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Sapropterin (By mouth)

Sapropterin (sap-roe-TER-in)

Lowers phenylalanine levels in the blood of patients with phenylketonuria (PKU). This medicine is usually given along with a special diet.

Brand Name(s):

Kuvan

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not use this medicine if you have had an allergic reaction to sapropterin.

How to Use This Medicine:

Dissolving Tablet

  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • Carefully follow your doctor's instructions about any special diet. It is important that you maintain a diet with restricted amounts of phenylalanine.
  • It is best to take this medicine with food or milk.
  • Mix the tablets in 4 to 8 ounces (1/2 to 1 cup) of water or apple juice before taking. It may take a few minutes for the tablets to dissolve. To make the tablets dissolve faster, you may stir or crush them. Drink this mixture within 15 minutes.

If a dose is missed:

  • Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are using levodopa (such as Dopar® or Larodopa®), methotrexate (such as Rheumatrex® or Trexall®), sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®).

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver problems, kidney problems, fever or any illness, an eating disorder (such as anorexia), or malnutrition.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Fever, cough, or sore throat.
  • Seizures.

If you notice these less serious side effects, talk with your doctor:

  • Bruising.
  • Diarrhea, nausea, vomiting, or stomach pain.
  • Headache.
  • Runny or stuffy nose.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 4/4/2014

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