Emgality

EMGALITY^® is a calcitonin-gene related peptide antagonist indicated in adults for the:

• preventive treatment of migraine.
• treatment of episodic cluster headache.

• 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.

EMGALITY is a sterile clear to opalescent, colorless to slightly yellow to slightly brown solution available as follows:

• Injection: 120 mg/mL in a single-dose prefilled pen
• Injection: 120 mg/mL in a single-dose prefilled syringe
• Injection: 100 mg/mL in a single-dose prefilled syringe

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EMGALITY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724 or by contacting the company at www.migrainepregnancyregistry.com.

There are no adequate data on the developmental risk associated with the use of EMGALITY in pregnant women. Administration of galcanezumab-gnlm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects on development

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. The estimated rate of major birth defects (2.2% - 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.