy, is discolored, or has 

small particles 
• the expiration date printed on the label has 

passed 
•  the medicine is frozen 

  

 
Prepare for injection Wash your hands with soap and water before you inject 

your Emgality. Make sure a sharps disposal container is 
close by. 

  
Choose your injection site Your doctor, pharmacist or nurse can help you choose the 

injection site that is best for you. 

 

• You may inject the medicine into your stomach 
area (abdomen) or thigh. Do not inject within 
5 centimeters of the belly button (navel). 

• Another person may give you the injection in the 
back of your upper arm or buttock. 

• Do not inject in the same spot as before. For 
example, if your first injection was in your 
abdomen, your next injection could be in another 
area of your abdomen. 

• Clean and dry the injection site before you 
inject. 

Expiration Date 

Back of arm 

Buttock 

Thigh 

Abdomen 



58 

1 Uncap 

 

• Leave the needle cap on until 
you are ready to inject. 

• When you are ready to inject, 
pull the needle cap off and throw 
it away in the bin. 

• Do not put the needle cap back 
on – you could damage the 
needle or injure yourself by 
accident. 

• Do not touch the needle. 
   
2 Insert 

 

 • Gently pinch and hold a fold of 
skin where you will inject. 

 • Insert the needle at a 45 degree 
angle. 

 
3 Inject  

 

• Slowly push on the thumb pad 
to push the plunger all the way 
in until all the medicine is 
injected. 

•   The grey syringe plunger 
should be pushed all the way to 
end of the syringe. 

 

• You should see the teal plunger 
rod show through the syringe 
body when the injection is 
complete as shown. 

 
• Remove the needle from your 

skin and gently let go of your 
skin. 

 
• Do not put the needle cap back 

on the syringe. 
 

Teal plunger rod 
 
 
Grey syringe plunger 

  

45° 

90° 



59 

After You Inject Your Medicine 
 
Dispose of the syringe 

DO NOT put the needle cap back on. 
Dispose of the syringe in a sharps 
disposal container or as directed by your 
doctor, pharmacist or nurse. 

 
 
When you dispose of the syringe and the sharps disposal container: 

 
• Do not recycle the filled sharps container. 
• Ask your doctor, pharmacist or nurse abou how to dispose of medicines you no longer 

use. 
 

  
 

Commonly Asked Questions 
 
Q. What if I see air bubbles in my Emgality syringe? 

A. It is normal to have air bubbles in the syringe. Emgality is injected under your skin 
(subcutaneous injection). 

  
Q. What if there is a drop of liquid on the tip of the needle when I remove the needle 

cap? 
A. It is okay to see a drop of liquid on the tip of the needle.  
  
Q. What if I cannot push in the plunger? 
A. If the plunger is stuck or damaged:  

• Do not continue to use the syringe 
• Remove the needle from your skin 
• Dispose of the syringe and get a new one 

  
Q. What if there is a drop of liquid or blood on my skin after my injection? 
A.  This is normal. Press a cotton ball or gauze over the injection site. Do not rub the 

injection site. 
  
Q. How can I tell if my injection is complete? 
A. When your injection is complete: 
 • The teal plunger rod should show through the body of the syringe.  
 • The grey syringe plunger should be pushed all the way to end of the syringe. 

 

Read the full Package Leaflet for Emgality inside this box to learn more about your medicine. 


	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