Sapropterin Disease Interactions

During clinical studies with sapropterin, gastritis was reported as a serious adverse reaction. Monitor patients for signs and symptoms of gastritis during treatment, and use with caution in patients with a history of gastritis.

Patients with liver impairment have not been evaluated in clinical trials with sapropterin. Hepatic damage has been associated in patients with impaired phenylalanine metabolism. Caution and monitoring is advised in patients with liver impairment who are receiving treatment with sapropterin.

A 10-year sapropterin postmarketing-marketing safety surveillance program for a non-phenylketonuria indication, showed that a few patients with underlying neurological disorders experienced seizures, exacerbation of seizures, over-stimulation, and irritability especially when coadministered with levodopa. Patients with neurological disorders, especially those receiving levodopa should be monitored for changes in neurological status during treatment with sapropterin.

Patients with renal impairment have not been evaluated in sapropterin clinical trials. Monitor patients who have renal impairment carefully if receiving treatment with sapropterin.