EMGALITY SOLUTION

Canada - English - Health Canada

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Active ingredient:
GALCANEZUMAB
Available from:
ELI LILLY CANADA INC
ATC code:
N02CD02
INN (International Name):
GALCANEZUMAB
Dosage:
120MG
Pharmaceutical form:
SOLUTION
Composition:
GALCANEZUMAB 120MG
Administration route:
SUBCUTANEOUS
Units in package:
1ML/5ML
Prescription type:
Prescription
Therapeutic area:
CALCITONIN-GENE-RELATED PEPTIDE (CGRP) ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0161690001; AHFS: 28:32.12
Authorization status:
APPROVED
Authorization number:
02491087
Authorization date:
2019-07-30

Documents in other languages

EMGALITY

®

Product Monograph

Page 1 of 51

PRODUCT MONOGRAPH

INCLUDING PATIENT MEDICATION INFORMATION

Pr

EMGALITY

®

Galcanezumab Injection

100 mg/mL solution for subcutaneous injection

120 mg/mL solution for subcutaneous injection

CGRP binding antibody

Eli Lilly Canada Inc.

Exchange Tower

130 King Street West, Suite 900

P.O. Box 73

Toronto, Ontario

M5X 1B1

1-888-545-5972

www.lilly.ca

Date of Initial Approval:

July 30, 2019

Date of Revision:

September 17, 2020

Submission Control No: 232324

EMGALITY is a registered trademark owned by or licensed to Eli Lilly and Company, its

subsidiaries or affiliates.

EMGALITY

®

Product Monograph

Page 2 of 51

RECENT MAJOR LABEL CHANGES

Indications (1)

09/2020

Dosage and Administration, Dosing Considerations (3.1)

09/2020

Dosage and Administration, Recommended Dose and Dosage Adjustment (3.2)

09/2020

Dosage and Administration, Administration (3.3)

09/2020

Dosage and Administration, Missed Dose (3.4)

09/2020

Warnings and Precautions (7)

09/2020

Warnings and Precautions, Pregnant Women (7.1.1)

09/2020

TABLE OF CONTENTS

PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4

1

INDICATIONS ...................................................................................................... 4

Pediatrics ..................................................................................................... 4

Geriatrics ..................................................................................................... 4

2

CONTRAINDICATIONS ....................................................................................... 4

3

DOSAGE AND ADMINISTRATION ..................................................................... 4

Dosing Considerations................................................................................. 4

Recommended Dose and Dosage Adjustment ............................................ 4

Administration .............................................................................................. 5

Missed Dose ................................................................................................ 6

4

OVERDOSAGE .................................................................................................... 6

5

DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 6

6

DESCRIPTION ..................................................................................................... 7

7

WARNINGS AND PRECAUTIONS ...................................................................... 7

Special Populations ..................................................................................... 7

7.1.1

Pregnant Women ..................................................................................... 7

7.1.2

Breast-feeding .......................................................................................... 8

7.1.3

Pediatrics ................................................................................................. 8

7.1.4

Geriatrics .................................................................................................. 8

8

ADVERSE REACTIONS ...................................................................................... 8

Adverse Reaction Overview ........................................................................ 8

Clinical Trial Adverse Reactions .................................................................. 9

Less Common Clinical Trial Adverse Reactions ........................................ 14

Immunogenicity ......................................................................................... 14

Post-Market Adverse Reactions ................................................................ 15

9

DRUG INTERACTIONS ..................................................................................... 15

Drug-Drug Interactions .............................................................................. 15

Drug-Food Interactions .............................................................................. 15

Drug-Herb Interactions .............................................................................. 15

Drug-Laboratory Test Interactions ............................................................. 15

10

ACTION AND CLINICAL PHARMACOLOGY ................................................... 16

EMGALITY

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Product Monograph

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10.1

Mechanism of Action .............................................................................. 16

10.2

Pharmacodynamics ................................................................................ 16

10.3

Pharmacokinetics ................................................................................... 16

11

STORAGE, STABILITY AND DISPOSAL ......................................................... 17

PART II: SCIENTIFIC INFORMATION ......................................................................... 18

12

PHARMACEUTICAL INFORMATION ............................................................... 18

13

CLINICAL TRIALS ............................................................................................. 18

13.1

Migraine Trial Design and Study Demographics .................................... 18

13.2

Migraine Study Results .......................................................................... 19

13.3

Episodic Cluster Headache Trial Design and Study Demographics ....... 22

13.4

Episodic Cluster Headache Study Results ............................................. 24

14

NON-CLINICAL TOXICOLOGY ......................................................................... 24

PATIENT MEDICATION INFORMATION ..................................................................... 27

EMGALITY

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Product Monograph

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PART I: HEALTH PROFESSIONAL INFORMATION

1

INDICATIONS

EMGALITY

(galcanezumab) is indicated for:

the prevention of migraine in adults who have at least 4 migraine days per month.

the reduction in the frequency of attacks throughout a cluster period in adults with episodic

cluster headache with prior cluster headache periods lasting at least 6 weeks and who have

had an inadequate response to, or tolerated poorly, or had contraindications to conventional

preventive therapies established by Canadian practice guidelines.

For patients with episodic cluster headache, the treatment benefit should be assessed within

3 weeks after initiation of the treatment. In patients with no improvement within this time period,

continuation of the treatment should be carefully considered based on individual patient basis

and clinical judgement (see PART I: DOSAGE AND ADMINISTRATION and PART II: CLINICAL

TRIALS).

EMGALITY should be initiated by physicians experienced in the diagnosis and treatment of

migraine or episodic cluster headache.

1.1

Pediatrics

Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health

Canada has not authorized an indication for pediatric use.

1.2

Geriatrics

Geriatrics (≥ 65 years of age): The safety and efficacy of EMGALITY has not been studied in

patients aged 65 or older.

2

CONTRAINDICATIONS

EMGALITY is contraindicated in patients with known serious hypersensitivity to galcanezumab

or to any ingredient in the formulation, including any non-medicinal ingredient, or component of

the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION

and PACKAGING.

3

DOSAGE AND ADMINISTRATION

3.1

Dosing Considerations

EMGALITY is administered subcutaneously through a

single-use prefilled syringe or prefilled

pen. EMGALITY is intended for patient self-administration. Administration should be performed

by an individual who has been trained to administer the product (see ADMINISTRATION and

INSTRUCTIONS FOR USE).

3.2

Recommended Dose and Dosage Adjustment

Migraine

The recommended dose is an initial (loading) dose of 240 mg (administered as two consecutive

subcutaneous injections of 120 mg), followed by once monthly doses of 120 mg (one injection).

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Episodic Cluster Headache

The recommended dose is 300 mg once a month (administered as three consecutive

subcutaneous injections of 100 mg each) at the onset of the cluster period. The dose regimen

must be followed as prescribed.

The treatment benefit should be assessed within 3 weeks after initiation of the treatment. In

patients with no improvement within this time period, any further decisions for continuation of

the treatment during the current cluster period or initiation of the treatment for subsequent

cluster periods should be carefully considered based on individual patient basis and clinical

judgement (see PART II: CLINICAL TRIALS).

If further dosing is warranted, EMGALITY should not be administered more than once a month

during a cluster period.

EMGALITY should not be used after the end of a cluster period and during the remission time.

Health Canada has not authorized an indication for pediatric use (see INDICATIONS).

3.3

Administration

EMGALITY is for subcutaneous use only.

EMGALITY may be administered by healthcare professionals, patients, and/or caregivers. Prior

to use, provide proper training to patients and/or caregivers on the preparation and

administration of EMGALITY prefilled syringe or prefilled pen, including aseptic technique (see

INSTRUCTIONS FOR USE).

Remove EMGALITY from the refrigerator. Prior to use, allow EMGALITY to sit at room

temperature for 30 minutes protected from direct sunlight. Do not warm by using a heat

source such as hot water or a microwave.

Follow aseptic injection technique every time EMGALITY is administered.

Inspect EMGALITY visually for particles or discolouration prior to administration. Do not use

if the solution is cloudy, discoloured, or contains particles (see DOSAGE FORMS,

STRENGTHS, COMPOSITION AND PACKAGING).

Do not shake the product.

Administer EMGALITY by subcutaneous injection into areas of the abdomen, thigh, upper

arm, or buttocks that are not tender, bruised, red, or indurated.

For multiple injections, you may use the same body site, but not the exact location of the

previous injection.

Do not co-administer EMGALITY with other injectable drugs at the same injection site.

Migraine

EMGALITY for migraine is available both as a 120 mg/mL prefilled syringe and 120 mg/mL

prefilled pen.

Two prefilled syringes or pens will deliver the initial 240 mg loading dose. One prefilled syringe

or pen will deliver the monthly 120 mg dose. Deliver the entire contents of the prefilled syringe

or pen.

Episodic Cluster Headache

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EMGALITY for episodic cluster headache is only available as a 100 mg/mL prefilled syringe.

Patients should be advised that one dose consists of three consecutive injections of 100 mg.

Three prefilled syringes will deliver the 300 mg dose. Deliver the entire contents of each prefilled

syringe.

3.4

Missed Dose

Migraine

Instruct patients to inject a missed dose as soon as possible. Thereafter, resume monthly

dosing.

Episodic Cluster Headache

The treatment benefit should be assessed within 3 weeks after initiation of the treatment. In

patients with no improvement within this time period, any further decisions for continuation of

the treatment during the current cluster period or initiation of the treatment for subsequent

cluster periods should be carefully considered based on individual patient basis and clinical

judgement (see PART II: CLINICAL TRIALS).

If patients administer a partial dose (inject only 1 or 2 of the three syringes), they should be

instructed to inject the missed injection(s) as soon as possible.

If further dosing is warranted and required, inject the next complete dose one month from the

date of administering the missed injection(s).

4

OVERDOSAGE

Doses up to 600 mg subcutaneously have been administered to healthy subjects (N = 7) in

clinical trials with no evidence of 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.

For management of a suspected drug overdose, contact your regional poison control centre.

