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Javygtor is a prescription phenylalanine hydroxylase activator containing sapropterin dihydrochloride. It is indicated to reduce blood phenylalanine levels in adults and children age 1 month and older with hyperphenylalaninemia due to tetrahydrobiopterin-responsive phenylketonuria. Treatment is used with a phenylalanine-restricted diet.
read more about javygtor ...Sapropterin is a synthetic form of tetrahydrobiopterin, a cofactor for phenylalanine hydroxylase. In responsive patients, sapropterin increases residual enzyme activity, improves conversion of phenylalanine to tyrosine, and lowers blood phenylalanine concentrations.
Javygtor is used in patients age 1 month and older with BH4-responsive phenylketonuria. Response is determined by changes in blood phenylalanine after treatment begins. Patients who do not show a biochemical response after the labeled trial period discontinue treatment.
Children age 1 month through 6 years start at 10 mg per kg once daily. Patients age 7 and older start at 10 mg to 20 mg per kg once daily. After responsiveness is established, dosing can range from 5 mg to 20 mg per kg daily according to blood phenylalanine response. Javygtor is taken with a meal, preferably at the same time each day.
Serious concerns include hypersensitivity reactions such as anaphylaxis, upper gastrointestinal mucosal inflammation, and excessively low phenylalanine concentrations. Children younger than 7 receiving 20 mg per kg daily have an increased risk of low blood phenylalanine. Blood phenylalanine is monitored frequently during treatment.
Javygtor lowers blood phenylalanine in BH4-responsive phenylketonuria in patients age 1 month and older.
The recommended starting dose is 10 mg per kg once daily.
The recommended starting dose is 10 mg to 20 mg per kg once daily.
Yes. Current labeling directs continued dietary phenylalanine restriction during treatment.
Efficacy of Sapropterin Dihydrochloride in Increasing Phenylalanine Tolerance in Children With Phenylketonuria: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study. https://pubmed.ncbi.nlm.nih.gov/19261295/. Date Accessed October 6, 2026.
Efficacy of Sapropterin Dihydrochloride for Reduction of Phenylalanine Concentration in Patients With Phenylketonuria: A Phase III Randomised Placebo-Controlled Study. https://pubmed.ncbi.nlm.nih.gov/17693179/. Date Accessed October 6, 2026.
JAVYGTOR (Sapropterin Dihydrochloride) Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4. Date Accessed October 6, 2026.
Sapropterin Dihydrochloride for Phenylketonuria. https://pubmed.ncbi.nlm.nih.gov/25812600/. Date Accessed October 6, 2026.
Sapropterin: MedlinePlus Drug Information. https://www.medlineplus.gov/druginfo/meds/a608020.html. Date Accessed October 6, 2026.