PROMACTA^® (eltrombopag) Pregnancy Registry

The PROMACTA Pregnancy Registry is an observational pregnancy exposure study conducted in the United States to detect and record adverse events in a mother exposed to PROMACTA during her pregnancy, and any adverse events observed in the neonate/infant through the first year of life.

Registration

The PROMACTA Pregnancy Registry requires registration of pregnancies exposed to PROMACTA. To reduce possible bias in reporting, enrollment into the Registry as early in pregnancy as possible, and before any prenatal testing for congenital anomalies, is strongly urged. Ongoing pregnancies may also be registered where exposure to PROMACTA has already occurred.

Contact Information

Patients can be registered into the PROMACTA Pregnancy Registry by using the following information:

Additional Information

The PROMACTA Pregnancy Registry requires that the patient must provide informed consent for participation in this registry. Measures are in place to protect patient confidentiality.

• After the informed consent is provided, the PROMACTA Pregnancy Registry provides the Pregnancy Initial Notification Form to the healthcare provider to report initial information about the pregnancy.
• Around the patient's estimated date of delivery, the Pregnancy Outcome Form is sent to the registering healthcare provider to report on the pregnancy course and outcome.
• Within the first year of life of the neonate/infant, a One Year Follow Up Form is sent to the child's healthcare provider to report on any adverse events.

Forms

Healthcare providers of the pregnant patient and the neonate/child will be responsible for providing information requested on the following forms:

• Pregnancy Initial Notification Form
• Pregnancy Outcome Form
• One Year Follow Up Form

For more information, please refer to the US Prescribing Information Section 8 USE IN SPECIFIC POPULATIONS - Section 8.1 Pregnancy.