5

DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING

Table 1: Dosage Forms, Strengths, Composition and Packaging

EMGALITY is a sterile, preservative-free, clear and colourless to slightly yellow solution.

For migraine, each single-use prefilled syringe or pen contains 120 mg EMGALITY in 1 mL

(120 mg/mL) (see 3.2 RECOMMENDED DOSE and DOSAGE ADJUSTMENT).

Route of

Administration

Dosage Form /

Strength/Composition

Non-medicinal Ingredients

By subcutaneous

injection

120 mg/mL solution in a 1 mL

single-use prefilled syringe or pen

L-histidine, L-histidine

hydrochloride monohydrate,

polysorbate 80, sodium chloride,

and water for injection

By subcutaneous

injection

100 mg/mL solution in a 1 mL

single-use prefilled syringe

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For episodic cluster headache, each single-use prefilled syringe contains 100 mg EMGALITY in

1 mL (100 mg/mL) (see 3.2 RECOMMENDED DOSE and DOSAGE ADJUSTMENT).

6

DESCRIPTION

EMGALITY (galcanezumab) is a humanized IgG4 monoclonal antibody that binds calcitonin

gene-related peptide (CGRP).

7

WARNINGS AND PRECAUTIONS

Sensitivity

Serious Hypersensitivity

Serious hypersensitivity reactions, including cases of anaphylaxis, angioedema and urticaria,

have been reported with CGRP-class products, including EMGALITY, in clinical trials and in

post-market experience.

These reactions may occur within minutes, although some may occur up to one month after

administration.

If a serious hypersensitivity reaction occurs, administration of EMGALITY should be

discontinued immediately and appropriate therapy initiated.

Patients with Cardiovascular Diseases

No safety data are available in these populations. In the migraine and episodic cluster headache

studies, patients who had myocardial infarction, unstable angina, percutaneous coronary

intervention, coronary artery bypass graft, stroke, certain ECG abnormalities or deep vein

thrombosis/pulmonary embolism within 6 months of screening, or had planned cardiovascular

surgery or percutaneous coronary angioplasty were excluded (see PART II: CLINICAL TRIALS).

Vascular Disorders

No safety data are available in these populations. In the episodic cluster headache study only,

patients who had uncontrolled high blood pressure, characterized by systolic blood pressure

> 160 mmHg or diastolic blood pressure > 100 mmHg, and evidence of peripheral vascular

disease or a diagnosis of Raynaud’s phenomenon were excluded (see PART II: CLINICAL

TRIALS).

7.1

Special Populations

7.1.1

Pregnant Women

There are very limited human data to establish the safety of EMGALITY during pregnancy.

Human IgG is known to cross the placental barrier; therefore, EMGALITY may be transmitted

from the mother to the developing fetus.

EMGALITY has a half-life of approximately 27 days (see CLINICAL PHARMACOLOGY). This

should be taken into consideration for women who are pregnant or plan to become pregnant

while using EMGALITY (see NON-CLINICAL TOXICOLOGY).

EMGALITY should not be used by pregnant women unless the expected benefit to the mother

justifies the potential risk to the fetus.

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7.1.2

Breast-feeding

There are no data on the presence of EMGALITY in human milk, the effects on the breastfed

infant, or the effects on milk production. The developmental and health benefits of breastfeeding

should be considered along with the mother’s clinical need for EMGALITY and any potential

effects on the breastfed infant. Human IgG is known to be excreted in breast milk; therefore,

EMGALITY may be transmitted from the mother to the breastfed infant. Precaution should be

exercised.

7.1.3

Pediatrics

Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health

Canada has not authorized an indication for pediatric use.

7.1.4

Geriatrics

Geriatrics (≥ 65 years of age): The safety and efficacy of EMGALITY has not been studied in

patients aged 65 or older.

8

ADVERSE REACTIONS

8.1

Adverse Reaction Overview

A total of 3459 patients and healthy volunteers were exposed to EMGALITY, representing more

than 1807 patient years of exposure. Of these, 2129 patients were exposed to EMGALITY once

monthly for at least 6 months and 750 patients were exposed for 12 months.

In the migraine and cluster headache studies, patients who had myocardial infarction, unstable

angina, percutaneous coronary intervention, coronary artery bypass graft, stroke, certain ECG

abnormalities or deep vein thrombosis/pulmonary embolism within 6 months of screening, or

had planned cardiovascular surgery or percutaneous coronary angioplasty, and BMI ≥

40 kg/mg

were excluded.

In the cluster headache studies only, patients who had uncontrolled high blood pressure,

characterized by systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg,

and evidence of peripheral vascular disease or a diagnosis of Raynaud’s phenomenon were

also excluded.

In three controlled migraine trials, 705 patients received at least one dose of EMGALITY

(120 mg) once monthly. Of those patients, 1.8% of patients treated with EMGALITY

discontinued double-blind treatment because of adverse events.

In the two controlled cluster headache trials, 166 patients received at least one dose of

EMGALITY (300 mg) once monthly. Of those patients, 1.8% treated with EMGALITY

discontinued double-blind treatment because of adverse events.

Adverse drug reactions (ADRs) were identified based on findings across Phase 3 efficacy and

safety clinical studies in migraine and cluster headache.

The most common adverse reaction reported in ≥ 10% of patients in any study receiving

galcanezumab were injection site reactions, and less frequent (≤ 2%) adverse reactions

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included constipation, vertigo, pruritus and urticaria. Injection site reactions included multiple

preferred terms, such as injection site pain, injection site erythema, injection site pruritus,

injection site bruising, injection site swelling, and injection site induration.

8.2

Clinical Trial Adverse Reactions

Because clinical trials are conducted under very specific conditions, the adverse reaction rates

observed in the clinical trials may not reflect the rates observed in practice and should not be

compared to the rates in the clinical trials of another drug. Adverse reaction information from

clinical trials is useful for identifying drug-related adverse events and for approximating rates.

Migraine

The data described below reflect exposure to EMGALITY in 1435 patients. In the pivotal

studies, the following adverse events listed in Tables 2 and 3 were observed to occur at or

above 1% during the double-blind treatment phase.

Table 2: Incidence of Treatment-emergent Adverse Events in ≥ 1% of Patients with

Episodic Migraine in either EMGALITY Group (120 mg or 240 mg) in Studies EVOLVE-1

(CGAG) and EVOLVE-2 (CGAH)

System Organ Class

Preferred Term

EMGALITY

120 mg

N = 432

n (%)

EMGALITY

240 mg

N = 448

n (%)

Placebo

N = 893

n (%)

Ear and labyrinth disorders

Vertigo

4 (0.9)

7 (1.6)

3 (0.3)

Gastrointestinal disorders

Nausea

9 (2.1)

11 (2.5)

30 (3.4)

Diarrhea

11 (2.6)

5 (1.1)

21 (2.4)

Constipation

5 (1.2)

8 (1.8)

5 (0.6)

Abdominal pain upper

6 (1.4)

5 (1.1)

4 (0.5)

Dyspepsia

4 (0.9)

6 (1.3)

6 (0.7)

Abdominal pain

7 (1.6)

2 (0.5)

15 (1.7)

Vomiting

1 (0.2)

5 (1.1)

9 (1.0)

General disorders and administration site conditions

Injection site pain

54 (12.5)

65 (14.5)

114 (12.8)

Injection site reaction

14 (3.2)

30 (6.7)

4 (0.5)

Injection site erythema

16 (3.7)

16 (3.6)

15 (1.7)

Injection site pruritus

15 (3.5)

17 (3.8)

1 (0.1)

Fatigue

11 (2.6)

10 (2.2)

24 (2.7)

Injection site bruising

4 (0.9)

6 (1.3)

7 (0.8)

Injection site swelling

8 (1.9)

2 (0.5)

1 (0.1)

Infections and infestations

Nasopharyngitis

35 (8.1)

22 (4.9)

68 (7.6)

Upper respiratory tract infection

22 (5.1)

27 (6.0)

47 (5.3)

Sinusitis

16 (3.7)

11 (2.5)

26 (2.9)

Urinary tract infection

13 (3.0)

14 (3.1)

26 (2.9)

Influenza

8 (1.9)

14 (3.1)

19 (2.1)

Bronchitis

5 (1.2)

10 (2.2)

14 (1.6)

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Viral infection

8 (1.9)

2 (0.5)

8 (0.9)

Tonsillitis

1 (0.2)

5 (1.1)

6 (0.7)

Injury, poisoning and procedural complications

Contusion

6 (1.4)

2 (0.5)

8 (0.9)

Investigations

Weight increased

5 (1.2)

3 (0.7)

11 (1.2)

Musculoskeletal and connective tissue disorders

Back pain

7 (1.6)

12 (2.7)

26 (2.9)

Arthralgia

8 (1.9)

6 (1.3)

18 (2.0)

Neck pain

8 (1.9)

6 (1.3)

13 (1.5)

Pain in extremity

6 (1.4)

5 (1.1)

14 (1.6)

Musculoskeletal pain

6 (1.4)

3 (0.7)

11 (1.2)

Myalgia

3 (0.7)

6 (1.3)

8 (0.9)

Nervous system disorders

Dizziness

14 (3.2)

12 (2.7)

21 (2.4)

Headache

4 (0.9)

7 (1.6)

11 (1.2)

Migraine

2 (0.5)

8 (1.8)

9 (1.0)

Psychiatric disorders

Anxiety

8 (1.9)

2 (0.5)

9 (1.0)

Reproductive system and breast disorders

Dysmenorrhea

1 (0.3)

5 (1.3)

3 (0.4)

Menorrhagia

2 (0.5)

4 (1.1)

0 (0.0)

Respiratory, thoracic and mediastinal disorders

Cough

8 (1.9)

9 (2.0)

16 (1.8)

Oropharyngeal pain

8 (1.9)

7 (1.6)

10 (1.1)

Nasal congestion

3 (0.7)

6 (1.3)

6 (0.7)

Skin and subcutaneous tissue disorders

Rash

6 (1.4)

7 (1.6)

14 (1.6)

Pruritus

5 (1.2)

7 (1.6)

2 (0.2)

Vascular disorders

Hypertension

6 (1.4)

4 (0.9)

11 (1.2)

Denominator adjusted for female-specific event.

