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HEALTHCARE PROFESSIONALS

What is the PROVIGIL Pregnancy Registry and why is it important?

Because no adequate and well-controlled studies of PROVIGIL in pregnant women have been conducted, Teva Pharmaceuticals has established the PROVIGIL Pregnancy Registry to evaluate maternal and infant pregnancy outcomes in women who have received PROVIGIL within 6 weeks prior to conception or at any time during pregnancy.

The PROVIGIL Pregnancy Registry is a US-based, prospective, observational study designed to collect clinically relevant human data to assist clinicians in treating and counseling patients who are pregnant or anticipating pregnancy.

PROVIGIL is designated by the US Food and Drug Administration as Pregnancy Category C and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The success of the PROVIGIL Pregnancy Registry depends on the continued participation of healthcare providers like you who will identify and enroll patients in the Registry and assist in the collection of follow-up information during pregnancy and postdelivery.

For more information about pregnancy registries, visit
http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm134844.htm.

What are the criteria for enrollment?

Enrollment in the Registry is entirely voluntary and may be initiated by healthcare providers or pregnant women themselves. Pregnant women who have taken at least one dose of PROVIGIL within 6 weeks prior to conception or at any time during pregnancy are eligible for enrollment. Patients must be willing and able to read and sign an informed consent document and to supply contact information for all healthcare providers involved in the care of their pregnancy and that of their infants. They must also be willing to be contacted periodically by Registry staff.

Because the conduct of the Registry depends on the ability of Registry staff to contact patients and healthcare providers, it is important that the Registry is informed of any changes in contact information throughout participation.

How do I enroll a patient in the Registry?

Healthcare providers are encouraged to contact the PROVIGIL Pregnancy Registry at
1-866-404-4106 to enroll patients as early in pregnancy as possible (preferably, before any prenatal testing has been performed). Retrospective information that is reported after the pregnancy outcome is known will also be accepted.

If a patient is eligible for participation, she will be asked to read and sign an informed consent document containing details about the Registry and requesting permission to collect personal health information from all healthcare providers involved in the care of her pregnancy and that of her infant.

After my patient is enrolled, what will my participation involve?

Healthcare providers will be asked to verify patient-reported health information or to provide health information directly via telephone interview or paper-based case report form on enrollment, at each trimester of pregnancy, within 2 months after delivery, and when the infant reaches 6 months and 1 year of age.

How can my patient enroll?

Pregnant women may enroll themselves directly in the PROVIGIL Pregnancy Registry by calling 1-866-404-4106. A representative will explain the Registry and determine the patient’s eligibility for participation.

If a patient is eligible for participation, she will be asked to read and sign an informed consent document containing details about the Registry and requesting permission to collect personal health information from all healthcare providers involved the care of her pregnancy and that of her infant.

After my patient enrolls, what will her participation involve?

Your patient may be asked to participate in brief telephone interviews to collect information about her health and that of her infant at each trimester of pregnancy, within 2 months after delivery, and when her infant reaches 6 months and 1 year of age. The information she provides, as well as any information obtained from her healthcare providers, will be held in strict confidence.

How will data be collected, analyzed, and reported?

No study site visits are required. Registry data received from patients and healthcare providers will be entered into the Registry database. A Registry Advisory Committee comprising specialists in neonatology, teratology, pediatrics, obstetrics/gynecology, and epidemiology will oversee Registry data, analysis, and presentation of results.

How long will the Registry be active?

Registry enrollment will continue until sufficient information has been collected to meet the Registry’s scientific objectives.

Whom can I contact for more information?

To speak to a Registry representative, contact the PROVIGIL Pregnancy Registry at
1-866-404-4106.

The PROVIGIL Pregnancy Registry
Phone: 1-866-404-4106
Fax: 610-738-6396