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For more information on fingolimod, please click here.
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About the Registry Enrollment for the study has ended
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 your pregnancy from voluntary participants.
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.
Who is eligible to participate?
You are eligible to participate in the registry if:
- you are currently pregnant and you have used fingolimod during pregnancy or up to 8 weeks before your last menstrual period
AND
- you are willing to allow your health care professional to provide medical information about you and your baby to the registry
What does participation involve?
This is an observational study, which means that there are no additional visits or tests outside of your usual medical care. Your participation does not affect your medical care. By participating in the registry you allow your health care professional(s) to provide Novartis, its affiliates and business partners with medical information about you and the health of your baby.
Enrollment for the study has ended
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