Table 3: Incidence of Treatment-emergent Adverse Events in ≥ 1% of Patients with

Chronic Migraine in either EMGALITY Group (120 mg or 240 mg) in Study REGAIN (CGAI)

System Organ Class

Preferred Term

EMGALITY

120 mg

N = 273

n (%)

EMGALITY

240 mg

N = 282

n (%)

Placebo

N = 558

n (%)

Gastrointestinal disorders

Nausea

9 (3.3)

8 (2.8)

23 (4.1)

Abdominal pain

6 (2.2)

4 (1.4)

9 (1.6)

Diarrhea

3 (1.1)

6 (2.1)

9 (1.6)

Constipation

2 (0.7)

3 (1.1)

3 (0.5)

Toothache

1 (0.4)

3 (1.1)

3 (0.5)

General disorders and administration site conditions

Injection site pain

17 (6.2)

20 (7.1)

24 (4.3)

Injection site reaction

8 (2.9)

15 (5.3)

10 (1.8)

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Injection site erythema

4 (1.5)

13 (4.6)

5 (0.9)

Fatigue

6 (2.2)

6 (2.1)

10 (1.8)

Influenza like illness

5 (1.8)

4 (1.4)

3 (0.54)

Injection site pruritus

0 (0.0)

7 (2.5)

1 (0.2)

Pyrexia

5 (1.8)

1 (0.4)

2 (0.4)

Injection site bruising

0 (0.0)

4 (1.4)

2 (0.4)

Injection site swelling

0 (0.0)

3 (1.1)

6 (1.1)

Infections and infestations

Nasopharyngitis

17 (6.2)

9 (3.2)

26 (4.7)

Upper respiratory tract infection

9 (3.3)

9 (3.2)

13 (2.3)

Sinusitis

4 (1.5)

8 (2.8)

5 (0.9)

Urinary tract infection

6 (2.2)

4 (1.4)

7 (1.3)

Influenza

0 (0.0)

6 (2.1)

15 (2.7)

Bronchitis

4 (1.5)

1 (0.4)

3 (0.5)

Gastrointestinal viral

1 (0.4)

4 (1.4)

1 (0.2)

Pneumonia

1 (0.4)

3 (1.1)

1 (0.2)

Pharyngitis streptococcal

0 (0.0)

3 (1.1)

1 (0.2)

Tooth infection

0 (0.0)

3 (1.1)

4 (0.7)

Injury, poisoning and procedural complications

Arthropod bite

0 (0.0)

3 (1.1)

0 (0.0)

Fall

0 (0.0)

3 (1.1)

3 (0.5)

Investigations

Weight increased

4 (1.5)

3 (1.1)

1 (0.2)

Musculoskeletal and connective tissue disorders

Back pain

9 (3.3)

2 (0.7)

14 (2.5)

Neck pain

7 (2.6)

0 (0.0)

8 (1.4)

Arthralgia

1 (0.4)

5 (1.8)

5 (0.9)

Pain in extremity

3 (1.1)

2 (0.7)

6 (1.1)

Nervous system disorders

Dizziness

6 (2.2)

8 (2.8)

20 (3.6)

Migraine

5 (1.8)

4 (1.4)

5 (0.9)

Headache

4 (1.5)

1 (0.4)

10 (1.8)

Somnolence

4 (1.5)

1 (0.4)

3 (0.5)

Lethargy

3 (1.1)

0 (0.0)

0 (0.0)

Respiratory, thoracic and mediastinal disorders

Cough

4 (1.5)

4 (1.4)

3 (0.5)

Oropharyngeal pain

2 (0.7)

5 (1.8)

3 (0.5)

Sinus congestion

3 (1.1)

3 (1.1)

2 (0.4)

Rhinitis allergic

2 (0.7)

3 (1.1)

2 (0.4)

Skin and subcutaneous tissue disorders

Rash

2 (0.7)

3 (1.1)

3 (0.5)

Acne

3 (1.1)

1 (0.4)

0 (0.0)

Injection site reactions

In the 3 integrated pivotal migraine placebo-controlled study periods, injection site pain was the

most frequently (≥10%) reported event. In most patients, reported injection site pain occurred

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within 1 hour of injection and resolved the same day. The majority of injection site reactions

were reported within 1 day and most resolved within a few days. Most events were mild to

moderate and did not lead to discontinuation of galcanezumab.

Constipation

In the 3 integrated pivotal migraine placebo-controlled study periods, all constipation events

were mild or moderate in severity. There were no serious events.

Vertigo

In the 3 integrated pivotal migraine placebo-controlled study periods, the majority of vertigo

events were mild or moderate in severity. There were no serious events.

Pruritus

In the 3 integrated pivotal migraine placebo-controlled study periods, the majority of pruritus

events were mild or moderate in severity. There were no serious events.

Urticaria

In the 3 integrated pivotal migraine placebo-controlled study periods, cases of urticaria were

uncommon. However, serious cases of urticaria have been reported in galcanezumab clinical

studies.

Episodic Cluster Headache

The safety of EMGALITY (300 mg once a month) is based on the assessment of data from

2 placebo-controlled clinical studies: CGAL and CGAM. The efficacy assessment of EMGALITY

300 mg once a month is based on Study CGAL (episodic cluster headache). Study CGAM was

performed in patients with chronic cluster headache and used for the safety assessment only.

The data described below reflect exposure to EMGALITY in 166 patients. In the placebo-

controlled studies, the following adverse events listed in Table 4 were observed to occur in ≥ 1%

of patients during the double-blind treatment phase.

Table 4: Incidence of Treatment-emergent Adverse Events in ≥1% of Patients in the

EMGALITY Safety Population Group (300 mg) (Studies CGAL and CGAM)

System Organ Class

Preferred Term

EMGALITY

300 mg

N = 166

n (%)

Placebo

N = 177

n (%)

Ear and labyrinth disorders

Tinnitus

3 (1.8)

2 (1.1)

Vertigo

2 (1.2)

3 (1.7)

Gastrointestinal disorders

Nausea

6 (3.6)

6 (3.4)

Constipation

3 (1.8)

2 (1.1)

Vomiting

3 (1.8)

3 (1.7)

Abdominal pain

2 (1.2)

3 (1.7)

Gastrointestinal disorder

2 (1.2)

0 (0.0)

Toothache

2 (1.2)

2 (1.1)

General disorders and administration site conditions

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Injection site pain

17 (10.2)

11 (6.2)

Injection site erythema

9 (5.4)

1 (0.6)

Fatigue

6 (3.6)

7 (4.0)

Influenza like illness

5 (3.0)

2 (1.1)

Injection site pruritis

5 (3.0)

2 (1.1)

Pyrexia

5 (3.0)

2 (1.1)

Injection site swelling

3 (1.8)

1 (0.6)

Non-cardiac chest pain

3 (1.8)

1 (0.6)

Chills

2 (1.2)

1 (0.6)

Injection site bruising

2 (1.2)

0 (0.0)

Injection sire induration

2 (1.2)

0 (0.0)

Infections and infestations

Nasopharyngitis

15 (9.0)

16 (9.0)

Gastroenteritis

3 (1.8)

1 (0.6)

Influenza

3 (1.8)

3 (1.7)

Bronchitis

2 (1.2)

1 (0.6)

Rhinitis

2 (1.2)

1 (0.6)

Tooth abscess

2 (1.2)

0 (0.0)

Urinary tract infection

2 (1.2)

0 (0.0)

Metabolism and nutrition disorders

Decreased appetite

2 (1.2)

1 (0.6)

Musculoskeletal and connective tissue disorders

Back pain

5 (3.0)

4 (2.

Myalgia

4 (2.4)

3 (1.

Pain in extremity

4 (2.4)

1 (0.6)

Nervous system disorders

Dizziness

5 (3.0)

5 (2.8)

Headache

3 (1.8)

4 (2.

Memory impairment

2 (1.2)

0 (0.0)

Migraine

2 (1.2)

1 (0.6)

Psychiatric disorders

Irritability

2 (1.2)

0 (0.0)

Reproductive system and breast disorders

Dysmenorrhoea

1 (2.6)

0 (0.0)

Menstrual disorder

1 (2.6)

0 (0.0)

Prostatitis

2 (1.

0 (0.0)

Respiratory, thoracic and mediastinal disorders

Asthma

2 (1.2)

0 (0.0)

Cough

2 (1.2)

1 (0.6)

Skin and subcutaneous tissue disorders

Pruritis

3 (1.8)

0 (0.0)

Erythema

2 (1.2)

1 (0.6)

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Vascular disorders

Hot flush

3 (1.8)

0 (0.0)

Hypertension

2 (1.2)

3 (1.

Denominator adjusted for female-specific event.

Denominator adjusted for male-specific event.

Injection site reactions

In two integrated cluster headache placebo-controlled study periods, injection site pain was the

most frequently reported event (10.2%). The majority of injection site reactions, including pain,

were reported within 1 day and most resolved within a few days. Most events were mild to

moderate and did not lead to discontinuation of galcanezumab. There were no serious adverse

events.

Constipation

In two integrated cluster headache placebo-controlled study periods, three patients reported

constipation. None led to discontinuation. One event was reported as serious, which resolved.

Vertigo

In two integrated cluster headache placebo-controlled study periods, two patients reported

vertigo both of mild severity, one led to discontinuation. There were no serious adverse events.

Pruritus

In two integrated cluster headache placebo-controlled study periods, three patients reported

pruritus of mild to moderate severity and did not lead to discontinuation. There were no serious

adverse events.

Urticaria

In two integrated cluster headache placebo-controlled study periods, no patients reported

urticaria.

8.3

Less Common Clinical Trial Adverse Reactions

From all clinical trials with EMGALITY in adult patients with episodic and chronic migraine, and

episodic and chronic cluster headache, the following less common adverse events of < 1% have

been observed. The causality to EMGALITY has not been established.

