EMGALITY 120 MG

What is EMGALITY?

EMGALITY 120 MG contains GALCANEZUMAB : 120 MG. It is listed in the Health Canada Drug Product Database under DIN 02491087, held by ELI LILLY CANADA INC, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 02-Oct-2019. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is EMGALITY used for?

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.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

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. 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). 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. Administration Instructions: • Remove EMGALITY from the refrigerator. Allow EMGALITY to sit at room temperature for 30 minutes protected from direct sunlight. Do not warm by using a heat source. • Follow aseptic injection technique. • Inspect EMGALITY visually for particles or discolouration prior to administration. Do not use if cloudy, discoloured, or contains particles. • 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. Missed Dose: Migraine: Instruct patients to inject a missed dose as soon as possible. Thereafter, resume monthly dosing. Episodic Cluster Headache: 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).

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

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.

How is it supplied?

120 mg/mL solution in a 1 mL single-use prefilled syringe or pen for migraine. 100 mg/mL solution in a 1 mL single-use prefilled syringe for episodic cluster headache.

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.

Warnings and precautions

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. 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.

What can be used instead?

Other Canadian products sharing ATC code N02CD02 GALCANEZUMAB. 3 of 3 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies GALCANEZUMAB worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. GALCANEZUMAB appears in 13 registered pack listings across 9 markets, published on 8 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.