About the Firdapse Pregnancy Registry for LEMS Patients
The Firdapse Pregnancy Registry was created to collect information about the safety of Firdapse — the only approved symptomatic treatment for people with Lambert-Eaton myasthenic syndrome (LEMS) — among pregnant patients and their babies.
Data from the registry will be provided to the U.S. Food and Drug Administration (FDA) so that other patients who become pregnant while on Firdapse can better understand the therapy’s effects on pregnancies. This information also may be helpful to you should you have any more children.
Firdapse was approved by the FDA to treat the symptoms of LEMS, a rare disorder that can affect people of any age, in patients ages 17 and older.
The following will provide information about the registry and the information it seeks to collect.
What is the Firdapse Pregnancy Registry?
A U.S.- and Canada-based patient registry, the Firdapse Pregnancy Registry is sponsored by Catalyst Pharmaceuticals, the therapy’s marketer in the United States.
It is only observational, meaning that the patients’ care will not change based on their involvement in the study.
Who can participate?
The registry is open to women with LEMS who were exposed to Firdapse during their pregnancy, having taken at least one dose. Notably, it also is open to women with LEMS who are pregnant but did not use Firdapse. This second group will serve as controls to see whether Firdapse increases the risk of pregnancy complications.
Your participation is entirely voluntary and there will be no change to the care you receive from your healthcare provider.
What are the registry’s goals?
Catalyst designed the registry in conjunction with the FDA to investigate the possible effects of Firdapse on the mother and her unborn baby. The information that the registry collects may be able to help physicians and women in the future to weigh the benefits and risks of taking Firdapse while pregnant.
What information will the pregnancy registry collect?
If you enroll in the registry, someone from the Pregnancy Coordinating Center (PCC) will contact you once per trimester during your pregnancy for updates. This representative also will contact you on your expected delivery date, and then when your child is 3, 6, 9, and 12 months old.
The PCC will collect data about any changes in the status of your pregnancy, any modifications in your use of Firdapse or other medications, and the results of any prenatal testing that you had.
Your obstetrician will be contacted for information from your 34-week prenatal appointment and again within two weeks of your expected delivery date. Finally, a PCC representative will contact your baby’s doctor about any changes in the infant’s health.
How will my personal information be kept safe?
As in most studies, the information that the registry collects is anonymous and there is no personal identifying information.
Last updated: Mar. 1, 2021
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