Cardiac disorders: palpitations, angina pectoris, acute myocardial infarction

Eye disorders: amaurosis

Hepatobiliary disorders: cholelithiasis, cholecystitis

Psychiatric disorders: anxiety, confusion state, disorientation

Skin and subcutaneous tissue disorders

:

swelling face

8.4

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The immunogenicity of

EMGALITY has been evaluated using an immunoassay for the detection of binding anti-

galcanezumab antibodies. For patients whose sera tested positive in the screening

immunoassay, an in vitro ligand-binding immunoassay was performed to detect neutralizing

antibodies.

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In placebo-controlled clinical studies [EVOLVE -1 (CGAG), EVOLVE-2 (CGAH), and REGAIN

(CGAI)] with EMGALITY administration up to 6 months, the incidence of anti-galcanezumab

antibody development was 4.8% (33/688) in patients receiving EMGALITY once monthly (32 of

whom had in vitro neutralizing activity). With 12 months of treatment in an open-label study,

12.5% (16/128) of EMGALITY-treated patients developed anti-galcanezumab antibodies (all 16

of whom had in vitro neutralizing activity). With up to 3 months of double-blind treatment, up to

0.9% of galcanezumab treated patients with cluster headache developed antidrug antibodies of

low titer with neutralizing activity in vitro.

The incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the

assay. Additionally, the observed incidence of antibody (including neutralizing antibody)

positivity in an assay may be influenced by several factors including assay methodology,

sample handling, timing of sample collection, concomitant medications, and underlying disease.

For these reasons, comparison of the incidence of antibodies to galcanezumab with the

incidence of antibodies to other products may be misleading.

In clinical trials, the presence of anti-drug antibodies did not affect the efficacy or safety of

EMGALITY.

8.5

Post-Market Adverse Reactions

The following adverse reactions are based on post-marketing spontaneous reports. Because

these reactions are reported voluntarily from a population of uncertain size, it is not possible to

reliably estimate the frequency.

Immune System disorders: Anaphylaxis, Angioedema

Skin and subcutaneous tissue disorders: Rash

9

DRUG INTERACTIONS

9.1

Drug-Drug Interactions

Interactions with other drugs have not been studied.

EMGALITY is not metabolized by cytochrome P450 enzymes; therefore, interactions with

concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450

enzymes are unlikely.

9.2

Drug-Food Interactions

Interactions with food have not been studied.

9.3

Drug-Herb Interactions

Interactions with herbal products have not been studied.

9.4

Drug-Laboratory Test Interactions

Interactions with laboratory tests have not been studied.

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10

ACTION AND CLINICAL PHARMACOLOGY

10.1

Mechanism of Action

Galcanezumab is a humanized IgG4 monoclonal antibody that binds calcitonin gene-related

peptide (CGRP) and prevents its biological activity.

Galcanezumab targets CGRP with high affinity (K

= 31 pM) and does not bind to the CGRP

receptor or related peptides adrenomedullin, amylin, calcitonin and intermedin.

10.2

Pharmacodynamics

There are no relevant data on the pharmacodynamic effects of galcanezumab.

10.3

Pharmacokinetics

Galcanezumab exhibits linear pharmacokinetics (PK) and exposure increases proportionally

across the dose range of 5-300 mg.

Steady-state galcanezumab concentrations at 120 mg monthly are achieved with an initial

loading dose of 240 mg. Steady-state PK parameters after a 240 mg loading dose followed by

5 consecutive monthly doses of 120 mg are shown in Table 5.

A dose of 300 mg monthly achieves steady-state concentration after the fourth dose

administration. Table 5 shows steady-state PK parameters at 300 mg monthly.

Based upon population PK modelling, there were no significant differences in PK parameters

between healthy volunteers, patients with episodic or chronic migraine, and patients with

episodic cluster headache.

Table 5: Steady-State Pharmacokinetic Parameters of EMGALITY at 120 mg Monthly

(Migraine) and 300 mg Monthly (Episodic Cluster Headache)

a, b

Parameter

120 mg Monthly

300 mg Monthly

mean (%CV)

28 mcg/mL (35)

62 mcg/mL (24)

mean (%CV)

15,900 mcg x hour/mL (42)

34,700 mcg x hour/mL (28)

mean (% CV)

15 mcg/mL (53)

33 mcg/mL (35)

Based on population PK analysis.

PK parameters reported as geometric mean (percent coefficient of variation).

Absorption: Following administration of galcanezumab at steady-state, the median time to

maximum concentration was 5 days (range: 3 to 14 days).

Injection site location did not significantly influence the absorption of galcanezumab.

Distribution: Based on a population PK analysis, the apparent volume of distribution (V/F) of

galcanezumab was estimated to be 7.3 L (34% Inter Individual Variability [IIV]).

Metabolism: As a humanized 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.

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Elimination: Based on a population PK analysis, the apparent clearance (CL/F) of

galcanezumab was estimated to be 0.008 L/h and the half-life of galcanezumab was

approximately 27 days.

Special Populations and Conditions

Based on a population PK analysis, age (18-65),

sex, race, injection site, anti-drug antibodies,

or ethnicity had no clinically meaningful effects on the PK of galcanezumab.

Hepatic Insufficiency: No clinical studies have been conducted to evaluate the effect of

hepatic impairment on the PK of galcanezumab. Based on a population PK analysis, bilirubin

concentration did not significantly influence the CL/F of galcanezumab.

Renal Insufficiency: No clinical studies have been conducted to evaluate the effect of renal

impairment on the PK of galcanezumab. Population PK analysis of integrated data from the

galcanezumab clinical studies revealed that creatinine clearance did not affect the CL/F of

galcanezumab in patients with mild or moderate renal impairment. Patients with severe renal

impairment (creatinine clearance <30 mL/min) have not been studied.

11

STORAGE, STABILITY AND DISPOSAL

The prefilled syringes or pens should be stored under refrigeration at 2°C to 8°C until time of

use. Keep the syringe or pen in the carton in order to protect from exposure to light. DO NOT

FREEZE OR SHAKE the syringe or pen. The shelf life is 24 months when the syringes or pens

are stored at 2°C to 8°C.

The chemical and physical stability for the EMGALITY solution was demonstrated for up 7 days

outside of refrigeration when stored at temperatures up to 30°C. If these conditions are

exceeded, EMGALITY must be discarded.

Discard the EMGALITY single-use prefilled syringe or pen in a puncture-resistant container.

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PART II: SCIENTIFIC INFORMATION

12

PHARMACEUTICAL INFORMATION

Drug Substance

Proper name: galcanezumab

Chemical name: Immunoglobulin G4, anti-(human calcitonin gene-related peptide) (human-Mus

musculus clone III heavy side chain), disulfide with human-Mus musculus clone III

-chain,

dimer

Molecular mass: The observed molecular weight of the non-glycosylated, disulfide linked form of

galcanezumab is 144,084 Da

Structural formula: Galcanezumab is a humanized immunoglobulin G4 (IgG4) isotype

monoclonal antibody composed of two identical immunoglobulin light (

) chains consisting of

214 amino acids each of relative molecular weight 23,330 Da, and two identical immunoglobulin

heavy (

) chains consisting of 445 amino acids each of molecular weight 48,728 Da. The heavy

chain subunit contains an N-linked glycosylation, which is modified with oligosaccharides.

Physicochemical properties: Clear to colourless to slightly yellow solution. The solution pH is 5.3

to 6.3. The osmolality is 255 to 345 mOsm/kg.

13

CLINICAL TRIALS

13.1

Migraine Trial Design and Study Demographics

EMGALITY was evaluated as a preventive treatment (a treatment expected to decrease

migraine headache frequency) of episodic or chronic migraine in three Phase 3 randomized,

multicenter, double-blind, placebo-controlled studies in adult patients. Studies enrolled patients

with a history of migraine according to the International Classification of Headache Disorders

(ICHD-3). Patients who had myocardial infarction, unstable angina, percutaneous coronary

intervention, coronary artery bypass graft, stroke, certain ECG abnormalities or deep vein

thrombosis/pulmonary embolism within 6 months of screening, or had planned cardiovascular

surgery or percutaneous coronary angioplasty were excluded. Patients with a persistent daily

headache, history of headache other than migraine and BMI ≥40 kg/m

were also excluded.

Demographics for these studies are outlined in Table 6.

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Table 6: Summary of patient demographics for clinical trials in Migraine

Study #

Trial design

Dosage, route of

administration

and duration

Study

subjects

(n)

Mean age

(Range)

Sex

EVOLVE-1

(CGAG)

Randomized,

multicenter,

double-blind,

placebo-

controlled study

in episodic

migraine patients.

subcutaneous

injection

EMGALITY

(120 mg)

(n=213)

EMGALITY

(240 mg)

(n=212)

Placebo

(n=433)

40.7 (18-65)

Female: 84%

Male: 16%

EVOLVE-2

(CGAH)

Randomized,

multicenter,

double-blind,

placebo-

controlled study

in episodic

migraine patients.

subcutaneous

injection

EMGALITY

(120 mg)

(n=231)

EMGALITY

(240 mg)

(n=223)

Placebo

(n=461)

41.9 (18-65)

Female: 85%

Male: 15%

REGAIN

(CGAI)

Randomized,

multicenter,

double-blind,

placebo-

controlled study

in chronic

migraine patients.

subcutaneous

injection

EMGALITY

(120 mg)

(n=278)

EMGALITY

(240 mg)

(n=277)

Placebo

(n=558)

41.0 (18-65)

Female: 83%

Male: 17%

13.2

Migraine Study Results

Episodic Migraine

EVOLVE-1 (CGAG) and EVOLVE-2 (CGAH) were identically designed, randomized, 6-month,

double-blind, placebo-controlled studies. In EVOLVE-1 (CGAG), a total of 858 patients with a

history of episodic migraine (4 to 14 migraine days per month) were randomized to receive

either galcanezumab 120 mg (EMGALITY, N = 213), galcanezumab 240 mg (N = 212), or

placebo (N = 433) by subcutaneous injection once monthly (QM). In EVOLVE-2 (CGAH), a total

of 915 patients with a history of episodic migraine were randomized to receive either

galcanezumab 120 mg (EMGALITY, N = 231), galcanezumab 240 mg (N = 223), or placebo

(N = 461) by subcutaneous injection once monthly (QM). All patients in the 120 mg dose group

received an initial loading dose of 240 mg.

