HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
EMGALITY safely and effectively. See full prescribing information
for EMGALITY.
EMGALITY(galcanezumab-gnlm)injection, for subcutaneous use
Initial U.S. Approval: 2018
--------------------------------INDICATIONS AND USAGE-------------------------------
EMGALITY™ is a calcitonin-gene related peptide antagonist indicatedfor the preventive treatment of migraine in adults. (1)
---------------------------DOSAGE AND ADMINISTRATION--------------------------
•For subcutaneous use only. (2.1, 2.2)
•Recommended dosage: 240 mg loading dose (administered as twoconsecutive injections of 120 mg each), followed by monthly dosesof 120 mg. (2.1)
•Administer in the abdomen, thigh, back of the upper arm, orbuttocks subcutaneously. (2.2)
-------------------------DOSAGE FORMS AND STRENGTHS -----------------------
•Injection: 120 mg/mL solution in a single-dose prefilled pen (3)
•Injection: 120 mg/mL solution in a single-dose prefilled syringe (3)
----------------------------------- CONTRAINDICATIONS ----------------------------------
EMGALITY is contraindicated in patients with serious hypersensitivityto galcanezumab-gnlm or to any of the excipients. (4)
--------------------------- WARNINGS AND PRECAUTIONS --------------------------
Hypersensitivity Reactions: If a serious hypersensitivity reactionoccurs, discontinue administration of EMGALITY and initiateappropriate therapy. Hypersensitivity reactions could occur days afteradministration, and may be prolonged. (5.1)
-----------------------------------ADVERSE REACTIONS----------------------------------
The most common adverse reactions (incidence ≥2% and at least 2%greater than placebo) in EMGALITY clinical studies were injection sitereactions. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lillyand Company at 1-800-LillyRx (1-800-545-5979) or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved
patient labeling.
Revised: 9/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Important Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information
are not listed.
Reference ID: 4326715
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE