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For more information on fingolimod, please click here.
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About the Registry
What is the GILENYA® (fingolimod) Pregnancy Registry?
The GILENYA Pregnancy Registry is an observational study that collects information from physicians or patients about the effect of fingolimod use shortly before and/or during pregnancy from voluntary participants.
IQVIA, a leading research provider for patient registries, will manage the registry on behalf of Novartis Pharmaceuticals Corporation and collect information related to fingolimod exposure during pregnancy and maternal, fetal and infant outcomes.
Why is this Registry important?
Based on findings from animal studies, fingolimod may cause fetal harm when administered to a pregnant woman. Data from prospective reports to the GILENYA Pregnancy Registry (GPR) are currently not sufficient to allow for an adequate assessment of the drug-associated risk for birth defects and miscarriage in humans.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their health care provider of a known or suspected pregnancy.
Because it takes approximately 2 months to eliminate fingolimod from the body, advise females of reproductive potential to use effective contraception to avoid pregnancy during and for 2 months after stopping fingolimod treatment.
The findings from the registry will be used to give health care professionals important information for treating and counseling patients who are pregnant or may become pregnant and are treated, or plan to be treated with fingolimod.
What is the Registry design?
The GILENYA Pregnancy Registry is a prospective observational study that aims to recruit 500 pregnant women into the registry and will collect and evaluate safety data on fingolimod exposure immediately before (up to 8 weeks before last menstrual period), during pregnancy and associated pregnancy outcomes to compare the maternal, fetal, and infant outcomes in the registry to the background frequency from reference populations.
IQVIA will provide you with more information on how patient data are being collected in the registry, as well as the procedure to follow in order to become involved. Physicians are encouraged to enroll pregnant patients as early in their pregnancy as possible or pregnant women may register themselves in the GILENYA Pregnancy Registry by calling 1-877-598-7237 or sending an e-mail to gpr@quintiles.com/gpr@IQVIA.com with the completed registration form.
Paternal exposure pregnancy cases will not be included.
The registry is voluntary and any pregnant woman exposed to fingolimod, as defined below, is eligible for enrollment. No compensation for participating in the registry will be provided.
Who is eligible to be enrolled?
Patient is eligible to participate in the registry if:
- patient is currently pregnant and has used fingolimod during pregnancy or up to 8 weeks before last menstrual period.
AND
- patient is willing to allow their health care professional to provide medical information about them and their baby to the registry
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How do I enroll a patient?
To enroll a patient in the registry, please complete the registration form.
You will be contacted and provided with all necessary information to be included in the registry.
You can complete the registration form using any of the following methods (select one):
1. Phone: 1-877-598-7237
2. Mail : download and send the registration form to the registry team in the US:
GILENYA Pregnancy Registry
IQVIA
2400 Ellis Rd.
Durham, NC 27703
USA
3. E-mail completed form to: gpr@quintiles.com/ gpr@IQVIA.com
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