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The primary efficacy endpoint for EVOLVE-1 (CGAG) and EVOLVE-2 (CGAH) was the mean

change from baseline in the number of monthly migraine headache days over months 1 to 6.

Key secondary endpoints included response rates (the mean percentages of patients with ≥50%

reduction) and mean change from baseline in the number of monthly migraine headache days

that acute medication was taken over months 1 to 6.

Patients were 18 to 65 years of age (mean age of 40.7 in EVOLVE-1 and 41.9 in EVOLVE-2)

with a history of migraine for at least 1 year (mean 20 years in EVOLVE-1 and 2 trials) and

migraine onset prior to age 50. The mean number of monthly migraine headache days at

baseline was 9.1 in each study. Most patients were female (84% EVOLVE-1, 85% EVOLVE-2),

white (80% EVOLVE-1, 70% EVOLVE-2) and had failed one or more migraine preventive

therapies in the past. Patients were allowed to use acute headache treatments including

migraine-specific medications (i.e., triptans, ergotamine derivatives), NSAIDs, and

acetaminophen. Patients were not allowed any treatments for the prevention of migraine. Both

studies excluded patients with medication overuse headache. A total of 60% and 65% of

patients in EVOLVE-1 (CGAG) and EVOLVE-2 (CGAH), respectively, had taken preventive

treatments for migraine prior to baseline. A total of 177 (83%) patients in the EMGALITY 120 mg

dose group and 351 (81%) patients on placebo completed the double-blind phase in EVOLVE-1

(CGAG), and a total of 203 (88%) patients in the EMGALITY 120 mg dose arm and 387 (84%)

patients on placebo completed the double-blind phase in EVOLVE-2 (CGAH).

The results of the studies are presented in Table 7.

Table

7: Efficacy Results in Studies EVOLVE-1 (CGAG) and EVOLVE-2 (CGAH)

EVOLVE-1 (CGAG)

EVOLVE-2 (CGAH)

EMGALITY

120 mg

N = 210

Placebo

N = 425

EMGALITY

120 mg

N = 226

Placebo

N = 450

Primary Endpoint

Mean Reduction in Monthly Migraine Headache Days (over Months 1 to 6)

a

Mean change from baseline

-4.7

-2.8

-4.3

-2.3

Difference from placebo

-1.9

-2.0

p-value

<0.001

<0.001

Key Secondary Endpoints

≥50% Migraine Headache Days Responders (over Months 1 to 6)

% Responders

62.3%

38.6%

59.3%

36.0%

Difference from placebo

23.7%

23.3%

p-value

<0.001

<0.001

Mean Reduction in Monthly Migraine Headache Days that Acute Medication was Taken (over Months 1 to

6)

a, c

Mean change from baseline (days)

-4.0

-2.2

-3.7

-1.9

Difference from placebo

-1.8

-1.8

p-value

<0.001

<0.001

LS mean change from baseline, difference from placebo, and p-value are based on a mixed effects repeated

measures model including treatment group, region or country (North America, Europe, or Other), month, interaction

of treatment and month, baseline value, and interaction of baseline value and month. For the key secondary

endpoints, the model also includes mean reduction in baseline migraine headache day category (<8 vs. ≥8).

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A superchain procedure adjusting for multiple testing was used to maintain the 2-sided type I error at 0.05 for the

primary and key secondary endpoints.

Monthly migraine headache days that acute medication was taken was calculated as the number of calendar days

in a 30-day period on which migraine or probable migraine occurred and acute medication was used

A treatment effect was observed in a prespecified monthly analysis as early as month one.

Data from EVOLVE-1 (CGAG) and EVOLVE-2 (CGAH) studies were pooled and in 453 (26%)

patients who failed one or more preventive treatments for efficacy reasons, the difference in the

reduction of mean monthly migraine headache days observed between EMGALITY and placebo

was -2.7 days. In 173 (10%) patients who failed two or more preventive treatments for efficacy

reasons, the difference in the reduction of mean monthly migraine headache days observed

between EMGALITY and placebo was -2.6 days.

Chronic Migraine

REGAIN (CGAI) was a randomized, 3-month, double-blind, placebo-controlled study. A total of

1113 patients with a history of chronic migraine (≥15 headache days per month with ≥8 migraine

days per month) were randomized to receive either galcanezumab 120 mg (EMGALITY,

N = 278), galcanezumab 240 mg (N = 277), or placebo (N = 558) by subcutaneous injection

once monthly (QM). All patients in the 120 mg dose group received an initial loading dose of

240 mg.

The primary endpoint was the mean change from baseline in the number of monthly migraine

headache days over months 1 to 3. Key secondary endpoints included response rates (the

mean percentages of patients with ≥50% reduction) and mean change from baseline in the

number of monthly migraine headache days that acute medication was taken over months 1

to 3.

Patients were 18 to 65 years of age (mean age of 41.0 in REGAIN) with a history of migraine for

at least 1 year (mean duration

21.1

years). The mean number of monthly migraine headache

days at baseline was 19.4.Patients were allowed to use acute headache treatments including

migraine-specific medications (i.e., triptans, ergotamine derivatives), NSAIDs, and

acetaminophen. A total of 78% of patients had taken preventive treatments for migraine prior to

baseline, 15% of patients were taking concomitant stable doses of topiramate or propranolol for

prevention of migraine. Patients with medication overuse headache were not excluded.

A total of 263 (95%) patients in the EMGALITY 120 mg dose group and 508 (91%) patients on

placebo completed the double-blind phase in REGAIN (CGAI).

The results of this study are shown in Table 8.

Table 8: Efficacy Results in REGAIN (CGAI)

EMGALITY

120 mg

N = 273

Placebo

N = 538

Primary Endpoint

Mean Reduction in Monthly Migraine Headache Days (over Months 1 to 3)

a

Mean change from baseline

-4.8

-2.7

Difference from placebo

-2.1

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p-value

<0.001

Key Secondary Endpoints

≥50% Migraine Headache Days Responders (over Months 1 to 3)

% Responders

27.6%

15.4%

Difference from placebo

12.2%

p-value

<0.001

Mean Reduction in Monthly Migraine Headache Days that Acute Medication was Taken (over

Months 1 to 3)

a, c

Mean change from baseline (days)

-4.7

-2.2

Difference from placebo

-2.5

p-value

<0.001

LS mean change from baseline, difference from placebo, and p-value are based on a mixed effects repeated

measures model including treatment group, baseline medication overuse [yes vs. no], use of concurrent migraine

prophylaxis [yes vs. no], and country, month, interaction of treatment and month, baseline value, and interaction of

baseline value and month.

A superchain procedure adjusting for multiple testing was used to maintain the 2-sided type I error at 0.05 for the

primary and key secondary endpoints.

Monthly migraine headache days that acute medication was taken was calculated as the number of calendar days

in a 30-day period on which migraine or probable migraine occurred and acute medication was used.

Not statistically significant versus placebo after multiplicity adjustment.

A treatment effect was observed in a prespecified monthly analysis as early as month one.

In the 355 (64%) patients from the REGAIN (CGAI) Study who had acute headache medication

overuse at baseline, the difference in the reduction of mean monthly migraine headache days

observed between EMGALITY and placebo was -2.53 days.

In the 549 (49%) patients from the REGAIN (CGAI) Study who failed one or more preventive

treatment for efficacy reasons, the difference in the reduction of mean monthly migraine

headache days observed between EMGALITY and placebo was -3.5. In 328 (30%) patients who

failed two or more preventive treatments, the difference in the reduction of mean monthly

migraine headache days observed between EMGALITY and placebo was -4.5 days.

13.3

Episodic Cluster Headache Trial Design and Study Demographics

The safety of EMGALITY (300 mg once a month) is based on the assessment of data from

2 placebo-controlled clinical studies: CGAL and CGAM.

Study CGAM was conducted in patients with chronic cluster headache and used for the safety

assessment only.

The efficacy assessment of EMGALITY 300 mg once a month is based on Study CGAL

(episodic cluster headache).

EMGALITY was evaluated as a preventive treatment (a treatment expected to decrease the

frequency of cluster headache attacks throughout a cluster period) in adult patients with

episodic cluster headache. Study CGAL included adults who met the International Classification

of Headache Disorders 3rd edition (ICHD-3-beta version) diagnostic criteria for episodic cluster

headache and had a prior history of a cluster period lasting 6 weeks or longer.

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Study CGAL excluded patients on other preventive treatments; patients with medication overuse

headache; patients with a history of myocardial infarction, unstable angina, percutaneous

coronary intervention, coronary artery bypass graft, certain ECG abnormalities or deep vein

thrombosis/pulmonary embolism within 6 months of screening; and patients who had planned

cardiovascular surgery or percutaneous coronary angioplasty. Patients with any history of

stroke, intracranial or carotid aneurysm, intracranial hemorrhage, or vasospastic angina; clinical

evidence of peripheral vascular disease; diagnosis of Raynaud’s disease or BMI ≥ 40 kg/m

were also excluded.

Table 9: Summary of patient demographics for clinical trials in Episodic Cluster Headache

(CGAL)

Study #

Trial design

Dosage, route of

administration

and duration

Study

subjects

(n)

Mean age

(Range)

Sex

CGAL

Randomized,

multicenter, 8 week,

double-blind,

placebo-controlled

study in adult

patients with

episodic cluster

headache, and a

prior history of a

cluster period lasting

6 weeks or longer.

Once a month:

EMGALITY 300 mg

or placebo

administered via

subcutaneous

injection

EMGALITY

(300 mg)

(n = 49)

Placebo

(n = 57)

46 (19 – 65)

Male: 88/106

(83%)

Female: 18/106

(17%)

The study was composed of: I) screening/washout phase; II) a prospective baseline phase; III)

8-week double-blind treatment phase; IV) post-treatment follow up. Patients who entered phase

I in an active cluster period and did not need to wash out any excluded medications moved

directly to phase II. Patients could enter screening in an active cluster period, or in remission,

but were required to be an active cluster period to enter the prospective baseline phase which

was used to establish baseline attack frequency. During the prospective 7-day baseline

assessment, patients were required to have a maximum of 8 attacks per day, a minimum of one

attack every other day, and at least 4 attacks.

