Do you have patients who have tried Rezdiffra™ (resmetirom) at any time while pregnant and/or breastfeeding?
If your patient took Rezdiffra™ (resmetirom) while pregnant and/or lactating, they may be eligible to participate in the Rezdiffra™ Pregnancy and Lactation Registry.
Talk to your patients about the Rezdiffra™ Pregnancy and Lactation Registry.
Help them enroll in this registry online.
The purpose of the Rezdiffra™ Pregnancy and Lactation Registry is to create a worldwide information source. The Rezdiffra™ Pregnancy and Lactation Registry will collect information about the safety of Rezdiffra™ (resmetirom) (an approved medication) during pregnancy and/or while breastfeeding. This will help doctors and other healthcare providers learn more about its effect on pregnant and breastfeeding individuals. By registering and providing information about pregnancy and breastfeeding outcomes, your patients could help individuals in the future make informed decisions when they become pregnant so that taking Rezdiffra can continue without harming the pregnancy or the developing baby.
Find out if your patients prequalify by answering a few questions.
Resmetirom (Rezdiffra™) is developed by Madrigal Pharmaceuticals, Inc. There are no data on its use in pregnant or lactating women to assess the risk of major birth defects, miscarriage, or adverse maternal/fetal outcomes. Therefore, we believe your pregnant or lactating patients may be interested in enrolling in the Rezdiffra™ Pregnancy and Lactation Registry.
- No study visits involved; they can participate from the comfort of their homes.
- They could help doctors and other healthcare providers learn more about the effects of Rezdiffra™ (resmetirom) on individuals during pregnancy or while breastfeeding.
- They may receive financial compensation for their time spent participating in this registry.
Your patients should be made aware that there are a few requirements to qualify for the Rezdiffra™ Pregnancy and Lactation Registry. Being pregnant, having been pregnant and/or breastfeeding while taking Rezdiffra™ (resmetirom) are the basic requirements for participating in the Rezdiffra™ Pregnancy and Lactation Registry.
Find out if your patients prequalify by answering a few questions.
We encourage you to have an informative discussion with your patient about the role of pregnancy and lactation registries. It is important for them to know that there are many medications to treat medical conditions that continue to provide benefit to individuals while pregnant, but the effects of those medications on the pregnancy and developing baby are not fully known. A registry is a type of research study designed to create a database (collection of information) that helps doctors and other healthcare providers better understand if a certain medication has any effect on the pregnancy, lactation, or the developing baby.
Pregnancy registry studies collect information on pregnancy and lactation, and depending on their design, may continue to ask patients about childbirth and the baby’s health during the newborn period and while breastfeeding. The ultimate purpose of a pregnancy registry is to help other individuals with the same condition and their doctors know what to expect while taking a certain medicine during pregnancy and/or breastfeeding so that the condition can still be treated while pregnant/breastfeeding.
No visits are needed to be part of the Rezdiffra™ Pregnancy and Lactation Registry. If your patient prequalifies (by answering the prescreener questions online), they will be contacted by a member of the registry team for further screening with additional questions about their pregnancy and the health of the baby. If they qualify and decide to take part, they will be asked to consent to participate in the registry over the phone. They can also be given a copy of the consent language to review prior to deciding to take part. Then, you and your patients will be given access to a web-based platform to take part in the registry and record information each trimester during pregnancy, at the end of the pregnancy, and every three months until the baby turns 1 year. Explain to your patients that the Rezdiffra™ Pregnancy and Lactation Registry mostly involves answering questions for the Rezdiffra™ Pregnancy and Lactation Registry website, providing information about:
- Treatment history
- Pregnancy
- Obstetrical/delivery complications
- Breastfeeding
- Infant’s date of birth
- Infant’s birth weight
- Infant’s health during the first year
Please go to the prescreener page to see if your patient qualifies.
Frequently asked questions (FAQs)
Inform your patient that taking part in this registry is entirely voluntary. It is up to your patient to decide whether to take part in the registry or not. If your patient decides to agree to take part, they will be asked to consent to participate in the registry over the phone. They can also receive a copy of the consent language via email to review prior to deciding to take part.
Your patient may opt out of participation at any time and stop participating without giving any reason even if she agreed earlier.
If your patient decides against taking part, your patient will not receive any penalties or any loss of benefits. Reassure your patient that you will continue to be the treating physician with the most appropriate therapy for her condition.
All information collected about your patient and her child during the registry will be kept strictly confidential.
By consenting to take part in the Rezdiffra™ Pregnancy and Lactation Registry, your patient agrees for the clinical research organization (CRO) to collect and process her (and her child’s) personal information and agrees for Madrigal Pharmaceuticals, Inc., who is the Sponsor for this registry, to use her and her child’s personal data for the registry to learn about
Rezdiffra™ (resmetirom) and to support future research and to improve science.
Please explain to your patient that providing her (and her child’s) personal data is needed to verify if she can take part and to include her in the registry. Refusal to give consent to process her and her child’s personal data will mean that she cannot join the registry.
Rezdiffra™ (resmetirom) is an approved medication. The Rezdiffra™ Pregnancy and Lactation Registry will collect information to determine the safety of Rezdiffra™ (resmetirom) during pregnancy and/or while breastfeeding. Knowing this information will potentially help individuals in the future make informed decisions when they become pregnant.
Participation in this registry is completely voluntary. Your patient’s decision to participate—or not participate—in this registry will have no effect on the medical care that they receive now or in the future. If your patient is eligible to choose to participate in the registry, they may withdraw from the registry at any time.
Your patient may receive financial compensation for their time spent as part of their participation in this registry. The specific amount and details of this compensation will be explained to your patient prior to their participation.
Your patient will first be asked some general questions (here) that help us see whether your patient meets the basic requirements of the registry. If your patient does meet these criteria, they will be contacted to see if they fit the specific qualifications for the registry.
Every registry must be reviewed, and is continually monitored, by an ethics and/or regulatory review committee to ensure the risks are as low as possible and do not outweigh any potential benefits to the registry participant. As a volunteer, your patient has the right to discontinue participation and leave the registry at any time, with no penalty or loss of benefits to which she is otherwise entitled.
Madrigal Pharmaceuticals, Inc. is the pharmaceutical company that manufactures Rezdiffra™ (resmetirom) and is responsible for conducting this registry.
