What is the TEGSEDI-PRG Pregnancy Observational Study?

Akcea Therapeutics, Inc., the manufacturer of TEGSEDI® (inotersen), is conducting a study to monitor and collect information about women treated with TEGSEDI while pregnant. In addition, pregnant women with the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) who have not taken TEGSEDI are encouraged to join so that additional information can be collected that could help women and their healthcare providers make more informed decisions in the future. Pregnant women are typically excluded from clinical studies when new medicines are being tested and so the effects of those new medicines on the health of a baby are often not known. Information obtained from this study may help doctors and future pregnant women understand how their pregnancies and babies may or may not be affected by TEGSEDI.

This is an observational study which means your treatment or care will not change in any way as a result of your participation in this study. You will continue to receive care as decided by your doctor.

Who can participate in the Study?

Women who were treated with at least 1 dose of TEGSEDI during their pregnancy, or who became pregnant within 25 weeks of taking TEGSEDI


Women with a diagnosis of hATTR-PN during pregnancy who have not taken TEGSEDI during the pregnancy or within 25 weeks of conception

Why should I participate in this Study?

Your participation is voluntary but will provide important information that may eventually be used by healthcare providers and future patients when weighing the benefits and/or risks of taking TEGSEDI during pregnancy. The success of the study is dependent upon the participation of eligible patients and healthcare providers. There will be no change to the care you receive by your healthcare provider as this is an observational study. Information about your health collected while you are in the TEGSEDI-PRG Pregnancy Observational Study will be kept anonymous and any identifying information will not be used. Thank you for your time and consideration.

How can I enroll?

BY PHONE-Call the TEGSEDI-PRG Pregnancy Observational Study at 1-877-465-7510

ONLINE-"Click" on the link to Report a Pregnancy

By providing your contact information, you consent to a member of the Pregnancy Coordinating Center contacting you to confirm necessary information to complete the registration. You may also ask your healthcare provider to enroll you.

If you are eligible and would like to participate, you will be asked to provide verbal informed consent to acknowledge your understanding of the study and to provide your permission for your personal or infant's healthcare information to be collected. After consent is received, a study representative will contact your healthcare provider to confirm your personal health information.

What will be my participation once I am enrolled?

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 or your infant's health. At each time point, you will be asked to confirm your contact information.