All patients were randomized at the initiation of phase III (1:1) to receive subcutaneous

injections of either EMGALITY 300 mg once a month or placebo once a month, over an 8-week

treatment period. Patients were allowed to use pre-specified acute/abortive cluster headache

treatments, including triptans, oxygen, acetaminophen, and NSAIDs during the study.

No preventive medications were allowed during the double-blind 8-week treatment period.

Randomization was stratified based on sex, average daily attack frequency (≤ 4 attacks per day,

> 4 attacks per day), and investigative site.

Headache information was captured daily using the electronic patient-reported outcome (ePRO)

diary device during study phases II and III.

A total of 106 (18 females, 88 males), ranging age 19 to 65 years of age (mean age of 46)

patients were randomized and treated with either EMGALITY (galcanezumab) 300 mg (N = 49)

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or placebo (N = 57) by subcutaneous injection once a month (QM). In the prospective baseline

phase, a majority of patients had ≤ 4 cluster headache attacks per day at baseline (85.9%) and

the mean number of weekly cluster headache attacks was 17.3 for placebo group and 17.8 for

galcanezumab group, with an average severity of pain of moderate to severe. A total of 90

(84.9%) patients completed the 8-week double-blind treatment phase.

The primary efficacy endpoint was the mean change from baseline (defined as 7 consecutive

days from the daily ePRO diary during the prospective baseline assessment) in weekly cluster

headache attack frequency across Weeks 1 to 3. The key secondary endpoint was the

proportion of patients achieving response (defined as a reduction from baseline of 50% or

greater in the weekly cluster headache attack frequency) at Week 3. The primary endpoint

(Weeks 1-3) and gated secondary endpoint (at Week 3) of Study CGAL measured the effect of

only one dose of galcanezumab. Results are summarized in Table 10.

13.4

Episodic Cluster Headache Study Results

Table 10: Efficacy Results in Episodic Cluster Headache Study CGAL

EMGALITY

300 mg

N = 49

Placebo

N = 57

Primary Endpoint

Mean Reduction in Weekly Cluster Headache Attack Frequency (over Weeks 1 to 3)

a

Prospective Baseline Cluster Headache Attack Frequency

17.8

17.3

Mean change from prospective baseline

-8.7

-5.2

Difference from placebo

-3.5

p-value

0.036

Key Secondary Endpoint

≥50% Weekly Cluster Headache Attack Frequency Responders (at Week 3)

% Responders

71.4%

52.6%

Difference from placebo

18.8%

p-value

0.046

LS mean change from baseline, difference from placebo, and p-value are based on a mixed effects repeated

measures model including treatment group, sex, pooled investigative site, week, interaction of treatment and week,

and baseline value. The key secondary analysis is based on an ANCOVA model including treatment group, sex,

baseline value, and stratified by pooled investigative site.

A sequential testing procedure adjusting for multiple testing was used to maintain the 2-sided type I error at 0.05 for

the primary and key secondary endpoints.

Important baseline characteristics such as time from cluster onset before randomization, the historical

length of cluster periods, and historical number of cluster headache attacks per day were not collected in

pivotal Study CGAL. More patients in the EMGALITY treatment group had attacks in last 7 days prior to

screening (visit 1) than in the placebo treatment group. No differences between the treatment groups

have been observed in pain severity, attack duration, use of acute medication through week 1 to 8. The

statistical significance for the primary and gated secondary endpoints was observed only up to week 3.

When interpreting the efficacy results of the trial, these observations should be taken into consideration.

14

NON-CLINICAL TOXICOLOGY

General Toxicology

EMGALITY

®

Product Monograph

Page 25 of 51

Galcanezumab was well tolerated in cynomolgus monkeys and Sprague Dawley rats at weekly

subcutaneous doses of up to 100 mg/kg and 20 mg/kg (72 and 3.7 times greater than the

human exposure at the 300 mg once monthly dose based on AUC), respectively, for up to

6 months. There was no evidence of galcanezumab-related systemic toxicity in cynomolgus

monkeys; however, in rats, two male deaths were observed at a dose of 250 mg/kg (8.7 times

greater than the human exposure at 300 mg once monthly dose based on AUC) for which a

drug-related effect could not be ruled out. In both rats and monkeys, galcanezumab-related non-

adverse macroscopic and microscopic changes were limited to the injection sites and were

consistent with inflammation. There were no galcanezumab-related effects on cardiovascular,

respiratory, or central nervous systems as assessed in cynomolgus monkeys.

Carcinogenesis

Non-clinical studies have not been conducted to evaluate the carcinogenic potential of

galcanezumab.

Genotoxicity

Non-clinical studies have not been conducted to evaluate the genotoxic potential of

galcanezumab.

Reproductive and Developmental Toxicity

Male fertility and female fertility were assessed in separate studies in Sprague Dawley rats. In

the male fertility study, males were administered subcutaneous doses up to 250 mg/kg once

weekly prior to and during mating. In combined female fertility and embryo-fetal development

studies, females were administered subcutaneous doses up to 250 mg/kg once every three

days prior to and during mating and continuing throughout organogenesis. No galcanezumab-

related adverse effects on male or female fertility parameters, including adverse effects on

reproductive organs, estrous cycle, sperm motility and concentration, and mating and fertility

indices, were observed at a dose of 250 mg/kg (3.6 and 18 times greater than the human

exposure at the 300 mg once monthly dose based on AUC in males and females, respectively).

No galcanezumab-related malformations or embryo-fetal toxicity were observed in the combined

female fertility and embryo-fetal development studies conducted in Sprague Dawley rats at

maternal doses up to 250 mg/kg or in an embryo-fetal development study conducted in New

Zealand White Rabbits at maternal doses up to 100 mg/kg administered on gestation day 7, 12,

16, and 20. Exposures (AUC) were 18 and 29 times higher than the human exposure at the

300 mg once monthly dose in rats and rabbits, respectively. While galcanezumab-related

increases in the number of fetuses and litters with skeletal variations, consisting of short ribs

and a decrease in the mean number of ossified caudal vertebrae, occurred at 250 mg/kg in the

rat embryo-fetal development study, these deviations were considered non-adverse.

In a pre- and post-natal development study conducted in Sprague Dawley rats, there were no

effects on survival, growth, sexual maturation, behaviour or reproduction in offspring exposed to

galcanezumab in utero and through lactation at maternal doses up to 250 mg/kg administered

once every three days (16 times greater than the human exposure at the 300 mg once monthly

dose based on AUC).

Juvenile Toxicity

EMGALITY

®

Product Monograph

Page 26 of 51

In a juvenile toxicology study, Sprague Dawley rats were administered galcanezumab at doses

of 30 and 250 mg/kg twice weekly from Postnatal Day 21 through 90. There were no

galcanezumab-related adverse effects on survival, clinical observations, body weight, food

consumption, sexual maturation, behavioral assessments, reproduction, bone length, clinical

pathology and histopathology. Decreases in metaphysis total bone mineral content associated

with decreases in trabecular bone mineral content and bone mineral density occurred at

250 mg/kg. In males only, decreases in metaphysis and diaphysis total surface area and

diaphysis periosteal circumference were also observed at 250 mg/kg. No galcanezumab-related

findings were observed upon histopathological examination of bone.

Galcanezumab-related microscopic changes were limited to the injection sites and consisted of

an increased incidence and severity of mononuclear inflammatory cell infiltrates in the

subcutaneous tissue at the administration site in males and females given 30 and 250 mg/kg.

Minimal to mild increases in fibrinogen and minimal increases in globulins occurred in males at

250 mg/kg and in females at 30 and 250 mg/kg. These changes were supportive of a minimal to

mild inflammatory process and correlated with the injection site histopathology findings. At the

end of the recovery period, the incidence of the injection site histopathology findings as well as

the correlating clinical pathology changes were decreased, suggesting partial recovery.

EMGALITY

®

Product Monograph

Page 27 of 51

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

PATIENT MEDICATION INFORMATION

Pr

EMGALITY

®

(pronounced em-GAL-it-ē)

galcanezumab injection

_____________________________________________________________________

www.lilly.ca

Lilly

Read this carefully before you start taking EMGALITY and each time you get a refill. This leaflet

is a summary and will not tell you everything about this drug. Talk to your healthcare

professional about your medical condition and treatment and ask if there is any new information

about EMGALITY.

What is EMGALITY used for?

EMGALITY is a medicine used in adults:

to prevent migraine in patients who have at least 4 migraine days per month

to reduce the number of attacks throughout a cluster period in patients with episodic cluster

headache

How does EMGALITY work?

EMGALITY contains the active substance galcanezumab, which belongs to a group of

substances called monoclonal antibodies. Galcanezumab binds to a protein called calcitonin

gene-related peptide (CGRP). Increased CGRP levels in the blood have been linked to migraine

and episodic cluster headache.

What are the ingredients in EMGALITY?

Medicinal ingredients: galcanezumab

Non-medicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80,

sodium chloride, water for injection

EMGALITY comes in the following dosage forms:

120 mg solution for injection in a 1 mL prefilled syringe for migraine

120 mg solution for injection in a 1 mL prefilled pen for migraine

100 mg solution for injection in a 1 mL prefilled syringe for episodic cluster headache

Do not use EMGALITY if:

You have an allergy to galcanezumab or any of the other ingredients of this medicine

(see What are the ingredients in EMGALITY? above).

To help avoid side effects and ensure proper use, talk to your healthcare professional

before you take EMGALITY. Talk about any health conditions or problems you may have,

including if you:

have had an allergic reaction to EMGALITY.

have any chronic medical disease or need to take medication regularly.

Other warnings you should know about:

Allergic reactions with EMGALITY are usually mild to moderate (such as rash or itching).

Rarely patients taking EMGALITY have experienced a serious allergic reaction and the signs

EMGALITY

®

Product Monograph

Page 28 of 51

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.

