Emgality®(Galcanezumab-Gnlm) | ®() |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | Dosage & Administration comparison data |
Administration | |
Subcutaneous. Learn more. | |
Dosing | |
Migraine: 240 mg loading dose (120 mg x 2) followed by 120 mg monthly. . Learn more. | |
Latin Shorthand | |
240 mg LD (120 mg x 2) then 120 mg/mo.. Learn more. | |
| Financial Assistance | Financial Assistance comparison data |
Out-Of-Pocket Costs With Copay Card | |
$0. Learn more. | |
Annual Cap | |
$4900. Learn more. | |
Assistance Expiration | |
12 months. Learn more. | |
Generics | |
No lower-cost generic available | No lower-cost generic available |
| Physician Advisory | Physician Advisory comparison data |
Adverse Reactions | |
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions. . Learn more. | |
Mechanism of Actions (MoA) | |
CGRP Antagonist. Learn more. | |
Special Populations | |
What is the Pregnancy Exposure Registry for EMGALITY? The Pregnancy Exposure Registry is a program that monitors pregnancy outcomes in women who have been exposed to EMGALITY during pregnancy. It is designed to collect information on any potential risks to the developing fetus. How can pregnant women enroll in the Pregnancy Exposure Registry? Pregnant women can enroll in the registry by calling 1-833-464-4724 or by contacting the company at www.migrainepregnancyregistry.com. What is the estimated risk of major birth defects and miscarriage in the general population and among women with migraine? The estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively, in the general population. 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. Are there any known risks associated with the use of EMGALITY during pregnancy? There are no adequate data on the developmental risk associated with the use of EMGALITY in pregnant women. However, animal studies have shown that 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. Can EMGALITY be used during lactation? There are no data on the presence of galcanezumab-gnlm in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EMGALITY and any potential adverse effects on the breastfed infant from EMGALITY or from the underlying maternal condition. Is EMGALITY safe for pediatric use? Safety and effectiveness in pediatric patients have not been established. Is there any difference in the response to EMGALITY in geriatric patients compared to younger patients? Clinical studies of EMGALITY did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. | |