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sapropterin

Pronunciation: SAP roe TER in

Brand: Kuvan

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is sapropterin?

Sapropterin is a synthetic form of a natural substance that activates an enzyme needed to break down phenylalanine in the body.

Phenylketonuria (PKU) is a disorder in which the body cannot break down phenylalanine. Elevated phenylalanine levels can cause problems with thinking and behavior.

Sapropterin is used to lower blood levels of phenylalanine in people with a certain type of PKU.

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

What should I discuss with my health care provider before taking sapropterin?

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You should not use sapropterin if you are allergic to it.

To make sure sapropterin is safe for you, tell your doctor if you have:

  • liver or kidney disease;
  • a fever or loss of appetite;
  • a history of stomach ulcer or bleeding;
  • epilepsy or other seizure disorder;
  • if you are malnourished;
  • if you take levodopa or methotrexate; or
  • if you take sildenafil (Viagra) or other erectile dysfunction medicines (Cialis, Levitra, Stendra).
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FDA pregnancy category C. It is not known whether sapropterin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of sapropterin on the baby.

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It is not known whether sapropterin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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Sapropterin should not be given to a child younger than 4 years old without a doctor's advice.

How should I take sapropterin?

Sapropterin is usually given once daily. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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Sapropterin works best if you take it with food.

You may swallow the tablet whole or dissolve it in 4 to 8 ounces of water or apple juice.

  • It will take a few minutes for the tablet to dissolve, and you may see small pieces in the liquid. These pieces are safe for you to swallow.
  • Stir the mixture and then drink all of it within 15 minutes after the tablet dissolves.
  • To get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Sapropterin can reduce your phenylalanine blood levels within 24 hours of when you take it. However, it may take up to 30 days of using this medicine before it reaches its fullest effect in your body. For best results, keep using the medication as directed.

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

While using sapropterin, you may need frequent blood tests.

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Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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Do not take 2 doses on the same day.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking sapropterin?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of sapropterin?

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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.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives, rash; wheezing, cough, difficult breathing; nausea, feeling light-headed; flushing (warmth, redness, or tingly feeling); swelling of your face, lips, tongue, or throat.

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Call your doctor at once if you have:

  • severe stomach discomfort;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • hyperactive behavior;
  • seizure (convulsions); or
  • chest pain or pressure, pain spreading to your jaw or shoulder.

Common side effects may include:

  • headache, dizziness;
  • feeling agitated or irritable;
  • nausea, vomiting, stomach pain, diarrhea;
  • swelling in your hands or feet;
  • joint pain;
  • increased urination; or
  • cold symptoms such as runny or stuffy nose, sneezing, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sapropterin?

Other drugs may interact with sapropterin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about sapropterin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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