July 1, 2016
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Kuvan Patient Information Including Side Effects

Brand Names: Kuvan

Generic Name: sapropterin (Pronunciation: SAP roe TER in)

What is sapropterin (Kuvan)?

Sapropterin is a synthetic form of a natural salt that contributes to the function of a certain enzyme in the body. In people with a condition called phenylketonuria (PKU), this enzyme is lacking or missing in the body. Without the enzyme, phenylalanine levels can become elevated and cause a variety of neurologic symptoms.

Sapropterin is used to help the body activate the enzyme needed to control blood levels of phenylalanine. This medication is used in people with PKU.

Sapropterin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sapropterin (Kuvan)?

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 or shoulder, general ill feeling;
  • easy bruising or bleeding;
  • fever, chills, body aches, flu symptoms;
  • swelling in your hands or feet;
  • pain or burning when you urinate;
  • weakness or fainting;
  • black, bloody, or tarry stools; or
  • coughing up blood or vomit that looks like coffee grounds.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, diarrhea;
  • runny or stuffy nose, cough;
  • headache, feeling agitated;
  • dizziness; or
  • joint pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Kuvan (saproterin dihydrochloride tablets) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about sapropterin (Kuvan)?

Before using sapropterin, tell your doctor if you are allergic to any drugs, or if you have liver disease, a history of stomach ulcer or bleeding, or a seizure disorder.

Also tell your doctor about any medications you use, especially levodopa (Larodopa, Altamet, Parcopa, Sinemet), methotrexate (Rheumatrex, Trexall), or any medication to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra).

To be sure sapropterin is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Sapropterin is only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.

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 if you have any of these symptoms.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using sapropterin.

Side Effects Centers

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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