Helpful Downloads

KUVAN® (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution Tools

What Is KUVAN Flyer

What Is KUVAN Flyer

Learn how KUVAN can be a part of PKU treatment and see if KUVAN could be right for you.

How KUVAN Works Flyer

How KUVAN Works Flyer

Describes how KUVAN works within the body to help lower blood Phe levels.

How to Take KUVAN Tablets Flyer

How to Take KUVAN Tablets Flyer

A guide to taking KUVAN Tablets including things to keep in mind during your treatment with KUVAN.

How to Take KUVAN Powder Flyer

How to Take KUVAN Powder Flyer

See how easy it is to take your dose of KUVAN Powder in 3 simple steps.

KUVAN Powder FAQ Flyer

KUVAN Powder FAQ Flyer

Answers to some of the most frequently asked questions about the KUVAN Powder dosage form.

PKU Management Tools

ACMG Guidelines Summary Flyer

ACMG Guidelines Summary Flyer

A summary of the PKU guidelines recently released by a group of PKU experts – the American College of Medical Genetics and Genomics (ACMG).

Importance of Blood Phe Control Flyer

Importance of Blood Phe Control Flyer

Learn why it’s important for people with PKU to keep blood Phe levels within recommended ranges.

Collecting Your Blood at Home

Collecting Your Blood at Home

Learn how to prepare and perform your blood test in the comfort of your own home.

PKU and the Brain Educational Overview
PKU and the Brain Educational Overview
An interactive learning module that shows how high blood Phe can affect the brain.

PKU Diet Tools

Food Portion Size Chart

Food Portion Size Chart

A helpful tool for estimating food size portions to use in tracking your low-Phe diet.

Food Protein Content List

Food Protein Content List

See a list of the protein content in many common foods to help you maintain your low-Phe diet.

Low-Protein Sweets and Treats Flyer

Low-Protein Sweets and Treats Flyer

Tips to enjoy sweet treats while managing your low-Phe diet.

Low Protein Thanksgiving Tips

Low Protein Thanksgiving Tips

Get the nutrient breakdown on a traditional Thanksgiving meal.

Low Protein Holiday Flyer

Low Protein Holiday Flyer

Get the nutrient breakdown on a traditional Holiday meal.

Quick Poll
Which of the following best describes you?
Parent/caregiver of an infant with PKU
Parent/caregiver of a child with PKU
Teenager with PKU
Adult with PKU
Grandparent of a child with PKU
Know someone with PKU
Healthcare professional

Indication

KUVAN® (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution are approved to reduce blood Phe levels in people with a certain type of Phenylketonuria (PKU). KUVAN is to be used with a Phe-restricted diet.

Important Safety Information

It is not possible to know if KUVAN will work for you without a trial of the medicine.

Your doctor will check your blood Phe levels when you start taking KUVAN to see if the medicine is working.

Starting KUVAN does not eliminate the need for ongoing dietary management. Any change to your diet may impact your blood Phe level. Follow your doctor’s instructions carefully. Your doctor and dietitian will continue to monitor your diet and blood Phe levels throughout your treatment with KUVAN to make sure your blood Phe levels are not too high or too low. If you have a fever, or if you are sick, your Phe level may go up. Tell your doctor and dietitian as soon as possible so they can make any necessary changes to your treatment.

Children younger than 7 years old treated with KUVAN doses of 20 mg/kg per day are at an increased risk for low levels of blood Phe compared with children 7 years and older. Frequent blood monitoring is recommended in this population to ensure that blood Phe levels do not fall too low.

Tell your doctor if you have ever had liver or kidney problems, have poor nutrition or have a loss of appetite, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

KUVAN is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. KUVAN and other medicines may interact with each other. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal and dietary supplements.

If you forget to take your dose of KUVAN, take it as soon as you remember that day. Do not take 2 doses in a day. If you take too much KUVAN, call your doctor for advice.

The most common side effects reported when using KUVAN are headache, runny nose and nasal congestion, sore throat, diarrhea, vomiting, and cough. Additional adverse reactions reported in connection with worldwide marketing include sore throat, heartburn or pain in the esophagus, inflammation of the lining of the stomach, indigestion, stomach pain, and nausea. These are not all the possible side effects seen with KUVAN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KUVAN can cause serious side effects, including:

  • Severe allergic reactions. Stop taking KUVAN and get medical help right away if you develop any of these symptoms of a severe allergic reaction:
    • Wheezing or trouble breathing
    • Nausea
    • Flushing
    • Lightheadedness or fainting
    • Coughing
    • Rash
  • Inflammation of the lining of the stomach (gastritis). Gastritis can happen with KUVAN and may be severe. Call your doctor right away if you have any:
    • Severe upper stomach-area discomfort or pain
    • Blood in your vomit or stool
    • Nausea and vomiting
    • Black, tarry stools
  • Too much or constant activity (hyperactivity) can happen with KUVAN. Tell your doctor if you have any signs of hyperactivity, including fidgeting, moving around or talking too much.

For more information, call BioMarin RareConnectionsTM at 1-877-MY-KUVAN (1-877-695-8826). Please read the full Patient Information by clicking here.