How should I store Kuvan?

Store Kuvan at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Kuvan tablets in the original bottle with the cap closed tightly.
Protect from moisture.
Keep Kuvan and all medicines out of the reach of children.

General information about the safe and effective use of Kuvan

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Kuvan for a condition for which it was not prescribed. Do not give Kuvan to other people, even if they have the same symptoms you have. It may harm them.

If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Kuvan that is written for health professionals. For more information, call BioMarin Patient and Physician Support (BPPS) at 1-866-906-6100.

What are the ingredients in Kuvan?

Active ingredient: sapropterin dihydrochloride.

Kuvan tablet inactive ingredients: ascorbic acid, crospovidone, dibasic calcium phosphate, D‑mannitol, riboflavin, and sodium stearyl fumarate.

Kuvan powder for oral solution inactive ingredients: ascorbic acid, D‑mannitol, potassium citrate, and sucralose.

This Patient Information has been approved by the U.S. Food and Drug Administration.

 
BioMarin Pharmaceutical Inc.

Novato, CA 94949

Revised: 07/2015

© BioMarin Pharmaceutical Inc. All rights reserved.

v5/2015

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INSTRUCTIONS FOR USE

Kuvan (COO-van)

(sapropterin dihydrochloride)

tablets

Kuvan (COO-van)

(sapropterin dihydrochloride)

powder for oral solution

Read this Instructions for Use before you start taking Kuvan and each time you refill your prescription. There may be new information. This information does not take the place of talking with your healthcare provider about your treatment. Talk to your doctor if you have any questions about the right dose of Kuvan to take or how to mix it.

Important information:

Kuvan comes as a tablet or in a packet containing powder.
Take Kuvan exactly as your doctor tells you. Your doctor should tell you how much Kuvan to take and when to take it. 
Your doctor may change your dose of Kuvan depending on how you respond to treatment, or based on your baby’s weight.
If your baby weighs 22 pounds or less, follow the section called “Instructions for giving Kuvan powder for oral solution (Kuvan 100 mg packets) to babies who weigh 22 pounds or less”.
Take Kuvan 1 time each day with a meal. It is best to take Kuvan at the same time each day.
Instructions for taking Kuvan tablets:

Kuvan tablets can be swallowed whole or dissolved in water or apple juice. You may also crush the tablets and mix in a small amount of soft food, such as apple sauce or pudding.

To dissolve Kuvan tablets:

Mix Kuvan tablets in 4 ounces to 8 ounces (½ cup to 1 cup) of water or apple juice. It may take a few minutes for the tablets to dissolve. To make the tablets dissolve faster, you can stir or crush them.
The tablets may not dissolve completely. You may see small pieces floating on top of the water or apple juice. This is normal and safe for you to swallow.
Drink within 15 minutes.
After drinking your medicine, if you still see small pieces of the tablet, add more water or apple