What is the TECFIDERA® (dimethyl fumarate) Pregnancy Exposure Registry?

TecGistry, the TECFIDERA Pregnancy Exposure Registry, is a global registry for women with MS who are pregnant and have taken TECFIDERA. The purpose of this pregnancy registry is to learn more about the health of pregnant women who are taking or have taken TECFIDERA and the health of their babies. This will be done by monitoring participants throughout their pregnancy, followed by monitoring the health of their babies until they are 12 months old.

In the future, other pregnant women who are exposed to TECFIDERA may have more information as a result of this registry about how their pregnancies and babies may or may not be affected.

Can I take part in this registry?

You may be able to take part in this registry if you are pregnant, have MS and:

  • have taken TECFIDERA at any time since your last menstrual period or
  • are currently taking TECFIDERA.

What will I have to do?

In order to take part in the registry, you will first be asked to give informed consent during a telephone interview with a registry representative. This means that you will receive information about the registry and what it will involve, have a chance to ask any questions, and decide if you want to take part.

If you decide to participate and give your informed consent, then a registry representative will:

  • collect some information about you and your pregnancy via telephone
  • call you once each trimester to ask if there have been any changes in your pregnancy, or any changes to your contact information
  • contact your obstetrician and neurologist after you join, when you are approximately 6–7 months pregnant, and about 4 weeks after your estimated delivery date to ask about any changes in your pregnancy, health, treatment since the last call, and details of your birth
  • contact your baby’s doctor when your baby is 1, 3, and 12 months old to ask about the health of your baby.

Following the contact you receive when you first enroll, you will be contacted for telephone interviews at the times shown on the diagram below.

Why and when will my doctors be contacted?

With your permission, a registry representative will contact the doctor caring for you during your pregnancy, the doctor who prescribed you TECFIDERA, and your baby’s doctor, in order to collect information about your MS, your general health during pregnancy, and your baby’s health. Following your enrollment, these doctors will be contacted at the times shown on the diagram below.

Contact with you and your doctors during the registry

 

contact-schedule

If you participate in the registry, you will not need to:

  • attend any extra doctor's visits
  • have any extra medical tests
  • take any additional medications.

What else will happen if I participate?

After you enroll in the registry, we will send you a welcome package by post. With your consent, we will also send you occasional emails and text messages. The texts and some of the emails will remind you about an upcoming telephone interview. The other emails will contain information about multiple sclerosis (MS), pregnancy, new babies, healthy living, and other topics that we hope you will find useful and enjoyable to read. You can choose to stop receiving these communications at any time.

Our Privacy Policy contains full details of our commitment to your privacy.

Our FAQs contain answers to many frequently asked questions.

For additional important safety information, please see full Prescribing Information and Patient Information. This is not intended to replace discussions with your doctor.