KUVAN

Before taking this medicine

The label lists no formal contraindications. However, KUVAN is not recommended for anyone who has previously had anaphylaxis (a severe allergic reaction) to it. If anaphylaxis occurs, stop KUVAN and seek immediate medical care. Signs may include wheezing, difficulty breathing, coughing, low blood pressure, flushing, nausea or rash. Continue prescribed dietary protein and phenylalanine (Phe) restrictions. KUVAN requires caution and monitoring for: • Inflammation of the food pipe or stomach, which can lead to narrowing, ulcers or bleeding if untreated. • Blood Phe levels that become too low or remain too high. Regular blood tests and dietary management are needed to maintain Phe control and nutritional balance, especially in children. • Changes in neurological symptoms when taken with levodopa, including seizures, overstimulation or irritability. • Hyperactivity. Not everyone with phenylketonuria (PKU) responds to KUVAN. Response generally cannot be predicted by laboratory testing and must be assessed through a treatment trial. Safety and effectiveness have not been established in newborns. Clinical studies in people with PKU did not include adults aged 65 or older, so it is unknown whether they respond differently from younger people.