Summary:
Have You Been Prescribed VYVGART® (efgartigimod alfa-fcab) and/or VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc)*?
argenx BV, the manufacturer of VYVGART® (efgartigimod alfa-fcab) and VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc), is conducting an observational pregnancy study to collect information and better understand any possible effects efgartigimod has on the outcomes of women treated with efgartigimod while pregnant and/or breastfeeding.
During the development of pharmaceutical products, pregnant women are typically excluded from clinical trials and therefore, limited information is available on the use of efgartigimod during pregnancy. Information obtained from this study may assist healthcare providers and future pregnant women in weighing the risks and benefits of being treated with efgartigimod during pregnancy and/or breastfeeding.
Who can participate in the Study?
- Women who were treated with efgartigimod during their pregnancy, or who became pregnant within 25 days after taking efgartigimod.
- Women who are being treated/have been treated with efgartigimod during breastfeeding.
- Women can participate in the study even if they were pregnant or breastfeeding in the past but met any of the above conditions at that time.
What will my participation involve once I am enrolled?
This is an observational study which means you will continue to receive medical care as decided by you and your healthcare provider(s). Your treatment and care will not change in any way because of your participation in this study.
Your participation in the study may last throughout your pregnancy and up to one year after your delivery date. You will be contacted once per trimester, at the estimated date of delivery, and when your baby is 3, 6, 9, and 12 months of age to provide basic information about your pregnancy and your infant’s health. At each timepoint you will be asked to confirm your contact information.
To learn more about the Vyvgart Pregnancy Observational Study visit https://clinicaltrials.gov/study/NCT06298565
*referred to as “efgartigimod” or “VYVGART” interchangeably throughout this site.