If you experience any of the signs of a serious allergic reaction, stop taking EMGALITY

immediately and contact your healthcare professional immediately.

Reactions may occur within minutes but may occur up to one month after taking EMGALITY.

Tell your healthcare professional if you are pregnant, think you are pregnant, or are planning

to have a baby while receiving this medicine.

Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not

known whether EMGALITY passes into breast milk.

EMGALITY should not be given to patients under the age of 18 years.

How to take EMGALITY:

See the detailed Instructions for Use that comes with this Patient Medication

Information for instructions about the right way to give yourself EMGALITY injections

EMGALITY is given as an injection under the skin (subcutaneous injection).

EMGALITY comes as a single-use (1 time) prefilled syringe or pen.

If your healthcare professional decides that you or your caregiver can give the injections of

EMGALITY, you or your caregiver should receive training on the right way to inject

EMGALITY. Do not try to inject EMGALITY until you have been shown the right way to give

the injections by a healthcare professional.

Your healthcare professional may help you decide where on your body to inject your dose.

You can also read the “Choose your injection site” section of the Instructions for Use to

help you choose which area can work best for you.

If you have vision problems, do not use EMGALITY prefilled syringe or pen without help

from a caregiver.

Usual dose:

For migraine: The recommended dose of EMGALITY is a first dose of 240 mg (2 injections of

the 120 mg/mL strength) followed by 120 mg (1 injection of the 120 mg/mL strength) every

month thereafter.

EMGALITY is not intended for the acute treatment of migraine; patients should not exceed the

monthly dose prescribed by the healthcare professional.

For episodic cluster headache: The recommended dose of EMGALITY is 300 mg (3 injections

of the 100 mg/mL strength) at the start of a cluster period. After 3 weeks your healthcare

provider will decide if you should continue treatment. If you continue treatment, EMGALITY

300 mg should not be administered more than once every month during a cluster period.

EMGALITY is not intended for the acute treatment of individual cluster headache attacks;

patients should not exceed the monthly dose prescribed by the healthcare professional.

EMGALITY should not be used after the end of a cluster period and during the remission time.

Overdose:

EMGALITY

®

Product Monograph

Page 29 of 51

If you think you have taken too much EMGALITY, contact your healthcare professional, hospital

emergency department or regional poison control centre immediately, even if there are no

symptoms.

Missed Dose:

For migraine: If you miss a dose take your dose as soon as you can. Thereafter resume

monthly dosing.

For episodic cluster headache: If you take a partial dose (only 1 or 2 of the three prefilled

syringes), take the missed injection(s) as soon as you can. If your healthcare provider

determines that you should continue treatment, take the next complete dose one month from

the date you took the missed injection(s).

What are possible side effects from using EMGALITY?

These are not all the possible side effects you may feel when taking EMGALITY. If you

experience any side effects not listed here, contact your healthcare professional.

Very Common (≥ 1 in 10):

injection site itching, redness, or swelling

injection site pain

injection site bruising

injection site hardness

Common (≥ 1 in 100 and < 1 in 10)

constipation

dizziness

itching

rash

Uncommon (≥ 1 in 1000 and < 1 in 100):

hives

Rare (≥ 1 in 10,000 and < 1 in 1000)

serious allergic reaction

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough

to interfere with your daily activities, talk to your healthcare professional.

EMGALITY

®

Product Monograph

Page 30 of 51

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to

Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-

mps/medeff/report-declaration/index-eng.php) for information on how to report online,

by mail or by fax; or

Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your

side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store EMGALITY in a refrigerator at 2°C to 8°C until time of use. Keep the syringe or pen in the

carton in order to protect from light.

If needed, EMGALITY may be left out of the refrigerator at a temperature up to 30°C for up to

7 days. EMGALITY should be discarded if not used within this 7-day period.

Do not freeze or shake the syringe or pen.

Keep out of reach and sight of children.

If you want more information about EMGALITY:

Talk to your healthcare professional

Find the full product monograph that is prepared for healthcare professionals and

includes this Patient Medication Information by visiting the Health Canada website; the

manufacturer’s website www.lilly.ca, or by calling 1-888-545-5972.

Instructions for Use can be found on www.lilly.ca

The information in this document is current as of the last revision date shown below. For the

most current information please visit our website or contact us directly.

EMGALITY is a registered trademark owned by or licensed to Eli Lilly and Company, its

subsidiaries or affiliates.

You may need to read this package insert again.

Please do not throw it away until you have finished your medicine.

This leaflet was prepared by Eli Lilly Canada, Inc.

Last Revised September 11, 2020

A3.0-EMG-NL0002-CA-PM-YYYYMMDD

EMGALITY

®

Product Monograph

Page 31 of 51

INSTRUCTIONS FOR USE

Pr

EMGALITY

®

(em-GAL-it-ē)

galcanezumab injection

120 mg/mL solution for subcutaneous use

prefilled syringe

www.lilly.ca

This Instructions for Use is for patients with migraine.

If you are using EMGALITY for episodic cluster headache, there is a

different Instructions for Use because the dose and number of syringes

needed is different.

For subcutaneous injection only.

Before you use the EMGALITY prefilled syringe, read and carefully follow all

the step-by-step instructions.

Important Information

Your healthcare professional should show you how to prepare and inject

EMGALITY using the prefilled syringe. Do not inject yourself or someone else

until you have been shown how to inject EMGALITY.

Keep this Instructions for Use and refer to it as needed.

Each EMGALITY prefilled syringe is for one-time use only. Do not share or

reuse your EMGALITY prefilled syringe. You may give or get an infection.

Your healthcare professional may 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 prefilled syringe without

help from a caregiver.

EMGALITY

®

Product Monograph

Page 32 of 51

INSTRUCTIONS FOR USE

Before you use the EMGALITY prefilled syringe, read and carefully follow all the

step-by-step instructions.

Parts of the EMGALITY Prefilled Syringe

Thumb Pad

Teal Plunger

Rod

Finger

Grips

Syringe

Body with

Medicine

Grey Syringe

Plunger

Needle Cap

Needle

EMGALITY

®

Product Monograph

Page 33 of 51

Before You Get Started

Take the Prefilled 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.

For a more comfortable injection, leave the

prefilled syringe at room temperature for

30 minutes before injecting.

Do not microwave the prefilled syringe, run hot

water over it, or leave it in direct sunlight.

Do not shake.

Gather Supplies

For each injection you will need:

1 alcohol wipe

1 cotton ball or piece of gauze

1 sharps disposal container. See “After

You Inject Your Medicine.

Inspect the Prefilled Syringe

and the medicine

Make sure you have the right medicine. The

medicine inside should be clear. Its colour may

be colourless to slightly yellow.

Do not use the prefilled syringe, and dispose of

as directed by your healthcare professional or

pharmacist if:

it looks damaged

the medicine is cloudy, is discoloured, 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 healthcare professional can help you

choose the injection site that is best for you.

Expiration Date

EMGALITY

®

Product Monograph

Page 34 of 51

1

Uncap

Leave the needle cap on

until you are ready to

inject.

Pull the needle cap off and

throw it away in your

household trash.

Do not put the needle cap

back on – you could

damage the needle or stick

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

You may inject the medicine into your

stomach area (abdomen) or thigh. Do not

inject within 2 inches of the belly button

(navel).

Another person may give you the

injection in the back of your upper arm or

buttocks.

Do not inject in the exact same spot. For

example, if your first injection was in your

abdomen, your next injection could be in

another area of your abdomen.

Clean the injection site with an alcohol

wipe. Let the injection site dry before

you inject.

Back of arm

Abdomen

Buttock

Thigh

EMGALITY

®

Product Monograph

Page 35 of 51

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 the needle 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.

If you have bleeding at the

injection site, press a cotton

ball or gauze over the

injection site. Do not rub the

injection site.

Teal plunger rod

Grey syringe

plunger

Do not put the

needle cap back on the

prefilled syringe.

After You Inject Your Medicine

Throw away the used prefilled syringe

EMGALITY

®

Product Monograph

Page 36 of 51

Put the used EMGALITY prefilled

syringe in a sharps disposal

container right away after use. Do

not throw away (dispose of) the

EMGALITY prefilled syringe in

your household trash.

If you do not have a sharps disposal container, you may use a household

container that is:

– made of a heavy-duty plastic,

– can be closed with a tight-fitting, puncture-resistant lid, without sharps being

able to come out,

– upright and stable during use,

– leak-resistant, and

– properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow

your community guidelines for the right way to dispose of your sharps disposal

container. There may be provincial or local laws about how you should throw

away needles and syringes. For more information about the proper way to

dispose of the container contact your healthcare professional.

Do not recycle your used sharps disposal container.

Commonly Asked Questions

Q.

What if I see air bubbles in my EMGALITY prefilled syringe?

A.

It is normal to have air bubbles in the prefilled 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.

How can I tell if my injection is complete?

EMGALITY

®

Product Monograph

Page 37 of 51

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 the needle end of

the syringe.

If you have more questions about how to use the EMGALITY prefilled syringe:

Call your healthcare professional

Call 1-888-545-5972

Visit www.lilly.ca

Storage and Handling

Store your prefilled syringe in the refrigerator between 2ºC to 8ºC.

Your prefilled syringe may be stored unrefrigerated for up to 7 days. Do not store

above 30°C.

Do not freeze your prefilled syringe.

Protect your prefilled syringe from light until use.

Do not shake your prefilled syringe.

Discard your prefilled syringe if any of the above conditions are not followed.

Keep your prefilled syringe and all medicines out of the reach of children.

Read the Patient Medication Information for EMGALITY inside this box to learn

more about your medicine.

Eli Lilly Canada Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

EMGALITY is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries or

affiliates.

Copyright © 2019, YYYY, Eli Lilly and Company. All rights reserved.

Document Revision Date: September 11, 2020

A 3.0-EMG-120MG-PFS-NL0002-CA-IFU-YYYYMMDD

EMGALITY

®

Product Monograph

Page 38 of 51

INSTRUCTIONS FOR USE

Pr

EMGALITY

®

(em-GAL-it-ē)

galcanezumab injection

120 mg/mL solution for subcutaneous use

prefilled pen

www.lilly.ca

This Instructions for Use is for patients with migraine.

For subcutaneous injection only.

Before you use the EMGALITY prefilled pen (Pen), read and carefully follow all

the step-by-step instructions.

Important Information

Your healthcare professional 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 this Instructions for Use and refer to it as needed.

Each EMGALITY Pen is for one-time use only. Do not share or reuse your

EMGALITY Pen. 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 healthcare professional may 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 EMGALITY Pen without

help from a caregiver.

EMGALITY

®

Product Monograph

Page 39 of 51

INSTRUCTIONS FOR USE

Before you use the EMGALITY Pen, read and carefully follow all the step-by-

step instructions.

Parts of the EMGALITY Pen

Teal

Injection

Button

Lock Ring

Lock/Unlock

Symbols

Medicine

Clear Base

Bottom

Base Cap

EMGALITY

®

Product Monograph

Page 40 of 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.

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.

Do not shake.

Gather Supplies

For each injection you will need:

1 alcohol wipe

1 cotton ball or piece of gauze

1 sharps disposal container. See “After

You Inject Your Medicine.

Inspect the Pen and the

medicine

Make sure you have the right medicine. The

medicine inside should be clear. Its colour may be

colourless to slightly yellow.

Do not use the Pen, and dispose of as directed by

your healthcare professional or pharmacist if:

it looks damaged

the medicine is cloudy, is discoloured, 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 healthcare professional can help you choose

the injection site that is best for you.

Expiration Date

EMGALITY

®

Product Monograph

Page 41 of 51

1

Uncap the Pen

Make sure the Pen is

locked. Leave the base

cap on until you are ready

to inject.

Twist off the base cap and

throw it away in your

household trash.

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.

You may inject the medicine into your

stomach area (abdomen) or thigh. Do not

inject within 2 inches of the belly button

(navel).

Another person may give you the injection

in the back of your upper arm or buttocks.

Do not inject in the exact same spot. For

example, if your first injection was in your

abdomen, your next injection could be in

another area of your abdomen.

Clean the injection site with an alcohol

wipe. Let the injection site dry before

you inject.

Back of arm

Abdomen

Buttock

Thigh

EMGALITY

®

Product Monograph

Page 42 of 51

3

Press and Hold for 10

Seconds

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 10 seconds

after the first one. This

second click tells you that

your injection is complete.

Remove the Pen from your

skin.

If you have bleeding at the

injection site, press a cotton

ball or gauze over the

injection site. Do not rub the

injection site.

You will know

your injection

is complete

when the grey

plunger is

visible.

After You Inject Your Medicine

Throw away the used Pen

Put the used EMGALITY Pen in a

sharps disposal container right

away after use. Do not throw away

(dispose of) the EMGALITY Pen in

your household trash.

If you do not have a sharps disposal container, you may use a household

container that is:

– made of a heavy-duty plastic,

– can be closed with a tight-fitting, puncture-resistant lid, without sharps

being able to come out,

– upright and stable during use,

– leak-resistant, and

– properly labeled to warn of hazardous waste inside the container.

EMGALITY

®

Product Monograph

Page 43 of 51

When your sharps disposal container is almost full, you will need to follow your

community guidelines for the right way to dispose of your sharps disposal

container. There may be provincial or local laws about how you should throw

away needles and pens. For more information about the proper way to dispose

of the container contact your healthcare professional.

Do not recycle your used sharps disposal container.

Commonly Asked Questions

Q.

What if I see bubbles in the 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.

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 and contact 1-888-545-5972 for instructions on how to

return the Pen.

Q.

What if I heard 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.

If you have more questions about how to use the EMGALITY prefilled pen:

Call your healthcare professional

EMGALITY

®

Product Monograph

Page 44 of 51

Call 1-888-545-5972

Visit www.lilly.ca

Storage and Handling

Store your prefilled pen in the refrigerator between 2ºC to 8ºC.

Your prefilled pen may be stored unrefrigerated for up to 7 days. Do not store

above 30°C.

Do not freeze your prefilled pen.

Protect your prefilled pen from light until use.

Do not shake your prefilled pen.

Discard your prefilled pen if any of the above conditions are not followed.

Keep your prefilled pen and all medicines out of the reach of children.

The Pen meets the current dose accuracy and functional requirements of ISO 11608-

1 and 11608-5.

Read the Patient Medication Information for EMGALITY inside this box to learn

more about your medicine.

Eli Lilly Canada Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

EMGALITY is a registered trademark owned by or licensed to Eli Lilly and Company, its

subsidiaries or affiliates.

Copyright © 2019, YYYY, Eli Lilly and Company. All rights reserved.

Document revision date: September 08, 2020

A2.0-EMG-120MG-PEN-NL0002-CA-IFU-YYYYMMDD

EMGALITY

®

Product Monograph

Page 45 of 51

INSTRUCTIONS FOR USE

Pr

EMGALITY

®

(em-GAL-it-ē)

galcanezumab injection

100 mg/mL solution for subcutaneous use

prefilled syringe

www.lilly.ca

This Instructions for Use is for patients with episodic cluster headache.

If you are using EMGALITY for preventive treatment of migraine, there is a

different Instructions for Use because the dose and number of syringes

needed is different.

For subcutaneous injection only.

Before you use the EMGALITY prefilled syringe, read and carefully follow all the

step-by-step instructions.

Important Information

Your healthcare professional should show you how to prepare and inject

EMGALITY using the prefilled syringe. Do not inject yourself or someone else

until you have been shown how to inject EMGALITY.

Keep this Instructions for Use and refer to it as needed.

Each EMGALITY prefilled syringe is for one-time use only. Do not share or

reuse your EMGALITY prefilled syringe. You may give or get an infection.

Your healthcare professional may 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 prefilled syringe without

help from a caregiver.

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INSTRUCTIONS FOR USE

Before you use the EMGALITY prefilled syringe, read and carefully follow all the

step-by-step instructions.

Parts of the EMGALITY Prefilled Syringe

Thumb Pad

Coral

Plunger Rod

Finger

Grips

Syringe

Body with

Medicine

Grey Syringe

Plunger

Needle

Cap

Needle

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Before You Get Started

Take the Prefilled

Syringes from the

refrigerator

Take 3 EMGALITY prefilled syringes from the refrigerator.

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

For a more comfortable injection, leave the prefilled syringes

at room temperature for 30 minutes before injecting.

Do not microwave the prefilled syringe, run hot water over it,

or leave it in direct sunlight.

Do not shake.

Gather Supplies

For each injection you will need:

1 alcohol wipe

1 cotton ball or piece of gauze

1 sharps disposal container. See “After You Inject

Your Medicine.

Inspect the Prefilled

Syringe and the

medicine

Make sure you have the right medicine. The medicine inside

should be clear. Its colour may be colourless to slightly

yellow.

Do not use the prefilled syringe, and dispose of as directed

by your healthcare professional or pharmacist if:

it looks damaged

the medicine is cloudy, is discoloured, 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

Expiration Date

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1

Uncap

Leave the needle cap on

until you are ready to

inject.

Pull the needle cap off and

throw it away in your

household trash.

Do not put the needle cap

back on - you could damage

the needle or stick 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

Choose your injection site

Your healthcare professional 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 2 inches of the belly button

(navel).

Another person may give you the injection

in the back of your upper arm or buttocks.

Do not inject in the exact same spot. For

example, if your first injection was in your

abdomen, your next injection could be in

another area of your abdomen.

Clean the injection site with an alcohol

wipe. Let the injection site dry before you

inject.

Back of arm

Buttock

Thigh

Abdomen

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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 the

needle end of the syringe.

You should see the coral 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.

If you have bleeding at the

injection site, press a cotton ball

or gauze over the injection site.

Do not rub the injection site.

Do not put the needle cap back

on the prefilled syringe.

Coral plunger

Grey syringe

plunger

After You Inject Your Medicine

Throw away the used prefilled syringe

Put the used EMGALITY prefilled

syringe in a sharps disposal container

right away after use. Do not throw

away (dispose of) the EMGALITY

prefilled syringe in your household

trash.

If you do not have a sharps disposal container, you may use a household

container that is:

– made of a heavy-duty plastic,

– can be closed with a tight-fitting, puncture-resistant lid, without sharps being

able to come out,

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– upright and stable during use,

– leak-resistant, and

– properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your

community guidelines for the right way to dispose of your sharps disposal

container. There may be provincial or local laws about how you should throw

away needles and syringes. For more information about the proper way to

dispose of the container contact your healthcare professional.

Do not recycle your used sharps disposal container.

For each of the 3 injections, repeat all instructions with a new prefilled syringe.

Commonly Asked Questions

Q.

What if I see air bubbles in my EMGALITY prefilled syringe?

A.

It is normal to have air bubbles in the prefilled 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.

How can I tell if my injection is complete?

A.

When your injection is complete:

The coral plunger rod should show through the body of the syringe.

The grey syringe plunger should be pushed all the way to the needle end

of the syringe.

If you have more questions about how to use the EMGALITY prefilled syringe:

Call your healthcare professional

Call 1-888-545-5972

Visit www.lilly.ca

Storage and Handling

Store your prefilled syringe in the refrigerator between 2°C to 8°C.

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Your prefilled syringe may be stored unrefrigerated for up to 7 days. Do not store

above 30°C.

Do not freeze your prefilled syringe.

Protect your prefilled syringe from light until use.

Do not shake your prefilled syringe.

Discard your prefilled syringe if any of the above conditions are not followed.

Keep your prefilled syringe and all medicines out of the reach of children.

Read the Patient Medication Information for EMGALITY inside this box to learn

more about your medicine.

Eli Lilly Canada Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

EMGALITY is a registered trademark owned by or licensed to Eli Lilly and Company, its

subsidiaries or affiliates.

Copyright © YYYY, Eli Lilly and Company. All rights reserved.

Document Revision Date: September 11, 2020

A3.0-EMG-100MG-PFS-NL0000-CA-IFU-YYYYMMDD

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