The Mylan-Fingolimod Pregnancy Registry is sponsored by Mylan Pharmaceuticals ULC to collect information from voluntary participants about the effect of Mylan-Fingolimod treatment during pregnancy or around conception.
This registry is an observational study that aims to enroll pregnant women who were exposed to at least one dose of Mylan-Fingolimod during pregnancy.
Innomar Strategies Inc. is managing the registry on behalf of the sponsor, Mylan. Staff from Innomar Strategies Inc. will contact the patient or her healthcare provider to collect information related to Mylan-Fingolimod exposure during pregnancy. Also the staff will collect data related to the outcome of the pregnancy and health of the baby.
If you are a physician treating a patient with Mylan-Fingolimod who has become pregnant, you are encouraged to enroll the patient into the registry. For more information, please click the "Physician" tab.
If you are a patient who has taken at least one dose of Mylan-Fingolimod around the time of conception or while pregnant, contact your healthcare provider to learn about the registry. To learn more, please click the "Patient" tab.
Fingolimod may be prescribed to pregnant women or those who are planning to get pregnant if the potential benefit justifies the potential risk to the fetus. Data regarding the safety of fingolimod during pregnancy are lacking. Based on animal studies, it is known that fingolimod and its metabolites are capable of crossing the placental barrier. Also, fingolimod can be excreted in the milk during lactation at least in animals. Whether, fingolimod poses similar safety risks in pregnant women, which may potentially affect the health of the baby, is not known. Therefore, Mylan is sponsoring this study (the Registry) to evaluate the effect of fingolimod on maternal pregnancy outcomes and the health of the baby when Mylan-Fingolimod is taken around the time of conception or during pregnancy.
The findings from this study will be instrumental in better understanding the safety profile of fingolimod. It will assist the prescribing physicians and the patients in informed decision-making regarding the use of Mylan-Fingolimod during pregnancy.
This Registry will enroll 50 pregnant women over 5 years, who are exposed to at least one dose of Mylan-Fingolimod during pregnancy. This Registry involves asking questions regarding pregnancy and its outcome in Mylan-Fingolimod exposed pregnant women. Data from the participants will be collected every trimester and at the time of delivery. Data about the baby will be collected at the time of birth and followed up to 1 year of age.
This is an observational study, which means that only observation will be noted; no drug administration or special tests on the mother or the baby are involved.
Participation in the registry is voluntary; and the patients may withdraw their consent at any time if they choose to do so.
Patient is eligible to participate in the registry if:
Eligible participants may contact their healthcare provider to get enrolled in the Registry. The healthcare provider will initiate the enrollment process. In order to complete the enrollment process, patients need to provide a written informed consent and an authorization to release medical information of herself and the baby.
Patients may also contact the Mylan-Fingolimod Pregnancy Registry directly to learn more about the registry by calling 1-888-246-5830, sending a fax to 1-833-677-0484 or sending an e-mail to MylanFPR@innomar-strategies.com.
If the patients have any questions, they may refer to patient frequently asked questions. Patients may also contact their Mylan-Fingolimod prescribing healthcare provider or the Mylan-Fingolimod Pregnancy Registry directly by calling 1-888-246-5830, sending a fax to 1-833-677-0484 or sending an e-mail to MylanFPR@innomar-strategies.com. To learn more about the drug, please visit Mylan.ca
