Sapropterin (By mouth)

Introduction:

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

When This Medicine Should Not Be Used:

How to Use This Medicine:

Dissolving Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• 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:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use 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 leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and 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 need to check your blood at regular visits while you are using this medicine. Be sure to 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: