EMGALITY

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).

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).

EMGALITY® Product Monograph Page 5 of 51 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 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.

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/mg2 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. 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.

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 EMGALITY® Product Monograph Page 9 of 51 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. 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.

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).

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.

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.