INDICATIONS AND USAGE
EMGALITY® is a calcitonin-gene related peptide antagonist indicated in adults for the:
· preventive treatment of migraine.
· treatment of episodic cluster headache.
DOSAGE AND ADMINISTRATION
· For subcutaneous use only.
· Migraine recommended dosage: 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg.
· Episodic cluster headache recommended dosage: 300 mg (administered as three consecutive injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period.
· Administer in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously.
DOSAGE FORMS AND STRENGTHS
· Injection: 120 mg/mL solution in a single-dose prefilled pen
· Injection: 120 mg/mL solution in a single-dose prefilled syringe
· Injection: 100 mg/mL solution in a single-dose prefilled syringe
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration, and may be prolonged.
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions.
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
PP-GZ-US-1385 10/2020 © Lilly USA, LLC 2020. All rights reserved.
Emgality® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
IMPORTANT SAFETY INFORMATION
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Warnings and Precautions
Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.
HCP ISI 10DEC2019