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What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Kuvan (saproterin dihydrochloride tablets) is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Kuvan (saproterin dihydrochloride tablets) is to be used in conjunction with a Phe-restricted diet.
Read the complete drug monograph for Kuvan »
Drug Description - Indications & Dosage - Side Effects & Drug Interactions - Warnings & Precautions - Contraindications - Medication Guide and More
What is Patient information?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
If sapropterin is not controlling your condition properly, you may have symptoms such as behavior changes, numbness or tingling, or problems with speech, vision, or balance. Call your doctor right away if you have any of these symptoms.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of the serious side effects below:
Read the complete patient information for Kuvan »
Possible Side Effects - Images - What Is - How Should I Take It - What If I Miss a Dose - What Should I Avoid and More
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Tips to keep it under control.