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|Dosage & Administration
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Mechanism of Actions (MoA)
Is QULIPTA safe to use during pregnancy?
There are no adequate data on the developmental risk associated with the use of QULIPTA in pregnant women. In animal studies, oral administration of atogepant during the period of organogenesis (rats and rabbits) or throughout pregnancy and lactation (rats) resulted in adverse developmental effects (decreased fetal and offspring body weight in rats; increased incidence of fetal structural variations in rabbits) at exposures greater than those used clinically. Women who are pregnant or planning to become pregnant should consult with their healthcare provider to determine the best treatment option for their migraine.
Is QULIPTA safe to use during lactation?
There are no data on the presence of atogepant in human milk, the effects of atogepant on the breastfed infant, or the effects of atogepant on milk production. In lactating rats, oral dosing with atogepant resulted in levels of atogepant in milk approximately 2-fold higher than that in maternal plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QULIPTA and any potential adverse effects on the breastfed infant from QULIPTA or from the underlying maternal condition.
Is QULIPTA safe to use in pediatric patients?
Safety and effectiveness in pediatric patients have not been established. QULIPTA is not recommended for use in pediatric patients.
Is QULIPTA safe to use in elderly patients?
Population pharmacokinetic modeling suggests no clinically significant pharmacokinetic differences between elderly and younger subjects. Clinical studies of QULIPTA did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Is QULIPTA safe to use in patients with hepatic impairment?
No dose adjustment of QULIPTA is recommended for patients with mild or moderate hepatic impairment. Avoid use of QULIPTA in patients with severe hepatic impairment.
Is QULIPTA safe to use in patients with renal impairment?
The renal route of elimination plays a minor role in the clearance of atogepant. No dose adjustment is recommended for patients with mild or moderate renal impairment.
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.
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