Clinical Information
Gen. Code and Des.
78997 galcanezumab-gnlm SUBCUT SYRINGE 120 MG/ML
GCN and Des.
40419 galcanezumab-gnlm SUBCUT SYRINGE 120 MG/ML
Strength
120MG
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
28321200 CALCITONIN GENE-RELATED PEPTIDE ANTAG.
Active Ingredients
17757 galcanezumab-gnlm
Inactive Ingredients
2551 polysorbates 9005645
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 indicated for 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 two consecutive injections of 120 mg each), followed by monthly doses of 120 mg. (2.1)
Administer in the abdomen, thigh, back of the upper arm, or buttocks 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 hypersensitivity to galcanezumab-gnlm or to any of the excipients. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy. Hypersensitivity reactions could occur days after administration, 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 site reactions. (6.1)
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.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 9/2018