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Kuvan

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Kuvan Drug Center

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Kuvan Prescribing Information: Indications & Dosage

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 »

What is Patient information?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Kuvan Patient Information: Side Effects

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:

  • seizure (convulsions);
  • chest pain or heavy feeling, pain spreading to the arm ...

Read the complete patient information for Kuvan »

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.


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