PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry

Inclusion Criteria

• •PKUDOS Registry
• •Patient has confirmed diagnosis of PKU with hyperphenylalaninemia documented by a Phenylalanine level of greater than or equal to 360 umol/L (6 mg/dL)
• •Patient has previously received Kuvan
• •Patient is currently receiving Kuvan
• •Patient intends to receive Kuvan therapy within 90 days of enrollment into the registry
• •The Patient is being followed at a PKUDOS participating center
• •Willing and able to provide written authorization or, if under the age of 18 years, provide written assent (if required) and written patient authorization by a parent or legal guardian
• •Willing to provide personal health information
• •Willing to enroll in (or are already enrolled in) PKUDOS
• •Agree to follow the standard of care for pregnant women with PKU in the United States (NIH, 200, NIH Consensus Statement)
• •Agree to be followed by a hospital or PKU clinic offering the standard of care for maternal PKU
• •Are within 10 weeks of their last menstrual period